0A4F4F9BD490A749D5437F821CF06DF1
Supreme Decree No. 3 of 2010. Regulation of the National Control System of Pharmaceutical Products for Human Use
http://www.ispch.cl/ley20285/t_activa/marco_normativo/7c/ds_minsal_3_2010.pdf
http://leaux.net/URLS/ConvertAPI Text Files/33CE30B427997D56E2E413F4990BA69F.en.txt
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| Indicators in focus are typically shown highlighted in yellow; |
Peer Indicators (that share the same Vulnerability association) are shown highlighted in pink; |
"Outside" Indicators (those that do NOT share the same Vulnerability association) are shown highlighted in green; |
Trigger Words/Phrases are shown highlighted in gray. |
Link to Orphaned Trigger Words (Appendix (Indicator List, Indicator Peers, Trigger Words, Type/Vulnerability/Indicator Overlay)
Applicable Type / Vulnerability / Indicator Overlay for this Input
Political / Illegal Activity
Searching for indicator illegal:
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p.(None): 81) Possession: It is the possession of a pharmaceutical product by a natural or legal person, whether or not it accredits a fair
p.(None): title for it.
p.(None): 82) Health Record Holder: Natural or legal person, national or foreign, domiciled in Chile, whose
p.(None): name is on a health record.
p.(None): 83) Traceability of analytical data: Property or characteristic that has the result of a measurement or the value of
p.(None): a standard, which may be related to specified references, usually national standards or
p.(None): international, through a continuous chain of comparisons all with specified uncertainties.
p.(None): 84) Traceability of a product: Ability to identify the origin and displacement of a specific unit of a
p.(None): product in any of its manufacturing stages and / or a production batch, through the distribution chain,
p.(None): as well as through the different entities that intervene, until they are dispensed, administered or used.
p.(None): 85) Sales unit: Authorized sales presentation to be dispensed and issued.
p.(None): 86) Validation: Documented action, carried out in accordance with the principles of the Good Practices of
p.(None): Manufacturing and Laboratory, which demonstrate that the procedures, processes, activities or systems used in the
p.(None): Production and quality control are conducive to the results provided, within established limits.
p.(None): Article 6º.- The manufacture, import, possession, distribution and transfer, in any capacity, is prohibited.
p.(None): of pharmaceutical products that are in any of the following conditions:
p.(None): 1. Contaminated pharmaceutical product: one that contains microorganisms or parasites or parts thereof, capable of
p.(None): produce illnesses in people or illegal amounts of potentially toxic, carcinogenic or
p.(None): mutagenic or other foreign materials.
p.(None): 2. Altered pharmaceutical product: That finished product that due to deficiency in storage, transport,
p.(None): conservation or any other cause subsequent to its production:
p.(None): to. has decreased its activity below the limits specified in the respective health registry or, in the
p.(None): case of raw materials, in their quality specifications, referred to official texts,
p.(None): b. it has lost its effectiveness or has undergone modifications that alter its quality,
p.(None): c. is presented in a deteriorated container, or
p.(None): d. is distributed or expended after the effectiveness period.
p.(None): 3. Adulterated pharmaceutical product: The one whose composition, specifications
p.(None): or other conditions contemplated in the respective sanitary registry or, in the case of raw materials, in its
p.(None): quality specifications referring to official texts, has been modified without prior authorization or without giving
p.(None): compliance with said specifications.
p.(None): 4. Counterfeit pharmaceutical product: That pharmaceutical product that does not
p.(None): has a sanitary registration or authorization or that has been manufactured or imported by someone who does not have authorization
p.(None): sanitary for it. Counterfeit products will also be understood as those distributed or sold by those who do not
p.(None): You have authorization for it.
p.(None): The Institute will supervise the existence of pharmaceutical products in these situations, being able to apply the measures
p.(None): sanitary that proceed and, previous the instruction of the corresponding summary, the sanctions that there are place.
p.(None): The SEREMI will be responsible for supervising the sale and dispensing of products found in any of
p.(None): the conditions described, with the same powers as the previous paragraph.
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Political / political affiliation
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p.(None): 2) Administration: Act by which the medicine is placed in contact with the human being, so that it can
p.(None): exert local action or be absorbed and exert systemic action.
p.(None): 3) Quality assurance: A planned and comprehensive system that aims to ensure that the processes and their
p.(None): Results meet the quality requirements previously established for them.
p.(None): 4) Bioavailability: Amount of an active ingredient from a pharmaceutical form, which reaches the
p.(None): systemic circulation and the speed with which this occurs.
p.(None): 5) Good Laboratory Practices (GLP): Set of rules, operating procedures and practices that guarantee
p.(None): that the data generated by a quality control system is reproducible and representative, ensuring validity
p.(None): and reliability of the results; These technical standards will be approved by Supreme Decree of the Ministry,
p.(None): Institute proposal.
p.(None): 6) Good Manufacturing Practices (BPM): Minimum technical standards established for all procedures
p.(None): intended to guarantee the uniform and satisfactory quality of pharmaceutical products, within the limits
p.(None): accepted and valid for each of them; These technical standards will be approved by Supreme Decree of the Ministry,
p.(None): at the proposal of the Institute.
p.(None): 7) Quality of a medicine: Fitness of the medicine for the use for which it is intended, which is determined
p.(None): for its efficacy, safety and stability, in accordance with the characteristics of identity, potency, purity and others,
p.(None): according to the respective sanitary registry.
p.(None): 8) Health registration certificate: Document issued by the health authority of the producing country or
p.(None): provenance, at the request of the interested party, which must state:
p.(None): - That the producer establishment meets the conditions required by the health legislation of their country to
p.(None): elaborate, condition or package the registered product;
p.(None): - That the product is registered in the country that issues the certificate according to current regulations, indicating
p.(None): fully authorized formula;
p.(None): - That its sale or distribution under any title is subject to some restrictive regime or special control of
p.(None): sanitary type, if so.
p.(None): 9) Quality control: Activities that aim to ensure batches during all stages of manufacturing
p.(None): product uniforms conforming to identity, potency, purity and other quality requirements
p.(None): established in their respective monographs, authorized in the corresponding health registry.
p.(None): 10) Shelf control: Verification of quality of a product that is in its sale and delivery stage
p.(None): to the public and which is carried out by the Institute or by the health authority with which it agrees, according to
p.(None): programs established by the Ministry at the proposal of the Institute.
p.(None): 11) Key: Distinctive alphanumeric or numerical combination, which allows unique and unequaled identification in
p.(None): any of the stages of manufacture, storage, distribution and sale of a pharmaceutical product, for
p.(None): to ensure its traceability.
p.(None): 12) Counter sample: Finite portion of sample to be kept of the analyzed products, in the same terms
p.(None): of reference or retention samples.
p.(None): 13) Quarantine: Transitory condition of physical isolation or by other means, of raw materials, materials and
p.(None): intermediate, semi-finished, bulk, semi-finished or finished products, during which its
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p.(None): 33) Real-time stability study: Stability study carried out for the time proposed for the period of
p.(None): efficacy and under storage conditions, temperature and humidity determined according to the nature of the product.
p.(None): 34) Accelerated stability study: Stability study designed to increase the degradation rate
p.(None): chemical or physical changes of an active substance or a pharmaceutical product in its proposed primary packaging, using
p.(None): severe storage conditions, temperature and humidity, as part of a formal storage program,
p.(None): during a certain period of time according to the active ingredient under evaluation and whose results allow establishing
p.(None): its stability by
p.(None): www.bcn.cl - Library of the National Congress of Chile
p.(None): certain period.
p.(None): 35) Stability study: series of tests, trials and analyzes related to physical characteristics,
p.(None): chemical, biological and microbiological characteristics of an active ingredient or a pharmaceutical product, to obtain information
p.(None): on its stability, in order to define its period of effectiveness under certain packaging conditions and
p.(None): storage.
p.(None): 36) Bioavailability studies: Pharmacokinetic studies that, through a pre-established experimental design,
p.(None): allow to determine the bioavailability of an active principle.
p.(None): 37) Pharmacokinetic studies: "In vivo" tests that, through pre-established experimental designs, allow
p.(None): establish the kinetics of the processes of absorption, distribution, metabolism and excretion of the active ingredients and
p.(None): metabolites of a pharmaceutical product.
p.(None): 38) Evaluation of a pharmaceutical product: Systematic study of the background required of the interested party who
p.(None): requests the sanitary registration, regarding the relevance of the administrative and technical background, such as
p.(None): the pharmaceutical, pharmacological, toxicological, clinical and
p.(None): therapeutic, in order to determine or verify if the product is suitable for use in the proposed indications.
p.(None): 39) Excipient: Any raw material used in the manufacture of the products referred to in this
p.(None): regulation, which is not an active principle.
p.(None): 40) Sale: Retail sale of a pharmaceutical product to the user or consumer public.
p.(None): 41) Pharmacovigilance: Set of activities related to the detection, evaluation, understanding and prevention of
p.(None): the adverse effects associated with the use of medications.
p.(None): 42) Expiration, expiration or expiration date: The one indicated by the month and calendar year and in some cases, in addition
p.(None): for the day, as approved in the respective health registry; beyond which it cannot be expected that
p.(None): product retain its stability.
p.(None): 43) Pharmaceutical form: Physical form in which a medication is presented, to facilitate its fractionation,
p.(None): dispensing, dosing and administration or employment.
p.(None): 44) Standard formula or master formula: Document or set of documents that specify raw materials and their
p.(None): quantities, as well as packaging packaging materials, along with a description of procedures and precautions
p.(None): required to produce a specific quantity of a finished product, also including the instructions for
p.(None): manufacturing and controls in process.
p.(None): 45) Import: It is the act by which a pharmaceutical product from abroad enters, enters and
p.(None): it is in condition to be distributed, complying with current regulations.
p.(None): 46) Impurities: Any component that is not defined as constituent of the raw material or product.
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p.(None): is intended for the human being for the purpose of curing, mitigating, treating, preventing or diagnosing diseases or
p.(None): their symptoms, to modify physiological systems or mental state for the benefit of the person to whom it is
p.(None): administered.
p.(None): Active raw materials, pharmaceutical preparations, specialties are considered pharmaceutical products.
p.(None): pharmaceutical and traditional herbal medicines.
p.(None): Article 8º.- The Institute will be responsible for determining, through a well-founded resolution, the corresponding control regime
p.(None): apply to all those products that are attributed or possess some of the properties indicated in the article
p.(None): above and are labeled or advertised as food, being resolved as much binding
p.(None): to those products that want to be distributed and sold for the first time, such as those that are in
p.(None): circulation.
p.(None): The determination of the control regime to be applied may be carried out ex officio or at the request of individuals or others
p.(None): public bodies that in the exercise
p.(None): of their inspection activities detect products in the conditions indicated in the first paragraph of this
p.(None): Article.
p.(None): For the determination of the applicable control regime requested by the SEREMI, they will send the Institute a
p.(None): technical report and copy of all the antecedents in their possession, as well as, when appropriate, the
p.(None): results of its inspection and inspection activities.
p.(None): If the Institute determines that the control regime to be applied is that of a pharmaceutical product, the resolution
p.(None): that it so determines will be published in the Official Gazette and the interested party will be notified in order to request their
p.(None): health record, providing the background that the case requires, according to its category or classification, which
p.(None): will be applicable to all those products that have the components to which activity has been attributed
p.(None): therapy.
p.(None): From the communication mentioned in the previous paragraph and while the sanitary registration for the product is not obtained,
p.(None): that has been listed as a pharmaceutical product, it must be withdrawn from the market by whoever
p.(None): distributed or distributed, without prejudice to the sanitary responsibilities that this may give rise to. Also arranged
p.(None): will be applicable to the rest of the products that contain the declared component or components of a product
p.(None): pharmacist.
p.(None): In the event that the Institute determines that the control regime to be applied does not correspond to that of a product
p.(None): pharmacist, will send the background together with a technical report that bases its evaluation to the Ministry for
p.(None): your review.
p.(None): Article 9.- The determination of the applicable control regime may also be made when there are doubts
p.(None): about the classification of other products, such as cosmetics, household and sanitary pesticides, or
p.(None): medical devices; the same procedure indicated above is applicable.
p.(None): SECOND PARAGRAPH:
p.(None): PHARMACEUTICAL SPECIALTIES AND THEIR CLASSIFICATION.
p.(None): Article 10.- Pharmaceutical specialties, according to their nature, are classified into:
p.(None): www.bcn.cl - Library of the National Congress of Chile
p.(None): a) Products of chemical origin or synthesis;
p.(None): b) Biological products;
p.(None): c) Radiopharmaceuticals;
p.(None): d) Phytopharmaceuticals;
p.(None): e) Homeopathic products;
p.(None): f) Medicinal gases;
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p.(None): country
p.(None): of origin or manufacturing as appropriate. In both cases the
p.(None): authorizations granted to private parties may be required a second time before six
p.(None): months, as long as the application for sanitary registration is presented or antecedents are provided that prove that the
p.(None): Situation of emergency, urgency, catastrophe or urgent medicinal use has been maintained and they make their
p.(None): grant.
p.(None): Article 23.- Applications for the provisional use in scientific research or clinical trial of a product
p.(None): pharmacist must appear before the Institute accompanied by the protocol approved by the ethics committee, in the
p.(None): terms referred to in letter c) of article 21; the same document must be accompanied in the case of a
p.(None): product that has a sanitary registration and its use is intended differently from that authorized.
p.(None): Article 24 °. - In accordance with the collaboration agreements that are concluded between the Institute and the SEREMI of regions
p.(None): that have border customs, carried out in accordance with the provisions of the Organic Constitutional Law of
p.(None): General Bases of the State Administration, Law No. 18,575, whose consolidated, coordinated and systematized text was
p.(None): fixed by D.F.L. Nº 1 of 2000 of the Ministry General Secretariat of the Presidency, the latter authority may
p.(None): authorize the provisional use of pharmaceutical products without prior sanitary registration, when they are imported for
p.(None): individual use, directly by the interested party or his agent, provided they are prescribed by a professional
p.(None): enabled, to record the need and duration of treatment.
p.(None): Likewise, said health authority may authorize the hospitalization of medications by nationals or foreigners
p.(None): that carry them upon entering the country for treatment for a period not exceeding three weeks, unless it is
p.(None): of chronic diseases or other treatments, duly founded and accredited. All excess will be withheld and
p.(None): notified for subsequent confiscation.
p.(None): The respective SEREMI shall inform the Institute monthly of the authorizations granted pursuant to this
p.(None): Article.
p.(None): Article 25.- For the purposes of the provisions of article 102 of the Health Code, pharmaceutical preparations
p.(None): They will have an official sanitary registration number, which will be the one incorporated in the Official Registry of
p.(None): Preparation, which will be considered as the official record of the Institute of Public Health.
p.(None): Article 26º.- Active raw materials consisting of natural or synthetic drugs in bulk, shall be understood
p.(None): registered by the mere fact of being included in the formula of a pharmaceutical specialty that has registration
p.(None): sanitary or by the respective authorization of use and disposal, when these are imported by establishments
p.(None): authorized for it.
p.(None): Article 27º.- Traditional herbal medicines shall be understood as those constituted by the plants or parts of
p.(None): plants, fresh or dried, whole or crushed, packaged and labeled by hand and labeled with the
p.(None): denomination used by popular custom in the field of Chilean cultural traditions, which have been
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p.(None): activities of its processing, and must meet the following conditions:
p.(None): a) They must be in a list contained in a technical standard approved by
p.(None): www.bcn.cl - Library of the National Congress of Chile
p.(None): Supreme decree of the Ministry, issued in use of its legal, technical and regulatory powers, which will indicate the
p.(None): denomination, therapeutic properties and uses of each of them, should be used as auxiliaries
p.(None): symptomatic.
p.(None): b) Be packed by hand as isolated, unmixed plant species.
p.(None): c) Enter in their labels only those properties recognized in the aforementioned decree.
p.(None): SECOND PARAGRAPH:
p.(None): OF THE REQUIREMENTS OF THE SANITARY REGISTRY.
p.(None): Article 28º.- Applications for health registration must be submitted to the Institute, complying with the
p.(None): general and special requirements that are determined in this Title.
p.(None): The general registration requirements include administrative aspects, technical information, quality
p.(None): pharmaceutical and safety and clinical efficacy of the pharmaceutical product to be registered, which are commonly applied to
p.(None): all the
p.(None): records; for their part, the special requirements derive from their nature and from whose origin and veracity
p.(None): The professional who signs the request must be held responsible.
p.(None): 1º Of the general requirements of the sanitary registry. A.- Administrative requirements.
p.(None): Article 29.- Any request for health registration must comply with the following general requirements of a character
p.(None): administrative and accompany the following information:
p.(None): 1. Identification and address of the interested party and his legal representative, in the case of legal persons.
p.(None): 2. Name of the technical director of the entity requesting the health registration or of the suitable professional, when not
p.(None): technical direction is required, to assume
p.(None): responsibility for the technical information provided.
p.(None): 3. Name of the pharmaceutical product, the following should be stated in this section:
p.(None): a) Fantasy or generic name, corresponding to its international common name or, failing that, the name
p.(None): pharmacopoeic or chemical;
p.(None): b) Pharmaceutical form;
p.(None): c) Unit dose per pharmaceutical form;
p.(None): d) Administration route.
p.(None): 4. Therapeutic class or group, and the corresponding anatomical-therapeutic classification must also be indicated.
p.(None): 5. Manufacturing regime, distinguishing:
p.(None): a) National manufacturing, for those products manufactured in a pharmaceutical laboratory, legally and technically
p.(None): enabled for it, whether the manufacture is own or for others.
p.(None): b) Imported products, distinguishing between:
p.(None): b.1. Finished imported products that have been manufactured abroad, whether the import is carried out in
p.(None): directly or through other authorized establishments.
p.(None): b.2. Imported semi-finished products in their final primary packaging, to be conditioned in the country, either in
p.(None): directly or through other authorized establishments.
p.(None): b.3. Products imported in bulk in their final pharmaceutical form to be packaged in the country, whether this is
p.(None): run directly or through other authorized establishments.
p.(None): www.bcn.cl - Library of the National Congress of Chile
p.(None): b.4. Semi-finished imported products to carry out the other necessary production stages in the country
p.(None): to obtain a finished product, either directly or through other authorized establishments.
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p.(None): . Formula studied;
p.(None): . Identification of the manufacturer and responsible for the stability study;
p.(None): . Conditions of temperature, humidity, packaging material and series studied (minimum 3 series or pilot lots) and the
p.(None): scheduled design, analytical procedures used and finished product specifications, all
p.(None): as appropriate, according to the Product Stability Guide
p.(None): www.bcn.cl - Library of the National Congress of Chile
p.(None): Pharmaceuticals referred to in article 32.
p.(None): h.2. In the case of a biological product that contains an active ingredient that is incorporated for the first time in the
p.(None): field of medicine in our country, must include the results of stability studies for degradation
p.(None): forced and stressful conditions.
p.(None): h.3. Proposition of the efficacy period and storage precautions, both supported by the study of
p.(None): corresponding stability, also indicate the period of effectiveness for the reconstituted product, when appropriate.
p.(None): h.4. If the product must be diluted prior to administration, the compatibility studies and
p.(None): stability with corresponding diluents, as appropriate.
p.(None): i) Safety and Efficiency Requirements.
p.(None): In the cases of biotechnological products, by Supreme Decree of the Ministry, at the proposal of the Institute,
p.(None): will establish the technical standard that will determine the active principles and their respective presentations, with respect to each
p.(None): one of which the abbreviation of clinical studies destined to endorse efficacy and safety of the
p.(None): product, based on the existence of another registered biotech product, using the same principles
p.(None): active ingredients, unit dose, pharmaceutical form and route of administration.
p.(None): Notwithstanding the foregoing, the interested party must accompany the comparative studies with the reference product,
p.(None): that with respect to each active ingredient it is indicated, in order to appropriately characterize the product and demonstrate its
p.(None): similar nature with the innovator or reference already mentioned.
p.(None): THIRD PARAGRAPH:
p.(None): OF THE PROCEDURE APPLICABLE TO THE REGISTRATION APPLICATION.
p.(None): Article 43º.- The application for health registration, together with the background that must be accompanied according to the
p.(None): type of pharmaceutical product, will be presented to the Institute of Public Health on the approved forms, upon payment
p.(None): of the corresponding tariff.
p.(None): Said request shall be recorded in a written or electronic file, in which the documents will be recorded.
p.(None): presented by the interested parties, with expression of the time and date of presentation, granting a reference number
p.(None): for admission and follow-up, upon payment of the fee corresponding to the first phase of admissibility of the
p.(None): request.
p.(None): Article 44º.- Within the term of ten working days, the Institute will carry out a review of the application form and
p.(None): his background, issuing a pronouncement on his admissibility.
p.(None): Article 45º.- In the case of resolving the admissibility of the request for the purposes of its evaluation and review
p.(None): Regarding the merits, the interested party will be notified of the resolution that so determines, so that he or her
p.(None): The representative appears to pay the fee corresponding to the next phase of the procedure.
p.(None): If it is determined that the request is not admissible, the resolution that so establishes may only be based on the absence
p.(None): of the background required by this regulation and its complementary regulations, according to the type of specialty
p.(None): pharmaceutical, and will indicate the background that must be added to overcome the objection, granting a deadline for it
p.(None): five business days, expired which
p.(None): The Institute will proceed in the manner established in the first paragraph or it will declare no place for the request.
p.(None): Article 46º.- When the admissibility of the registration procedure is declared, the antecedents will be sent to the
p.(None): corresponding unit, which will proceed to the breakdown of the technical and administrative background, accompanied,
p.(None): for analysis, separately.
p.(None): In the case of the administrative background referred to in number 10
p.(None): www.bcn.cl - Library of the National Congress of Chile
p.(None): of article 29, will be previously analyzed by the legal advisory unit.
p.(None): The technical background referring to the requirements of technical information, pharmaceutical quality and
p.(None): safety and efficacy, as well as those individuals who, depending on the case, are from the type of
p.(None): pharmaceutical product and that correspond according to the previous paragraph, will be broken down and sent to the dependencies
p.(None): specialized techniques, which will be evaluated in accordance with these regulations.
p.(None): Article 47º.- If the evaluations carried out by the mentioned instances are favorable, and within the total term
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p.(None): j. Authorized therapeutic indications.
p.(None): k. Prescription and dispensing conditions, established according to the regulations issued by the Ministry.
p.(None): l. If the product is subject to legal control, serial control or others, indicating its basis the conditions
p.(None): in which it must be carried out.
p.(None): m. Limitations of the authorization regarding the validity and vigilance requirement in the use of the product
p.(None): registered.
p.(None): n. Specific obligations of the registration holder.
p.(None): or. Obligation to report the first production or import batch for distribution under any title, of
p.(None): according to the provisions of article 71.
p.(None): p. Others that are relevant, according to the nature and specific composition of each pharmaceutical product, as well
p.(None): such as those related to production, import, quality control, storage, distribution or delivery to
p.(None): any title and data protection of an "undisclosed" nature.
p.(None): q. In one or more stamped annexes, which will be considered to form an integral part of the resolution, the
p.(None): authorized graphic labeling, the patient information brochure or insert, the professional information brochure,
p.(None): the finished product specifications and the finished product analysis methodology.
p.(None): Article 49º.- In the event that the evaluation carried out recommends the denial of sanitary registration based on:
p.(None): - Related or accessory questions: these will be brought to the attention of the applicant, who will have a period
p.(None): 15 working days to formulate the allegations it deems appropriate, after which the Institute will decide
p.(None): about them in the final resolution.
p.(None): - Insufficiency of the background or studies presented: the interested party will be notified in order to provide
p.(None): greater antecedents within the term of 30 working days, and if said new antecedents are sufficient to
p.(None): guarantee the conditions indicated above, the sanitary registration will be granted.
p.(None): In the event that such new antecedents are not presented within the granted term or that, presented in
p.(None): time, they were again evaluated as insufficient, the Institute will request directly and justly the Ministry of
p.(None): Health your pronouncement regarding the refusal of registration.
p.(None): The Ministry will have a period of 10 working days to issue its report on the proposed denial,
p.(None): communicating it to the Institute so that it can issue the founded resolution that so establishes it, which will be
p.(None): notified to the applicant.
p.(None): Article 50: During the processing of the sanitary registry whoever has the
p.(None): www.bcn.cl - Library of the National Congress of Chile
p.(None): Stakeholder in accordance with Law No. 19,880 may adduce allegations and provide documents or other elements
p.(None): of judgment so that they are considered as antecedents for the concession or denial of the respective registration
p.(None): sanitary.
p.(None): Once the sanitary registration is granted, the resolution that grants it will be available on the official website
p.(None): of the Institute of Public Health.
p.(None): In the cases in which, by application of Law No. 19,039, such information has the nature of not
p.(None): disclosed, it will be to the dispositions contained in said norm and its complementary regulation.
p.(None): FOURTH PARAGRAPH:
p.(None): OF SPECIAL REGISTRATION PROCEDURES.
p.(None): 1 of the abbreviated registration procedure.
p.(None): Article 51º.- The ordinary sanitary registration procedure may be abbreviated in order to reduce the terms of
p.(None): processing established, based on a resolution of the Ministry of Health, founded on the concurrence of any of
p.(None): the following circumstances:
p.(None): 1) That the pharmaceutical product is necessary to be distributed to the population in compliance with plans or
p.(None): health programs approved by the Ministry, which address certain situations of health risk or
p.(None): specific pathologies and that are intended for certain groups of people, within the framework of health interests
p.(None): national public.
p.(None): 2) That the pharmaceutical product has been included in the list of products included in the National Form
p.(None): of Medicines, event in which the interested party must use the monographs of the Form to accelerate the
p.(None): registration process.
p.(None): The Institute will proceed to reduce the deadlines established for sanitary registration, attending the stage of
p.(None): processing in which you are. In any case, the total procedure may not exceed four months.
p.(None): 2 of the simplified registration procedure.
p.(None): Article 52º.- The ordinary sanitary registration procedure may be simplified, upon request of the
p.(None): interested, omitting certain antecedents, in the cases and in the manner indicated below:
p.(None): 1. In the case of pharmaceutical products that contain the same active ingredient, in the same quantity per form
p.(None): pharmaceutical and the same route of administration as another product that has or has had a health record
p.(None): canceled by the Institute for public health reasons, in which case the presentation of the
p.(None): antecedents that relate to safety and efficacy, except that for well-founded reasons and through resolution, the
p.(None): Institute determines the need to have all or some of those records.
p.(None): In the case of an unconventional release pharmaceutical product that is a pharmaceutical equivalent of one already
p.(None): registered, the corresponding therapeutic equivalence studies must be attached.
p.(None): 2. In the case of sufficiently known and experienced active ingredients, so that their effectiveness,
p.(None): safety of use and adverse reactions are stated in the scientific literature, the background may be substituted
p.(None): related to pre-clinical studies, by the pertinent bibliography. Likewise, the
p.(None): scientific information regarding the efficacy and safety of the product to be registered; on this last case
p.(None): The application will be evaluated by the Institute, and the entire background may well be required.
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p.(None): Regarding the pharmaceutical specialties that enter as a finished product, they can only be received and
p.(None): stored by establishments duly authorized for it.
p.(None): Raw materials destined for the manufacture of medicines or their marketing to producing establishments
p.(None): Of these, they may only be admitted by drug stores and pharmaceutical production laboratories.
p.(None): THIRD PARAGRAPH:
p.(None): OF THE PROCESS OF INTERNATION OF PHARMACEUTICAL PRODUCTS.
p.(None): www.bcn.cl - Library of the National Congress of Chile
p.(None): Article 98º.- For the hospitalization of all pharmaceutical products, a Certificate of Destination must be requested
p.(None): Customs office at SEREMI corresponding to the customs office of entry of the product, having to attach the background
p.(None): pertinent, in which the interned material, its quantity and its nature, as well as the
p.(None): route and means of transport to carry out your transfer from the customs premises to an authorized establishment for
p.(None): it.
p.(None): SEREMI must rule on the request referred to in the preceding paragraph, within three
p.(None): business days counted from the filing date of the petition and, in case of rejection, must do so by
p.(None): founded resolution.
p.(None): The SEREMI, through the Ministry, may sign agreements with other public entities for the issuance of the
p.(None): designated certificates, signed in accordance with the provisions of the Organic Constitutional Law of Bases
p.(None): Of the State Administration, Law No. 18,575, whose consolidated, coordinated and systematized text was set
p.(None): by D.F.L. Nº 1, from 2000, of the Ministry General Secretariat of the Presidency.
p.(None): Article 99.- To study any customs destination for pharmaceutical products, the interested party must present to the
p.(None): National Customs Service the certificate issued by the respective SEREMI.
p.(None): Once the processing of the customs destination document has been completed and the products have been removed from the
p.(None): customs, they will be deposited under the responsibility of the consignee, who will not be able to use, consume, sell,
p.(None): assign or dispose of them under any title, without obtaining the approval of the Institute by granting their authorization for use and
p.(None): provision, denying it or setting a period of
p.(None): security to practice the corresponding sanitary controls, during which time the products cannot be
p.(None): used or distributed under any circumstances.
p.(None): Said authorization will be requested from the Public Health Institute attaching the documentation related to the import.
p.(None): (invoice and shipping document), the customs destination certification and the control control analysis protocol of
p.(None): quality of the producing country or, failing that, the analysis protocol carried out in the country, except for samples of
p.(None): pharmaceutical products intended exclusively for analysis and development or for obtaining their health registration,
p.(None): the authorization must be issued within three business days from the date the interested party
p.(None): notify the authority of the entry of the products to the warehouse.
p.(None): The granting of the use and disposal authorization will not exempt applicants from the obligation to comply
p.(None): in parallel with the other legal, regulatory or administrative requirements that are required to authorize its use or
p.(None): distribution, as well as the observance of the rights of third parties established by law.
p.(None): The National Customs Service will inform the Institute monthly about the pharmaceutical products that have
p.(None): been imported into the country, as well as their quantity and the name of the importer.
p.(None): In any case, in the case of pharmaceutical specialties, the warehouse or deposit establishment declared by the
p.(None): importer must have the authorization of the corresponding SEREMI of Health.
p.(None): TITLE V:
p.(None): EXPORT OF PHARMACEUTICAL SPECIALTIES.
p.(None): Article 100.- Only pharmaceutical products that have a valid health registration in
p.(None): Chile, after notifying the Institute.
p.(None): Article 101.- Pharmaceutical specialties destined for export that are labeled "Products for the
p.(None): Export "the regulatory requirements regarding packaging, graphic labeling, brochure will not be applicable to them
p.(None): information to the patient, except for the identification of the finished product, which must have the
p.(None): following mentions:
p.(None): A. Name of the product, including its generic name.
p.(None): B. Pharmaceutical form.
p.(None): C. I.S.P.
p.(None): D. Name of the manufacturing establishment.
p.(None): E. Serial number and expiration date.
p.(None): Article 102.- They will be applicable to the elaboration, quality control and
p.(None): www.bcn.cl - Library of the National Congress of Chile
...
p.(None): www.bcn.cl - Library of the National Congress of Chile
p.(None): Article 109 ° .- The installation of a pharmaceutical laboratory, whatever its category, must be authorized in
p.(None): expressly by resolution of the Institute, regarding its installation, operation and eventual transfer.
p.(None): The expansion, modification of the physical plant or the lines of
p.(None): activities within each category of establishments.
p.(None): Article 110 °. - The authorization of installation and operation granted by the Institute, will have a validity of 3
p.(None): years and will be renewed in accordance with the ninth paragraph of this title.
p.(None): Article 111.- Any natural or legal person who acquires a pharmaceutical laboratory or takes charge of its
p.(None): exploitation or administration on its own account or that of others, must notify the Institute within 30 days,
p.(None): accompanying the instruments that prove their right, identifying the legal representative and attaching the payroll of
p.(None): professionals in charge of the Technical Directorate, Production Headquarters, Quality Assurance and Control of
p.(None): Quality, which correspond according to the type of establishment.
p.(None): Article 112 ° .- The Institute may inspect the establishment to verify the conditions of its operation,
p.(None): in accordance with the provisions of these regulations and Good Manufacturing and Laboratory Practices.
p.(None): THIRD PARAGRAPH:
p.(None): INSTALLATION AND OPERATION AUTHORIZATION PROCEDURE.
p.(None): Article 113º.- The installation of a pharmaceutical laboratory must be done in an independent location.
