Standard Type: Decree 3
Publication Date: 25-06-2011
Date of enactment: 01-25-2010
Agency: MINISTRY OF HEALTH; UNDERSECRETARIAT OF PUBLIC