p.(None): Article 114º.- The laboratory installation authorization must be made by resolution of the Institute, within
p.(None): of the term of 30 working days, counted from the time the interested party presents the following to the Institute in full
p.(None): documents:
p.(None): a) Individualization of the applicant.
p.(None): b) Legal instruments that prove the title invoked for the possession of the establishment and denomination
p.(None): commercial.
p.(None): c) Architectural plan, in duplicate of the premises, together with flow charts or personnel displacement,
p.(None): critical support materials and systems when applicable as well as technical specifications of the establishment,
p.(None): regarding the areas and their distribution, in accordance with Good Manufacturing and Laboratory Practices, according to
p.(None): it corresponds.
p.(None): d) Laboratory category and production lines, analyzes and / or activities to be carried out.
p.(None): e) Proof of payment of customs duty.
p.(None): Prior to requesting authorization to install the premises, interested parties may request the Institute,
p.(None): upon payment of the corresponding fee, the evaluation of the flow diagrams indicated above.
p.(None): Article 115º.- Once the establishment in question is installed, the interested party will request the Institute, prior to
p.(None): require operating authorization, on-site verification of conformity between the information delivered to the
p.(None): At the time of requesting the installation authorization, what was developed and the Good Manufacturing Practices and
p.(None): Laboratory, as applicable; leaving record of the non-conformities.
p.(None): Article 116º.- The authorization of the operation of a pharmaceutical laboratory must be made by resolution
p.(None): of the Institute within the term
p.(None): 30 days from when the interested party fully accompanies the following information:
p.(None): a) List of facilities and equipment that the establishment has,
p.(None): www.bcn.cl - Library of the National Congress of Chile
p.(None): duly qualified, as appropriate to the category.
p.(None): b) Declarations signed by the professionals who will assume the technical direction, production management,
p.(None): quality assurance and quality control, as appropriate; without prejudice to special provisions
p.(None): that this regulation contemplates.
p.(None): c) Activities, production lines or quality control to be carried out.
p.(None): d) Description of the key or keys that will be used in accordance with the provisions of these regulations, when
p.(None): Try pharmaceutical production labs.
p.(None): e) Any other information that the Institute has justly requested.
p.(None): Article 117.- Once the application for operating authorization has been received, the Institute will declare its
p.(None): admissibility or inadmissibility within 15 days of submission, based on the background
p.(None): enunciated in the previous article. Declared inadmissible, the Institute will inform the interested party of the background
p.(None): missing so that in a period of 5 working days he can accompany them, under the warning of having him for their
p.(None): request.
p.(None): If the background information is insufficient, or does not comply with what has been developed and what is required in the regulations
p.(None): in force, the Institute will issue within 30 days, a founded resolution that will reject the request for
p.(None): functioning.
p.(None): If the accompanied background is sufficient, the Institute will issue within 30 days, a resolution
p.(None): authorizing the operation of the laboratory, which will contain the following mentions:
p.(None): 1. Name, category and address of the pharmaceutical laboratory.
p.(None): 2. Legal representative and professionals who assume technical responsibilities.
p.(None): 3. Lines of activities, production and / or authorized analysis.
p.(None): FOURTH PARAGRAPH:
p.(None): PHYSICAL PLANT REQUIREMENTS OF PHARMACEUTICAL LABORATORIES.
p.(None): Article 118 ° .- All pharmaceutical laboratories will be specially designed and their size and construction must comply
p.(None): with the provisions of these regulations and Good Manufacturing and Laboratory Practices, as appropriate to its
p.(None): category. The location should be such that it is not close to
p.(None): establishments that, due to the activities they carry out, are a source of contamination, nor that in turn originate it in their
p.(None): environment.
p.(None): Article 119 ° .- The laboratory must have special and independent rooms for the storage of
p.(None): flammable or explosive, corrosive, toxic and polluting risks substances. These enclosures
p.(None): They will strictly comply with the security measures determined by the competent bodies.
p.(None): Article 120 ° .- The laboratory that manufactures or packages pharmaceutical products that have active ingredients
...
p.(None): c) Sampling of raw materials.
p.(None): d) Fractionation of raw materials.
p.(None): e) Storage of approved materials.
p.(None): f) Storage of rejected materials.
p.(None): g) Manufacturing.
p.(None): h) Washing and drying of utensils and materials.
p.(None): i) Primary packaging and labeling.
p.(None): j) Secondary packaging and labeling.
p.(None): k) Quarantine of finished products and those subject to serial control, when appropriate.
p.(None): l) Storage of approved finished products.
p.(None): m) Storage of reference samples and counter samples.
p.(None): n) Storage of recalled products.
p.(None): o) Storage of rejected products.
p.(None): p) Storage of returned products.
p.(None): q) Storage of products in process.
p.(None): r) Quality control laboratory.
p.(None): s) Areas for quality control operations of products in process.
p.(None): t) Manufacture and sterile and aseptic fractionation of pharmaceutical products, in accordance with Good Practices
p.(None): Manufacturing, when applicable.
p.(None): u) Expedition or dispatch.
p.(None): v) Maintenance.
p.(None): w) Offices for responsible professionals.
p.(None): x) Bathroom and changing rooms for the use of personnel, prior to entering or leaving the plant, as appropriate.
p.(None): In the cases of the zones described in letters b), e), k) and l), no physically separate sections will be required,
p.(None): if there is an electronic system that allows adequate control of the different states of the materials.
p.(None): The Pharmaceutical Production Laboratories may outsource, in independent premises, the areas of
p.(None): storage of finished products. If the independent premises are owned by the laboratory, it will constitute a
p.(None): expansion of its plant; whereas if it belongs to a third party, the latter must have the authorization
p.(None): corresponding sanitary, issued by the respective SEREMI, which must supervise the activity that it
p.(None): develop, in accordance with the general storage requirements provided in these regulations.
p.(None): Article 123 ° .- The area corresponding to production must be structured, equipped and enabled, according to the forms
p.(None): Pharmaceuticals that are manufactured and controlled to prevent cross contamination.
p.(None): Article 124 ° .- The manufacturing and packaging areas may constitute a single unit, when systems are used
p.(None): serial production technicians, who do not allow separating the different stages of product development and always
p.(None): that the necessary measures be taken to avoid cross contamination.
p.(None): Article 125 ° .- The manufacture and packaging of sterile pharmaceutical products can only be carried out in rooms
p.(None): specially enabled for this purpose, also complying with the necessary conditions to execute:
p.(None): a) The sterile fractionation of non-sterilizable products in final containers.
p.(None): b) The aseptic fractionation of sterilizable products in final containers.
p.(None): Article 126 ° .- When laboratory animals are used, they must be kept in isolated enclosures and
p.(None): specially authorized for said effects, in the form and conditions authorized by the Institute.
p.(None): Article 127 ° .- The facilities, equipment and other implements used in a production laboratory must
p.(None): have the design, size and manufacturing materials in accordance with Good Manufacturing Practices ensuring, at
p.(None): less, the following:
p.(None): a) Continuous and orderly stages of manufacturing and quality control.
p.(None): www.bcn.cl - Library of the National Congress of Chile
p.(None): b) Maintaining the necessary hygienic conditions.
...
p.(None): of each sample will be enough to carry out two complete analyzes, according to the product specifications
p.(None): completed authorized in the respective sanitary registry and will be carried out through sampling procedures
p.(None): determined by resolution of the Institute.
p.(None): Article 186 ° .- The approval or rejection of a lot or sublot under series control, will be made within the
p.(None): 20 business days, counted from the time they are received according to the background described in article 184 of this
p.(None): regulations, with the exception of vaccines, whose serial control will be carried out within 40 working days.
p.(None): Notwithstanding the foregoing, the Institute may for reasonable reasons increase the term indicated in the preceding paragraph.
p.(None): Once the serial control is rejected, the manufacturer or importer must proceed to the immediate destruction of the product, the
p.(None): which will be effective in authorized places, in the presence of the Technical Director and a minister of public faith
p.(None): designated by the Institute, drawing up a record of everything done.
p.(None): Exceptionally, the Institute may authorize the reprocessing of the rejected product, after a well-founded request from the
p.(None): interested, in which case the respective resolution will set the conditions under which it will be carried out.
p.(None): FOURTH PARAGRAPH:
p.(None): OF THE EXEMPTION OF QUALITY CONTROL AND SERIAL CONTROL.
p.(None): Article 187 ° .- The Institute may exempt finished imported products from quality and / or serial control,
p.(None): in all or part of them, in the case of products with very low turnover and high unit cost, and requests and
p.(None): justify by the holder of the sanitary registry.
p.(None): For these purposes, the interested party must provide sufficient information about the validation of the methods.
p.(None): analytical used in the release of the batch in the country of manufacture, analysis bulletin of the country of origin and
p.(None): cold chain maintenance records, where applicable.
p.(None): Article 188 ° .- The resolution granting the exemption or denial must be founded. In case of being favorable
p.(None): It will contain the following mentions:
p.(None): www.bcn.cl - Library of the National Congress of Chile
p.(None): 1. Name of the pharmaceutical specialty.
p.(None): 2. Maximum authorized quantity and frequency of importation.
p.(None): 3. Exempt analyzes.
p.(None): 4. Number of counter samples to be kept.
p.(None): 5. Validity of the resolution granting the exemption.
p.(None): FIFTH PARAGRAPH:
p.(None): OBLIGATIONS RELATED TO QUALITY CONTROL.
p.(None): Article 189 ° .- The holder of the sanitary registry will be responsible for keeping counter samples of each batch of
p.(None): Pharmaceutical products manufactured locally or on each import made, in sufficient quantity to make, to
p.(None): at least two complete analyzes of the product, according to the specifications approved in the respective registry
p.(None): sanitary, suitably labeled and stored, under the custody of the Chief of Quality Control, whether this is his own
p.(None): pharmaceutical laboratory or the one that provides services externally by agreement.
p.(None): The counter samples and corresponding documentation must be kept for one year beyond the expiration date.
p.(None): of the product.
p.(None): SIXTH PARAGRAPH:
p.(None): QUALITY INSPECTION.
p.(None): Article 190 ° .- The Public Health Institute is the health authority in charge of supervising the quality of the
p.(None): pharmaceutical products through inspection, shelf control or other actions in establishments
...
p.(None): instruction of the respective sanitary summary, in accordance with the provisions of this decree and in accordance with the provisions
p.(None): in Book X of the Sanitary Code and complementary sanitary legislation.
p.(None): Of the sanctions applied, they can only be judicially claimed in the manner established in article 171 of the Code.
p.(None): Sanitary.
p.(None): The provisions, whose oversight has been filed in the SEREMI will be sanctioned by them in accordance with the
p.(None): preceding paragraphs.
p.(None): Article 224 °. - In use of its powers of sanitary inspection, the Institute, in justified cases, may
p.(None): apply emergency measures, without the need for a prior sanitary summary. The same measures may be applied by
p.(None): the minister of faith designated by the Institute, with the sole merit of the act that it draws up, when there is a risk
p.(None): imminent for health. The same attributions will have the SEREMI or their ministers of faith, regarding the inspection
p.(None): that these regulations expressly instruct them.
p.(None): Article 225 ° .- Except as provided in the second paragraph of article 223, of the actions and resolutions it adopts
p.(None): the Director of the Institute in the exercise of his functions, in relation to the matters referred to in this
p.(None): regulation, an appeal may be filed before the Ministry of Health, within five days
p.(None): business days counted from the date of the notification of the respective resolution in your case.
p.(None): In the event that the affected party requires a longer time to present antecedents that support their claim, they must
p.(None): request it within the deadline, from the Ministry of Health,
p.(None): the one who will decide about it.
p.(None): Once the appeal is presented, the Ministry must request the background from the Institute and will rule on the
p.(None): claim within ten days
p.(None): upon receipt of said documents, unless technically it requires a longer period for said effect.
p.(None): If an appeal for reversal is filed before the same Institute, the claim referred to in this article may
p.(None): interpose within the same term and subsidiarily. In this case the resolution that resolves the replacement will serve as
p.(None): report for the purposes indicated in the preceding paragraph.
p.(None): FINAL TITLE: VALIDITY.
p.(None): Article 226 ° .- These regulations will come into effect 6 months later
p.(None): of its publication in the Official Gazette, the date on which Supreme Decree No. 1,876 of 1995 of the
p.(None): Ministry of Health, as well as any other norm, resolution or provision that is contrary or incompatible with the
p.(None): contained in this regulatory decree.
p.(None): Without prejudice to the provisions of the preceding paragraph, the provisions contained in article 175 of this
p.(None): regulations, will come into effect from its publication in the Official Gazette.
p.(None): TRANSITIONAL ITEMS
p.(None): FIRST TRANSITORY Article:
p.(None): OF THE SANITARY RECORDS.
p.(None): The health records granted under the Supreme Decree No. 1,876 of 1995 of the Ministry of Health, which
p.(None): This act is repealed, they will remain valid and valid. All in all, the Institute of Public Health, through resolution
p.(None): founded, may require the background that it deems pertinent for updating health records, with
p.(None): In order to comply with the provisions of this regulation, granting a term for it, which may not be
...
Searching for indicator political:
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p.(None): Standard Type: Decree 3
p.(None): Publication Date: 25-06-2011
p.(None): Date of enactment: 01-25-2010
p.(None): Agency: MINISTRY OF HEALTH; UNDERSECRETARIAT OF PUBLIC HEALTH
p.(None): Title: APPROVES REGULATION OF THE NATIONAL SYSTEM OF CONTROL OF PHARMACEUTICAL PRODUCTS FOR USE
p.(None): HUMAN
p.(None): Version Type: With Deferred Validity by Date From: 26-12-2011 Beginning Validity: 12-26-2011
p.(None): Id Standard 1026879
p.(None): URL: http: //www.leychile.cl/N? I = 1026879 & f = 2011-12-26 & p =
p.(None): APPROVES REGULATION OF THE NATIONAL SYSTEM OF CONTROL OF PHARMACEUTICAL PRODUCTS FOR HUMAN USE
p.(None): No. 3.- Santiago, January 25, 2010.- Seen: the provisions of Books fourth and sixth and other provisions
p.(None): Relevant of the Decree with Force of Law No. 725, of 1967, of the Ministry of Health, which approves the Sanitary Code.
p.(None): Considering: The need to update, organize and complete the current regulations regarding the matter, and
p.(None): Bearing in mind the powers conferred on me by Article 32 No. 6 of the Political Constitution of the Republic,
p.(None): I dictate the following
p.(None): Decree:
p.(None): The following Regulations of the National Control System for Pharmaceutical Products for Human Use be approved:
p.(None): PRELIMINARY TITLE:
p.(None): SCOPE OF APPLICATION AND COMPETENT AUTHORITIES.
p.(None): Article 1º.- This regulation includes the technical, administrative norms and other conditions or requirements that
p.(None): must comply with registration, import, internationalization and export, production, storage and possession, distribution to
p.(None): Free or onerous title, advertising and information on pharmaceutical products, as well as their use for
p.(None): scientific research.
p.(None): Article 2º.- It corresponds to the Ministry of Health, through the Undersecretariat of Public Health, to exercise a leading role
p.(None): and regulator in pharmaceutical products, for which it must approve the national drug policy and
p.(None): dictate the regulations and technical and administrative standards that public and private entities must comply with
p.(None): that address the activities indicated in the previous article, which will be approved through the acts
p.(None): administrative procedures that are relevant.
p.(None): Article 3.- The Institute of Public Health is the health authority in charge of the entire national territory of the
p.(None): sanitary control of pharmaceutical products and to ensure compliance with the provisions contained
p.(None): in these regulations, in the Health Code, in its complementary regulations and in other legal norms
p.(None): on the matter.
p.(None): It corresponds to exercise the actions of quality control of pharmaceutical products in any of the phases
...
Health / Drug Dependence
Searching for indicator dependency:
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p.(None): must comply with registration, import, internationalization and export, production, storage and possession, distribution to
p.(None): Free or onerous title, advertising and information on pharmaceutical products, as well as their use for
p.(None): scientific research.
p.(None): Article 2º.- It corresponds to the Ministry of Health, through the Undersecretariat of Public Health, to exercise a leading role
p.(None): and regulator in pharmaceutical products, for which it must approve the national drug policy and
p.(None): dictate the regulations and technical and administrative standards that public and private entities must comply with
p.(None): that address the activities indicated in the previous article, which will be approved through the acts
p.(None): administrative procedures that are relevant.
p.(None): Article 3.- The Institute of Public Health is the health authority in charge of the entire national territory of the
p.(None): sanitary control of pharmaceutical products and to ensure compliance with the provisions contained
p.(None): in these regulations, in the Health Code, in its complementary regulations and in other legal norms
p.(None): on the matter.
p.(None): It corresponds to exercise the actions of quality control of pharmaceutical products in any of the phases
p.(None): referred to in article 1, authorize the installation and operation of Pharmaceutical Laboratories, authorize
p.(None): and register pharmaceutical products and others subject to these control modalities, control the conditions of
p.(None): import and internment, export, manufacture, distribution, as well as the advertising and information of the
p.(None): same products, control narcotic drugs and dependency-causing pharmaceuticals and other substances
p.(None): psychotropic susceptible to supply analogous
p.(None): effect, with respect to their import, export and their lawful use in the product manufacturing process
p.(None): pharmacists and supervise compliance with the rules contained in these regulations and in the others that govern these
p.(None): subjects.
p.(None): www.bcn.cl - Library of the National Congress of Chile
p.(None): Article 4.- The Regional Ministerial Secretaries of Health, hereinafter the SEREMI, are the authorities
p.(None): competent to authorize the admission of pharmaceutical products in accordance with the provisions of article 2 of
p.(None): Law No.
p.(None): 18,164. In addition, they will be responsible for applying and supervising compliance with the rules contained in these regulations.
p.(None): regarding its distribution, storage and possession, insofar as it is carried out by establishments of the
p.(None): authorized pharmaceutical area, with the exception of the Pharmaceutical Laboratories.
p.(None): Article 5.- For the purposes of these regulations, the following definitions shall apply:
p.(None): 1) Biological activity: Measurable response of activity or potency, in vivo or in vitro, that characterizes a
p.(None): certain quantity of pharmaceutical product, with respect to a reference standard.
p.(None): 2) Administration: Act by which the medicine is placed in contact with the human being, so that it can
p.(None): exert local action or be absorbed and exert systemic action.
p.(None): 3) Quality assurance: A planned and comprehensive system that aims to ensure that the processes and their
p.(None): Results meet the quality requirements previously established for them.
p.(None): 4) Bioavailability: Amount of an active ingredient from a pharmaceutical form, which reaches the
p.(None): systemic circulation and the speed with which this occurs.
...
Health / Drug Usage
Searching for indicator drug:
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p.(None): Title: APPROVES REGULATION OF THE NATIONAL SYSTEM OF CONTROL OF PHARMACEUTICAL PRODUCTS FOR USE
p.(None): HUMAN
p.(None): Version Type: With Deferred Validity by Date From: 26-12-2011 Beginning Validity: 12-26-2011
p.(None): Id Standard 1026879
p.(None): URL: http: //www.leychile.cl/N? I = 1026879 & f = 2011-12-26 & p =
p.(None): APPROVES REGULATION OF THE NATIONAL SYSTEM OF CONTROL OF PHARMACEUTICAL PRODUCTS FOR HUMAN USE
p.(None): No. 3.- Santiago, January 25, 2010.- Seen: the provisions of Books fourth and sixth and other provisions
p.(None): Relevant of the Decree with Force of Law No. 725, of 1967, of the Ministry of Health, which approves the Sanitary Code.
p.(None): Considering: The need to update, organize and complete the current regulations regarding the matter, and
p.(None): Bearing in mind the powers conferred on me by Article 32 No. 6 of the Political Constitution of the Republic,
p.(None): I dictate the following
p.(None): Decree:
p.(None): The following Regulations of the National Control System for Pharmaceutical Products for Human Use be approved:
p.(None): PRELIMINARY TITLE:
p.(None): SCOPE OF APPLICATION AND COMPETENT AUTHORITIES.
p.(None): Article 1º.- This regulation includes the technical, administrative norms and other conditions or requirements that
p.(None): must comply with registration, import, internationalization and export, production, storage and possession, distribution to
p.(None): Free or onerous title, advertising and information on pharmaceutical products, as well as their use for
p.(None): scientific research.
p.(None): Article 2º.- It corresponds to the Ministry of Health, through the Undersecretariat of Public Health, to exercise a leading role
p.(None): and regulator in pharmaceutical products, for which it must approve the national drug policy and
p.(None): dictate the regulations and technical and administrative standards that public and private entities must comply with
p.(None): that address the activities indicated in the previous article, which will be approved through the acts
p.(None): administrative procedures that are relevant.
p.(None): Article 3.- The Institute of Public Health is the health authority in charge of the entire national territory of the
p.(None): sanitary control of pharmaceutical products and to ensure compliance with the provisions contained
p.(None): in these regulations, in the Health Code, in its complementary regulations and in other legal norms
p.(None): on the matter.
p.(None): It corresponds to exercise the actions of quality control of pharmaceutical products in any of the phases
p.(None): referred to in article 1, authorize the installation and operation of Pharmaceutical Laboratories, authorize
p.(None): and register pharmaceutical products and others subject to these control modalities, control the conditions of
p.(None): import and internment, export, manufacture, distribution, as well as the advertising and information of the
p.(None): same products, control narcotic drugs and dependency-causing pharmaceuticals and other substances
p.(None): psychotropic susceptible to supply analogous
p.(None): effect, with respect to their import, export and their lawful use in the product manufacturing process
p.(None): pharmacists and supervise compliance with the rules contained in these regulations and in the others that govern these
p.(None): subjects.
p.(None): www.bcn.cl - Library of the National Congress of Chile
p.(None): Article 4.- The Regional Ministerial Secretaries of Health, hereinafter the SEREMI, are the authorities
...
p.(None): 11) Key: Distinctive alphanumeric or numerical combination, which allows unique and unequaled identification in
p.(None): any of the stages of manufacture, storage, distribution and sale of a pharmaceutical product, for
p.(None): to ensure its traceability.
p.(None): 12) Counter sample: Finite portion of sample to be kept of the analyzed products, in the same terms
p.(None): of reference or retention samples.
p.(None): 13) Quarantine: Transitory condition of physical isolation or by other means, of raw materials, materials and
p.(None): intermediate, semi-finished, bulk, semi-finished or finished products, during which its
p.(None): use or distribution, while the decision is made on its release, rejection or reprocessing, in accordance with the
p.(None): Result of the respective quality control.
p.(None): 14) Dispensation: Act by which the pharmaceutical chemical professional
p.(None): provides a medication to a person, generally to fulfill the prescription of a licensed professional, to
p.(None): through which you are informed and guided about its use, influence of food, interactions with others
p.(None): medicines,
p.(None): www.bcn.cl - Library of the National Congress of Chile
p.(None): recognition of potential adverse reactions, storage conditions or other relevant information, all
p.(None): this according to what is authorized in the registry.
p.(None): 15) Distribution: Distribution of the pharmaceutical product that is made between producing establishments, importers,
p.(None): distributors, or other sanitary authorized to dispose of them.
p.(None): 16) Dosage: Interval of administration and period of treatment arranged for the dose of a medicine or
p.(None): pharmaceutical product.
p.(None): 17) Dose: The total quantity of a drug or pharmaceutical product contained in the authorized pharmaceutical form and
p.(None): that is administered at every opportunity.
p.(None): 18) Plant drug or plant material: The raw plant or parts of it, used for a medicinal purpose or
p.(None): pharmacist.
p.(None): 19) Efficacy: Aptitude of a medicine or pharmaceutical product to produce the proposed therapeutic effects,
p.(None): determined by scientific methods and clinical studies conducted in humans.
p.(None): 20) Insert: Cardboard sleeve or other material that protects the blister or strip and that contains the information of the brochure
p.(None): patient and / or authorized graphic labeling.
p.(None): 21) Dissolution tests: "In vitro" tests that, through defined experimental conditions, allow determining
p.(None): the dissolution rate of a solid active ingredient from a pharmaceutical form.
p.(None): 22) Dispenser container: That destined to pharmaceutical specialties of direct sale, allowed to be sold in
p.(None): blister, strips, envelopes, inserts or other protective system of the primary container, according to the conditions
p.(None): authorized in your registration.
p.(None): 23) Primary packaging: One that is used to contain a pharmaceutical product in its final pharmaceutical form
p.(None): and who is in direct contact with her.
p.(None): 24) Secondary container: One that being inviolable, also allows containing, protecting and preserving the primary container.
p.(None): 25) Clinical packaging: Those intended for exclusive use in pharmacies or first-aid kits of establishments
p.(None): medical-care, to be administered or delivered to patients who are treated therein, in accordance with the
p.(None): dosage and prescribed form.
p.(None): 26) Pharmaceutical equivalents: Pharmaceutical products that contain identical amounts of the same principles
p.(None): active ingredients or their same salts or esters, presented in the same pharmaceutical form and route of administration, but not
p.(None): they necessarily contain the same excipients and that they meet the same or comparable quality specifications.
...
p.(None): for the day, as approved in the respective health registry; beyond which it cannot be expected that
p.(None): product retain its stability.
p.(None): 43) Pharmaceutical form: Physical form in which a medication is presented, to facilitate its fractionation,
p.(None): dispensing, dosing and administration or employment.
p.(None): 44) Standard formula or master formula: Document or set of documents that specify raw materials and their
p.(None): quantities, as well as packaging packaging materials, along with a description of procedures and precautions
p.(None): required to produce a specific quantity of a finished product, also including the instructions for
p.(None): manufacturing and controls in process.
p.(None): 45) Import: It is the act by which a pharmaceutical product from abroad enters, enters and
p.(None): it is in condition to be distributed, complying with current regulations.
p.(None): 46) Impurities: Any component that is not defined as constituent of the raw material or product.
p.(None): 47) Internment: It is the act by which a pharmaceutical product from abroad enters a place of
p.(None): duly authorized storage, pending authorization for distribution and use.
p.(None): 48) License: Power or permission legally granted by a natural or legal person, which grants another the
p.(None): authorization to request, modify or cancel a sanitary registry, as its owner.
p.(None): 49) Plant markers: They are chemically defined constituents of the active ingredients of the plant, of
p.(None): interest for quality control purposes, regardless of whether or not they have therapeutic activity and that
p.(None): can be used to calculate the amount of active ingredients of the vegetable in the final product, provided that they have
p.(None): been quantified in the drug or vegetable preparation used as raw material in the preparation.
p.(None): 50) Tolerance margins: Percentages, maximum and minimum, officially allowed of an active principle declared in
p.(None): a product.
p.(None): 51) Raw material: Any substance of defined quality that is directly involved in the manufacture of the form
p.(None): pharmaceutical, whether it remains unchanged or is modified or eliminated in the course of the manufacturing process.
p.(None): 52) Packaging material: Material used as primary, secondary or insert packaging.
p.(None): 53) Monograph: Document containing the technical, pharmaceutical and scientific description of the characteristics and
p.(None): properties of a product.
p.(None): 54) Medical sample: Unit of a pharmaceutical specialty, exclusively intended for free distribution to
p.(None): professionals legally qualified for its prescription, whose labeling is identical to that of the registered product,
p.(None): with the indication of your condition as a medical sample, which may include information to the professional.
p.(None): 55) Reference samples or retention samples: These are the samples collected from each batch of finished product that
p.(None): must be maintained for up to one year after
p.(None): www.bcn.cl - Library of the National Congress of Chile
p.(None): the expiration date, in its final container and stored under the conditions indicated in the health record.
p.(None): 56) Sample or legal counter sample: Sample that has been taken by the health authority in use of its powers
p.(None): auditors, recording this fact in the respective act and under chain of custody conditions.
p.(None): 57) Generic name of a pharmaceutical product: Denomination accepted by the World Health Organization
...
p.(None): for its implementation by the technical professionals responsible for the establishment in which they are used, being
p.(None): used to complement production documentation and for quality assurance and control.
p.(None): 65) Bulk product: Product that is in its final pharmaceutical form.
p.(None): 66) Pharmaceutical association product: One that contains two or more principles incorporated in a form
p.(None): pharmaceutical.
p.(None): 67) Pharmaceutical combination product: One that consists of two or more pharmaceutical products that are
p.(None): They include in a single package to be administered sequentially or simultaneously.
p.(None): 68) Pharmaceutical reference or comparator product: Product determined by the health authority as such,
p.(None): compared to which another that requires evaluation of its therapeutic equivalence is compared.
p.(None): 69) Semi-finished product: Substance or mixture of partially processed substances, which precedes its form
p.(None): pharmaceutical and requiring more manufacturing stages.
p.(None): 70) Semi-finished product: Product that is in its final pharmaceutical form and primary packaging.
p.(None): 71) Finished product: Product that is in its final container, labeled and ready for distribution to any
p.(None): Title.
p.(None): 72) Production, production process, manufacturing, manufacturing or slaughter: set of operations involved in the
p.(None): obtaining a pharmaceutical product, from the acquisition and receipt of materials, to the release,
p.(None): storage and its corresponding quality controls.
p.(None): 73) Adverse Drug Reaction (ADR): The harmful and unintended reaction that occurs at doses used
p.(None): normally in the human being.
p.(None): 74) Serious adverse reaction: Any adverse reaction that is life threatening or life threatening or that
p.(None): implies serious disability or invalidity or that results in hospitalization or prolongation of the same.
p.(None): 75) Unexpected adverse reaction: Adverse reaction not mentioned in the product monograph,
p.(None): information to the patient and the prescribing professional authorized in the respective health registry.
p.(None): 76) Medical prescription: Order signed by a professional legally authorized to
p.(None): www.bcn.cl - Library of the National Congress of Chile
p.(None): This, in order for a quantity of one or more medications to be dispensed and administered as indicated in
p.(None): she.
p.(None): 77) Health registration: Evaluation process of a pharmaceutical product that, being favorable, results in a
p.(None): registration in a special role with correlative numbering maintained by the Institute, prior to its distribution and use.
p.(None): 78) Graphic labeling: Graphic representation that reproduces the officially authorized text in the respective registry
p.(None): sanitary, for the different types of packaging approved for the product, as appropriate.
p.(None): 79) Series or Lot: A defined quantity of raw material, packaging material or processed product, which is carried out in
p.(None): a single production cycle or through continuous stages, characterized by its homogeneity.
p.(None): 80) Subseries or Sublot: Specific and identified fraction of a batch.
p.(None): 81) Possession: It is the possession of a pharmaceutical product by a natural or legal person, whether or not it accredits a fair
p.(None): title for it.
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p.(None): of the Ministry, which include the dilution and dynamisation processes of their mother tinctures,
p.(None): which, in addition, must have been tested on healthy individuals and repertorized, to be prescribed or used
p.(None): according to the law of similarity. A homeopathic product may contain one or more homeopathic substances.
p.(None): Article 16.- They are medicinal gases, pharmaceutical specialties
p.(None): www.bcn.cl - Library of the National Congress of Chile
p.(None): consisting of one or more gaseous components of known concentration, limited degree of impurity and made from
p.(None): According to registered specifications, which is intended for administration to human beings, which will be governed by
p.(None): the specific regulations that regulate them.
p.(None): Article 17.- In addition to the groups indicated, they will be understood to be included within the pharmaceutical specialties,
p.(None): any other product that is labeled, advertised or attributed by any means, with therapeutic properties, be these
p.(None): curative, mitigation, treatment, diagnosis or prevention of diseases or their symptoms, or to modify
p.(None): physiological systems or mental state for the benefit of the person to whom it is administered, and that are not
p.(None): classifiable in any of the previous categories.
p.(None): The following are understood to be included in this final group, among others:
p.(None): a) Products for parenteral administration, whatever their composition, properties or effects.
p.(None): b) Vitamins, minerals and other nutrients, in the therapeutic doses determined in the technical standard
p.(None): respective approved by supreme decree of the Ministry.
p.(None): c) Products of animal or mineral origin, as well as those that constitute vegetable drug associations and
p.(None): vegetable preparations with active ingredients of different nature.
p.(None): TITLE II:
p.(None): OF THE SANITARY REGISTRY OF PHARMACEUTICAL SPECIALTIES AND OTHER PHARMACEUTICAL PRODUCTS
p.(None): FIRST PARAGRAPH:
p.(None): CONCEPT AND PURPOSE.
p.(None): Article 18.- The health registration of a pharmaceutical specialty consists of an evaluation and study process.
p.(None): systematic of its pharmaceutical, pharmacological, toxicological and clinical properties, intended to verify its
p.(None): quality, safety and efficacy, which translates into an enrollment in a special role with correlative numbering that
p.(None): maintains the Institute, which enables and authorizes its distribution and use in the country.
p.(None): The sanitary registry does not exempt its owner or user to any title, from the obligation to comply with the
p.(None): other legal or regulatory provisions that regulate the marketing of said products.
p.(None): The health registration may be requested by any natural or legal person, national or foreign, duly
p.(None): represented and domiciled in Chile.
p.(None): Article 19.- The administrative act of sanitary registration is independent of commercial or property aspects.
p.(None): intellectual or industrial of those who require or obtain it, in the terms provided for in article 49 of Law No.
p.(None): 19.039 on Industrial Property, whose consolidated, coordinated and systematized text was set by D.F.L. No. 3 of
p.(None): 2006, from the Ministry of Economy, Development and Reconstruction.
p.(None): Article 20.- Any pharmaceutical product imported or manufactured in the country, to be distributed or used to
p.(None): Any title in the national territory must previously have a health registry.
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p.(None): active on which the main therapeutic action is determined and its condition of sale is direct.
p.(None): Article 84.- The containers of all parenteral solutions of 100 ml or more, must bear a label that must indicate,
p.(None): in addition to the mentions of article 74, its date of manufacture in a clear, indelible and visible way,
p.(None): www.bcn.cl - Library of the National Congress of Chile
p.(None): indicating day, month and year and the warning to discard in case of turbidity or precipitate, unless these conditions
p.(None): are indicated as specifications of the finished product and authorized in the respective registry.
p.(None): In the case of solutions for parenteral use that contain electrolytes in monodrug, in addition to what is indicated in the
p.(None): previous paragraph, this must be indicated in the inscription of the label in letters of a defined color or, failing that,
p.(None): with a
p.(None): badge of the corresponding color. The Institute will establish the colors for each cation of the active principle of the
p.(None): respective solutions.
p.(None): Article 85º.- The quantity of pharmaceutical product must be expressed in weight, volume or unit, as the case may be.
p.(None): In the case of ampoules or vial-ampoules, each one shall bear the indications indicated for the primary containers and the
p.(None): amount of the active ingredient (s), unless by the size of the container, the Institute through resolution
p.(None): consider it appropriate to exempt, totally or partially, from some of these requirements.
p.(None): Article 86º.- The composition of the product must be reproduced in its active components, according to what is approved in
p.(None): registration shall be granted and shall also indicate the equivalence of the active ingredient (s) in its base drug and the
p.(None): qualitative list of all excipients.
p.(None): The composition of the formula will be expressed in percentages and in the respective unit dose in the case of syrups,
p.(None): solutions, emulsions, powders, ointments, creams and gels and other pharmaceutical forms of a similar nature.
p.(None): In the case of ampoules, capsules, tablets, dragees, ovules and suppositories, the composition formulas are
p.(None): will express for each unit dose.
p.(None): Those solid or liquid pharmaceutical forms that do not appear in units such as tablets, dragees, ovules
p.(None): or others similar, will also express the active principle or principles contained in the administration measures
p.(None): current or usual.
p.(None): Article 87º.- The labels must prominently indicate, when appropriate, the following legends:
p.(None): - "SUBJECT TO CONTROL OF NARCOTICS"
p.(None): - "SUBJECT TO PSYCHOTROPIC CONTROL"
p.(None): - "NATIONAL FORM"
p.(None): - "CLINICAL PACKAGE FOR MEDICAL AND CARE ESTABLISHMENTS ONLY"
p.(None): - "CLINICAL PACK FOR SALE IN AUTHORIZED PHARMACEUTICAL ESTABLISHMENTS"
p.(None): - "EXTERNAL USE"
p.(None): - "USE UNDER MEDICAL SUPERVISION"
p.(None): - "MEDICAL SAMPLE FORBIDDEN SALE"
p.(None): - R = Simple Recipe, RR = Retained Recipe, RCH = Recipe Check, VD = Direct Selling
p.(None): Article 88.- Any series or batch or sub-series or sublot of a pharmaceutical product will be identified by means of a password.
p.(None): that will allow it to be individualized in any of the stages, from its production to its dispensation or use.
p.(None): The structure of the code, for the purposes of its interpretation, must be informed to the Institute by the holder of the
p.(None): respective sanitary registry. In the same way it will proceed for its modifications and for different keys that
p.(None): can be used.
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p.(None): Once the above is accredited, the Institute will authorize, by resolution, the import of a quantity
p.(None): determined and will authorize its use and disposal with the sole merit of the authorization and the respective bulletins
p.(None): corresponding to the analyzes carried out by a quality control laboratory at the interned items.
p.(None): SECOND PARAGRAPH:
p.(None): OF IMPORT AND INTERNATION.
p.(None): Article 95.- The importation of pharmaceutical specialties may be carried out by laboratories.
p.(None): authorized pharmacists, pharmacies, drugstores and warehouses for pharmaceutical products and, in general, by anyone
p.(None): natural or legal person, in accordance with the rules established in current legislation.
p.(None): Article 96º.- Any natural or legal person may import pharmaceutical specialties, as well as materials
p.(None): raw materials for their production. Notwithstanding the foregoing, for admission to the national territory,
p.(None): will require having a duly authorized place for its storage, processing or subsequent distribution,
p.(None): such as: pharmaceutical laboratories, pharmacies, drugstores and warehouses of pharmaceutical products, as appropriate
p.(None): to the nature and purpose of the imported material.
p.(None): Article 97º.- Only the pharmaceutical production laboratories may enter pharmaceutical products in any
p.(None): of its production stages.
p.(None): The conditioning pharmaceutical laboratories may enter semi-finished pharmaceutical products.
p.(None): Regarding the pharmaceutical specialties that enter as a finished product, they can only be received and
p.(None): stored by establishments duly authorized for it.
p.(None): Raw materials destined for the manufacture of medicines or their marketing to producing establishments
p.(None): Of these, they may only be admitted by drug stores and pharmaceutical production laboratories.
p.(None): THIRD PARAGRAPH:
p.(None): OF THE PROCESS OF INTERNATION OF PHARMACEUTICAL PRODUCTS.
p.(None): www.bcn.cl - Library of the National Congress of Chile
p.(None): Article 98º.- For the hospitalization of all pharmaceutical products, a Certificate of Destination must be requested
p.(None): Customs office at SEREMI corresponding to the customs office of entry of the product, having to attach the background
p.(None): pertinent, in which the interned material, its quantity and its nature, as well as the
p.(None): route and means of transport to carry out your transfer from the customs premises to an authorized establishment for
p.(None): it.
p.(None): SEREMI must rule on the request referred to in the preceding paragraph, within three
p.(None): business days counted from the filing date of the petition and, in case of rejection, must do so by
p.(None): founded resolution.
p.(None): The SEREMI, through the Ministry, may sign agreements with other public entities for the issuance of the
p.(None): designated certificates, signed in accordance with the provisions of the Organic Constitutional Law of Bases
p.(None): Of the State Administration, Law No. 18,575, whose consolidated, coordinated and systematized text was set
p.(None): by D.F.L. Nº 1, from 2000, of the Ministry General Secretariat of the Presidency.
p.(None): Article 99.- To study any customs destination for pharmaceutical products, the interested party must present to the
p.(None): National Customs Service the certificate issued by the respective SEREMI.
p.(None): Once the processing of the customs destination document has been completed and the products have been removed from the
p.(None): customs, they will be deposited under the responsibility of the consignee, who will not be able to use, consume, sell,
...
p.(None): the quality requirements established in the respective sanitary registry, according to the general guidelines
p.(None): established in the Good Manufacturing and Laboratory Practices.
p.(None): Notwithstanding the foregoing, in the case of validations of pharmaceutical manufacturing processes, you may
p.(None): accept a compliance schedule.
p.(None): Article 176 ° .- The Institute may suspend, by reasoned resolution, the distribution of a pharmaceutical product
p.(None): that does not prove or comply with the requirements of the previous article. In this case, the owner may make the
p.(None): pertinent adjustments to ensure that the processes are validated, being able to restore the authorization for the
p.(None): distribution, after resolution of the Institute.
p.(None): Article 177 ° .- Any natural or legal person who has authorization to provisionally use a product
p.(None): pharmacist without prior health registration, according to letters a) and b) of article 21 of this regulation, will have
p.(None): the obligation to have instruments that guarantee product quality and to carry out tests and analyzes of
p.(None): quality control, to be determined in the resolution that authorized it.
p.(None): SECOND PARAGRAPH:
p.(None): QUALITY REQUIREMENTS
p.(None): Article 178 ° .- The quality requirements of pharmaceutical specialties will be established in the
p.(None): Product specifications and control methods to be used will be those approved when granting the respective
p.(None): sanitary registry or in its subsequent modifications.
p.(None): Article 179º.- The quality requirements of the raw materials destined to the manufacture of products
p.(None): pharmacists, will be those declared in the specifications of the health registry, being the responsibility of
p.(None): pharmaceutical laboratories for drug production, quality control and compliance with the others
p.(None): requirements, before distribution.
p.(None): Any change in the manufacturer of the active ingredient (s) that occurs after the granting of the
p.(None): sanitary registry, must be informed to the Institute, providing the background showing that the modification of
p.(None): origin does not affect the quality, efficacy and stability of the product, without prejudice to the power of the Institute to
p.(None): carry out a selective sampling in order to verify the specifications with which the registration was granted, for which
p.(None): which may request further information.
p.(None): THIRD PARAGRAPH:
p.(None): OF THE SERIAL CONTROL
p.(None): Article 180.- Without prejudice to the general quality control provisions indicated above, the
p.(None): Institute, by means of a founded resolution, may subject serial control, temporarily or permanently, to any
p.(None): product, taking into account its nature, the variability of the analysis methods used in its control or
p.(None): other reasons duly substantiated.
p.(None): Article 181 °. - For series control, the Institute of Public Health
p.(None): www.bcn.cl - Library of the National Congress of Chile
p.(None): determine, by resolution, the performance of all or part of the tests or analyzes included in the specifications
p.(None): of finished product, authorized in the respective sanitary registry and its frequency for each product.
p.(None): Article 182 ° .- The approval of the lot or sublot does not exempt the holder of the sanitary registry from the obligation of
p.(None): carry out the quality controls established by this regulation and its complementary regulations.
p.(None): Article 183 ° .- All biological products must undergo the serial control procedure.
p.(None): Article 184 ° .- The request for series control must correspond to a fully finished lot or sublot.
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p.(None): country recognized as accreditation, have been declared homologated by resolution of the Ministry of Health or that
p.(None): they appear in International Treaties.
p.(None): In case they are not homologated, the Institute will proceed in the manner indicated in the previous article at the expense of the
p.(None): Applicant for health registration or its owner, when appropriate.
p.(None): Article 194 °. - In the event that through the respective sanitary summary,
p.(None): www.bcn.cl - Library of the National Congress of Chile
p.(None): check for quality failures of three or more batches of different pharmaceutical products from the same line of
p.(None): production of a certain manufacturing laboratory, the Institute will modify the sanitary authorization, excluding the
p.(None): production line corresponding to said products or will proceed to the suspension of import and distribution
p.(None): authorized in the health registers of all those pharmaceutical specialties whose authorized manufacturer
p.(None): include that production line.
p.(None): TITLE VIII:
p.(None): OF THE ºDISTRIBUTION.
p.(None): Article 195 ° .- The distribution of the products will be done by the pharmaceutical production laboratories and
p.(None): conditioners, drugstores and
p.(None): warehouses for pharmaceutical products for human and dental use, under the conditions that for each of them are
p.(None): establish in the respective sanitary registry and only sanitary authorized establishments for their
p.(None): reception.
p.(None): Article 196 ° .- The sale to the public of pharmaceutical specialties may only be made in pharmacies, warehouses
p.(None): pharmaceuticals and warehouses of dental or other pharmaceutical products, under the conditions that for each of them
p.(None): are statutorily established.
p.(None): Pharmaceutical laboratories and drug stores may sell their products, manufactured or imported, to the public in
p.(None): separate enclosures within its physical plant and specially enabled for these purposes, under the conditions of
p.(None): approved outlets in the health registry. These venues will function under the responsibility of the Technical Director
p.(None): of the establishment or the chemical-pharmaceutical professional appointed. These venues must have the
p.(None): approval, regarding its location and operation, granted by the competent Institute or SEREMI of Health,
p.(None): respectively.
p.(None): Also, these establishments may sell such products to the public,
p.(None): in the approved sales conditions, in independent premises, separated from its physical plant, in charge of a
p.(None): chemical-pharmaceutical professional, prior
p.(None): authorization of the corresponding SEREMI of Health.
p.(None): Article 197 ° .- The condition of sale to the public of a pharmaceutical specialty will be determined in the respective
p.(None): health registration and in the case of use authorizations without health registration, in the respective resolution; for
p.(None): both cases will consider the therapeutic indications and authorized mode of use, as well as adverse reactions and
p.(None): product interactions.
p.(None): Article 198 °. - The condition of sale of a pharmaceutical specialty must be strictly observed in its
p.(None): sale or delivery to any title to users and may not be freely distributed anywhere, by any
p.(None): medium, or under any pretext or condition.
p.(None): Those units labeled and distributed directly and exclusively are excepted from the provisions of the preceding paragraph.
p.(None): professionals legally empowered to prescribe, as medical samples, in their consultations or at meetings
p.(None): scientific in which they participate, which must be provided directly by the professional to the patient.
...
p.(None): Notwithstanding the foregoing, vending companies may announce the price of pharmaceutical specialties,
p.(None): Whatever its condition of sale, by means of the exact reproduction of its labels in the places of sale.
p.(None): Products subject to special controls, such as psychotropic, are exempt from these provisions.
p.(None): and narcotics.
p.(None): Article 215.- In these establishments, advertising procedures that may induce the
p.(None): purchase, use or unspecified choice of medicines, such as raffles, raffles, donation of samples or other forms
p.(None): that stimulate consumption, misuse or self-medication, if applicable. Likewise, the sale of
p.(None): pharmaceutical products through incentives of any kind aimed at pharmacy staff.
p.(None): TITLE X:
p.(None): OF HEALTH SURVEILLANCE.
p.(None): FIRST PARAGRAPH:
p.(None): OF PHARMACOVIGILANCE.
p.(None): Article 216 °. - The Institute is the sanitary authority in charge of the security surveillance of the specialties
p.(None): Registered and non-registered pharmaceutical companies have been authorized for use in research
p.(None): scientific or provisional.
p.(None): Article 217 ° .- Health professionals have the duty to communicate to the Institute, all suspicions of
p.(None): Adverse reactions of which they are aware and which could have been caused by a certain product
p.(None): pharmacist.
p.(None): The same obligation will fall on the Technical Director of the healthcare establishments, which must maintain
p.(None): an updated record of these events.
p.(None): The communication of the information referred to in this article, must be made on the forms that for this purpose
p.(None): determine the Institute of Public Health, by resolution.
p.(None): In the case of suspicion of a serious adverse drug reaction, the communication must be made within
p.(None): 72 hours after taking
p.(None): www.bcn.cl - Library of the National Congress of Chile
p.(None): knowledge of the fact. In all other cases, you must communicate within the
p.(None): 30 days.
p.(None): Article 218 °. - The holders of sanitary registrations or authorizations must implement and maintain a system of
p.(None): pharmacovigilance, own or outsourced, being its Technical Advisor, responsible for:
p.(None): a) Create, adopt and maintain a documented system to collect and process information on a single file
p.(None): all suspected adverse reactions.
p.(None): b) Prepare and submit quarterly to the Institute of Public Health, information about suspicions of
p.(None): adverse reactions in the authorized forms, unless by means of a founded resolution the Institute determines a
p.(None): lower term.
p.(None): c) Ensure that a prompt and complete response is given to any request for additional information that the
p.(None): Institute of Public Health and that is necessary to evaluate the benefits and risks of a pharmaceutical specialty,
p.(None): within the terms established by that entity.
p.(None): In qualified cases, the Institute of Public Health, by founded resolution, may also provide special measures of
p.(None): pharmacovigilance for certain products.
p.(None): Article 219 °. - The holders of sanitary registry of pharmaceutical specialties will be obliged to maintain
p.(None): updated the information on product safety and a continuous evaluation of the risk-benefit ratio of the
p.(None): same, in accordance with the provisions of the Seventh Paragraph of Title II of this regulation.
p.(None): Article 220 ° .- The Institute will analyze the surveillance information
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p.(None): sanitary type, if so.
p.(None): 9) Quality control: Activities that aim to ensure batches during all stages of manufacturing
p.(None): product uniforms conforming to identity, potency, purity and other quality requirements
p.(None): established in their respective monographs, authorized in the corresponding health registry.
p.(None): 10) Shelf control: Verification of quality of a product that is in its sale and delivery stage
p.(None): to the public and which is carried out by the Institute or by the health authority with which it agrees, according to
p.(None): programs established by the Ministry at the proposal of the Institute.
p.(None): 11) Key: Distinctive alphanumeric or numerical combination, which allows unique and unequaled identification in
p.(None): any of the stages of manufacture, storage, distribution and sale of a pharmaceutical product, for
p.(None): to ensure its traceability.
p.(None): 12) Counter sample: Finite portion of sample to be kept of the analyzed products, in the same terms
p.(None): of reference or retention samples.
p.(None): 13) Quarantine: Transitory condition of physical isolation or by other means, of raw materials, materials and
p.(None): intermediate, semi-finished, bulk, semi-finished or finished products, during which its
p.(None): use or distribution, while the decision is made on its release, rejection or reprocessing, in accordance with the
p.(None): Result of the respective quality control.
p.(None): 14) Dispensation: Act by which the pharmaceutical chemical professional
p.(None): provides a medication to a person, generally to fulfill the prescription of a licensed professional, to
p.(None): through which you are informed and guided about its use, influence of food, interactions with others
p.(None): medicines,
p.(None): www.bcn.cl - Library of the National Congress of Chile
p.(None): recognition of potential adverse reactions, storage conditions or other relevant information, all
p.(None): this according to what is authorized in the registry.
p.(None): 15) Distribution: Distribution of the pharmaceutical product that is made between producing establishments, importers,
p.(None): distributors, or other sanitary authorized to dispose of them.
p.(None): 16) Dosage: Interval of administration and period of treatment arranged for the dose of a medicine or
p.(None): pharmaceutical product.
p.(None): 17) Dose: The total quantity of a drug or pharmaceutical product contained in the authorized pharmaceutical form and
p.(None): that is administered at every opportunity.
p.(None): 18) Plant drug or plant material: The raw plant or parts of it, used for a medicinal purpose or
p.(None): pharmacist.
p.(None): 19) Efficacy: Aptitude of a medicine or pharmaceutical product to produce the proposed therapeutic effects,
p.(None): determined by scientific methods and clinical studies conducted in humans.
p.(None): 20) Insert: Cardboard sleeve or other material that protects the blister or strip and that contains the information of the brochure
p.(None): patient and / or authorized graphic labeling.
p.(None): 21) Dissolution tests: "In vitro" tests that, through defined experimental conditions, allow determining
p.(None): the dissolution rate of a solid active ingredient from a pharmaceutical form.
p.(None): 22) Dispenser container: That destined to pharmaceutical specialties of direct sale, allowed to be sold in
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p.(None): conditioned for its use and designated with a generic name or another denomination. Those included shall be understood
p.(None): elements or devices suitable for administration, in cases where they are so presented.
p.(None): 29) Specifications: Technical document that defines the attributes of a raw material, material, product, service or
p.(None): other and that determines the variables that must be evaluated in them, describing all the tests, trials and analyzes
p.(None): used for their determination and establishing the acceptance or rejection criteria.
p.(None): 30) Stability: Ability to maintain the original properties within the specified specifications and
p.(None): authorized in the monograph of an active ingredient or of a finished pharmaceutical product, which allows to ensure its
p.(None): physical, chemical, biological and microbiological properties, where applicable, within specified limits,
p.(None): throughout its period of effectiveness.
p.(None): 31) Production status: manufacturing stage in which a pharmaceutical product is found in the process
p.(None): productive, distinguishing semi-finished, bulk, semi-finished or finished products.
p.(None): 32) Therapeutic equivalence study: Comparative study (clinical, bioavailability, pharmacodynamic or "in
p.(None): vitro ") between a reference or comparator pharmaceutical product and another under study.
p.(None): 33) Real-time stability study: Stability study carried out for the time proposed for the period of
p.(None): efficacy and under storage conditions, temperature and humidity determined according to the nature of the product.
p.(None): 34) Accelerated stability study: Stability study designed to increase the degradation rate
p.(None): chemical or physical changes of an active substance or a pharmaceutical product in its proposed primary packaging, using
p.(None): severe storage conditions, temperature and humidity, as part of a formal storage program,
p.(None): during a certain period of time according to the active ingredient under evaluation and whose results allow establishing
p.(None): its stability by
p.(None): www.bcn.cl - Library of the National Congress of Chile
p.(None): certain period.
p.(None): 35) Stability study: series of tests, trials and analyzes related to physical characteristics,
p.(None): chemical, biological and microbiological characteristics of an active ingredient or a pharmaceutical product, to obtain information
p.(None): on its stability, in order to define its period of effectiveness under certain packaging conditions and
p.(None): storage.
p.(None): 36) Bioavailability studies: Pharmacokinetic studies that, through a pre-established experimental design,
p.(None): allow to determine the bioavailability of an active principle.
p.(None): 37) Pharmacokinetic studies: "In vivo" tests that, through pre-established experimental designs, allow
p.(None): establish the kinetics of the processes of absorption, distribution, metabolism and excretion of the active ingredients and
p.(None): metabolites of a pharmaceutical product.
p.(None): 38) Evaluation of a pharmaceutical product: Systematic study of the background required of the interested party who
p.(None): requests the sanitary registration, regarding the relevance of the administrative and technical background, such as
p.(None): the pharmaceutical, pharmacological, toxicological, clinical and
p.(None): therapeutic, in order to determine or verify if the product is suitable for use in the proposed indications.
p.(None): 39) Excipient: Any raw material used in the manufacture of the products referred to in this
p.(None): regulation, which is not an active principle.
...
p.(None): dispensing, dosing and administration or employment.
p.(None): 44) Standard formula or master formula: Document or set of documents that specify raw materials and their
p.(None): quantities, as well as packaging packaging materials, along with a description of procedures and precautions
p.(None): required to produce a specific quantity of a finished product, also including the instructions for
p.(None): manufacturing and controls in process.
p.(None): 45) Import: It is the act by which a pharmaceutical product from abroad enters, enters and
p.(None): it is in condition to be distributed, complying with current regulations.
p.(None): 46) Impurities: Any component that is not defined as constituent of the raw material or product.
p.(None): 47) Internment: It is the act by which a pharmaceutical product from abroad enters a place of
p.(None): duly authorized storage, pending authorization for distribution and use.
p.(None): 48) License: Power or permission legally granted by a natural or legal person, which grants another the
p.(None): authorization to request, modify or cancel a sanitary registry, as its owner.
p.(None): 49) Plant markers: They are chemically defined constituents of the active ingredients of the plant, of
p.(None): interest for quality control purposes, regardless of whether or not they have therapeutic activity and that
p.(None): can be used to calculate the amount of active ingredients of the vegetable in the final product, provided that they have
p.(None): been quantified in the drug or vegetable preparation used as raw material in the preparation.
p.(None): 50) Tolerance margins: Percentages, maximum and minimum, officially allowed of an active principle declared in
p.(None): a product.
p.(None): 51) Raw material: Any substance of defined quality that is directly involved in the manufacture of the form
p.(None): pharmaceutical, whether it remains unchanged or is modified or eliminated in the course of the manufacturing process.
p.(None): 52) Packaging material: Material used as primary, secondary or insert packaging.
p.(None): 53) Monograph: Document containing the technical, pharmaceutical and scientific description of the characteristics and
p.(None): properties of a product.
p.(None): 54) Medical sample: Unit of a pharmaceutical specialty, exclusively intended for free distribution to
p.(None): professionals legally qualified for its prescription, whose labeling is identical to that of the registered product,
p.(None): with the indication of your condition as a medical sample, which may include information to the professional.
p.(None): 55) Reference samples or retention samples: These are the samples collected from each batch of finished product that
p.(None): must be maintained for up to one year after
p.(None): www.bcn.cl - Library of the National Congress of Chile
p.(None): the expiration date, in its final container and stored under the conditions indicated in the health record.
p.(None): 56) Sample or legal counter sample: Sample that has been taken by the health authority in use of its powers
p.(None): auditors, recording this fact in the respective act and under chain of custody conditions.
p.(None): 57) Generic name of a pharmaceutical product: Denomination accepted by the World Health Organization
p.(None): (O.M.S.), under the distinctive and initials "International Common Denominations" (D.C.I.) or International Non
p.(None): Proprietary Names (INN) and, failing that, in the officially recognized pharmacopoeias in the country.
p.(None): 58) Country of origin: One from which a pharmaceutical product is dispatched for import into our
p.(None): country, without considering those territories through which it transits.
p.(None): 59) Country of production: The country in which the manufacturing establishment of a pharmaceutical product is located, in
p.(None): any of the steps required to obtain a finished product.
p.(None): 60) Effective period: Period authorized by the Institute in the respective
p.(None): sanitary registration, during which a product must maintain its stability under the conditions of packaging and
p.(None): Storage defined in your stability study.
p.(None): 61) Potency: Therapeutic activity of a pharmaceutical product to produce a given effect, verified by tests
p.(None): laboratory tests or controlled clinical data, obtained through the administration of the product in the
p.(None): prescribed, recommended and approved employment conditions, which is expressed, according to the concentration of
p.(None): active ingredients that make up the formula
p.(None): of the product, in the weight / weight, weight / volume ratios, dose / volume unit or in units referred to a standard
p.(None): recognized internationally.
p.(None): 62) Vegetable preparation: Plant or parts of pulverized plant, its extract, tincture, squeezed juice, fatty oil or
p.(None): essential, rubber or resin or other product of a certain process, excluding its defined isolated constituents
p.(None): chemically or their mixtures, without prejudice to the possibility of containing other components, such as solvents,
p.(None): diluents or preservatives, which must be declared.
p.(None): 63) Active ingredient: Substance or mixture of substances with a specific pharmacological effect, or that without
p.(None): possess pharmacological activity, being administered to the body they acquire it.
p.(None): 64) Standard Operating Procedure (POE): Written document containing updated instructions, numbered in
p.(None): logical and continuous sequence, to carry out operations of a general nature, not necessarily limited to a
p.(None): specific product or material, which must be designed, reviewed and updated by competent and authorized personnel
p.(None): for its implementation by the technical professionals responsible for the establishment in which they are used, being
p.(None): used to complement production documentation and for quality assurance and control.
p.(None): 65) Bulk product: Product that is in its final pharmaceutical form.
p.(None): 66) Pharmaceutical association product: One that contains two or more principles incorporated in a form
p.(None): pharmaceutical.
p.(None): 67) Pharmaceutical combination product: One that consists of two or more pharmaceutical products that are
p.(None): They include in a single package to be administered sequentially or simultaneously.
p.(None): 68) Pharmaceutical reference or comparator product: Product determined by the health authority as such,
p.(None): compared to which another that requires evaluation of its therapeutic equivalence is compared.
p.(None): 69) Semi-finished product: Substance or mixture of partially processed substances, which precedes its form
p.(None): pharmaceutical and requiring more manufacturing stages.
p.(None): 70) Semi-finished product: Product that is in its final pharmaceutical form and primary packaging.
p.(None): 71) Finished product: Product that is in its final container, labeled and ready for distribution to any
p.(None): Title.
p.(None): 72) Production, production process, manufacturing, manufacturing or slaughter: set of operations involved in the
p.(None): obtaining a pharmaceutical product, from the acquisition and receipt of materials, to the release,
p.(None): storage and its corresponding quality controls.
p.(None): 73) Adverse Drug Reaction (ADR): The harmful and unintended reaction that occurs at doses used
p.(None): normally in the human being.
p.(None): 74) Serious adverse reaction: Any adverse reaction that is life threatening or life threatening or that
p.(None): implies serious disability or invalidity or that results in hospitalization or prolongation of the same.
p.(None): 75) Unexpected adverse reaction: Adverse reaction not mentioned in the product monograph,
p.(None): information to the patient and the prescribing professional authorized in the respective health registry.
p.(None): 76) Medical prescription: Order signed by a professional legally authorized to
p.(None): www.bcn.cl - Library of the National Congress of Chile
p.(None): This, in order for a quantity of one or more medications to be dispensed and administered as indicated in
p.(None): she.
p.(None): 77) Health registration: Evaluation process of a pharmaceutical product that, being favorable, results in a
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p.(None): quality specifications referring to official texts, has been modified without prior authorization or without giving
p.(None): compliance with said specifications.
p.(None): 4. Counterfeit pharmaceutical product: That pharmaceutical product that does not
p.(None): has a sanitary registration or authorization or that has been manufactured or imported by someone who does not have authorization
p.(None): sanitary for it. Counterfeit products will also be understood as those distributed or sold by those who do not
p.(None): You have authorization for it.
p.(None): The Institute will supervise the existence of pharmaceutical products in these situations, being able to apply the measures
p.(None): sanitary that proceed and, previous the instruction of the corresponding summary, the sanctions that there are place.
p.(None): The SEREMI will be responsible for supervising the sale and dispensing of products found in any of
p.(None): the conditions described, with the same powers as the previous paragraph.
p.(None): SEREMIs must inform the Institute of their findings related to the
p.(None): www.bcn.cl - Library of the National Congress of Chile
p.(None): previous paragraph, in order for the latter to carry out the inspections, have
p.(None): the measures and instruct the pertinent summaries regarding the holders of the sanitary registries, the
p.(None): manufacturers, importers or distributors, as appropriate.
p.(None): Likewise, the Institute or SEREMI, as the case may be, must make the respective complaint to the Public Ministry with
p.(None): the purpose that it investigates and establishes the penal responsibilities that proceed.
p.(None): TITLE I:
p.(None): OF PHARMACEUTICAL PRODUCTS.
p.(None): FIRST PARAGRAPH:
p.(None): OF ITS DEFINITION.
p.(None): Article 7º.- Pharmaceutical product or medicine is any substance, natural or synthetic, or a mixture of them, that
p.(None): is intended for the human being for the purpose of curing, mitigating, treating, preventing or diagnosing diseases or
p.(None): their symptoms, to modify physiological systems or mental state for the benefit of the person to whom it is
p.(None): administered.
p.(None): Active raw materials, pharmaceutical preparations, specialties are considered pharmaceutical products.
p.(None): pharmaceutical and traditional herbal medicines.
p.(None): Article 8º.- The Institute will be responsible for determining, through a well-founded resolution, the corresponding control regime
p.(None): apply to all those products that are attributed or possess some of the properties indicated in the article
p.(None): above and are labeled or advertised as food, being resolved as much binding
p.(None): to those products that want to be distributed and sold for the first time, such as those that are in
p.(None): circulation.
p.(None): The determination of the control regime to be applied may be carried out ex officio or at the request of individuals or others
p.(None): public bodies that in the exercise
p.(None): of their inspection activities detect products in the conditions indicated in the first paragraph of this
p.(None): Article.
p.(None): For the determination of the applicable control regime requested by the SEREMI, they will send the Institute a
p.(None): technical report and copy of all the antecedents in their possession, as well as, when appropriate, the
p.(None): results of its inspection and inspection activities.
p.(None): If the Institute determines that the control regime to be applied is that of a pharmaceutical product, the resolution
p.(None): that it so determines will be published in the Official Gazette and the interested party will be notified in order to request their
...
p.(None): vegetable marker, where applicable.
p.(None): b.5. They may not include narcotic or psychotropic substances, nor mixtures with allopathic medicines.
p.(None): b.6. The identity and purity of the components will be established according to what the pharmacopoeias or
p.(None): international or foreign sources of scientific information, and the corresponding validation of
p.(None): the proposed analytical methodology.
p.(None): b.7. The analytical methodology for the evaluation of the finished product as well as its raw materials must appear
p.(None): in any of the pharmacopoeias officially accepted in our country or in foreign scientific information sources
p.(None): or the corresponding validation of the proposed analytical methodology must be presented.
p.(None): b.8. They must comply with the specifications of the finished product according to the pharmaceutical form in which they
p.(None): they are presented, however the valuation of the active ingredient (s) in the finished product may be excepted,
p.(None): replacing it with the valuation of the specific plant marker.
p.(None): b.9. Products containing isolated or synthetic active principles will not be considered as phytopharmaceuticals, although
p.(None): are prepared from raw materials of plant origin.
p.(None): Article 41º.- Regarding the sanitary registry of homeopathic products, considering their nature, they will be kept in
p.(None): Consideration of the following details about the following matters:
p.(None): a) Regarding the pharmaceutical quality history of the product:
p.(None): a.1. The generic names of its active ingredients will be expressed in Latin, as established in the
p.(None): recognized pharmacopoeias.
p.(None): a.2. In qualitative-quantitative formulas, each homeopathic substance must be expressed with its Latin name
p.(None): followed by its final degree of dilution, that is, in the finished product, plus its concentration.
p.(None): a.3. There must be a clear and complete description of the raw material or materials of the heading used in the
p.(None): preparation of the homeopathic substance, its characterization, method of preparation and physical-chemical controls
p.(None): effected.
p.(None): a.4. The description of the manufacturing method or methods used in the preparation of the product must be included.
p.(None): finished.
p.(None): to 5. Homeopathic pharmaceutical products must meet the finished product specifications according
p.(None): to the pharmaceutical form in which they are presented, like any other type of medicine, with the exception of
p.(None): valuation of the active ingredient (s) in the finished product.
p.(None): a.6. When homeopathic products are administered in the form of conventional tablets, tests should be carried out
p.(None): of disintegration to replace the dissolution test.
p.(None): b) Regarding the presentation of antecedents that support the efficacy and safety of the product, they may be used
p.(None): in addition to the texts expressly mentioned in article 33 of this decree, other pharmacopoeias, documents
p.(None): issued by WHO expert committees or others recognized by supreme decree of the Ministry, issued under the
p.(None): formula "By order of the President of the Republic",
p.(None): www.bcn.cl - Library of the National Congress of Chile
p.(None): at the proposal of the Institute.
p.(None): Article 42º.- In the case of sanitary registration of biological products, requests, in addition to complying with the
p.(None): general requirements regarding the product to be registered, must observe the following details and
p.(None): Accompany the background information regarding:
p.(None): a) Name of the product, in the following order:
p.(None): a.1. Fantasy name or in its case the generic name (INN) or pharmacopoeia. In the case of vaccines, the
p.(None): Latin name according to the disease against which it protects.
p.(None): a.2. The production process when the active ingredients are living or dead microorganisms; mentioning the
...
p.(None): with such protection;
p.(None): c) The pharmaceutical product whose registration is requested includes a new therapeutic utility, dosage scheme,
p.(None): extension of a previously approved route of administration or age group, with respect to one already registered;
p.(None): d) The pharmaceutical product whose health registration is requested presents: a modification in the composition and
p.(None): concentration of the active ingredients of an already registered formula; or contains new salts, esters, complexes or
p.(None): isoforms of the active ingredients that make up a pharmaceutical specialty already registered; or constitutes
p.(None): combinations of active ingredients at fixed doses, which separately or not have a health registry;
p.(None): e) In all cases in which the pharmaceutical product, whose registration is requested is presented in a form
p.(None): pharmaceutical different from another registered and that modifies the release of the active ingredient (s);
p.(None): f) In the cases that a sanitary registration of a combination pharmaceutical product is requested for the first time;
p.(None): g) When the sanitary registration of a biological product is requested.
p.(None): Article 54º.- In the case of requests for health registration of homeopathic pharmaceutical products, they may only
p.(None): use a simplified registration procedure when they copulatively meet the following conditions:
p.(None): a) Route of oral or external administration;
p.(None): b) Absence of a particular therapeutic indication in the graphic labeling project or in the draft brochure
p.(None): information to the professional and the patient;
p.(None): c) Be made up of a single homeopathic substance, in a degree of dilution that guarantees the safety of the
p.(None): medication, and
p.(None): d) The homeopathic substance that makes up the pharmaceutical must be
p.(None): obtained from substances or raw materials of plant, animal, mineral or chemical origin found
p.(None): described in recognized pharmacopoeias, according to a homeopathic manufacturing procedure that is also found
p.(None): described in
p.(None): said texts.
p.(None): FIFTH PARAGRAPH:
p.(None): VALIDITY, SUSPENSION AND CANCELLATION OF THE SANITARY REGISTRY.
p.(None): Article 55º.- The sanitary registry of a pharmaceutical specialty will be valid for five years, counted from
p.(None): the date of the resolution that grants it, and it may be renewed for equal and successive periods, provided there is no
p.(None): been canceled and the following conditions are met:
p.(None): 1. Payment of the corresponding fee.
p.(None): 2. Overcoming of the observations made for the suspension of the sanitary registration within the term granted
p.(None): for it. In the event that the validity of the sanitary registry expires pending that period, the
p.(None): renewal within 15 days after the expiration of the period granted to overcome said observations.
p.(None): 3. Non-existence of fines pending payment or compliance with other sanitary measures or sanctions applied by the
p.(None): Institute, if applicable, in relation to the registration to be renewed.
p.(None): www.bcn.cl - Library of the National Congress of Chile
p.(None): The renewal of the sanitary registry must be denied when the non-compliance of some of the
p.(None): obligations that correspond to the holder of the sanitary registry.
p.(None): Article 56º.- The request for renewal of the health registration must be submitted to the Institute and, in the case of
p.(None): imported products, must be accompanied by the Pharmaceutical Product Certificate or Registration Certificate or
p.(None): Health authorization certificate or official certification recommended by the World Health Organization,
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p.(None): manufacturing and inducing potential allergic reactions in certain individuals.
p.(None): b.12. If there are colorants in the composition of the product, they must be specified with their generic names or, in the absence of
p.(None): of these, by their chemical designation or their equivalents that they have in the Indices of Dyes allowed and approved
p.(None): in the country by the corresponding technical standard, approved by the Supreme Decree of the Ministry. The same provision will be
p.(None): applicable when using colored capsules.
p.(None): c) Requirements for the active ingredient (s), including specification of quality and purity as well as the methods
p.(None): control thereof, accompanying the following information:
p.(None): c.1. Declare manufacturer and supplier of the active ingredient.
p.(None): c.2. Declare supplier as well as the traceability, when appropriate, of the reference standard used for the
p.(None): qualification of the active principle.
p.(None): c.3. Storage conditions of the active ingredient: temperature, humidity and quality of the container.
p.(None): c.4. Description of other desired elements and related compounds, their properties and characteristics:
p.(None): structure, biological activity or other.
p.(None): c.5. When describing active ingredients from human blood or blood products, the
p.(None): procedures used to ensure the maximum absence of potentially pathogenic agents that may
p.(None): be transmitted, including:
p.(None): c.5.1. Donor selection protocol.
p.(None): c.5.2. Plasma fractionation method.
p.(None): c.5.3. All the tests carried out on the plasma, before and during the process, including the determination of
p.(None): Hepatitis B surface antigens (HBV) and antibodies against Human Immunodeficiency Viruses (HIV)
p.(None): and against the Hepatitis C virus (HCV) and others that proceed.
p.(None): c.5.4. Storage temperature of the active ingredient and its controls.
p.(None): c.5.5. Validity period and expiration date.
p.(None): c.5.6. Inactivation methods for infectious contaminants that may be contained in the starting material, products
p.(None): intermediates and final products.
p.(None): d) Manufacturing method:
p.(None): d.1. Description of the manufacturing method of the product, including the controls in process and its tolerance.
p.(None): d.2. Description of the manufacturing process, which must include the description of the raw materials, stages
p.(None): criticism and reprocessing, when appropriate, also include the way in which the controls to be used were selected
p.(None): as routine in the control of the finished product.
p.(None): d.3. Description of the source and starting materials for the preparation of the biological active ingredient.
p.(None): d.4. Describe the actions taken to avoid or control contamination by adventitious agents, both viral
p.(None): such as HIV, HBV, HCV, among others, as non-virals, such as agents
p.(None): www.bcn.cl - Library of the National Congress of Chile
p.(None): of Transmissible Spongiform Encephalopathy (TSE), bacteria, mycoplasma or fungi.
p.(None): d.5. Description and background of the validation process.
p.(None): e) Excipient Control:
p.(None): e.1. Attach the quality and purity specification as well as the control methods of the excipients to be used in
p.(None): the formulation, adjusting to the requirements contemplated in official texts authorized in these regulations or
p.(None): monographs thereof, if not indicated in said texts.
p.(None): e.2. Attach accreditation about the absence of raw materials from animal species affected by
p.(None): TSEs or other transferable.
p.(None): f) Control of finished product:
p.(None): f.1. You must include at least the following information:
p.(None): . Description and appearance (physical state, color, odor, and clarity, where applicable);
p.(None): . Selective identification for the active ingredient (s);
p.(None): . Assessment, potency or activity of the active ingredient (s);
p.(None): . Determination of impurities, when appropriate;
p.(None): . Description of the nature and type of packaging material, both primary and secondary packaging, and accessories,
p.(None): when the latter are in contact with the pharmaceutical product;
p.(None): . Any other determined by resolution of the Institute, according to the nature and composition of the product
p.(None): biological.
p.(None): f.2. Indicate the acceptance criteria and maximum and minimum values when they are determining factors.
p.(None): f.3. Summary sheet, which includes the analytical parameters and their acceptance criteria with which the
p.(None): biological product. This document, once official, will become the specifications of the finished product,
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p.(None): 65) Bulk product: Product that is in its final pharmaceutical form.
p.(None): 66) Pharmaceutical association product: One that contains two or more principles incorporated in a form
p.(None): pharmaceutical.
p.(None): 67) Pharmaceutical combination product: One that consists of two or more pharmaceutical products that are
p.(None): They include in a single package to be administered sequentially or simultaneously.
p.(None): 68) Pharmaceutical reference or comparator product: Product determined by the health authority as such,
p.(None): compared to which another that requires evaluation of its therapeutic equivalence is compared.
p.(None): 69) Semi-finished product: Substance or mixture of partially processed substances, which precedes its form
p.(None): pharmaceutical and requiring more manufacturing stages.
p.(None): 70) Semi-finished product: Product that is in its final pharmaceutical form and primary packaging.
p.(None): 71) Finished product: Product that is in its final container, labeled and ready for distribution to any
p.(None): Title.
p.(None): 72) Production, production process, manufacturing, manufacturing or slaughter: set of operations involved in the
p.(None): obtaining a pharmaceutical product, from the acquisition and receipt of materials, to the release,
p.(None): storage and its corresponding quality controls.
p.(None): 73) Adverse Drug Reaction (ADR): The harmful and unintended reaction that occurs at doses used
p.(None): normally in the human being.
p.(None): 74) Serious adverse reaction: Any adverse reaction that is life threatening or life threatening or that
p.(None): implies serious disability or invalidity or that results in hospitalization or prolongation of the same.
p.(None): 75) Unexpected adverse reaction: Adverse reaction not mentioned in the product monograph,
p.(None): information to the patient and the prescribing professional authorized in the respective health registry.
p.(None): 76) Medical prescription: Order signed by a professional legally authorized to
p.(None): www.bcn.cl - Library of the National Congress of Chile
p.(None): This, in order for a quantity of one or more medications to be dispensed and administered as indicated in
p.(None): she.
p.(None): 77) Health registration: Evaluation process of a pharmaceutical product that, being favorable, results in a
p.(None): registration in a special role with correlative numbering maintained by the Institute, prior to its distribution and use.
p.(None): 78) Graphic labeling: Graphic representation that reproduces the officially authorized text in the respective registry
p.(None): sanitary, for the different types of packaging approved for the product, as appropriate.
p.(None): 79) Series or Lot: A defined quantity of raw material, packaging material or processed product, which is carried out in
p.(None): a single production cycle or through continuous stages, characterized by its homogeneity.
p.(None): 80) Subseries or Sublot: Specific and identified fraction of a batch.
p.(None): 81) Possession: It is the possession of a pharmaceutical product by a natural or legal person, whether or not it accredits a fair
p.(None): title for it.
p.(None): 82) Health Record Holder: Natural or legal person, national or foreign, domiciled in Chile, whose
p.(None): name is on a health record.
p.(None): 83) Traceability of analytical data: Property or characteristic that has the result of a measurement or the value of
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p.(None): its distribution.
p.(None): 1º Of the Pharmaceutical Production Laboratories.
p.(None): Article 122 ° .- The physical plant of a pharmaceutical production laboratory must consider, at least the
p.(None): following areas, which will be
p.(None): www.bcn.cl - Library of the National Congress of Chile
p.(None): clearly specified in the diagrams presented and approved by the Institute:
p.(None): a) Reception and sampling of materials and products.
p.(None): b) Quarantine of materials and products.
p.(None): c) Sampling of raw materials.
p.(None): d) Fractionation of raw materials.
p.(None): e) Storage of approved materials.
p.(None): f) Storage of rejected materials.
p.(None): g) Manufacturing.
p.(None): h) Washing and drying of utensils and materials.
p.(None): i) Primary packaging and labeling.
p.(None): j) Secondary packaging and labeling.
p.(None): k) Quarantine of finished products and those subject to serial control, when appropriate.
p.(None): l) Storage of approved finished products.
p.(None): m) Storage of reference samples and counter samples.
p.(None): n) Storage of recalled products.
p.(None): o) Storage of rejected products.
p.(None): p) Storage of returned products.
p.(None): q) Storage of products in process.
p.(None): r) Quality control laboratory.
p.(None): s) Areas for quality control operations of products in process.
p.(None): t) Manufacture and sterile and aseptic fractionation of pharmaceutical products, in accordance with Good Practices
p.(None): Manufacturing, when applicable.
p.(None): u) Expedition or dispatch.
p.(None): v) Maintenance.
p.(None): w) Offices for responsible professionals.
p.(None): x) Bathroom and changing rooms for the use of personnel, prior to entering or leaving the plant, as appropriate.
p.(None): In the cases of the zones described in letters b), e), k) and l), no physically separate sections will be required,
p.(None): if there is an electronic system that allows adequate control of the different states of the materials.
p.(None): The Pharmaceutical Production Laboratories may outsource, in independent premises, the areas of
p.(None): storage of finished products. If the independent premises are owned by the laboratory, it will constitute a
p.(None): expansion of its plant; whereas if it belongs to a third party, the latter must have the authorization
p.(None): corresponding sanitary, issued by the respective SEREMI, which must supervise the activity that it
p.(None): develop, in accordance with the general storage requirements provided in these regulations.
p.(None): Article 123 ° .- The area corresponding to production must be structured, equipped and enabled, according to the forms
p.(None): Pharmaceuticals that are manufactured and controlled to prevent cross contamination.
p.(None): Article 124 ° .- The manufacturing and packaging areas may constitute a single unit, when systems are used
p.(None): serial production technicians, who do not allow separating the different stages of product development and always
p.(None): that the necessary measures be taken to avoid cross contamination.
p.(None): Article 125 ° .- The manufacture and packaging of sterile pharmaceutical products can only be carried out in rooms
p.(None): specially enabled for this purpose, also complying with the necessary conditions to execute:
p.(None): a) The sterile fractionation of non-sterilizable products in final containers.
p.(None): b) The aseptic fractionation of sterilizable products in final containers.
p.(None): Article 126 ° .- When laboratory animals are used, they must be kept in isolated enclosures and
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p.(None): risky materials.
p.(None): Article 130 °. - Only in rooms properly conditioned and equipped to minimize the risk of contamination,
p.(None): may:
p.(None): a) Manipulate microorganisms, toxins, cell cultures and others determined by the Institute.
p.(None): b) Prepare and package biological products that contain microorganisms, toxins, cell cultures and others.
p.(None): In any case, the packaging of the processed products must be carried out in areas of controlled contamination.
p.(None): 2nd Of the Pharmaceutical Conditioning Laboratories.
p.(None): Article 131 ° .- The physical plant of the Conditioning Pharmaceutical Laboratories must consider, at least, the
p.(None): following areas:
p.(None): a) Reception and sampling of materials and products.
p.(None): b) Quarantine of materials and products.
p.(None): c) Storage of approved materials and products.
p.(None): d) Conditioning.
p.(None): e) Quarantine of finished products and those subject to serial control, when appropriate.
p.(None): f) Storage of approved finished product.
p.(None): g) Storage of rejected and withdrawn materials and products, duly circumscribed.
p.(None): h) Storage of returned finished products.
p.(None): i) Storage of reference samples and counter samples.
p.(None): j) Expedition or dispatch.
p.(None): k) Maintenance: if applicable.
p.(None): l) Quality control regarding the production line or lines that are developed, including at least
p.(None): an area for the analysis of labeling material, packaging and finished product with respect to its graphic labeling.
p.(None): m) Office for the responsible professional or professionals.
p.(None): n) Bathrooms and changing rooms.
p.(None): In the cases of the zones described in letters b), c) e) and f), no physically separate sections will be required, if
p.(None): There is an electronic system that allows adequate control of the different states of the materials.
p.(None): 3rd Of the Pharmaceutical Quality Control Laboratories.
p.(None): Article 132 ° .- The External Quality Control Pharmaceutical Laboratory, or the quality control department of
p.(None): a Pharmaceutical Production Laboratory,
p.(None): www.bcn.cl - Library of the National Congress of Chile
p.(None): You must have the following areas, as appropriate to your lines of activities:
p.(None): a) Reception and storage of samples.
p.(None): b) Storage of counter samples.
p.(None): c) Physical-chemical analysis.
p.(None): d) Material washing.
p.(None): e) Instrument room.
p.(None): f) Microbiology, as appropriate.
p.(None): g) Analysis of packaging materials.
p.(None): h) Biological tests.
p.(None): i) Bioterios.
p.(None): j) Office (s) for the professional (s) responsible (s).
p.(None): k) Bathrooms and changing rooms.
p.(None): l) Storage of reagents.
p.(None): These sections must have a sufficient number of rooms or areas to ensure that the testing systems
p.(None): are isolated from each other.
p.(None): Article 133 ° .- The quality control department of a Pharmaceutical Production Laboratory must have
p.(None): the areas indicated in the previous article, in what corresponds to their line of activities.
p.(None): In cases where a microbiology area is available, there must be separate sterility rooms, counting
p.(None): and washing.
p.(None): This service may be contracted externally, except in the case of quality controls carried out in the process.
p.(None): from production to the primary packaging stage inclusive, in the manufacture of injectable products and those
p.(None): that are made by aseptic filling.
p.(None): 4º Considerations common to all the physical plants of a Pharmaceutical Laboratory.
p.(None): Article 134 ° .- All physical plants must comply with the requirements established in the Good Practices of
p.(None): Manufacturing and Laboratory.
p.(None): Article 135 ° .- The manufacture of products with highly active principles, such as hormones, cytostatics,
p.(None): Beta-lactams, radiopharmaceuticals, and immunosuppressants contained in international or other authorized or
p.(None): recognized by the Institute through a well-founded resolution, must be carried out in special facilities and
p.(None): independent or isolated as appropriate, from those used in the elaboration of the other products, taking
p.(None): the special measures required for personnel handling such products, in terms of clothing and items
p.(None): protectors that avoid health risks, as determined in the technical standards approved by decree
p.(None): supreme of the Ministry, dictated under the formula "By order of the President of the Republic" at the proposal of the Institute.
p.(None): By founded resolution of the Institute, the lists of highly active principles that may be established will also be established.
p.(None): be manufactured or conditioned in common areas, using the campaign work system, with validated methods
p.(None): cleaning areas and equipment.
p.(None): Article 136 ° .- The production and quality control areas will be physically separated, without prejudice to the
p.(None): quality control applied in the same production process.
p.(None): FIFTH PARAGRAPH:
p.(None): THE PROCEDURES AND RECORDS.
p.(None): Article 137 °. - Of each one of the operations carried out in the production stage, a record must be made
p.(None): written, which must faithfully correspond to the standard production operating procedure and Good
p.(None): Manufacturing practices.
p.(None): Article 138 ° .- There must be a master formula for each product
p.(None): www.bcn.cl - Library of the National Congress of Chile
p.(None): and batch size to be manufactured, which corresponds faithfully to the qualitative-quantitative unit formula, authorized in the
p.(None): respective sanitary registry.
p.(None): Article 139 ° .- The production process of each series or batch of a product must be consigned in documents
p.(None): sheets called "Manufacturing form" and "Container-packaging or conditioning form", which must
p.(None): stay permanently updated. In the case of pharmaceutical conditioning laboratories, only
p.(None): the "Conditioning sheet" will apply.
p.(None): Article 140 ° .- The manufacturing worksheet is the foliated document based on the pertinent parts of the formula
p.(None): updated teacher. It must include, at least, the following information:
p.(None): a) Product individualization.
p.(None): b) Quantity to manufacture.
p.(None): c) Serial number assigned according to the authorized key.
p.(None): d) Manufacturing start and end dates.
p.(None): e) Qualitative and quantitative formula, which must correspond proportionally to the formula authorized in the
p.(None): Health Register.
p.(None): f) Raw materials used in the manufacture of the product.
p.(None): g) Number of analysis bulletins of raw materials used in the manufacture of the product.
...
Social / Access to Social Goods
Searching for indicator access:
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p.(None): in force, the Institute will issue within 30 days, a founded resolution that will reject the request for
p.(None): functioning.
p.(None): If the accompanied background is sufficient, the Institute will issue within 30 days, a resolution
p.(None): authorizing the operation of the laboratory, which will contain the following mentions:
p.(None): 1. Name, category and address of the pharmaceutical laboratory.
p.(None): 2. Legal representative and professionals who assume technical responsibilities.
p.(None): 3. Lines of activities, production and / or authorized analysis.
p.(None): FOURTH PARAGRAPH:
p.(None): PHYSICAL PLANT REQUIREMENTS OF PHARMACEUTICAL LABORATORIES.
p.(None): Article 118 ° .- All pharmaceutical laboratories will be specially designed and their size and construction must comply
p.(None): with the provisions of these regulations and Good Manufacturing and Laboratory Practices, as appropriate to its
p.(None): category. The location should be such that it is not close to
p.(None): establishments that, due to the activities they carry out, are a source of contamination, nor that in turn originate it in their
p.(None): environment.
p.(None): Article 119 ° .- The laboratory must have special and independent rooms for the storage of
p.(None): flammable or explosive, corrosive, toxic and polluting risks substances. These enclosures
p.(None): They will strictly comply with the security measures determined by the competent bodies.
p.(None): Article 120 ° .- The laboratory that manufactures or packages pharmaceutical products that have active ingredients
p.(None): narcotic, psychotropic or others subject to special controls, must have storage areas
p.(None): independent and restricted access.
p.(None): Article 121 ° .- The establishments that import, manufacture, package, condition or distribute under any title
p.(None): biological products or others that require special storage conditions, according to what is authorized in the
p.(None): respective sanitary registry, they must ensure the conservation of temperature and keep records of them until
p.(None): its distribution.
p.(None): 1º Of the Pharmaceutical Production Laboratories.
p.(None): Article 122 ° .- The physical plant of a pharmaceutical production laboratory must consider, at least the
p.(None): following areas, which will be
p.(None): www.bcn.cl - Library of the National Congress of Chile
p.(None): clearly specified in the diagrams presented and approved by the Institute:
p.(None): a) Reception and sampling of materials and products.
p.(None): b) Quarantine of materials and products.
p.(None): c) Sampling of raw materials.
p.(None): d) Fractionation of raw materials.
p.(None): e) Storage of approved materials.
p.(None): f) Storage of rejected materials.
p.(None): g) Manufacturing.
p.(None): h) Washing and drying of utensils and materials.
p.(None): i) Primary packaging and labeling.
p.(None): j) Secondary packaging and labeling.
p.(None): k) Quarantine of finished products and those subject to serial control, when appropriate.
p.(None): l) Storage of approved finished products.
p.(None): m) Storage of reference samples and counter samples.
p.(None): n) Storage of recalled products.
p.(None): o) Storage of rejected products.
p.(None): p) Storage of returned products.
p.(None): q) Storage of products in process.
p.(None): r) Quality control laboratory.
p.(None): s) Areas for quality control operations of products in process.
p.(None): t) Manufacture and sterile and aseptic fractionation of pharmaceutical products, in accordance with Good Practices
p.(None): Manufacturing, when applicable.
p.(None): u) Expedition or dispatch.
...
p.(None): special controls, must maintain official records in the form and conditions that the regulations
p.(None): corresponding demand.
p.(None): Article 144 ° .- Pharmaceutical laboratories must carry out activities
p.(None): of quality control to ensure compliance with the technical specifications of the product, authorized in the
p.(None): respective sanitary registry.
p.(None): The analytical methodologies and quality specifications will be those that have been authorized in the respective
p.(None): monographs when granting the sanitary registration or in the modifications approved later.
p.(None): There must also be a quality assurance system, which must be developed in accordance with the notion of
p.(None): integrated security, understood as such,
p.(None): the set of planned and systematized rules and procedures necessary to guarantee product quality
p.(None): finished.
p.(None): Article 145 ° .- The pharmaceutical laboratory must keep records of
p.(None): each of the operations and analyzes carried out on each series or batch manufactured and their corresponding materials
p.(None): raw materials and packaging-packaging material, for one year beyond the expiration date of the product.
p.(None): The records mentioned will include: raw material analysis bulletins, packaging materials, products
p.(None): in process and finished products, production equipment qualification protocols; technique validation
p.(None): analytical;
p.(None): operating resumes, calibrations, maintenance of facilities, equipment and instruments and others, all
p.(None): This in accordance with Good Manufacturing Practices and Good Laboratory Practices.
p.(None): Article 146 ° .- The records referred to in this paragraph must be kept permanently updated, be easy
p.(None): access and record any changes.
p.(None): These records may be kept in a computer system to the extent that it meets the stated requirements.
p.(None): Article 147º.- In the case of conditioning laboratories, the provisions of the articles shall apply
p.(None): above, regarding the process that
p.(None): www.bcn.cl - Library of the National Congress of Chile
p.(None): performed, and the process must be approved by signing the professional responsible for quality.
p.(None): SIXTH PARAGRAPH:
p.(None): OF PERSONNEL AND RESPONSIBILITIES
p.(None): Article 148º.- Pharmaceutical production laboratories must have suitable personnel for the performance of
p.(None): the following charges:
p.(None): 1.- Technical Director. 2.- Production Manager.
p.(None): 3.- Head of Quality Control.
p.(None): 4.- Head of Quality Assurance.
p.(None): Notwithstanding the provisions, the Institute may authorize, by means of a founded resolution, the complexity of the
p.(None): laboratory in question, that the same professional assume the Technical Direction and the Production Headquarters, and / or that
p.(None): the same professional assumes the Head of Quality Control and Quality Assurance.
p.(None): In the case of conditioning laboratories, the professional in charge of the Technical Directorate may also assume the
p.(None): roles and responsibilities of the Production Manager; for his part, the Head of Quality Control may assume those of the
p.(None): Head of Quality Assurance.
p.(None): Notwithstanding the provisions of the preceding paragraph, these positions must be held by chemical professionals
p.(None): pharmacists, independently, being technically responsible for the obligations that these regulations
p.(None): it imposes on them.
p.(None): Article 149 ° .- External quality control laboratories will function under the responsibility of a Director
p.(None): Technician, by profession a pharmaceutical chemist.
...
Social / Age
Searching for indicator age:
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p.(None): case in which the corresponding studies that the specific norm indicates must be presented.
p.(None): 4. In the case of a product manufactured in the country with the sole purpose of being exported, which according to the
p.(None): Chilean regulations are considered as a product
p.(None): www.bcn.cl - Library of the National Congress of Chile
p.(None): pharmacist and that proves that in the country of destination it is considered as a food product, by means of a document
p.(None): issued by your health authority, the presentation of the background information that relates to the
p.(None): safety and efficacy, unless the Institute determines through a founded resolution the need to have all or
p.(None): some of that background.
p.(None): Article 53º.- The cases indicated to
p.(None): continuation:
p.(None): a) The pharmaceutical product whose health registration is requested is incorporated for the first time in the field of
p.(None): medicine in the country; except in the case indicated in article 52, second numeral;
p.(None): b) The pharmaceutical product whose health registration is requested contains the same active ingredient as another already
p.(None): registered, whose information or data have the protection established in paragraph 2 of Title VIII of the law
p.(None): No. 19,039, granted according to the specific regulations governing the matter, or is based on data that count
p.(None): with such protection;
p.(None): c) The pharmaceutical product whose registration is requested includes a new therapeutic utility, dosage scheme,
p.(None): extension of a previously approved route of administration or age group, with respect to one already registered;
p.(None): d) The pharmaceutical product whose health registration is requested presents: a modification in the composition and
p.(None): concentration of the active ingredients of an already registered formula; or contains new salts, esters, complexes or
p.(None): isoforms of the active ingredients that make up a pharmaceutical specialty already registered; or constitutes
p.(None): combinations of active ingredients at fixed doses, which separately or not have a health registry;
p.(None): e) In all cases in which the pharmaceutical product, whose registration is requested is presented in a form
p.(None): pharmaceutical different from another registered and that modifies the release of the active ingredient (s);
p.(None): f) In the cases that a sanitary registration of a combination pharmaceutical product is requested for the first time;
p.(None): g) When the sanitary registration of a biological product is requested.
p.(None): Article 54º.- In the case of requests for health registration of homeopathic pharmaceutical products, they may only
p.(None): use a simplified registration procedure when they copulatively meet the following conditions:
p.(None): a) Route of oral or external administration;
p.(None): b) Absence of a particular therapeutic indication in the graphic labeling project or in the draft brochure
p.(None): information to the professional and the patient;
p.(None): c) Be made up of a single homeopathic substance, in a degree of dilution that guarantees the safety of the
p.(None): medication, and
p.(None): d) The homeopathic substance that makes up the pharmaceutical must be
p.(None): obtained from substances or raw materials of plant, animal, mineral or chemical origin found
...
p.(None): Article 64º.- The Institute may require, by reasoned resolution,
p.(None): make or demand that within a defined period the registry modifications that are necessary to
p.(None): guarantee the quality, safety and efficacy in the use of one or more pharmaceutical specialties, when
p.(None): scientific background emanating from the World Health Organization, national organizations or entities,
p.(None): international or foreign or from their own research, the conviction is formed that any of the conditions of use
p.(None): authorized presents a risk in its safety and effectiveness.
p.(None): Article 65º.- At the request of the holder of the sanitary registry, the Institute, by resolution, may authorize
p.(None): modifications, regarding its analytical, technical and legal aspects, and may include the following:
p.(None): 1. Expression of the formula, including the composition of the excipients.
p.(None): 2. Specifications of the finished product, the methods of control of the finished product and the period of effectiveness.
p.(None): 3. Presentation, content, type of container and devices or elements incorporated for administration.
p.(None): Regarding the modification of the primary packaging, the respective stability studies must be attached, if
p.(None): corresponds.
p.(None): 4. Condition of sale.
p.(None): 5. Denomination and graphic labeling.
p.(None): 6. Regimen, origin, conditioner, licensor, distributor, importer, pharmaceutical control laboratory
p.(None): of quality, as well as the modification of the company name and the owner.
p.(None): 7. Information leaflets for professionals and patients.
p.(None): 8. Therapeutic indications, therapeutic schemes, age group modification and new route of administration, the
p.(None): that will be submitted to the pertinent technical evaluation, in accordance with the ordinary sanitary registration procedure of
p.(None): proprietary medicines.
p.(None): 9. Any other, with the exception of those that alter the nature and identity of the pharmaceutical specialty,
p.(None): that is to say, those that relate to the active ingredient, its dosage, its pharmaceutical form or when the
p.(None): modification alter your release system. In these latter cases, another registration will be required.
p.(None): Article 66º.- The requests for modification of the sanitary registry of pharmaceutical specialties will be presented
p.(None): before the Institute in the forms authorized for this purpose, attaching the technical-scientific background that
p.(None): support what is requested and duly foliated.
p.(None): The Institute will grant or not, by reasoned resolution, requests for modification of registration within a period not
p.(None): greater than three months from the date of submission of the application, with the exception of those indicated in the
p.(None): number 8 of the preceding article.
p.(None): When during the evaluation of the modification request and the background provided, the
p.(None): Insufficiency of the same to support the request, the user must be notified of such situation, indicating
p.(None): specifically the objections and the background that must be added to overcome them, granting a deadline for
p.(None): less than ten nor more than thirty business days.
p.(None): 2º Of the administrative aspects.
p.(None): Article 67º.- Any modification of the sanitary registry that does not affect the
p.(None): www.bcn.cl - Library of the National Congress of Chile
p.(None): technical aspects related to the quality, safety and efficacy of pharmaceutical specialties, should be
...
p.(None): referred to in article 21, letter a), to public or private healthcare establishments, with a minimum advance notice
p.(None): one year to maturity or six months in the latter case, with prior authorization from the Institute, which must include
p.(None): in its packaging with a legend referring to its condition of free distribution, to be dispensed in the same
p.(None): condition to patients.
p.(None): The establishment receiving the donation must deliver them free of charge.
p.(None): TITLE IX:
p.(None): ADVERTISING AND INFORMATION.
p.(None): FIRST PARAGRAPH:
p.(None): www.bcn.cl - Library of the National Congress of Chile
p.(None): GENERAL DISPOSITION.
p.(None): Article 199 ° .- Advertising and information, to the patient and the professional, related to specialties
p.(None): pharmaceutical companies, will be governed by the rules of this Title, for which it will be understood as:
p.(None): a) Advertising: Set of procedures or activities used to publicize, highlight, distinguish directly or
p.(None): indirectly to the public, through any means or method of dissemination, its own characteristics,
p.(None): conditions of distribution, sale and use of the products referred to in these regulations.
p.(None): b) Information for professionals: Set of procedures and activities, aimed at professionals legally
p.(None): authorized to prescribe or dispense pharmaceutical products, in order to make them known to the products
p.(None): referred to in these regulations, adjusting to what is authorized in the respective sanitary registry.
p.(None): c) Professional information brochure: Document that will contain at least the characteristics of the specialty
p.(None): pharmaceutical; pharmacokinetic, pharmacodynamic and toxicological aspects thereof; as well as the indications,
p.(None): dosage, age group to which it is directed, contraindications, interactions, precautions and / or warnings,
p.(None): adverse reactions, within which it is necessary to point out those that may occur during pregnancy, lactation
p.(None): or in special populations; the measures to be taken in cases of overdose and other aspects, determined by the
p.(None): authority based on the nature and scientific information available of a pharmaceutical product, in order to
p.(None): inform professionals legally empowered to prescribe or dispense pharmaceutical products.
p.(None): d) Patient information brochure: Document intended to inform the patient about a specialty
p.(None): pharmaceutical. It will contain at least the information regarding the authorized indication, warnings,
p.(None): contraindications, interactions with other products, precautions and all other information that the health authority
p.(None): determine in the registry, to ensure its correct use. The Pharmaceutical Products for Sale brochure
p.(None): direct, you must also indicate information
p.(None): about the usual dosage for particular use and how they are approved for use in the registry.
p.(None): Article 200.- The advertising of the direct sale pharmaceutical specialties may be carried out without authorization.
p.(None): prior to the Institute, having to do so, reproduce the exact content, total or partial, authorized in the brochures
p.(None): of information to the patient and labels, which have been approved in the respective health registry.
p.(None): You can only refer to therapeutic recommendations that have been approved by the Institute in the respective
p.(None): sanitary registry and, in no case, may contain titles, figures, indications, effects, allusions or mentions,
p.(None): do not settle for it.
...
Social / Incarcerated
Searching for indicator restricted:
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p.(None): request.
p.(None): If the background information is insufficient, or does not comply with what has been developed and what is required in the regulations
p.(None): in force, the Institute will issue within 30 days, a founded resolution that will reject the request for
p.(None): functioning.
p.(None): If the accompanied background is sufficient, the Institute will issue within 30 days, a resolution
p.(None): authorizing the operation of the laboratory, which will contain the following mentions:
p.(None): 1. Name, category and address of the pharmaceutical laboratory.
p.(None): 2. Legal representative and professionals who assume technical responsibilities.
p.(None): 3. Lines of activities, production and / or authorized analysis.
p.(None): FOURTH PARAGRAPH:
p.(None): PHYSICAL PLANT REQUIREMENTS OF PHARMACEUTICAL LABORATORIES.
p.(None): Article 118 ° .- All pharmaceutical laboratories will be specially designed and their size and construction must comply
p.(None): with the provisions of these regulations and Good Manufacturing and Laboratory Practices, as appropriate to its
p.(None): category. The location should be such that it is not close to
p.(None): establishments that, due to the activities they carry out, are a source of contamination, nor that in turn originate it in their
p.(None): environment.
p.(None): Article 119 ° .- The laboratory must have special and independent rooms for the storage of
p.(None): flammable or explosive, corrosive, toxic and polluting risks substances. These enclosures
p.(None): They will strictly comply with the security measures determined by the competent bodies.
p.(None): Article 120 ° .- The laboratory that manufactures or packages pharmaceutical products that have active ingredients
p.(None): narcotic, psychotropic or others subject to special controls, must have storage areas
p.(None): independent and restricted access.
p.(None): Article 121 ° .- The establishments that import, manufacture, package, condition or distribute under any title
p.(None): biological products or others that require special storage conditions, according to what is authorized in the
p.(None): respective sanitary registry, they must ensure the conservation of temperature and keep records of them until
p.(None): its distribution.
p.(None): 1º Of the Pharmaceutical Production Laboratories.
p.(None): Article 122 ° .- The physical plant of a pharmaceutical production laboratory must consider, at least the
p.(None): following areas, which will be
p.(None): www.bcn.cl - Library of the National Congress of Chile
p.(None): clearly specified in the diagrams presented and approved by the Institute:
p.(None): a) Reception and sampling of materials and products.
p.(None): b) Quarantine of materials and products.
p.(None): c) Sampling of raw materials.
p.(None): d) Fractionation of raw materials.
p.(None): e) Storage of approved materials.
p.(None): f) Storage of rejected materials.
p.(None): g) Manufacturing.
p.(None): h) Washing and drying of utensils and materials.
p.(None): i) Primary packaging and labeling.
p.(None): j) Secondary packaging and labeling.
p.(None): k) Quarantine of finished products and those subject to serial control, when appropriate.
p.(None): l) Storage of approved finished products.
p.(None): m) Storage of reference samples and counter samples.
p.(None): n) Storage of recalled products.
p.(None): o) Storage of rejected products.
p.(None): p) Storage of returned products.
p.(None): q) Storage of products in process.
p.(None): r) Quality control laboratory.
p.(None): s) Areas for quality control operations of products in process.
p.(None): t) Manufacture and sterile and aseptic fractionation of pharmaceutical products, in accordance with Good Practices
...
Social / Linguistic Proficiency
Searching for indicator language:
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p.(None): enabled for it, whether the manufacture is own or for others.
p.(None): b) Imported products, distinguishing between:
p.(None): b.1. Finished imported products that have been manufactured abroad, whether the import is carried out in
p.(None): directly or through other authorized establishments.
p.(None): b.2. Imported semi-finished products in their final primary packaging, to be conditioned in the country, either in
p.(None): directly or through other authorized establishments.
p.(None): b.3. Products imported in bulk in their final pharmaceutical form to be packaged in the country, whether this is
p.(None): run directly or through other authorized establishments.
p.(None): www.bcn.cl - Library of the National Congress of Chile
p.(None): b.4. Semi-finished imported products to carry out the other necessary production stages in the country
p.(None): to obtain a finished product, either directly or through other authorized establishments.
p.(None): 6. Individualization of the licensor according to the name that appears on the license, if the process is done
p.(None): in use of license.
p.(None): 7. Name and address of the producing establishment, if it is manufactured in the country or abroad.
p.(None): 8. Presentation of the product, describing it or the contents of the different packages: sale to the public, packages
p.(None): clinical and / or as medical samples when appropriate; including those elements or devices that are incorporated
p.(None): for your administration.
p.(None): 9. Physical description of the packaging material, indicating its type, both with respect to the primary packaging and
p.(None): secondary, as well as those elements or devices that are incorporated for its administration, when appropriate.
p.(None): 10. Legal documents, in Spanish language or duly translated under the signature of the legal representative,
p.(None): professional assigned for this purpose by the company or the Technical Director, when appropriate, made up of
p.(None): following, depending on whether the products are imported or manufactured in the country:
p.(None): a) In the case of imported products in any of its phases, it must be accompanied by:
p.(None): a.1. Health registration certificate or Pharmaceutical product certificate or Health authorization certificate
p.(None): o Official certification recommended by the World Health Organization, issued by the health authority of the
p.(None): country of origin and that proves under legalized signature that the producer or warehouse establishment, if applicable,
p.(None): meets the conditions required by the health legislation of your country; that the product is registered in your country of
p.(None): according to current regulations, fully stating its authorized formula; and that your store is subject to some
p.(None): restrictive regime or special sanitary control, if it were so.
p.(None): a.2. Manufacturing agreement signed between the applicant and a foreign production pharmaceutical laboratory,
p.(None): duly legalized.
p.(None): a.3. Legalized license of the one who grants it, when appropriate.
p.(None): a.4. Official certificate issued by the competent health authority of the country where the establishment is located
p.(None): producer, proving that the foreign manufacturer is duly authorized in his country; that meets Good
p.(None): Manufacturing practices, according to WHO recommendations, indicating the production areas or types of
p.(None): products that it is authorized to manufacture, unless said accreditations are contained in the
p.(None): document indicated in letter a1) of this article.
p.(None): to 5. Import agreement authorized before a notary public or duly legalized, when appropriate.
p.(None): a.6. National manufacturing and / or distribution agreement authorized by a notary, when appropriate, attaching the
p.(None): sanitary authorization of each establishment.
p.(None): a.7. Quality control agreement with a pharmaceutical laboratory authorized by the Institute, authorized before
p.(None): notary, where appropriate.
p.(None): b) Products manufactured in the country:
p.(None): www.bcn.cl - Library of the National Congress of Chile
p.(None): b.1. National manufacturing and / or distribution agreement authorized by a notary, incorporating the authorization
p.(None): of each establishment, when appropriate.
p.(None): b.2. Legalized license of the one who grants it, if applicable.
p.(None): b.3. Quality control agreement with a pharmaceutical laboratory authorized by the Institute, when appropriate.
p.(None): Article 30 ° .- In the case of imported pharmaceutical products such as
p.(None): Finished, semi-finished, bulk or semi-finished products, the applicant will be allowed to prove the
p.(None): compliance with the manufacturer's Good Manufacturing Practices in accordance with the provisions of articles 192 °
p.(None): and 193 °, in which case the requirements indicated in letter a.4 will not be applicable. of the preceding article.
p.(None): B.- Technical Information Requirements.
p.(None): Article 31.- Any application for health registration must meet the following general requirements regarding the
p.(None): Technical information related to the pharmaceutical product, the following information being attached for this purpose:
p.(None): 1. Clinical and pharmacological monograph, in Spanish, signed by the technical director or technical advisor.
p.(None): 2. Graphic labeling project for all sales presentations to the public, clinic and medical sample, in language
p.(None): Spanish.
p.(None): 3. Draft information brochure for professionals, backed by relevant scientific information and with the
p.(None): declaration of bioavailability studies and their therapeutic equivalence, in the case of products
p.(None): pharmacists whose active ingredients are subject to this requirement.
p.(None): 4. Draft patient information brochure, backed by relevant scientific information.
p.(None): C.- Pharmaceutical Quality Requirements.
p.(None): Article 32º.- Any request for health registration must comply with the general requirements accredited by the
p.(None): pharmaceutical quality of the product, for which purpose you must enter the following information:
p.(None): 1. Quali-quantitative composition of the pharmaceutical product, expressed in the following order and with the following
p.(None): rules:
p.(None): a) Quali-quantitative statement of each of the active ingredients.
p.(None): b) Quali-quantitative statement of each of the excipients.
p.(None): c) Qualitative declaration of any excipient used and eliminated during the production process, when
p.(None): proceed.
p.(None): d) The quali-quantitative composition expressed in units of mass or volume of the decimal metric system, or units
p.(None): of biological activity. Whenever possible, biological activity will be indicated per unit of mass or volume.
p.(None): e) The active ingredients and excipients will be designated by their international common name (INN) or, failing that,
p.(None): the existing pharmacopoeial name. In the case of non-pharmacopoeic substances, the chemical name will be used in
p.(None): Spanish Language. No abbreviations or trademarks may be used for the name.
p.(None): f) If there are colorants in the composition of the product, they must be specified with their generic names or, in the absence of
p.(None): these, by their designation
p.(None): www.bcn.cl - Library of the National Congress of Chile
p.(None): chemical or its equivalents that have in the Indices of Dyes Allowed and approved in the country by the standard
p.(None): corresponding technique, approved by supreme decree of the Ministry; the same provision will be applicable when
p.(None): use colored capsules.
p.(None): 2. Regarding the active ingredients used in the manufacture of pharmaceutical products, the information
p.(None): following:
p.(None): a) Specification and quality control method, adjusting to the requirements of pharmacopoeias or texts
p.(None): Officials in force in Chile or pharmacopoeial-type monographs thereof, if not indicated in said texts
p.(None): officers.
p.(None): b) Declare supplier and manufacturer of the active ingredient (s), attaching the analysis bulletin with all the
p.(None): parameters that characterize the active principle.
p.(None): c) Origin of the primary reference standard, attaching the respective analysis certificate pointing to the
p.(None): less its origin, potency, traceability and other pertinent tests that characterize it.
p.(None): d) Spectrogram or chromatogram of the active ingredient and the standard by any instrumental method, when
p.(None): it corresponds.
p.(None): e) Storage conditions of the active ingredient as raw material.
p.(None): 3. Specifications and control methods of all its excipients, adjusting to the requirements set forth in the
p.(None): pharmacopoeias or official texts in force in Chile or monographs thereof if not indicated in said texts.
p.(None): 4. Analytical methodology, in Spanish, signed by the technical professional who submits the request and by
...
p.(None): months respectively.
p.(None): 5) Keep the sanitary registry updated, in accordance with the state of science and technique, especially in
p.(None): in relation to quality control methods, as well as the safety and efficacy of the pharmaceutical specialty.
p.(None): 6) Communicate to the Institute the changes in your administrative information within 30 days.
p.(None): 7) The owner of a registered pharmaceutical product must inform the Institute of the date of manufacture of the first
p.(None): industrial lot and attach the validation schedule of the production process.
p.(None): 8) The others that the regulation indicates.
p.(None): TITLE III:
p.(None): OF CONTAINERS AND LABELING.
p.(None): Article 72º.- All pharmaceutical specialty must be presented in a primary and secondary container, both of which must
p.(None): guarantee its inviolability as a finished product and also contain the patient information brochure.
p.(None): www.bcn.cl - Library of the National Congress of Chile
p.(None): At the request of the owner of the registry, the Institute may exceptionally exempt it from the requirement of the container
p.(None): secondary or patient information booklet, when the primary alone guarantees that it can preserve the
p.(None): quality of the pharmaceutical form and the inclusion of all the indications that the labeling requires for the secondary packaging
p.(None): or for the patient information brochure.
p.(None): Article 73º.- The primary packaging of pharmaceutical specialties must be suitable and suitable for conservation
p.(None): of its content, in accordance with the
p.(None): stability studies presented for the same in the registry or its subsequent modifications.
p.(None): Article 74º.- The labeling of the secondary containers will be in the Spanish language, clearly marked
p.(None): visible and must indicate, at least, the mentions expressed below, the legends being prohibited
p.(None): advertising or promotional:
p.(None): 1. Name of the pharmaceutical specialty.
p.(None): 2. Pharmaceutical form and unit dose in the case of monodrugs.
p.(None): 3. In the case of non-conventional release pharmaceutical forms, this circumstance must be registered in
p.(None): the container, as declared in the respective registry.
p.(None): 4. Number of dosage units.
p.(None): 5. Composition of the formula: active ingredient or ingredients indicated qualitatively and quantitatively and excipients
p.(None): qualitatively listed.
p.(None): 6. Name and address of the owner and the manufacturer, conditioner or importer laboratory, as appropriate.
p.(None): 7. Route of administration.
p.(None): 8. Approved sales condition, expressed in the corresponding acronym or with its full text.
p.(None): 9. Expiration date. In the case of extemporaneously prepared products, the solvent will also be indicated, including
p.(None): or recommended and the period of effectiveness once reconstituted, if applicable.
p.(None): 10. Registration number granted by the Institute, preceded by the acronym of individualization "Reg. I.S.P:".
p.(None): 11. The product key. If the finished product is imported, it will keep the origin key.
p.(None): 12. Storage and conservation conditions.
p.(None): 13. Incorporation of the legend: "More information on www.ispch.cl" and of the others referred to in article 87,
p.(None): as appropriate.
p.(None): 14. Any other indication that is specially and additionally required in these regulations or that the Institute considers
p.(None): fundamentally necessary when granting the registration or that is determined later.
p.(None): Article 75º.- The primary packaging must bear printed, at least the mentions indicated in numbers 1, 2, 7,
...
Social / Marital Status
Searching for indicator single:
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p.(None): active ingredients that make up the formula
p.(None): of the product, in the weight / weight, weight / volume ratios, dose / volume unit or in units referred to a standard
p.(None): recognized internationally.
p.(None): 62) Vegetable preparation: Plant or parts of pulverized plant, its extract, tincture, squeezed juice, fatty oil or
p.(None): essential, rubber or resin or other product of a certain process, excluding its defined isolated constituents
p.(None): chemically or their mixtures, without prejudice to the possibility of containing other components, such as solvents,
p.(None): diluents or preservatives, which must be declared.
p.(None): 63) Active ingredient: Substance or mixture of substances with a specific pharmacological effect, or that without
p.(None): possess pharmacological activity, being administered to the body they acquire it.
p.(None): 64) Standard Operating Procedure (POE): Written document containing updated instructions, numbered in
p.(None): logical and continuous sequence, to carry out operations of a general nature, not necessarily limited to a
p.(None): specific product or material, which must be designed, reviewed and updated by competent and authorized personnel
p.(None): for its implementation by the technical professionals responsible for the establishment in which they are used, being
p.(None): used to complement production documentation and for quality assurance and control.
p.(None): 65) Bulk product: Product that is in its final pharmaceutical form.
p.(None): 66) Pharmaceutical association product: One that contains two or more principles incorporated in a form
p.(None): pharmaceutical.
p.(None): 67) Pharmaceutical combination product: One that consists of two or more pharmaceutical products that are
p.(None): They include in a single package to be administered sequentially or simultaneously.
p.(None): 68) Pharmaceutical reference or comparator product: Product determined by the health authority as such,
p.(None): compared to which another that requires evaluation of its therapeutic equivalence is compared.
p.(None): 69) Semi-finished product: Substance or mixture of partially processed substances, which precedes its form
p.(None): pharmaceutical and requiring more manufacturing stages.
p.(None): 70) Semi-finished product: Product that is in its final pharmaceutical form and primary packaging.
p.(None): 71) Finished product: Product that is in its final container, labeled and ready for distribution to any
p.(None): Title.
p.(None): 72) Production, production process, manufacturing, manufacturing or slaughter: set of operations involved in the
p.(None): obtaining a pharmaceutical product, from the acquisition and receipt of materials, to the release,
p.(None): storage and its corresponding quality controls.
p.(None): 73) Adverse Drug Reaction (ADR): The harmful and unintended reaction that occurs at doses used
p.(None): normally in the human being.
p.(None): 74) Serious adverse reaction: Any adverse reaction that is life threatening or life threatening or that
p.(None): implies serious disability or invalidity or that results in hospitalization or prolongation of the same.
p.(None): 75) Unexpected adverse reaction: Adverse reaction not mentioned in the product monograph,
p.(None): information to the patient and the prescribing professional authorized in the respective health registry.
p.(None): 76) Medical prescription: Order signed by a professional legally authorized to
p.(None): www.bcn.cl - Library of the National Congress of Chile
p.(None): This, in order for a quantity of one or more medications to be dispensed and administered as indicated in
p.(None): she.
p.(None): 77) Health registration: Evaluation process of a pharmaceutical product that, being favorable, results in a
p.(None): registration in a special role with correlative numbering maintained by the Institute, prior to its distribution and use.
p.(None): 78) Graphic labeling: Graphic representation that reproduces the officially authorized text in the respective registry
p.(None): sanitary, for the different types of packaging approved for the product, as appropriate.
p.(None): 79) Series or Lot: A defined quantity of raw material, packaging material or processed product, which is carried out in
p.(None): a single production cycle or through continuous stages, characterized by its homogeneity.
p.(None): 80) Subseries or Sublot: Specific and identified fraction of a batch.
p.(None): 81) Possession: It is the possession of a pharmaceutical product by a natural or legal person, whether or not it accredits a fair
p.(None): title for it.
p.(None): 82) Health Record Holder: Natural or legal person, national or foreign, domiciled in Chile, whose
p.(None): name is on a health record.
p.(None): 83) Traceability of analytical data: Property or characteristic that has the result of a measurement or the value of
p.(None): a standard, which may be related to specified references, usually national standards or
p.(None): international, through a continuous chain of comparisons all with specified uncertainties.
p.(None): 84) Traceability of a product: Ability to identify the origin and displacement of a specific unit of a
p.(None): product in any of its manufacturing stages and / or a production batch, through the distribution chain,
p.(None): as well as through the different entities that intervene, until they are dispensed, administered or used.
p.(None): 85) Sales unit: Authorized sales presentation to be dispensed and issued.
p.(None): 86) Validation: Documented action, carried out in accordance with the principles of the Good Practices of
p.(None): Manufacturing and Laboratory, which demonstrate that the procedures, processes, activities or systems used in the
p.(None): Production and quality control are conducive to the results provided, within established limits.
p.(None): Article 6º.- The manufacture, import, possession, distribution and transfer, in any capacity, is prohibited.
p.(None): of pharmaceutical products that are in any of the following conditions:
...
p.(None): with such protection;
p.(None): c) The pharmaceutical product whose registration is requested includes a new therapeutic utility, dosage scheme,
p.(None): extension of a previously approved route of administration or age group, with respect to one already registered;
p.(None): d) The pharmaceutical product whose health registration is requested presents: a modification in the composition and
p.(None): concentration of the active ingredients of an already registered formula; or contains new salts, esters, complexes or
p.(None): isoforms of the active ingredients that make up a pharmaceutical specialty already registered; or constitutes
p.(None): combinations of active ingredients at fixed doses, which separately or not have a health registry;
p.(None): e) In all cases in which the pharmaceutical product, whose registration is requested is presented in a form
p.(None): pharmaceutical different from another registered and that modifies the release of the active ingredient (s);
p.(None): f) In the cases that a sanitary registration of a combination pharmaceutical product is requested for the first time;
p.(None): g) When the sanitary registration of a biological product is requested.
p.(None): Article 54º.- In the case of requests for health registration of homeopathic pharmaceutical products, they may only
p.(None): use a simplified registration procedure when they copulatively meet the following conditions:
p.(None): a) Route of oral or external administration;
p.(None): b) Absence of a particular therapeutic indication in the graphic labeling project or in the draft brochure
p.(None): information to the professional and the patient;
p.(None): c) Be made up of a single homeopathic substance, in a degree of dilution that guarantees the safety of the
p.(None): medication, and
p.(None): d) The homeopathic substance that makes up the pharmaceutical must be
p.(None): obtained from substances or raw materials of plant, animal, mineral or chemical origin found
p.(None): described in recognized pharmacopoeias, according to a homeopathic manufacturing procedure that is also found
p.(None): described in
p.(None): said texts.
p.(None): FIFTH PARAGRAPH:
p.(None): VALIDITY, SUSPENSION AND CANCELLATION OF THE SANITARY REGISTRY.
p.(None): Article 55º.- The sanitary registry of a pharmaceutical specialty will be valid for five years, counted from
p.(None): the date of the resolution that grants it, and it may be renewed for equal and successive periods, provided there is no
p.(None): been canceled and the following conditions are met:
p.(None): 1. Payment of the corresponding fee.
p.(None): 2. Overcoming of the observations made for the suspension of the sanitary registration within the term granted
p.(None): for it. In the event that the validity of the sanitary registry expires pending that period, the
p.(None): renewal within 15 days after the expiration of the period granted to overcome said observations.
p.(None): 3. Non-existence of fines pending payment or compliance with other sanitary measures or sanctions applied by the
p.(None): Institute, if applicable, in relation to the registration to be renewed.
p.(None): www.bcn.cl - Library of the National Congress of Chile
p.(None): The renewal of the sanitary registry must be denied when the non-compliance of some of the
p.(None): obligations that correspond to the holder of the sanitary registry.
p.(None): Article 56º.- The request for renewal of the health registration must be submitted to the Institute and, in the case of
...
p.(None): o) Storage of rejected products.
p.(None): p) Storage of returned products.
p.(None): q) Storage of products in process.
p.(None): r) Quality control laboratory.
p.(None): s) Areas for quality control operations of products in process.
p.(None): t) Manufacture and sterile and aseptic fractionation of pharmaceutical products, in accordance with Good Practices
p.(None): Manufacturing, when applicable.
p.(None): u) Expedition or dispatch.
p.(None): v) Maintenance.
p.(None): w) Offices for responsible professionals.
p.(None): x) Bathroom and changing rooms for the use of personnel, prior to entering or leaving the plant, as appropriate.
p.(None): In the cases of the zones described in letters b), e), k) and l), no physically separate sections will be required,
p.(None): if there is an electronic system that allows adequate control of the different states of the materials.
p.(None): The Pharmaceutical Production Laboratories may outsource, in independent premises, the areas of
p.(None): storage of finished products. If the independent premises are owned by the laboratory, it will constitute a
p.(None): expansion of its plant; whereas if it belongs to a third party, the latter must have the authorization
p.(None): corresponding sanitary, issued by the respective SEREMI, which must supervise the activity that it
p.(None): develop, in accordance with the general storage requirements provided in these regulations.
p.(None): Article 123 ° .- The area corresponding to production must be structured, equipped and enabled, according to the forms
p.(None): Pharmaceuticals that are manufactured and controlled to prevent cross contamination.
p.(None): Article 124 ° .- The manufacturing and packaging areas may constitute a single unit, when systems are used
p.(None): serial production technicians, who do not allow separating the different stages of product development and always
p.(None): that the necessary measures be taken to avoid cross contamination.
p.(None): Article 125 ° .- The manufacture and packaging of sterile pharmaceutical products can only be carried out in rooms
p.(None): specially enabled for this purpose, also complying with the necessary conditions to execute:
p.(None): a) The sterile fractionation of non-sterilizable products in final containers.
p.(None): b) The aseptic fractionation of sterilizable products in final containers.
p.(None): Article 126 ° .- When laboratory animals are used, they must be kept in isolated enclosures and
p.(None): specially authorized for said effects, in the form and conditions authorized by the Institute.
p.(None): Article 127 ° .- The facilities, equipment and other implements used in a production laboratory must
p.(None): have the design, size and manufacturing materials in accordance with Good Manufacturing Practices ensuring, at
p.(None): less, the following:
p.(None): a) Continuous and orderly stages of manufacturing and quality control.
p.(None): www.bcn.cl - Library of the National Congress of Chile
p.(None): b) Maintaining the necessary hygienic conditions.
p.(None): c) Verification of the correct operation of the equipment, facilities and instruments, as well as
p.(None): corresponding qualification of the same.
p.(None): Article 128.- The production laboratories that carry out research and product development actions in their
p.(None): establishments must have equipment and qualified personnel for such purposes.
p.(None): Article 129 ° .- The manufacture of raw materials or drugs of biological origin that are obtained by processes of this
p.(None): nature, intended for the elaboration of biological products, can only be carried out in laboratories especially
...
p.(None): pharmaceutical products through incentives of any kind aimed at pharmacy staff.
p.(None): TITLE X:
p.(None): OF HEALTH SURVEILLANCE.
p.(None): FIRST PARAGRAPH:
p.(None): OF PHARMACOVIGILANCE.
p.(None): Article 216 °. - The Institute is the sanitary authority in charge of the security surveillance of the specialties
p.(None): Registered and non-registered pharmaceutical companies have been authorized for use in research
p.(None): scientific or provisional.
p.(None): Article 217 ° .- Health professionals have the duty to communicate to the Institute, all suspicions of
p.(None): Adverse reactions of which they are aware and which could have been caused by a certain product
p.(None): pharmacist.
p.(None): The same obligation will fall on the Technical Director of the healthcare establishments, which must maintain
p.(None): an updated record of these events.
p.(None): The communication of the information referred to in this article, must be made on the forms that for this purpose
p.(None): determine the Institute of Public Health, by resolution.
p.(None): In the case of suspicion of a serious adverse drug reaction, the communication must be made within
p.(None): 72 hours after taking
p.(None): www.bcn.cl - Library of the National Congress of Chile
p.(None): knowledge of the fact. In all other cases, you must communicate within the
p.(None): 30 days.
p.(None): Article 218 °. - The holders of sanitary registrations or authorizations must implement and maintain a system of
p.(None): pharmacovigilance, own or outsourced, being its Technical Advisor, responsible for:
p.(None): a) Create, adopt and maintain a documented system to collect and process information on a single file
p.(None): all suspected adverse reactions.
p.(None): b) Prepare and submit quarterly to the Institute of Public Health, information about suspicions of
p.(None): adverse reactions in the authorized forms, unless by means of a founded resolution the Institute determines a
p.(None): lower term.
p.(None): c) Ensure that a prompt and complete response is given to any request for additional information that the
p.(None): Institute of Public Health and that is necessary to evaluate the benefits and risks of a pharmaceutical specialty,
p.(None): within the terms established by that entity.
p.(None): In qualified cases, the Institute of Public Health, by founded resolution, may also provide special measures of
p.(None): pharmacovigilance for certain products.
p.(None): Article 219 °. - The holders of sanitary registry of pharmaceutical specialties will be obliged to maintain
p.(None): updated the information on product safety and a continuous evaluation of the risk-benefit ratio of the
p.(None): same, in accordance with the provisions of the Seventh Paragraph of Title II of this regulation.
p.(None): Article 220 ° .- The Institute will analyze the surveillance information
p.(None): available and, where appropriate, will require the necessary studies to evaluate the safety of a pharmaceutical specialty,
p.(None): in the authorized conditions of use. You can also propose the necessary measures to minimize risks
p.(None): associated with the use of pharmaceutical specialties and to maintain an adequate balance in the risk-benefit ratio
p.(None): from the same.
p.(None): Without prejudice to the provisions of Law No. 19,628, on Protection of Personal Data, the background, the
...
Social / Property Ownership
Searching for indicator property:
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p.(None): implies serious disability or invalidity or that results in hospitalization or prolongation of the same.
p.(None): 75) Unexpected adverse reaction: Adverse reaction not mentioned in the product monograph,
p.(None): information to the patient and the prescribing professional authorized in the respective health registry.
p.(None): 76) Medical prescription: Order signed by a professional legally authorized to
p.(None): www.bcn.cl - Library of the National Congress of Chile
p.(None): This, in order for a quantity of one or more medications to be dispensed and administered as indicated in
p.(None): she.
p.(None): 77) Health registration: Evaluation process of a pharmaceutical product that, being favorable, results in a
p.(None): registration in a special role with correlative numbering maintained by the Institute, prior to its distribution and use.
p.(None): 78) Graphic labeling: Graphic representation that reproduces the officially authorized text in the respective registry
p.(None): sanitary, for the different types of packaging approved for the product, as appropriate.
p.(None): 79) Series or Lot: A defined quantity of raw material, packaging material or processed product, which is carried out in
p.(None): a single production cycle or through continuous stages, characterized by its homogeneity.
p.(None): 80) Subseries or Sublot: Specific and identified fraction of a batch.
p.(None): 81) Possession: It is the possession of a pharmaceutical product by a natural or legal person, whether or not it accredits a fair
p.(None): title for it.
p.(None): 82) Health Record Holder: Natural or legal person, national or foreign, domiciled in Chile, whose
p.(None): name is on a health record.
p.(None): 83) Traceability of analytical data: Property or characteristic that has the result of a measurement or the value of
p.(None): a standard, which may be related to specified references, usually national standards or
p.(None): international, through a continuous chain of comparisons all with specified uncertainties.
p.(None): 84) Traceability of a product: Ability to identify the origin and displacement of a specific unit of a
p.(None): product in any of its manufacturing stages and / or a production batch, through the distribution chain,
p.(None): as well as through the different entities that intervene, until they are dispensed, administered or used.
p.(None): 85) Sales unit: Authorized sales presentation to be dispensed and issued.
p.(None): 86) Validation: Documented action, carried out in accordance with the principles of the Good Practices of
p.(None): Manufacturing and Laboratory, which demonstrate that the procedures, processes, activities or systems used in the
p.(None): Production and quality control are conducive to the results provided, within established limits.
p.(None): Article 6º.- The manufacture, import, possession, distribution and transfer, in any capacity, is prohibited.
p.(None): of pharmaceutical products that are in any of the following conditions:
p.(None): 1. Contaminated pharmaceutical product: one that contains microorganisms or parasites or parts thereof, capable of
p.(None): produce illnesses in people or illegal amounts of potentially toxic, carcinogenic or
p.(None): mutagenic or other foreign materials.
p.(None): 2. Altered pharmaceutical product: That finished product that due to deficiency in storage, transport,
p.(None): conservation or any other cause subsequent to its production:
p.(None): to. has decreased its activity below the limits specified in the respective health registry or, in the
...
p.(None): classifiable in any of the previous categories.
p.(None): The following are understood to be included in this final group, among others:
p.(None): a) Products for parenteral administration, whatever their composition, properties or effects.
p.(None): b) Vitamins, minerals and other nutrients, in the therapeutic doses determined in the technical standard
p.(None): respective approved by supreme decree of the Ministry.
p.(None): c) Products of animal or mineral origin, as well as those that constitute vegetable drug associations and
p.(None): vegetable preparations with active ingredients of different nature.
p.(None): TITLE II:
p.(None): OF THE SANITARY REGISTRY OF PHARMACEUTICAL SPECIALTIES AND OTHER PHARMACEUTICAL PRODUCTS
p.(None): FIRST PARAGRAPH:
p.(None): CONCEPT AND PURPOSE.
p.(None): Article 18.- The health registration of a pharmaceutical specialty consists of an evaluation and study process.
p.(None): systematic of its pharmaceutical, pharmacological, toxicological and clinical properties, intended to verify its
p.(None): quality, safety and efficacy, which translates into an enrollment in a special role with correlative numbering that
p.(None): maintains the Institute, which enables and authorizes its distribution and use in the country.
p.(None): The sanitary registry does not exempt its owner or user to any title, from the obligation to comply with the
p.(None): other legal or regulatory provisions that regulate the marketing of said products.
p.(None): The health registration may be requested by any natural or legal person, national or foreign, duly
p.(None): represented and domiciled in Chile.
p.(None): Article 19.- The administrative act of sanitary registration is independent of commercial or property aspects.
p.(None): intellectual or industrial of those who require or obtain it, in the terms provided for in article 49 of Law No.
p.(None): 19.039 on Industrial Property, whose consolidated, coordinated and systematized text was set by D.F.L. No. 3 of
p.(None): 2006, from the Ministry of Economy, Development and Reconstruction.
p.(None): Article 20.- Any pharmaceutical product imported or manufactured in the country, to be distributed or used to
p.(None): Any title in the national territory must previously have a health registry.
p.(None): Article 21º.- Exceptionally, the Institute may authorize the sale or provisional use of certain
p.(None): pharmaceutical products without sanitary registration, based on any of the following causes, which are stated by
p.(None): exemplary according to the provisions of article 102 of the Health Code:
p.(None): a) Epidemics or situations of emergency, urgency or catastrophe, which pose a serious risk to the health or life of
p.(None): the habitants.
p.(None): b) In the case of a pharmaceutical product that is required for an urgent medicinal purpose, without there being a
p.(None): alternative when required.
p.(None): www.bcn.cl - Library of the National Congress of Chile
p.(None): c) In the case of products to be used in scientific research or clinical trials, prior report
p.(None): favorable of the corresponding ethics committee or committees, in accordance with the rules on clinical trials carried out on human beings
p.(None): human, approved by the Ministry of Health.
p.(None): Article 22 ° .- The requests presented by the interested parties, for sale
p.(None): or provisional use of pharmaceutical products without prior health registration, based on letters a) and b) of the article
p.(None): above will be presented to the Institute, and the authorization granted by the health authority of the
p.(None): country
...
p.(None): or recommended and the period of effectiveness once reconstituted, if applicable.
p.(None): 10. Registration number granted by the Institute, preceded by the acronym of individualization "Reg. I.S.P:".
p.(None): 11. The product key. If the finished product is imported, it will keep the origin key.
p.(None): 12. Storage and conservation conditions.
p.(None): 13. Incorporation of the legend: "More information on www.ispch.cl" and of the others referred to in article 87,
p.(None): as appropriate.
p.(None): 14. Any other indication that is specially and additionally required in these regulations or that the Institute considers
p.(None): fundamentally necessary when granting the registration or that is determined later.
p.(None): Article 75º.- The primary packaging must bear printed, at least the mentions indicated in numbers 1, 2, 7,
p.(None): 9, 10 and 11 of the previous article.
p.(None): Article 76º.- In the case of the pharmaceutical specialties that are available in a medical sample presentation,
p.(None): must also inscribe the mention: "MEDICAL SAMPLE FORBIDDEN SALE", both in the primary and secondary packaging,
p.(None): clearly, indelibly and visibly.
p.(None): Article 77º.- The labels must be printed or attached on the outside of the containers and without contact with their
p.(None): content. The letter must use Arial characters or others of similar rectilinear type and with a minimum body size
p.(None): 6.
p.(None): Article 78.- Exceptionally, the graphic labeling of a finished imported pharmaceutical product may include
p.(None): texts in other languages, in addition to Spanish, provided that it does not alter the text authorized by the Institute.
p.(None): Article 79º.- Holders of health records may include in the labels, under their sole responsibility
p.(None): with respect to third parties, the mentions that, in relation to industrial property rights, are required by law, to enable
p.(None): the exercise of the rights conferred by it.
p.(None): www.bcn.cl - Library of the National Congress of Chile
p.(None): Article 80º.- All the graphic labels and the information brochure for the patient and the professional, presented to the
p.(None): At the time of requesting the health registration, they must correspond to the final text that they will have once authorized,
p.(None): without prejudice to the modifications that the Institute may introduce to them.
p.(None): For the patient information brochures, the rule of article 77 regarding the size and type of
p.(None): letter in which they must be incorporated in the secondary packaging.
p.(None): The same requirements shall apply for subsequent modifications of such graphic labeling and information brochure to
p.(None): patient and professional.
p.(None): Article 81º.- The pharmaceutical specialties whose condition of sale is direct, must carry in the brochure of
p.(None): information to the patient or on their labels, in addition to the indications described in article 74, which are mentioned
p.(None): then:
p.(None): a) Instructions regarding the usual dosage for each indication, according to what is authorized in the respective
p.(None): registry.
p.(None): b) Warnings necessary for safe and effective use, pointing out contraindications, interactions and
p.(None): adverse reactions, when appropriate, all as determined by the Institute when granting the sanitary registration.
p.(None): The presentation of these products may be made in dispensing containers provided that each blister or strip is
p.(None): contained in an insert or other unit, containing the full text of the approved legend on the packaging
p.(None): secondary and in the patient information brochure, in the event that I do not attach it.
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Social / Religion
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p.(None): national or by the manufacturer or health authority of your country, in the case of imported, finished or
p.(None): semi-finished, as appropriate.
p.(None): b) The respective Analysis Bulletin made in Chile or the analysis bulletin of the manufacturing country in the case of
p.(None): finished, semi-finished or bulk imported products.
p.(None): c) Standards necessary to carry out the analysis.
p.(None): Article 185 ° .- To carry out the serial control procedure, the Institute will proceed to take two samples, one of
p.(None): which will be sealed and
p.(None): documented in the premises where the sampling is carried out, under the responsibility of the Technical Director. The size
p.(None): of each sample will be enough to carry out two complete analyzes, according to the product specifications
p.(None): completed authorized in the respective sanitary registry and will be carried out through sampling procedures
p.(None): determined by resolution of the Institute.
p.(None): Article 186 ° .- The approval or rejection of a lot or sublot under series control, will be made within the
p.(None): 20 business days, counted from the time they are received according to the background described in article 184 of this
p.(None): regulations, with the exception of vaccines, whose serial control will be carried out within 40 working days.
p.(None): Notwithstanding the foregoing, the Institute may for reasonable reasons increase the term indicated in the preceding paragraph.
p.(None): Once the serial control is rejected, the manufacturer or importer must proceed to the immediate destruction of the product, the
p.(None): which will be effective in authorized places, in the presence of the Technical Director and a minister of public faith
p.(None): designated by the Institute, drawing up a record of everything done.
p.(None): Exceptionally, the Institute may authorize the reprocessing of the rejected product, after a well-founded request from the
p.(None): interested, in which case the respective resolution will set the conditions under which it will be carried out.
p.(None): FOURTH PARAGRAPH:
p.(None): OF THE EXEMPTION OF QUALITY CONTROL AND SERIAL CONTROL.
p.(None): Article 187 ° .- The Institute may exempt finished imported products from quality and / or serial control,
p.(None): in all or part of them, in the case of products with very low turnover and high unit cost, and requests and
p.(None): justify by the holder of the sanitary registry.
p.(None): For these purposes, the interested party must provide sufficient information about the validation of the methods.
p.(None): analytical used in the release of the batch in the country of manufacture, analysis bulletin of the country of origin and
p.(None): cold chain maintenance records, where applicable.
p.(None): Article 188 ° .- The resolution granting the exemption or denial must be founded. In case of being favorable
p.(None): It will contain the following mentions:
p.(None): www.bcn.cl - Library of the National Congress of Chile
p.(None): 1. Name of the pharmaceutical specialty.
p.(None): 2. Maximum authorized quantity and frequency of importation.
p.(None): 3. Exempt analyzes.
p.(None): 4. Number of counter samples to be kept.
p.(None): 5. Validity of the resolution granting the exemption.
p.(None): FIFTH PARAGRAPH:
p.(None): OBLIGATIONS RELATED TO QUALITY CONTROL.
p.(None): Article 189 ° .- The holder of the sanitary registry will be responsible for keeping counter samples of each batch of
p.(None): Pharmaceutical products manufactured locally or on each import made, in sufficient quantity to make, to
...
p.(None): necessary to determine the pharmaceutical products that require demonstration of therapeutic equivalence.
p.(None): The rules and other procedures for conducting bioavailability studies, as well as studies of
p.(None): therapeutic equivalence, in the corresponding cases, will be established by resolution of the Ministry, at the proposal
p.(None): from high school.
p.(None): TITLE XI:
p.(None): OF THE PROCEDURES, SANCTIONS AND REMEDIES.
p.(None): Article 222 °. - The administrative procedures, notifications and calculation of terms to which the application of the
p.(None): these regulations, will be governed by
p.(None): provisions of law No. 19,880, on the basis of the administrative procedures governing the acts of the organs
p.(None): of the state administration.
p.(None): www.bcn.cl - Library of the National Congress of Chile
p.(None): Article 223 °. - The infractions to the dispositions of the present regulation will be sanctioned by the Institute, previous
p.(None): instruction of the respective sanitary summary, in accordance with the provisions of this decree and in accordance with the provisions
p.(None): in Book X of the Sanitary Code and complementary sanitary legislation.
p.(None): Of the sanctions applied, they can only be judicially claimed in the manner established in article 171 of the Code.
p.(None): Sanitary.
p.(None): The provisions, whose oversight has been filed in the SEREMI will be sanctioned by them in accordance with the
p.(None): preceding paragraphs.
p.(None): Article 224 °. - In use of its powers of sanitary inspection, the Institute, in justified cases, may
p.(None): apply emergency measures, without the need for a prior sanitary summary. The same measures may be applied by
p.(None): the minister of faith designated by the Institute, with the sole merit of the act that it draws up, when there is a risk
p.(None): imminent for health. The same attributions will have the SEREMI or their ministers of faith, regarding the inspection
p.(None): that these regulations expressly instruct them.
p.(None): Article 225 ° .- Except as provided in the second paragraph of article 223, of the actions and resolutions it adopts
p.(None): the Director of the Institute in the exercise of his functions, in relation to the matters referred to in this
p.(None): regulation, an appeal may be filed before the Ministry of Health, within five days
p.(None): business days counted from the date of the notification of the respective resolution in your case.
p.(None): In the event that the affected party requires a longer time to present antecedents that support their claim, they must
p.(None): request it within the deadline, from the Ministry of Health,
p.(None): the one who will decide about it.
p.(None): Once the appeal is presented, the Ministry must request the background from the Institute and will rule on the
p.(None): claim within ten days
p.(None): upon receipt of said documents, unless technically it requires a longer period for said effect.
p.(None): If an appeal for reversal is filed before the same Institute, the claim referred to in this article may
p.(None): interpose within the same term and subsidiarily. In this case the resolution that resolves the replacement will serve as
p.(None): report for the purposes indicated in the preceding paragraph.
p.(None): FINAL TITLE: VALIDITY.
p.(None): Article 226 ° .- These regulations will come into effect 6 months later
p.(None): of its publication in the Official Gazette, the date on which Supreme Decree No. 1,876 of 1995 of the
p.(None): Ministry of Health, as well as any other norm, resolution or provision that is contrary or incompatible with the
p.(None): contained in this regulatory decree.
p.(None): Without prejudice to the provisions of the preceding paragraph, the provisions contained in article 175 of this
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Searching for indicator conviction:
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p.(None): warehouse, as appropriate, meets the conditions required by the health legislation of your country, that the product
p.(None): is registered in the country according to regulations
p.(None): in force, fully stating its authorized formula and that its sale is subject to some restrictive regime or
p.(None): special sanitary control, if it were so.
p.(None): Article 57º.- The sanitary registry renewal resolution must maintain the registry number assigned in
p.(None): registration, adding the year of renewal and indicate the expiration date thereof.
p.(None): Article 58º.- All health registration may be suspended for any of the following reasons:
p.(None): 1. If there are significant changes in the therapeutic indication or in the composition or in the forms of
p.(None): dosage or in the application or other conditions announced in the labeling or in the information to the professional or the
p.(None): advertising or others, which do not correspond to what is approved in the health registry.
p.(None): 2. If there are failures to product quality in two series.
p.(None): The resolution that establishes the suspension of the sanitary registry will determine its scope and will set the term in which
p.(None): the observations that motivated it must be satisfactorily corrected; in case of non-compliance, it will proceed to
p.(None): cancellation.
p.(None): Article 59º.- All sanitary registration may be canceled ex officio or by complaint of interested parties, with pronouncement
p.(None): prior to the Ministry of Health, when one of the following causes occurs:
p.(None): a) When through scientific background emanating from the World Organization
p.(None): Health, national or foreign organizations or entities or their own research, the
p.(None): Institute forms the conviction that a product is not safe or effective, as approved in the respective
p.(None): sanitary registry, generating in his respect some of the following situations:
p.(None): a.1. Manifest danger to public health.
p.(None): a.2. Unfavorable therapeutic risk / benefit ratio.
p.(None): a.3. Therapeutic ineffectiveness.
p.(None): b) When it is verified that any of the data provided in the sanitary registration request has been
p.(None): duly credited as false.
p.(None): c) When the sanitary registration having been suspended, the reasons that founded it within the
p.(None): term set for this purpose.
p.(None): Article 60º.- The holder of the canceled or suspended sanitary registry will be responsible for taking the measures
p.(None): necessary for the adequate collection, destruction or denaturation, when the Institute so determines, of the
p.(None): units of the pharmaceutical product that are stored in its dependencies and those distributed, of
p.(None): according to current regulations, to other establishments in the pharmaceutical or healthcare area and to inform the public
p.(None): user who may be able to make personal use of the product in question.
p.(None): Article 61º.- The suspension and cancellation of a sanitary registry must be determined by the Institute through
p.(None): a well-founded resolution that will be notified to whoever appears as the owner thereof.
p.(None): Article 62º.- Without prejudice to the provisions of article 59, the Institute may cancel the sanitary registration,
p.(None): upon instruction of the summary
p.(None): www.bcn.cl - Library of the National Congress of Chile
p.(None): corresponding sanitary, in addition to the fine that is applied, in accordance with the provisions of article 174 of the
p.(None): Sanitary Code.
p.(None): SIXTH PARAGRAPH:
p.(None): OF THE MODIFICATIONS OF THE SANITARY REGISTRY.
p.(None): 1º Of the sanitary technical aspects.
p.(None): Article 63º.- By founded resolution of the Institute, ex officio or at the request of the owner, some of
p.(None): the mentions contained in the resolution of the sanitary registry of a pharmaceutical specialty.
p.(None): Article 64º.- The Institute may require, by reasoned resolution,
p.(None): make or demand that within a defined period the registry modifications that are necessary to
p.(None): guarantee the quality, safety and efficacy in the use of one or more pharmaceutical specialties, when
p.(None): scientific background emanating from the World Health Organization, national organizations or entities,
p.(None): international or foreign or from their own research, the conviction is formed that any of the conditions of use
p.(None): authorized presents a risk in its safety and effectiveness.
p.(None): Article 65º.- At the request of the holder of the sanitary registry, the Institute, by resolution, may authorize
p.(None): modifications, regarding its analytical, technical and legal aspects, and may include the following:
p.(None): 1. Expression of the formula, including the composition of the excipients.
p.(None): 2. Specifications of the finished product, the methods of control of the finished product and the period of effectiveness.
p.(None): 3. Presentation, content, type of container and devices or elements incorporated for administration.
p.(None): Regarding the modification of the primary packaging, the respective stability studies must be attached, if
p.(None): corresponds.
p.(None): 4. Condition of sale.
p.(None): 5. Denomination and graphic labeling.
p.(None): 6. Regimen, origin, conditioner, licensor, distributor, importer, pharmaceutical control laboratory
p.(None): of quality, as well as the modification of the company name and the owner.
p.(None): 7. Information leaflets for professionals and patients.
p.(None): 8. Therapeutic indications, therapeutic schemes, age group modification and new route of administration, the
p.(None): that will be submitted to the pertinent technical evaluation, in accordance with the ordinary sanitary registration procedure of
p.(None): proprietary medicines.
p.(None): 9. Any other, with the exception of those that alter the nature and identity of the pharmaceutical specialty,
p.(None): that is to say, those that relate to the active ingredient, its dosage, its pharmaceutical form or when the
p.(None): modification alter your release system. In these latter cases, another registration will be required.
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General/Other / Manipulable
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p.(None): specially authorized for said effects, in the form and conditions authorized by the Institute.
p.(None): Article 127 ° .- The facilities, equipment and other implements used in a production laboratory must
p.(None): have the design, size and manufacturing materials in accordance with Good Manufacturing Practices ensuring, at
p.(None): less, the following:
p.(None): a) Continuous and orderly stages of manufacturing and quality control.
p.(None): www.bcn.cl - Library of the National Congress of Chile
p.(None): b) Maintaining the necessary hygienic conditions.
p.(None): c) Verification of the correct operation of the equipment, facilities and instruments, as well as
p.(None): corresponding qualification of the same.
p.(None): Article 128.- The production laboratories that carry out research and product development actions in their
p.(None): establishments must have equipment and qualified personnel for such purposes.
p.(None): Article 129 ° .- The manufacture of raw materials or drugs of biological origin that are obtained by processes of this
p.(None): nature, intended for the elaboration of biological products, can only be carried out in laboratories especially
p.(None): enabled and equipped for it or in sections thereof and separate from the production laboratories,
p.(None): requiring, in any case, the corresponding authorization from the Institute.
p.(None): These venues, in addition to complying with the provisions of this Title, must have a system that includes
p.(None): exclusive facilities and equipment that allows the decontamination, neutralization, inactivation and incineration of
p.(None): risky materials.
p.(None): Article 130 °. - Only in rooms properly conditioned and equipped to minimize the risk of contamination,
p.(None): may:
p.(None): a) Manipulate microorganisms, toxins, cell cultures and others determined by the Institute.
p.(None): b) Prepare and package biological products that contain microorganisms, toxins, cell cultures and others.
p.(None): In any case, the packaging of the processed products must be carried out in areas of controlled contamination.
p.(None): 2nd Of the Pharmaceutical Conditioning Laboratories.
p.(None): Article 131 ° .- The physical plant of the Conditioning Pharmaceutical Laboratories must consider, at least, the
p.(None): following areas:
p.(None): a) Reception and sampling of materials and products.
p.(None): b) Quarantine of materials and products.
p.(None): c) Storage of approved materials and products.
p.(None): d) Conditioning.
p.(None): e) Quarantine of finished products and those subject to serial control, when appropriate.
p.(None): f) Storage of approved finished product.
p.(None): g) Storage of rejected and withdrawn materials and products, duly circumscribed.
p.(None): h) Storage of returned finished products.
p.(None): i) Storage of reference samples and counter samples.
p.(None): j) Expedition or dispatch.
p.(None): k) Maintenance: if applicable.
p.(None): l) Quality control regarding the production line or lines that are developed, including at least
p.(None): an area for the analysis of labeling material, packaging and finished product with respect to its graphic labeling.
p.(None): m) Office for the responsible professional or professionals.
p.(None): n) Bathrooms and changing rooms.
p.(None): In the cases of the zones described in letters b), c) e) and f), no physically separate sections will be required, if
p.(None): There is an electronic system that allows adequate control of the different states of the materials.
p.(None): 3rd Of the Pharmaceutical Quality Control Laboratories.
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General/Other / Public Emergency
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p.(None): systematic of its pharmaceutical, pharmacological, toxicological and clinical properties, intended to verify its
p.(None): quality, safety and efficacy, which translates into an enrollment in a special role with correlative numbering that
p.(None): maintains the Institute, which enables and authorizes its distribution and use in the country.
p.(None): The sanitary registry does not exempt its owner or user to any title, from the obligation to comply with the
p.(None): other legal or regulatory provisions that regulate the marketing of said products.
p.(None): The health registration may be requested by any natural or legal person, national or foreign, duly
p.(None): represented and domiciled in Chile.
p.(None): Article 19.- The administrative act of sanitary registration is independent of commercial or property aspects.
p.(None): intellectual or industrial of those who require or obtain it, in the terms provided for in article 49 of Law No.
p.(None): 19.039 on Industrial Property, whose consolidated, coordinated and systematized text was set by D.F.L. No. 3 of
p.(None): 2006, from the Ministry of Economy, Development and Reconstruction.
p.(None): Article 20.- Any pharmaceutical product imported or manufactured in the country, to be distributed or used to
p.(None): Any title in the national territory must previously have a health registry.
p.(None): Article 21º.- Exceptionally, the Institute may authorize the sale or provisional use of certain
p.(None): pharmaceutical products without sanitary registration, based on any of the following causes, which are stated by
p.(None): exemplary according to the provisions of article 102 of the Health Code:
p.(None): a) Epidemics or situations of emergency, urgency or catastrophe, which pose a serious risk to the health or life of
p.(None): the habitants.
p.(None): b) In the case of a pharmaceutical product that is required for an urgent medicinal purpose, without there being a
p.(None): alternative when required.
p.(None): www.bcn.cl - Library of the National Congress of Chile
p.(None): c) In the case of products to be used in scientific research or clinical trials, prior report
p.(None): favorable of the corresponding ethics committee or committees, in accordance with the rules on clinical trials carried out on human beings
p.(None): human, approved by the Ministry of Health.
p.(None): Article 22 ° .- The requests presented by the interested parties, for sale
p.(None): or provisional use of pharmaceutical products without prior health registration, based on letters a) and b) of the article
p.(None): above will be presented to the Institute, and the authorization granted by the health authority of the
p.(None): country
p.(None): of origin or manufacturing as appropriate. In both cases the
p.(None): authorizations granted to private parties may be required a second time before six
p.(None): months, as long as the application for sanitary registration is presented or antecedents are provided that prove that the
p.(None): Situation of emergency, urgency, catastrophe or urgent medicinal use has been maintained and they make their
p.(None): grant.
p.(None): Article 23.- Applications for the provisional use in scientific research or clinical trial of a product
p.(None): pharmacist must appear before the Institute accompanied by the protocol approved by the ethics committee, in the
p.(None): terms referred to in letter c) of article 21; the same document must be accompanied in the case of a
p.(None): product that has a sanitary registration and its use is intended differently from that authorized.
p.(None): Article 24 °. - In accordance with the collaboration agreements that are concluded between the Institute and the SEREMI of regions
p.(None): that have border customs, carried out in accordance with the provisions of the Organic Constitutional Law of
p.(None): General Bases of the State Administration, Law No. 18,575, whose consolidated, coordinated and systematized text was
p.(None): fixed by D.F.L. Nº 1 of 2000 of the Ministry General Secretariat of the Presidency, the latter authority may
p.(None): authorize the provisional use of pharmaceutical products without prior sanitary registration, when they are imported for
p.(None): individual use, directly by the interested party or his agent, provided they are prescribed by a professional
p.(None): enabled, to record the need and duration of treatment.
p.(None): Likewise, said health authority may authorize the hospitalization of medications by nationals or foreigners
p.(None): that carry them upon entering the country for treatment for a period not exceeding three weeks, unless it is
...
p.(None): list of pharmaceutical products that will serve as a reference for them.
p.(None): Likewise, by resolution of the Ministry, the criteria and the technical norm that establish the criteria will be approved.
p.(None): necessary to determine the pharmaceutical products that require demonstration of therapeutic equivalence.
p.(None): The rules and other procedures for conducting bioavailability studies, as well as studies of
p.(None): therapeutic equivalence, in the corresponding cases, will be established by resolution of the Ministry, at the proposal
p.(None): from high school.
p.(None): TITLE XI:
p.(None): OF THE PROCEDURES, SANCTIONS AND REMEDIES.
p.(None): Article 222 °. - The administrative procedures, notifications and calculation of terms to which the application of the
p.(None): these regulations, will be governed by
p.(None): provisions of law No. 19,880, on the basis of the administrative procedures governing the acts of the organs
p.(None): of the state administration.
p.(None): www.bcn.cl - Library of the National Congress of Chile
p.(None): Article 223 °. - The infractions to the dispositions of the present regulation will be sanctioned by the Institute, previous
p.(None): instruction of the respective sanitary summary, in accordance with the provisions of this decree and in accordance with the provisions
p.(None): in Book X of the Sanitary Code and complementary sanitary legislation.
p.(None): Of the sanctions applied, they can only be judicially claimed in the manner established in article 171 of the Code.
p.(None): Sanitary.
p.(None): The provisions, whose oversight has been filed in the SEREMI will be sanctioned by them in accordance with the
p.(None): preceding paragraphs.
p.(None): Article 224 °. - In use of its powers of sanitary inspection, the Institute, in justified cases, may
p.(None): apply emergency measures, without the need for a prior sanitary summary. The same measures may be applied by
p.(None): the minister of faith designated by the Institute, with the sole merit of the act that it draws up, when there is a risk
p.(None): imminent for health. The same attributions will have the SEREMI or their ministers of faith, regarding the inspection
p.(None): that these regulations expressly instruct them.
p.(None): Article 225 ° .- Except as provided in the second paragraph of article 223, of the actions and resolutions it adopts
p.(None): the Director of the Institute in the exercise of his functions, in relation to the matters referred to in this
p.(None): regulation, an appeal may be filed before the Ministry of Health, within five days
p.(None): business days counted from the date of the notification of the respective resolution in your case.
p.(None): In the event that the affected party requires a longer time to present antecedents that support their claim, they must
p.(None): request it within the deadline, from the Ministry of Health,
p.(None): the one who will decide about it.
p.(None): Once the appeal is presented, the Ministry must request the background from the Institute and will rule on the
p.(None): claim within ten days
p.(None): upon receipt of said documents, unless technically it requires a longer period for said effect.
p.(None): If an appeal for reversal is filed before the same Institute, the claim referred to in this article may
p.(None): interpose within the same term and subsidiarily. In this case the resolution that resolves the replacement will serve as
p.(None): report for the purposes indicated in the preceding paragraph.
p.(None): FINAL TITLE: VALIDITY.
...
General/Other / Relationship to Authority
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p.(None): No. 3.- Santiago, January 25, 2010.- Seen: the provisions of Books fourth and sixth and other provisions
p.(None): Relevant of the Decree with Force of Law No. 725, of 1967, of the Ministry of Health, which approves the Sanitary Code.
p.(None): Considering: The need to update, organize and complete the current regulations regarding the matter, and
p.(None): Bearing in mind the powers conferred on me by Article 32 No. 6 of the Political Constitution of the Republic,
p.(None): I dictate the following
p.(None): Decree:
p.(None): The following Regulations of the National Control System for Pharmaceutical Products for Human Use be approved:
p.(None): PRELIMINARY TITLE:
p.(None): SCOPE OF APPLICATION AND COMPETENT AUTHORITIES.
p.(None): Article 1º.- This regulation includes the technical, administrative norms and other conditions or requirements that
p.(None): must comply with registration, import, internationalization and export, production, storage and possession, distribution to
p.(None): Free or onerous title, advertising and information on pharmaceutical products, as well as their use for
p.(None): scientific research.
p.(None): Article 2º.- It corresponds to the Ministry of Health, through the Undersecretariat of Public Health, to exercise a leading role
p.(None): and regulator in pharmaceutical products, for which it must approve the national drug policy and
p.(None): dictate the regulations and technical and administrative standards that public and private entities must comply with
p.(None): that address the activities indicated in the previous article, which will be approved through the acts
p.(None): administrative procedures that are relevant.
p.(None): Article 3.- The Institute of Public Health is the health authority in charge of the entire national territory of the
p.(None): sanitary control of pharmaceutical products and to ensure compliance with the provisions contained
p.(None): in these regulations, in the Health Code, in its complementary regulations and in other legal norms
p.(None): on the matter.
p.(None): It corresponds to exercise the actions of quality control of pharmaceutical products in any of the phases
p.(None): referred to in article 1, authorize the installation and operation of Pharmaceutical Laboratories, authorize
p.(None): and register pharmaceutical products and others subject to these control modalities, control the conditions of
p.(None): import and internment, export, manufacture, distribution, as well as the advertising and information of the
p.(None): same products, control narcotic drugs and dependency-causing pharmaceuticals and other substances
p.(None): psychotropic susceptible to supply analogous
p.(None): effect, with respect to their import, export and their lawful use in the product manufacturing process
p.(None): pharmacists and supervise compliance with the rules contained in these regulations and in the others that govern these
p.(None): subjects.
p.(None): www.bcn.cl - Library of the National Congress of Chile
p.(None): Article 4.- The Regional Ministerial Secretaries of Health, hereinafter the SEREMI, are the authorities
p.(None): competent to authorize the admission of pharmaceutical products in accordance with the provisions of article 2 of
p.(None): Law No.
p.(None): 18,164. In addition, they will be responsible for applying and supervising compliance with the rules contained in these regulations.
p.(None): regarding its distribution, storage and possession, insofar as it is carried out by establishments of the
p.(None): authorized pharmaceutical area, with the exception of the Pharmaceutical Laboratories.
...
p.(None): certain quantity of pharmaceutical product, with respect to a reference standard.
p.(None): 2) Administration: Act by which the medicine is placed in contact with the human being, so that it can
p.(None): exert local action or be absorbed and exert systemic action.
p.(None): 3) Quality assurance: A planned and comprehensive system that aims to ensure that the processes and their
p.(None): Results meet the quality requirements previously established for them.
p.(None): 4) Bioavailability: Amount of an active ingredient from a pharmaceutical form, which reaches the
p.(None): systemic circulation and the speed with which this occurs.
p.(None): 5) Good Laboratory Practices (GLP): Set of rules, operating procedures and practices that guarantee
p.(None): that the data generated by a quality control system is reproducible and representative, ensuring validity
p.(None): and reliability of the results; These technical standards will be approved by Supreme Decree of the Ministry,
p.(None): Institute proposal.
p.(None): 6) Good Manufacturing Practices (BPM): Minimum technical standards established for all procedures
p.(None): intended to guarantee the uniform and satisfactory quality of pharmaceutical products, within the limits
p.(None): accepted and valid for each of them; These technical standards will be approved by Supreme Decree of the Ministry,
p.(None): at the proposal of the Institute.
p.(None): 7) Quality of a medicine: Fitness of the medicine for the use for which it is intended, which is determined
p.(None): for its efficacy, safety and stability, in accordance with the characteristics of identity, potency, purity and others,
p.(None): according to the respective sanitary registry.
p.(None): 8) Health registration certificate: Document issued by the health authority of the producing country or
p.(None): provenance, at the request of the interested party, which must state:
p.(None): - That the producer establishment meets the conditions required by the health legislation of their country to
p.(None): elaborate, condition or package the registered product;
p.(None): - That the product is registered in the country that issues the certificate according to current regulations, indicating
p.(None): fully authorized formula;
p.(None): - That its sale or distribution under any title is subject to some restrictive regime or special control of
p.(None): sanitary type, if so.
p.(None): 9) Quality control: Activities that aim to ensure batches during all stages of manufacturing
p.(None): product uniforms conforming to identity, potency, purity and other quality requirements
p.(None): established in their respective monographs, authorized in the corresponding health registry.
p.(None): 10) Shelf control: Verification of quality of a product that is in its sale and delivery stage
p.(None): to the public and which is carried out by the Institute or by the health authority with which it agrees, according to
p.(None): programs established by the Ministry at the proposal of the Institute.
p.(None): 11) Key: Distinctive alphanumeric or numerical combination, which allows unique and unequaled identification in
p.(None): any of the stages of manufacture, storage, distribution and sale of a pharmaceutical product, for
p.(None): to ensure its traceability.
p.(None): 12) Counter sample: Finite portion of sample to be kept of the analyzed products, in the same terms
p.(None): of reference or retention samples.
p.(None): 13) Quarantine: Transitory condition of physical isolation or by other means, of raw materials, materials and
p.(None): intermediate, semi-finished, bulk, semi-finished or finished products, during which its
p.(None): use or distribution, while the decision is made on its release, rejection or reprocessing, in accordance with the
p.(None): Result of the respective quality control.
p.(None): 14) Dispensation: Act by which the pharmaceutical chemical professional
p.(None): provides a medication to a person, generally to fulfill the prescription of a licensed professional, to
p.(None): through which you are informed and guided about its use, influence of food, interactions with others
p.(None): medicines,
p.(None): www.bcn.cl - Library of the National Congress of Chile
p.(None): recognition of potential adverse reactions, storage conditions or other relevant information, all
p.(None): this according to what is authorized in the registry.
p.(None): 15) Distribution: Distribution of the pharmaceutical product that is made between producing establishments, importers,
p.(None): distributors, or other sanitary authorized to dispose of them.
p.(None): 16) Dosage: Interval of administration and period of treatment arranged for the dose of a medicine or
p.(None): pharmaceutical product.
...
p.(None): can be used to calculate the amount of active ingredients of the vegetable in the final product, provided that they have
p.(None): been quantified in the drug or vegetable preparation used as raw material in the preparation.
p.(None): 50) Tolerance margins: Percentages, maximum and minimum, officially allowed of an active principle declared in
p.(None): a product.
p.(None): 51) Raw material: Any substance of defined quality that is directly involved in the manufacture of the form
p.(None): pharmaceutical, whether it remains unchanged or is modified or eliminated in the course of the manufacturing process.
p.(None): 52) Packaging material: Material used as primary, secondary or insert packaging.
p.(None): 53) Monograph: Document containing the technical, pharmaceutical and scientific description of the characteristics and
p.(None): properties of a product.
p.(None): 54) Medical sample: Unit of a pharmaceutical specialty, exclusively intended for free distribution to
p.(None): professionals legally qualified for its prescription, whose labeling is identical to that of the registered product,
p.(None): with the indication of your condition as a medical sample, which may include information to the professional.
p.(None): 55) Reference samples or retention samples: These are the samples collected from each batch of finished product that
p.(None): must be maintained for up to one year after
p.(None): www.bcn.cl - Library of the National Congress of Chile
p.(None): the expiration date, in its final container and stored under the conditions indicated in the health record.
p.(None): 56) Sample or legal counter sample: Sample that has been taken by the health authority in use of its powers
p.(None): auditors, recording this fact in the respective act and under chain of custody conditions.
p.(None): 57) Generic name of a pharmaceutical product: Denomination accepted by the World Health Organization
p.(None): (O.M.S.), under the distinctive and initials "International Common Denominations" (D.C.I.) or International Non
p.(None): Proprietary Names (INN) and, failing that, in the officially recognized pharmacopoeias in the country.
p.(None): 58) Country of origin: One from which a pharmaceutical product is dispatched for import into our
p.(None): country, without considering those territories through which it transits.
p.(None): 59) Country of production: The country in which the manufacturing establishment of a pharmaceutical product is located, in
p.(None): any of the steps required to obtain a finished product.
p.(None): 60) Effective period: Period authorized by the Institute in the respective
p.(None): sanitary registration, during which a product must maintain its stability under the conditions of packaging and
p.(None): Storage defined in your stability study.
p.(None): 61) Potency: Therapeutic activity of a pharmaceutical product to produce a given effect, verified by tests
p.(None): laboratory tests or controlled clinical data, obtained through the administration of the product in the
p.(None): prescribed, recommended and approved employment conditions, which is expressed, according to the concentration of
p.(None): active ingredients that make up the formula
p.(None): of the product, in the weight / weight, weight / volume ratios, dose / volume unit or in units referred to a standard
p.(None): recognized internationally.
p.(None): 62) Vegetable preparation: Plant or parts of pulverized plant, its extract, tincture, squeezed juice, fatty oil or
p.(None): essential, rubber or resin or other product of a certain process, excluding its defined isolated constituents
p.(None): chemically or their mixtures, without prejudice to the possibility of containing other components, such as solvents,
p.(None): diluents or preservatives, which must be declared.
p.(None): 63) Active ingredient: Substance or mixture of substances with a specific pharmacological effect, or that without
p.(None): possess pharmacological activity, being administered to the body they acquire it.
p.(None): 64) Standard Operating Procedure (POE): Written document containing updated instructions, numbered in
p.(None): logical and continuous sequence, to carry out operations of a general nature, not necessarily limited to a
p.(None): specific product or material, which must be designed, reviewed and updated by competent and authorized personnel
p.(None): for its implementation by the technical professionals responsible for the establishment in which they are used, being
p.(None): used to complement production documentation and for quality assurance and control.
p.(None): 65) Bulk product: Product that is in its final pharmaceutical form.
p.(None): 66) Pharmaceutical association product: One that contains two or more principles incorporated in a form
p.(None): pharmaceutical.
p.(None): 67) Pharmaceutical combination product: One that consists of two or more pharmaceutical products that are
p.(None): They include in a single package to be administered sequentially or simultaneously.
p.(None): 68) Pharmaceutical reference or comparator product: Product determined by the health authority as such,
p.(None): compared to which another that requires evaluation of its therapeutic equivalence is compared.
p.(None): 69) Semi-finished product: Substance or mixture of partially processed substances, which precedes its form
p.(None): pharmaceutical and requiring more manufacturing stages.
p.(None): 70) Semi-finished product: Product that is in its final pharmaceutical form and primary packaging.
p.(None): 71) Finished product: Product that is in its final container, labeled and ready for distribution to any
p.(None): Title.
p.(None): 72) Production, production process, manufacturing, manufacturing or slaughter: set of operations involved in the
p.(None): obtaining a pharmaceutical product, from the acquisition and receipt of materials, to the release,
p.(None): storage and its corresponding quality controls.
p.(None): 73) Adverse Drug Reaction (ADR): The harmful and unintended reaction that occurs at doses used
p.(None): normally in the human being.
p.(None): 74) Serious adverse reaction: Any adverse reaction that is life threatening or life threatening or that
p.(None): implies serious disability or invalidity or that results in hospitalization or prolongation of the same.
p.(None): 75) Unexpected adverse reaction: Adverse reaction not mentioned in the product monograph,
p.(None): information to the patient and the prescribing professional authorized in the respective health registry.
p.(None): 76) Medical prescription: Order signed by a professional legally authorized to
p.(None): www.bcn.cl - Library of the National Congress of Chile
p.(None): This, in order for a quantity of one or more medications to be dispensed and administered as indicated in
p.(None): she.
...
p.(None): 2006, from the Ministry of Economy, Development and Reconstruction.
p.(None): Article 20.- Any pharmaceutical product imported or manufactured in the country, to be distributed or used to
p.(None): Any title in the national territory must previously have a health registry.
p.(None): Article 21º.- Exceptionally, the Institute may authorize the sale or provisional use of certain
p.(None): pharmaceutical products without sanitary registration, based on any of the following causes, which are stated by
p.(None): exemplary according to the provisions of article 102 of the Health Code:
p.(None): a) Epidemics or situations of emergency, urgency or catastrophe, which pose a serious risk to the health or life of
p.(None): the habitants.
p.(None): b) In the case of a pharmaceutical product that is required for an urgent medicinal purpose, without there being a
p.(None): alternative when required.
p.(None): www.bcn.cl - Library of the National Congress of Chile
p.(None): c) In the case of products to be used in scientific research or clinical trials, prior report
p.(None): favorable of the corresponding ethics committee or committees, in accordance with the rules on clinical trials carried out on human beings
p.(None): human, approved by the Ministry of Health.
p.(None): Article 22 ° .- The requests presented by the interested parties, for sale
p.(None): or provisional use of pharmaceutical products without prior health registration, based on letters a) and b) of the article
p.(None): above will be presented to the Institute, and the authorization granted by the health authority of the
p.(None): country
p.(None): of origin or manufacturing as appropriate. In both cases the
p.(None): authorizations granted to private parties may be required a second time before six
p.(None): months, as long as the application for sanitary registration is presented or antecedents are provided that prove that the
p.(None): Situation of emergency, urgency, catastrophe or urgent medicinal use has been maintained and they make their
p.(None): grant.
p.(None): Article 23.- Applications for the provisional use in scientific research or clinical trial of a product
p.(None): pharmacist must appear before the Institute accompanied by the protocol approved by the ethics committee, in the
p.(None): terms referred to in letter c) of article 21; the same document must be accompanied in the case of a
p.(None): product that has a sanitary registration and its use is intended differently from that authorized.
p.(None): Article 24 °. - In accordance with the collaboration agreements that are concluded between the Institute and the SEREMI of regions
p.(None): that have border customs, carried out in accordance with the provisions of the Organic Constitutional Law of
p.(None): General Bases of the State Administration, Law No. 18,575, whose consolidated, coordinated and systematized text was
p.(None): fixed by D.F.L. Nº 1 of 2000 of the Ministry General Secretariat of the Presidency, the latter authority may
p.(None): authorize the provisional use of pharmaceutical products without prior sanitary registration, when they are imported for
p.(None): individual use, directly by the interested party or his agent, provided they are prescribed by a professional
p.(None): enabled, to record the need and duration of treatment.
p.(None): Likewise, said health authority may authorize the hospitalization of medications by nationals or foreigners
p.(None): that carry them upon entering the country for treatment for a period not exceeding three weeks, unless it is
p.(None): of chronic diseases or other treatments, duly founded and accredited. All excess will be withheld and
p.(None): notified for subsequent confiscation.
p.(None): The respective SEREMI shall inform the Institute monthly of the authorizations granted pursuant to this
p.(None): Article.
p.(None): Article 25.- For the purposes of the provisions of article 102 of the Health Code, pharmaceutical preparations
p.(None): They will have an official sanitary registration number, which will be the one incorporated in the Official Registry of
p.(None): Preparation, which will be considered as the official record of the Institute of Public Health.
p.(None): Article 26º.- Active raw materials consisting of natural or synthetic drugs in bulk, shall be understood
p.(None): registered by the mere fact of being included in the formula of a pharmaceutical specialty that has registration
p.(None): sanitary or by the respective authorization of use and disposal, when these are imported by establishments
p.(None): authorized for it.
p.(None): Article 27º.- Traditional herbal medicines shall be understood as those constituted by the plants or parts of
p.(None): plants, fresh or dried, whole or crushed, packaged and labeled by hand and labeled with the
p.(None): denomination used by popular custom in the field of Chilean cultural traditions, which have been
p.(None): recognized in the respective technical standard approved by supreme decree of the Ministry, referred to in the paragraph
p.(None): following. They will be understood as registered for the purposes of their free sale and distribution, by the sole fact that SEREMI
p.(None): competent authority has authorized the establishment where they are stored, processed, divided or packaged or other
p.(None): activities of its processing, and must meet the following conditions:
p.(None): a) They must be in a list contained in a technical standard approved by
p.(None): www.bcn.cl - Library of the National Congress of Chile
p.(None): Supreme decree of the Ministry, issued in use of its legal, technical and regulatory powers, which will indicate the
p.(None): denomination, therapeutic properties and uses of each of them, should be used as auxiliaries
p.(None): symptomatic.
p.(None): b) Be packed by hand as isolated, unmixed plant species.
p.(None): c) Enter in their labels only those properties recognized in the aforementioned decree.
p.(None): SECOND PARAGRAPH:
p.(None): OF THE REQUIREMENTS OF THE SANITARY REGISTRY.
p.(None): Article 28º.- Applications for health registration must be submitted to the Institute, complying with the
p.(None): general and special requirements that are determined in this Title.
p.(None): The general registration requirements include administrative aspects, technical information, quality
p.(None): pharmaceutical and safety and clinical efficacy of the pharmaceutical product to be registered, which are commonly applied to
p.(None): all the
p.(None): records; for their part, the special requirements derive from their nature and from whose origin and veracity
p.(None): The professional who signs the request must be held responsible.
p.(None): 1º Of the general requirements of the sanitary registry. A.- Administrative requirements.
p.(None): Article 29.- Any request for health registration must comply with the following general requirements of a character
p.(None): administrative and accompany the following information:
...
p.(None): run directly or through other authorized establishments.
p.(None): www.bcn.cl - Library of the National Congress of Chile
p.(None): b.4. Semi-finished imported products to carry out the other necessary production stages in the country
p.(None): to obtain a finished product, either directly or through other authorized establishments.
p.(None): 6. Individualization of the licensor according to the name that appears on the license, if the process is done
p.(None): in use of license.
p.(None): 7. Name and address of the producing establishment, if it is manufactured in the country or abroad.
p.(None): 8. Presentation of the product, describing it or the contents of the different packages: sale to the public, packages
p.(None): clinical and / or as medical samples when appropriate; including those elements or devices that are incorporated
p.(None): for your administration.
p.(None): 9. Physical description of the packaging material, indicating its type, both with respect to the primary packaging and
p.(None): secondary, as well as those elements or devices that are incorporated for its administration, when appropriate.
p.(None): 10. Legal documents, in Spanish language or duly translated under the signature of the legal representative,
p.(None): professional assigned for this purpose by the company or the Technical Director, when appropriate, made up of
p.(None): following, depending on whether the products are imported or manufactured in the country:
p.(None): a) In the case of imported products in any of its phases, it must be accompanied by:
p.(None): a.1. Health registration certificate or Pharmaceutical product certificate or Health authorization certificate
p.(None): o Official certification recommended by the World Health Organization, issued by the health authority of the
p.(None): country of origin and that proves under legalized signature that the producer or warehouse establishment, if applicable,
p.(None): meets the conditions required by the health legislation of your country; that the product is registered in your country of
p.(None): according to current regulations, fully stating its authorized formula; and that your store is subject to some
p.(None): restrictive regime or special sanitary control, if it were so.
p.(None): a.2. Manufacturing agreement signed between the applicant and a foreign production pharmaceutical laboratory,
p.(None): duly legalized.
p.(None): a.3. Legalized license of the one who grants it, when appropriate.
p.(None): a.4. Official certificate issued by the competent health authority of the country where the establishment is located
p.(None): producer, proving that the foreign manufacturer is duly authorized in his country; that meets Good
p.(None): Manufacturing practices, according to WHO recommendations, indicating the production areas or types of
p.(None): products that it is authorized to manufacture, unless said accreditations are contained in the
p.(None): document indicated in letter a1) of this article.
p.(None): to 5. Import agreement authorized before a notary public or duly legalized, when appropriate.
p.(None): a.6. National manufacturing and / or distribution agreement authorized by a notary, when appropriate, attaching the
p.(None): sanitary authorization of each establishment.
p.(None): a.7. Quality control agreement with a pharmaceutical laboratory authorized by the Institute, authorized before
p.(None): notary, where appropriate.
p.(None): b) Products manufactured in the country:
p.(None): www.bcn.cl - Library of the National Congress of Chile
p.(None): b.1. National manufacturing and / or distribution agreement authorized by a notary, incorporating the authorization
p.(None): of each establishment, when appropriate.
p.(None): b.2. Legalized license of the one who grants it, if applicable.
p.(None): b.3. Quality control agreement with a pharmaceutical laboratory authorized by the Institute, when appropriate.
p.(None): Article 30 ° .- In the case of imported pharmaceutical products such as
p.(None): Finished, semi-finished, bulk or semi-finished products, the applicant will be allowed to prove the
p.(None): compliance with the manufacturer's Good Manufacturing Practices in accordance with the provisions of articles 192 °
p.(None): and 193 °, in which case the requirements indicated in letter a.4 will not be applicable. of the preceding article.
p.(None): B.- Technical Information Requirements.
...
p.(None): canceled by the Institute for public health reasons, in which case the presentation of the
p.(None): antecedents that relate to safety and efficacy, except that for well-founded reasons and through resolution, the
p.(None): Institute determines the need to have all or some of those records.
p.(None): In the case of an unconventional release pharmaceutical product that is a pharmaceutical equivalent of one already
p.(None): registered, the corresponding therapeutic equivalence studies must be attached.
p.(None): 2. In the case of sufficiently known and experienced active ingredients, so that their effectiveness,
p.(None): safety of use and adverse reactions are stated in the scientific literature, the background may be substituted
p.(None): related to pre-clinical studies, by the pertinent bibliography. Likewise, the
p.(None): scientific information regarding the efficacy and safety of the product to be registered; on this last case
p.(None): The application will be evaluated by the Institute, and the entire background may well be required.
p.(None): 3. In the case of a pharmaceutical product that is the pharmaceutical equivalent of one already registered and that is
p.(None): find in the lists of active ingredients that have been required to demonstrate their therapeutic equivalence,
p.(None): case in which the corresponding studies that the specific norm indicates must be presented.
p.(None): 4. In the case of a product manufactured in the country with the sole purpose of being exported, which according to the
p.(None): Chilean regulations are considered as a product
p.(None): www.bcn.cl - Library of the National Congress of Chile
p.(None): pharmacist and that proves that in the country of destination it is considered as a food product, by means of a document
p.(None): issued by your health authority, the presentation of the background information that relates to the
p.(None): safety and efficacy, unless the Institute determines through a founded resolution the need to have all or
p.(None): some of that background.
p.(None): Article 53º.- The cases indicated to
p.(None): continuation:
p.(None): a) The pharmaceutical product whose health registration is requested is incorporated for the first time in the field of
p.(None): medicine in the country; except in the case indicated in article 52, second numeral;
p.(None): b) The pharmaceutical product whose health registration is requested contains the same active ingredient as another already
p.(None): registered, whose information or data have the protection established in paragraph 2 of Title VIII of the law
p.(None): No. 19,039, granted according to the specific regulations governing the matter, or is based on data that count
p.(None): with such protection;
p.(None): c) The pharmaceutical product whose registration is requested includes a new therapeutic utility, dosage scheme,
p.(None): extension of a previously approved route of administration or age group, with respect to one already registered;
p.(None): d) The pharmaceutical product whose health registration is requested presents: a modification in the composition and
p.(None): concentration of the active ingredients of an already registered formula; or contains new salts, esters, complexes or
p.(None): isoforms of the active ingredients that make up a pharmaceutical specialty already registered; or constitutes
p.(None): combinations of active ingredients at fixed doses, which separately or not have a health registry;
p.(None): e) In all cases in which the pharmaceutical product, whose registration is requested is presented in a form
...
p.(None): described in recognized pharmacopoeias, according to a homeopathic manufacturing procedure that is also found
p.(None): described in
p.(None): said texts.
p.(None): FIFTH PARAGRAPH:
p.(None): VALIDITY, SUSPENSION AND CANCELLATION OF THE SANITARY REGISTRY.
p.(None): Article 55º.- The sanitary registry of a pharmaceutical specialty will be valid for five years, counted from
p.(None): the date of the resolution that grants it, and it may be renewed for equal and successive periods, provided there is no
p.(None): been canceled and the following conditions are met:
p.(None): 1. Payment of the corresponding fee.
p.(None): 2. Overcoming of the observations made for the suspension of the sanitary registration within the term granted
p.(None): for it. In the event that the validity of the sanitary registry expires pending that period, the
p.(None): renewal within 15 days after the expiration of the period granted to overcome said observations.
p.(None): 3. Non-existence of fines pending payment or compliance with other sanitary measures or sanctions applied by the
p.(None): Institute, if applicable, in relation to the registration to be renewed.
p.(None): www.bcn.cl - Library of the National Congress of Chile
p.(None): The renewal of the sanitary registry must be denied when the non-compliance of some of the
p.(None): obligations that correspond to the holder of the sanitary registry.
p.(None): Article 56º.- The request for renewal of the health registration must be submitted to the Institute and, in the case of
p.(None): imported products, must be accompanied by the Pharmaceutical Product Certificate or Registration Certificate or
p.(None): Health authorization certificate or official certification recommended by the World Health Organization,
p.(None): issued by the health authority of the country of origin and that proves that the producer or
p.(None): warehouse, as appropriate, meets the conditions required by the health legislation of your country, that the product
p.(None): is registered in the country according to regulations
p.(None): in force, fully stating its authorized formula and that its sale is subject to some restrictive regime or
p.(None): special sanitary control, if it were so.
p.(None): Article 57º.- The sanitary registry renewal resolution must maintain the registry number assigned in
p.(None): registration, adding the year of renewal and indicate the expiration date thereof.
p.(None): Article 58º.- All health registration may be suspended for any of the following reasons:
p.(None): 1. If there are significant changes in the therapeutic indication or in the composition or in the forms of
p.(None): dosage or in the application or other conditions announced in the labeling or in the information to the professional or the
p.(None): advertising or others, which do not correspond to what is approved in the health registry.
p.(None): 2. If there are failures to product quality in two series.
p.(None): The resolution that establishes the suspension of the sanitary registry will determine its scope and will set the term in which
p.(None): the observations that motivated it must be satisfactorily corrected; in case of non-compliance, it will proceed to
p.(None): cancellation.
p.(None): Article 59º.- All sanitary registration may be canceled ex officio or by complaint of interested parties, with pronouncement
p.(None): prior to the Ministry of Health, when one of the following causes occurs:
p.(None): a) When through scientific background emanating from the World Organization
p.(None): Health, national or foreign organizations or entities or their own research, the
...
p.(None): month and year of manufacture and the serial number corresponding to the item, in correlative and chronological order.
p.(None): Failing that, any alpha-numeric combination may be used as a key but must jointly state:
p.(None): the production date in month and year, on all labels, in addition to the general labeling requirements.
p.(None): Article 91º.- In the case of finished imported pharmaceutical products, the owner of the registry must declare the
p.(None): code of the country of origin at the time of requesting registration, indicating its interpretation.
p.(None): www.bcn.cl - Library of the National Congress of Chile
p.(None): Article 92º.- If a pharmaceutical product from the same batch or series is finished in discontinuous stages, each of
p.(None): they will constitute a sublot and must be individualized with an addition to the original serial number.
p.(None): TITLE IV:
p.(None): OF THE IMPORT AND INTERNATION OF PHARMACEUTICAL PRODUCTS.
p.(None): FIRST PARAGRAPH:
p.(None): GENERAL DISPOSITION.
p.(None): Article 93º.- The importation of a pharmaceutical specialty can only be carried out when it has
p.(None): Sanitary registration in force and that its import has not been suspended, without prejudice to cases and conditions
p.(None): provided for in the First Paragraph of Title II of this regulation.
p.(None): Article 94º.- Exceptionally a pharmaceutical specialty to be imported as a finished product by
p.(None): Any natural or legal person will not require a new sanitary registry for its import and distribution.
p.(None): by persons other than those who obtained said registration, when accredited, through the registration certificate,
p.(None): pharmaceutical product certificate or health authorization or official certification recommended by the Organization
p.(None): World Health, granted by the health authority in accordance with the provisions of article 29, number 10, of
p.(None): this regulation, indicating that the pharmaceutical product, in addition to having the same formula, generic name or
p.(None): denomination, comes from the same producer laboratory and country of origin as the pharmaceutical specialty
p.(None): previously registered.
p.(None): Once the above is accredited, the Institute will authorize, by resolution, the import of a quantity
p.(None): determined and will authorize its use and disposal with the sole merit of the authorization and the respective bulletins
p.(None): corresponding to the analyzes carried out by a quality control laboratory at the interned items.
p.(None): SECOND PARAGRAPH:
p.(None): OF IMPORT AND INTERNATION.
p.(None): Article 95.- The importation of pharmaceutical specialties may be carried out by laboratories.
p.(None): authorized pharmacists, pharmacies, drugstores and warehouses for pharmaceutical products and, in general, by anyone
p.(None): natural or legal person, in accordance with the rules established in current legislation.
p.(None): Article 96º.- Any natural or legal person may import pharmaceutical specialties, as well as materials
p.(None): raw materials for their production. Notwithstanding the foregoing, for admission to the national territory,
p.(None): will require having a duly authorized place for its storage, processing or subsequent distribution,
p.(None): such as: pharmaceutical laboratories, pharmacies, drugstores and warehouses of pharmaceutical products, as appropriate
p.(None): to the nature and purpose of the imported material.
p.(None): Article 97º.- Only the pharmaceutical production laboratories may enter pharmaceutical products in any
p.(None): of its production stages.
p.(None): The conditioning pharmaceutical laboratories may enter semi-finished pharmaceutical products.
...
p.(None): Of the State Administration, Law No. 18,575, whose consolidated, coordinated and systematized text was set
p.(None): by D.F.L. Nº 1, from 2000, of the Ministry General Secretariat of the Presidency.
p.(None): Article 99.- To study any customs destination for pharmaceutical products, the interested party must present to the
p.(None): National Customs Service the certificate issued by the respective SEREMI.
p.(None): Once the processing of the customs destination document has been completed and the products have been removed from the
p.(None): customs, they will be deposited under the responsibility of the consignee, who will not be able to use, consume, sell,
p.(None): assign or dispose of them under any title, without obtaining the approval of the Institute by granting their authorization for use and
p.(None): provision, denying it or setting a period of
p.(None): security to practice the corresponding sanitary controls, during which time the products cannot be
p.(None): used or distributed under any circumstances.
p.(None): Said authorization will be requested from the Public Health Institute attaching the documentation related to the import.
p.(None): (invoice and shipping document), the customs destination certification and the control control analysis protocol of
p.(None): quality of the producing country or, failing that, the analysis protocol carried out in the country, except for samples of
p.(None): pharmaceutical products intended exclusively for analysis and development or for obtaining their health registration,
p.(None): the authorization must be issued within three business days from the date the interested party
p.(None): notify the authority of the entry of the products to the warehouse.
p.(None): The granting of the use and disposal authorization will not exempt applicants from the obligation to comply
p.(None): in parallel with the other legal, regulatory or administrative requirements that are required to authorize its use or
p.(None): distribution, as well as the observance of the rights of third parties established by law.
p.(None): The National Customs Service will inform the Institute monthly about the pharmaceutical products that have
p.(None): been imported into the country, as well as their quantity and the name of the importer.
p.(None): In any case, in the case of pharmaceutical specialties, the warehouse or deposit establishment declared by the
p.(None): importer must have the authorization of the corresponding SEREMI of Health.
p.(None): TITLE V:
p.(None): EXPORT OF PHARMACEUTICAL SPECIALTIES.
p.(None): Article 100.- Only pharmaceutical products that have a valid health registration in
p.(None): Chile, after notifying the Institute.
p.(None): Article 101.- Pharmaceutical specialties destined for export that are labeled "Products for the
p.(None): Export "the regulatory requirements regarding packaging, graphic labeling, brochure will not be applicable to them
p.(None): information to the patient, except for the identification of the finished product, which must have the
p.(None): following mentions:
p.(None): A. Name of the product, including its generic name.
p.(None): B. Pharmaceutical form.
p.(None): C. I.S.P.
p.(None): D. Name of the manufacturing establishment.
p.(None): E. Serial number and expiration date.
p.(None): Article 102.- They will be applicable to the elaboration, quality control and
p.(None): www.bcn.cl - Library of the National Congress of Chile
p.(None): storage of products intended exclusively for export, the Good Practice standards of
p.(None): Manufacturing and Laboratory.
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p.(None): Article 149 ° .- External quality control laboratories will function under the responsibility of a Director
p.(None): Technician, by profession a pharmaceutical chemist.
p.(None): Article 150 ° .- The technical management of pharmaceutical laboratories that exclusively manufacture raw materials or
p.(None): drugs of biological origin, which are obtained by processes of the same nature, may also correspond to a biochemist
p.(None): or a doctor-surgeon with a specialization in microbiology.
p.(None): Article 151 ° .- The positions of Technical Director, Head of Production, Head of Quality Control and Head of
p.(None): Quality Assurance, must be exercised continuously and permanently throughout the time of
p.(None): operation of the
p.(None): laboratory, and the Institute must be informed, within a period of 30 days from the date they assume, the
p.(None): name and address to which notifications will be validly made.
p.(None): In the absence of the owner, they must be immediately replaced by others of the same profession and for the time
p.(None): your absence lasts. In any case, the responsibility of the processes already started will always affect the owner, without
p.(None): prejudice of the one that exists with respect to the substitute.
p.(None): In the case of professionals who assume such positions as substitutes, it must be recorded in all
p.(None): existing forms and records, as well as being informed monthly to the Institute.
p.(None): If the holder's absence is prolonged for a period of more than 48 hours, it must be made up under the conditions
p.(None): previously indicated and also communicated to the Institute. The same communication must be made at the end of your
p.(None): functions or suspension thereof.
p.(None): Article 152 ° .- The Technical Director will be responsible for representing the establishment before the health authority, for
p.(None): purposes of compliance with these regulations regarding the following aspects:
p.(None): a) Guarantee the veracity of the information declared in the health registry.
p.(None): b) Keep a file with the product registration resolutions, their modifications, the information to the
p.(None): professional, advertising and all documentation sent or received from the Institute.
p.(None): c) Timely forward all the information that, pursuant to this
p.(None): www.bcn.cl - Library of the National Congress of Chile
p.(None): regulations, must be sent to the Institute or that the latter requires and that no other person has been appointed.
p.(None): d) Ensure that the advertising and information of pharmaceutical products complies with the provisions of the
p.(None): health registration and current health regulations.
p.(None): e) Exercise the other functions assigned to it by laws and regulations.
p.(None): Article 153.- The Production Manager will correspond, in general, the organization and development of the components of the
p.(None): production process in the technical order, being especially responsible for the following aspects:
p.(None): a) Guarantee the conformity of the formula of the products that are manufactured, packaged or imported with what has been declared and
p.(None): approved in the registry specifications.
p.(None): b) Observe and enforce Good Manufacturing Practices.
p.(None): c) Ensure correct compliance with the instructions related to the manufacturing, packaging and
p.(None): storage, including process controls.
p.(None): d) Monitor the maintenance of the department in general, facilities and equipment.
p.(None): e) Exercise the other functions assigned to it by laws and regulations.
p.(None): Article 154 ° .- The following functions will correspond to the Head of Quality Control of the establishment:
...
p.(None): the establishment.
p.(None): Article 155 °. - The Head of Quality Assurance will correspond, in general, to carry out the activities inherent to the
p.(None): adopted quality system and efforts to ensure that pharmaceutical products have the required quality
p.(None): in accordance with the respective sanitary registry and especially must:
p.(None): a) Verify that the elaboration of the products is carried out in accordance with Good Manufacturing Practices and
p.(None): Laboratory and supervise its compliance at all levels.
p.(None): b) Ensure the adequate establishment of data in each of the records that every pharmaceutical laboratory must
p.(None): keep in accordance with current regulations.
p.(None): c) Release for distribution to the market each production series or batch, which should refer, among others, to
p.(None): the evaluation of compliance with the specifications of the sanitary registry, compliance with Good Practices of
p.(None): Manufacturing and Laboratory, production process, analysis results practiced, documentation review
p.(None): of the batch or series, controls in process and
p.(None): analysis of deviations, without prejudice to the responsibilities that affect the Head of Production or Control of
p.(None): Quality, as appropriate.
p.(None): d) Establish the validation programs, both of the manufacturing processes that may be responsible for causing
p.(None): variation in the characteristics of products in process and finished products, such as the methodologies of
p.(None): analysis.
p.(None): www.bcn.cl - Library of the National Congress of Chile
p.(None): e) Register and analyze complaints and claims about the quality of products that have been reported or
p.(None): returned by users or investigated by the health authority and take the necessary measures to correct the
p.(None): deficiencies found.
p.(None): f) Establish and enforce the calibration and qualification programs of the equipment and instruments of the
p.(None): pharmaceutical laboratory, as appropriate.
p.(None): g) Study and carry out stability studies.
p.(None): h) Design and execute a program to verify the reliability of the methods used in the inspection and
p.(None): analysis of the quality characteristics of materials and products.
p.(None): i) Design and execute the programs for self-inspections and audits of suppliers and service providers
p.(None): external.
p.(None): j) Exercise the other functions assigned by the laws and regulations, regarding their professional activity in
p.(None): the establishment.
p.(None): Article 156 ° .- Corresponds to the Technical Director of the External Quality Control Pharmaceutical Laboratory
p.(None): represent the establishment before the health authority for the purposes of complying with these regulations and,
p.(None): in particular, carry out the following functions:
p.(None): a) Issue the analysis bulletins of raw materials, products in process or finished according to the
p.(None): methodologies and specifications, as appropriate, established in the respective health registers,
p.(None): deciding on their approval or rejection.
p.(None): b) Establish and periodically enforce the programs established to calibrate and qualify the instruments and
p.(None): laboratory equipment, as appropriate.
p.(None): c) Design and execute a program to verify the reliability of the methods used in sampling, inspection
p.(None): and analysis of the quality characteristics of products.
p.(None): d) Plan, establish and control the performance of laboratory work, ensuring compliance with
p.(None): the rules of Good Laboratory Practice.
p.(None): e) Guarantee the reliability of the analytical results of
p.(None): quality that are made in your laboratory in the products that are manufactured, packaged or imported, whose analyzes have
p.(None): been entrusted.
p.(None): f) Carry out the sampling of the products to be analyzed, according to a procedure that ensures their
p.(None): representativeness.
p.(None): Article 157 ° .- The natural or legal person who owns the establishment, when appropriate, must provide the
p.(None): Professionals indicated the technical and financial resources that they need to respond to the requirements
p.(None): established in this regulation.
p.(None): Article 158 ° .- The responsibilities that affect the Technical Director, the Production Manager, the Control Manager of
p.(None): Quality and the Head of Quality Assurance, will always reach the natural or legal person, owner of the
p.(None): establishment, when appropriate, according to the general rules that govern the matter.
p.(None): Article 159 ° .- The natural or legal person who owns the
...
p.(None): origin does not affect the quality, efficacy and stability of the product, without prejudice to the power of the Institute to
p.(None): carry out a selective sampling in order to verify the specifications with which the registration was granted, for which
p.(None): which may request further information.
p.(None): THIRD PARAGRAPH:
p.(None): OF THE SERIAL CONTROL
p.(None): Article 180.- Without prejudice to the general quality control provisions indicated above, the
p.(None): Institute, by means of a founded resolution, may subject serial control, temporarily or permanently, to any
p.(None): product, taking into account its nature, the variability of the analysis methods used in its control or
p.(None): other reasons duly substantiated.
p.(None): Article 181 °. - For series control, the Institute of Public Health
p.(None): www.bcn.cl - Library of the National Congress of Chile
p.(None): determine, by resolution, the performance of all or part of the tests or analyzes included in the specifications
p.(None): of finished product, authorized in the respective sanitary registry and its frequency for each product.
p.(None): Article 182 ° .- The approval of the lot or sublot does not exempt the holder of the sanitary registry from the obligation of
p.(None): carry out the quality controls established by this regulation and its complementary regulations.
p.(None): Article 183 ° .- All biological products must undergo the serial control procedure.
p.(None): Article 184 ° .- The request for series control must correspond to a fully finished lot or sublot.
p.(None): individualized with a different alphanumeric code each time the respective request is presented; owing
p.(None): attach the following:
p.(None): a) Batch release certificate issued by the Head of Quality Assurance in the case of production
p.(None): national or by the manufacturer or health authority of your country, in the case of imported, finished or
p.(None): semi-finished, as appropriate.
p.(None): b) The respective Analysis Bulletin made in Chile or the analysis bulletin of the manufacturing country in the case of
p.(None): finished, semi-finished or bulk imported products.
p.(None): c) Standards necessary to carry out the analysis.
p.(None): Article 185 ° .- To carry out the serial control procedure, the Institute will proceed to take two samples, one of
p.(None): which will be sealed and
p.(None): documented in the premises where the sampling is carried out, under the responsibility of the Technical Director. The size
p.(None): of each sample will be enough to carry out two complete analyzes, according to the product specifications
p.(None): completed authorized in the respective sanitary registry and will be carried out through sampling procedures
p.(None): determined by resolution of the Institute.
p.(None): Article 186 ° .- The approval or rejection of a lot or sublot under series control, will be made within the
p.(None): 20 business days, counted from the time they are received according to the background described in article 184 of this
p.(None): regulations, with the exception of vaccines, whose serial control will be carried out within 40 working days.
p.(None): Notwithstanding the foregoing, the Institute may for reasonable reasons increase the term indicated in the preceding paragraph.
p.(None): Once the serial control is rejected, the manufacturer or importer must proceed to the immediate destruction of the product, the
p.(None): which will be effective in authorized places, in the presence of the Technical Director and a minister of public faith
p.(None): designated by the Institute, drawing up a record of everything done.
...
p.(None): justify by the holder of the sanitary registry.
p.(None): For these purposes, the interested party must provide sufficient information about the validation of the methods.
p.(None): analytical used in the release of the batch in the country of manufacture, analysis bulletin of the country of origin and
p.(None): cold chain maintenance records, where applicable.
p.(None): Article 188 ° .- The resolution granting the exemption or denial must be founded. In case of being favorable
p.(None): It will contain the following mentions:
p.(None): www.bcn.cl - Library of the National Congress of Chile
p.(None): 1. Name of the pharmaceutical specialty.
p.(None): 2. Maximum authorized quantity and frequency of importation.
p.(None): 3. Exempt analyzes.
p.(None): 4. Number of counter samples to be kept.
p.(None): 5. Validity of the resolution granting the exemption.
p.(None): FIFTH PARAGRAPH:
p.(None): OBLIGATIONS RELATED TO QUALITY CONTROL.
p.(None): Article 189 ° .- The holder of the sanitary registry will be responsible for keeping counter samples of each batch of
p.(None): Pharmaceutical products manufactured locally or on each import made, in sufficient quantity to make, to
p.(None): at least two complete analyzes of the product, according to the specifications approved in the respective registry
p.(None): sanitary, suitably labeled and stored, under the custody of the Chief of Quality Control, whether this is his own
p.(None): pharmaceutical laboratory or the one that provides services externally by agreement.
p.(None): The counter samples and corresponding documentation must be kept for one year beyond the expiration date.
p.(None): of the product.
p.(None): SIXTH PARAGRAPH:
p.(None): QUALITY INSPECTION.
p.(None): Article 190 ° .- The Public Health Institute is the health authority in charge of supervising the quality of the
p.(None): pharmaceutical products through inspection, shelf control or other actions in establishments
p.(None): manufacturers, importers, conditioners, distributors, vending machines and healthcare services.
p.(None): These activities may be extended to bioavailability studies and to those intended to demonstrate equivalence
p.(None): therapeutic according to the provisions of Title X of these regulations.
p.(None): Article 191 °: Any failure of quality of pharmaceutical products or claim on it, must be notified to the
p.(None): Institute, which will be responsible for evaluating them and determining the appropriate actions in their case.
p.(None): If this failure occurs due to storage, distribution through drugstores or retail, the background
p.(None): will be forwarded to the corresponding SEREMI, so that it can make the responsibility of those who proceed, through
p.(None): of the respective sanitary summary.
p.(None): Article 192 ° .- In the case of importers of products manufactured abroad as finished products,
p.(None): semi-finished, made in bulk or semi-finished, it will be the responsibility of the Institute to verify compliance, by
p.(None): of the producer laboratory located abroad, of the Good Manufacturing Practices according to the lines of
p.(None): corresponding production.
p.(None): For the purposes of verification in foreign laboratories, the Institute may contract consultancies and services
p.(None): external or sign agreements with national or foreign entities, public or private, that are necessary for their
p.(None): realization in accordance with the required quality standards.
p.(None): Article 193 ° .- Notwithstanding the foregoing, the Institute may accept international accreditation and certification
p.(None): of pharmaceutical specialties and production plants, to the extent that the technical standards of production and control
p.(None): of quality applied by the sanitary authority of the manufacturing country or the
p.(None): country recognized as accreditation, have been declared homologated by resolution of the Ministry of Health or that
p.(None): they appear in International Treaties.
p.(None): In case they are not homologated, the Institute will proceed in the manner indicated in the previous article at the expense of the
p.(None): Applicant for health registration or its owner, when appropriate.
p.(None): Article 194 °. - In the event that through the respective sanitary summary,
p.(None): www.bcn.cl - Library of the National Congress of Chile
p.(None): check for quality failures of three or more batches of different pharmaceutical products from the same line of
p.(None): production of a certain manufacturing laboratory, the Institute will modify the sanitary authorization, excluding the
p.(None): production line corresponding to said products or will proceed to the suspension of import and distribution
p.(None): authorized in the health registers of all those pharmaceutical specialties whose authorized manufacturer
p.(None): include that production line.
p.(None): TITLE VIII:
p.(None): OF THE ºDISTRIBUTION.
p.(None): Article 195 ° .- The distribution of the products will be done by the pharmaceutical production laboratories and
p.(None): conditioners, drugstores and
p.(None): warehouses for pharmaceutical products for human and dental use, under the conditions that for each of them are
p.(None): establish in the respective sanitary registry and only sanitary authorized establishments for their
p.(None): reception.
p.(None): Article 196 ° .- The sale to the public of pharmaceutical specialties may only be made in pharmacies, warehouses
p.(None): pharmaceuticals and warehouses of dental or other pharmaceutical products, under the conditions that for each of them
p.(None): are statutorily established.
...
p.(None): condition to patients.
p.(None): The establishment receiving the donation must deliver them free of charge.
p.(None): TITLE IX:
p.(None): ADVERTISING AND INFORMATION.
p.(None): FIRST PARAGRAPH:
p.(None): www.bcn.cl - Library of the National Congress of Chile
p.(None): GENERAL DISPOSITION.
p.(None): Article 199 ° .- Advertising and information, to the patient and the professional, related to specialties
p.(None): pharmaceutical companies, will be governed by the rules of this Title, for which it will be understood as:
p.(None): a) Advertising: Set of procedures or activities used to publicize, highlight, distinguish directly or
p.(None): indirectly to the public, through any means or method of dissemination, its own characteristics,
p.(None): conditions of distribution, sale and use of the products referred to in these regulations.
p.(None): b) Information for professionals: Set of procedures and activities, aimed at professionals legally
p.(None): authorized to prescribe or dispense pharmaceutical products, in order to make them known to the products
p.(None): referred to in these regulations, adjusting to what is authorized in the respective sanitary registry.
p.(None): c) Professional information brochure: Document that will contain at least the characteristics of the specialty
p.(None): pharmaceutical; pharmacokinetic, pharmacodynamic and toxicological aspects thereof; as well as the indications,
p.(None): dosage, age group to which it is directed, contraindications, interactions, precautions and / or warnings,
p.(None): adverse reactions, within which it is necessary to point out those that may occur during pregnancy, lactation
p.(None): or in special populations; the measures to be taken in cases of overdose and other aspects, determined by the
p.(None): authority based on the nature and scientific information available of a pharmaceutical product, in order to
p.(None): inform professionals legally empowered to prescribe or dispense pharmaceutical products.
p.(None): d) Patient information brochure: Document intended to inform the patient about a specialty
p.(None): pharmaceutical. It will contain at least the information regarding the authorized indication, warnings,
p.(None): contraindications, interactions with other products, precautions and all other information that the health authority
p.(None): determine in the registry, to ensure its correct use. The Pharmaceutical Products for Sale brochure
p.(None): direct, you must also indicate information
p.(None): about the usual dosage for particular use and how they are approved for use in the registry.
p.(None): Article 200.- The advertising of the direct sale pharmaceutical specialties may be carried out without authorization.
p.(None): prior to the Institute, having to do so, reproduce the exact content, total or partial, authorized in the brochures
p.(None): of information to the patient and labels, which have been approved in the respective health registry.
p.(None): You can only refer to therapeutic recommendations that have been approved by the Institute in the respective
p.(None): sanitary registry and, in no case, may contain titles, figures, indications, effects, allusions or mentions,
p.(None): do not settle for it.
p.(None): Advertising that is contrary to the aforementioned will be sanctioned, prior sanitary summary.
p.(None): Article 201 °. - It will not be possible to advertise the specialties whose condition of sale is simple recipe, recipe
p.(None): withheld or prescription check.
p.(None): They may, however, advertise to professionals qualified for their prescription and dispensation, publicly without
p.(None): prior approval of the Institute, through notices intended exclusively to publicize its introduction or existence
p.(None): in the market, containing only the approved official name, with its identification on the main label, the
p.(None): name of the manufacturer or importer and distributor laboratory and the hallmark of the establishment, if any.
p.(None): Article 202.- The donation, delivery or free distribution of medicines for advertising purposes will be prohibited.
p.(None): This purpose will be presumed in any free, massive or individual delivery, donation or distribution that is not found.
p.(None): protected by article 198 °.
p.(None): Article 203 °. - The Institute may suspend or prohibit, by reasoned resolution, advertising and information to the
p.(None): professional, of pharmaceutical specialties that do not comply with the provisions of this Title, without
p.(None): www.bcn.cl - Library of the National Congress of Chile
p.(None): prejudice to the corresponding sanitary summary instruction.
p.(None): For these purposes, the Institute will require the corresponding parties, the texts of the publicity and information of such
p.(None): products.
p.(None): Article 204 °. - When the information to the professional proves not to correspond to that approved in the registry, the
p.(None): Institute, by founded resolution, may suspend the sanitary registration and, in addition, order the withdrawal of all
p.(None): brochures.
p.(None): Article 205 °. - The modifications of the information leaflets to the patient and the professional authorized in the
p.(None): registration, may be requested by the owner, must be approved or rejected by reasoned resolution.
p.(None): Likewise, the Institute may, by means of a founded resolution, modify the authorized brochures with prior notice to
p.(None): to take the appropriate measures.
p.(None): Article 206 ° .- The holders of sanitary registration, importers, manufacturers or distributors and vendors who
p.(None): advertise or carry out information activities to the prescribing professional, by itself or through third parties, with
p.(None): infringement of the provisions of these regulations, will be sanctioned upon instruction of the corresponding summary
p.(None): sanitary.
p.(None): Article 207 °. - Publications, projections, transmissions or any other propaganda system are prohibited.
p.(None): audiovisual by means of which any product that has not been
p.(None): authorized or recognized as such by the authority.
p.(None): The health authority may resolve the immediate cessation of said activity, under the terms of article 178
p.(None): of the Sanitary Code, without prejudice to the sanitary responsibility that may affect the offender, as determined
p.(None): in the corresponding summary.
p.(None): SECOND PARAGRAPH:
p.(None): FROM INFORMATION TO PROFESSIONAL.
p.(None): Article 208 °. - The information to the professional of the pharmaceutical specialties of sale under simple prescription, will be
p.(None): aimed exclusively at professionals legally empowered to prescribe, and chemical-pharmacists
p.(None): in charge of dispensing.
p.(None): Article 209 ° .- The information given to the professional must be
p.(None): true, exact, complete and testable, must be in accordance with the therapeutic use, properties and
p.(None): content of the professional information brochure, as approved in the corresponding registry.
p.(None): You must also indicate the formula, indications, interactions, contraindications, precautions and
p.(None): Warnings, adverse reactions, side effects, dosage and toxicity risks, as well as their treatment.
p.(None): The texts and graphic expressions must conform to the type of pharmaceutical product, without alterations, distortions or
p.(None): qualifying of any other nature and be exact, true and subject to verification.
p.(None): Article 210 °. - In the professional information brochure, the information regarding the
p.(None): bioavailability or therapeutic equivalence demonstrated in cases where these are mandatory.
p.(None): Article 211 ° .- When the information refers to clinical, pharmacological or other antecedents
p.(None): scientists, must be duly individualized and the citations must correspond to the faithful transcription of
p.(None): they. These studies must be fully available to professionals who request it, according to
p.(None): proceed.
...
p.(None): expressly indicating such condition and being the eventual use of that one, of exclusive responsibility of the professional.
p.(None): Article 213 ° .- Incentives of any kind such as money, goods, services or other directed may not be used
p.(None): to the professionals responsible for prescribing or dispensing, as well as to the people in charge of dispensing it,
p.(None): to stimulate the prescription, dispensing or sale of some products or companies over others.
p.(None): THIRD PARAGRAPH:
p.(None): ADVERTISING IN PHARMACEUTICAL ESTABLISHMENTS.
p.(None): Article 214 ° .- Only specialties may be announced in manufacturing and distribution establishments
p.(None): pharmaceutical companies whose condition of sale is direct, indicating their authorized name and approved packaging and the
p.(None): producer or distributor badge, if any.
p.(None): Notwithstanding the foregoing, vending companies may announce the price of pharmaceutical specialties,
p.(None): Whatever its condition of sale, by means of the exact reproduction of its labels in the places of sale.
p.(None): Products subject to special controls, such as psychotropic, are exempt from these provisions.
p.(None): and narcotics.
p.(None): Article 215.- In these establishments, advertising procedures that may induce the
p.(None): purchase, use or unspecified choice of medicines, such as raffles, raffles, donation of samples or other forms
p.(None): that stimulate consumption, misuse or self-medication, if applicable. Likewise, the sale of
p.(None): pharmaceutical products through incentives of any kind aimed at pharmacy staff.
p.(None): TITLE X:
p.(None): OF HEALTH SURVEILLANCE.
p.(None): FIRST PARAGRAPH:
p.(None): OF PHARMACOVIGILANCE.
p.(None): Article 216 °. - The Institute is the sanitary authority in charge of the security surveillance of the specialties
p.(None): Registered and non-registered pharmaceutical companies have been authorized for use in research
p.(None): scientific or provisional.
p.(None): Article 217 ° .- Health professionals have the duty to communicate to the Institute, all suspicions of
p.(None): Adverse reactions of which they are aware and which could have been caused by a certain product
p.(None): pharmacist.
p.(None): The same obligation will fall on the Technical Director of the healthcare establishments, which must maintain
p.(None): an updated record of these events.
p.(None): The communication of the information referred to in this article, must be made on the forms that for this purpose
p.(None): determine the Institute of Public Health, by resolution.
p.(None): In the case of suspicion of a serious adverse drug reaction, the communication must be made within
p.(None): 72 hours after taking
p.(None): www.bcn.cl - Library of the National Congress of Chile
p.(None): knowledge of the fact. In all other cases, you must communicate within the
p.(None): 30 days.
p.(None): Article 218 °. - The holders of sanitary registrations or authorizations must implement and maintain a system of
p.(None): pharmacovigilance, own or outsourced, being its Technical Advisor, responsible for:
p.(None): a) Create, adopt and maintain a documented system to collect and process information on a single file
p.(None): all suspected adverse reactions.
p.(None): b) Prepare and submit quarterly to the Institute of Public Health, information about suspicions of
p.(None): adverse reactions in the authorized forms, unless by means of a founded resolution the Institute determines a
p.(None): lower term.
...
Orphaned Trigger Words
p.(None): previous categories.
p.(None): Article 11º.- They are products of origin or chemical synthesis, those pharmaceutical specialties constituted by
p.(None): one or more purified and identified active ingredients, obtained through a chemical synthesis process or
p.(None): extraction.
p.(None): Article 12º.- Biological products are those pharmaceutical specialties whose obtaining and / or production involves
p.(None): to living organisms, as well as their fluids or tissues.
p.(None): Organic products are classified as follows:
p.(None): a) Vaccines: Biological products that have been formulated to provoke a specific active immunity.
p.(None): b) Serums: Biological products that have been formulated to provoke passive immunity.
p.(None): c) Blood products: Biological products derived from human blood or plasma, obtained by procedures
p.(None): industrial, whose raw material is human blood or plasma. These medications include, especially, the
p.(None): albumin, clotting factors and immunoglobulins of human origin, excluding whole blood, plasma
p.(None): and blood cells of human origin.
p.(None): d) Hormones: Biological products of protein type, amino acid derivative, spheroidal or lipid, which being
p.(None): Natural origin, they are used to treat some disorders, either compensating or increasing their lack. Those of origin
p.(None): Synthetic will be included in letter a) of article 10.
p.(None): e) Biotechnological or Recombinant Drugs: Biological products of protein type developed by engineering
p.(None): genetics, obtained by means of nucleic acid combination techniques (DNA, deoxyribonucleic acid and RNA,
p.(None): recombinant ribonucleic acid), monoclonal antibodies, among others.
p.(None): f) Antibiotics: They are biological products made up of substances secreted by a microorganism with capacity
p.(None): antimicrobial. In the case of antibiotics of synthetic origin, these will be considered within letter a) of the
p.(None): Article
p.(None): 10th.
p.(None): g) Allergens: Biological product, intended to identify or cause a specific and acquired modification of the
p.(None): immune response to an allergy agent.
p.(None): h) Gene therapy: Biological product obtained through the set of processes intended to transfer a gene (DNA or
p.(None): RNA) prophylactic, diagnostic or therapeutic, in vivo or ex vivo, to human or animal cells and their subsequent
p.(None): expression in vivo.
p.(None): Article 13.- Radiopharmaceuticals are those products or formulations marked with radionuclides or radioisotopes,
p.(None): intended to be used in the diagnosis or treatment of diseases, whatever the route of administration
p.(None): employee.
p.(None): Article 14º.- Phytopharmaceuticals are those pharmaceutical specialties whose active ingredients come from the
p.(None): aerial or underground parts of plants or other plant material and are properly standardized.
p.(None): Article 15º.- Homeopathic products are those pharmaceutical specialties made up of substances
p.(None): homeopathic and prepared from components or raw materials of plant, animal, mineral or chemical origin, of
p.(None): according to a homeopathic manufacturing procedure, described in standards officially approved by supreme decrees
p.(None): of the Ministry, which include the dilution and dynamisation processes of their mother tinctures,
p.(None): which, in addition, must have been tested on healthy individuals and repertorized, to be prescribed or used
p.(None): according to the law of similarity. A homeopathic product may contain one or more homeopathic substances.
p.(None): Article 16.- They are medicinal gases, pharmaceutical specialties
p.(None): www.bcn.cl - Library of the National Congress of Chile
...
p.(None): the formulation, adjusting to the requirements contemplated in official texts authorized in these regulations or
p.(None): monographs thereof, if not indicated in said texts.
p.(None): e.2. Attach accreditation about the absence of raw materials from animal species affected by
p.(None): TSEs or other transferable.
p.(None): f) Control of finished product:
p.(None): f.1. You must include at least the following information:
p.(None): . Description and appearance (physical state, color, odor, and clarity, where applicable);
p.(None): . Selective identification for the active ingredient (s);
p.(None): . Assessment, potency or activity of the active ingredient (s);
p.(None): . Determination of impurities, when appropriate;
p.(None): . Description of the nature and type of packaging material, both primary and secondary packaging, and accessories,
p.(None): when the latter are in contact with the pharmaceutical product;
p.(None): . Any other determined by resolution of the Institute, according to the nature and composition of the product
p.(None): biological.
p.(None): f.2. Indicate the acceptance criteria and maximum and minimum values when they are determining factors.
p.(None): f.3. Summary sheet, which includes the analytical parameters and their acceptance criteria with which the
p.(None): biological product. This document, once official, will become the specifications of the finished product,
p.(None): with which the biological product must comply throughout its period of effectiveness.
p.(None): g) Packaging material:
p.(None): g.1. Description of the nature and type of the packaging material, both primary, secondary and accessories, when
p.(None): the latter are in contact with the pharmaceutical product.
p.(None): g.2. You must include the information regarding the choice of the primary packaging material, considering the protection
p.(None): of the light and humidity it provides, compatibility of the chosen material with the pharmaceutical form and its administration.
p.(None): g.3. When the pharmaceutical form is sterile, it must include information on the integrity of the closure system of the
p.(None): primary packaging to avoid microbial contamination.
p.(None): h) Stability study for the formulation, the solvent and the reconstituted product, as appropriate:
p.(None): h.1. Stability history should include as a minimum:
p.(None): . Formula studied;
p.(None): . Identification of the manufacturer and responsible for the stability study;
p.(None): . Conditions of temperature, humidity, packaging material and series studied (minimum 3 series or pilot lots) and the
p.(None): scheduled design, analytical procedures used and finished product specifications, all
p.(None): as appropriate, according to the Product Stability Guide
p.(None): www.bcn.cl - Library of the National Congress of Chile
p.(None): Pharmaceuticals referred to in article 32.
p.(None): h.2. In the case of a biological product that contains an active ingredient that is incorporated for the first time in the
p.(None): field of medicine in our country, must include the results of stability studies for degradation
p.(None): forced and stressful conditions.
p.(None): h.3. Proposition of the efficacy period and storage precautions, both supported by the study of
p.(None): corresponding stability, also indicate the period of effectiveness for the reconstituted product, when appropriate.
p.(None): h.4. If the product must be diluted prior to administration, the compatibility studies and
p.(None): stability with corresponding diluents, as appropriate.
p.(None): i) Safety and Efficiency Requirements.
p.(None): In the cases of biotechnological products, by Supreme Decree of the Ministry, at the proposal of the Institute,
...
p.(None): The Institute will grant or not, by reasoned resolution, requests for modification of registration within a period not
p.(None): greater than three months from the date of submission of the application, with the exception of those indicated in the
p.(None): number 8 of the preceding article.
p.(None): When during the evaluation of the modification request and the background provided, the
p.(None): Insufficiency of the same to support the request, the user must be notified of such situation, indicating
p.(None): specifically the objections and the background that must be added to overcome them, granting a deadline for
p.(None): less than ten nor more than thirty business days.
p.(None): 2º Of the administrative aspects.
p.(None): Article 67º.- Any modification of the sanitary registry that does not affect the
p.(None): www.bcn.cl - Library of the National Congress of Chile
p.(None): technical aspects related to the quality, safety and efficacy of pharmaceutical specialties, should be
p.(None): notified by the holder to the Institute of Public Health, who will proceed to update it.
p.(None): Article 68º.- Changes in ownership of a health registry of a pharmaceutical specialty may be
p.(None): requested from the Institute, provided that the new owner complies with the relevant requirements, keeping the others
p.(None): conditions authorized in the registry or attaching the background to support your modification of the agreement
p.(None): to the provisions of the previous articles.
p.(None): The request must be supported with the corresponding legal instruments, duly legalized and translated
p.(None): under the signature of the legal representative.
p.(None): In the case of health records granted under a license, the provisions of the respective
p.(None): document and in the absence of express mention the change of ownership can only be authorized with the consent of the
p.(None): licensor, knowledge of the licensee and application for a new owner.
p.(None): Article 69º.- In cases where the change of ownership and other registry modifications is required
p.(None): sanitary, will proceed to solve them together, unless a change of manufacturer is required, in which case
p.(None): You must request a new registration.
p.(None): Article 70º.- The changes will be registered in the corresponding registry, in the same terms and conditions indicated in
p.(None): Article 66º for the other modifications of the sanitary registry.
p.(None): SEVENTH PARAGRAPH:
p.(None): FROM COMMON OBLIGATIONS TO ANY HEALTH REGISTRY HOLDER.
p.(None): Article 71º.- The holder of the health registry is ultimately responsible for the safety and efficacy of the medication.
p.(None): Without prejudice to the specific obligations established in attention to the nature of each specialty
p.(None): pharmaceutical, all health record holder will be obliged to:
p.(None): 1) Respect and enforce the authorization conditions contemplated in the respective sanitary registry and the
p.(None): others indicated by these regulations.
p.(None): 2) Comply with the obligations imposed by Title X on Health Surveillance.
p.(None): 3) Immediately communicate to the Institute and to the Undersecretariat of Public Health the recalls of products from the market that
p.(None): practice, adequately reporting the reasons and measures taken for this purpose.
p.(None): 4) Inform the Ministry, the Institute and the Supply Center of the National System of Health Services
p.(None): the intention to temporarily or permanently suspend the distribution of the product, with an advance of 3 to 6
p.(None): months respectively.
p.(None): 5) Keep the sanitary registry updated, in accordance with the state of science and technique, especially in
...
p.(None): a) The owner or his legal representative, communicate his will not to continue his activities.
p.(None): b) The authorized establishment suspends its operation for a period of six months.
p.(None): Article 169.- Without prejudice to the provisions of the previous article, the authorization of the operation of a
p.(None): pharmaceutical laboratory may also be canceled, according to the merit of the health summary that must be instructed,
p.(None): among others, in the following cases:
p.(None): a) No analysis of raw materials and finished products, as appropriate.
p.(None): b) One or more counterfeit, contaminated, altered or adulterated products are manufactured.
p.(None): c) There are repeated failures in the quality of the products manufactured or conditioned by the establishment,
p.(None): related to efficacy and safety, in more than three series of products that correspond to the same sanitary registry
p.(None): or more than four series that correspond to different products within the 1-year period.
p.(None): d) When the establishment has been totally or partially suspended, the same infractions will be verified
p.(None): that motivated its suspension.
p.(None): Article 170º.- The work stoppage or suspension of activities will proceed when any of the
p.(None): following conditions:
p.(None): a) That a pharmaceutical laboratory operates without a Technical Director, Production Manager, Quality Control Manager or
p.(None): Head of Quality Assurance, as appropriate.
p.(None): b) That the observed deficiencies that have been notified to it have not been corrected, within the terms that the
p.(None): Institute would have pointed out to him.
p.(None): c) That the manufacturing standards and specifications of the Good Manufacturing Practices and
p.(None): Laboratory, in what corresponds to the category and lines of establishment activities, that put at risk the
p.(None): efficacy, safety and quality of products.
p.(None): The suspension or suspension may be total or partial.
p.(None): Article 171 °. - In the case of suspension or suspension, the conditions and the term in which
p.(None): they must be fulfilled for the resumption of the tasks to be arranged.
p.(None): Article 172 ° .- Every owner must notify the Institute, within the
p.(None): 30 days following, the temporary or permanent closure of your pharmaceutical laboratory.
p.(None): In the case of temporary closure that exceeds 6 months or that involves any change in the physical plant, its
p.(None): facilities or its line of activities, the corresponding authorization must be requested to resume tasks or
p.(None): activities.
p.(None): TITLE VII:
p.(None): OF QUALITY
p.(None): FIRST PARAGRAPH:
p.(None): GENERAL DISPOSITION
p.(None): Article 173 ° .- All pharmaceutical products manufactured or imported into the country must be subject to quality control,
p.(None): except for the exceptions established in these regulations.
p.(None): The responsibility for the quality of the products will correspond to the manufacturers, importers, distributors,
p.(None): vendors or holders of any title, as appropriate and where appropriate.
p.(None): Article 174 ° .- Any natural or legal person, owner of an establishment that acts as a manufacturer of
p.(None): pharmaceutical products, you must adopt a quality control system that ensures compliance with the
p.(None): www.bcn.cl - Library of the National Congress of Chile
p.(None): production specifications, raw materials and finished product, through the realization of the
p.(None): corresponding analyzes.
p.(None): The same obligation will affect natural or legal persons, who
p.(None): act as importers of pharmaceutical products in any of their production stages, as appropriate.
...
Appendix
Indicator List
| Indicator | Vulnerability |
|---|
| HIV | HIV/AIDS |
| access | Access to Social Goods |
| age | Age |
| authority | Relationship to Authority |
| conviction | Religion |
| dependency | Drug Dependence |
| disability | Mentally Disabled |
| drug | Drug Usage |
| emergency | Public Emergency |
| faith | Religion |
| illegal | Illegal Activity |
| influence | Drug Usage |
| language | Linguistic Proficiency |
| manipulate | Manipulable |
| party | political affiliation |
| physically | Physically Disabled |
| political | political affiliation |
| property | Property Ownership |
| restricted | Incarcerated |
| single | Marital Status |
| substance | Drug Usage |
Indicator Peers (Indicators in Same Vulnerability)
| Indicator | Peers |
|---|
| conviction | ['faith'] |
| drug | ['influence', 'substance'] |
| faith | ['conviction'] |
| influence | ['drug', 'substance'] |
| party | ['political'] |
| political | ['party'] |
| substance | ['drug', 'influence'] |
Trigger Words
capacity
consent
cultural
ethics
protection
risk
Applicable Type / Vulnerability / Indicator Overlay for this Input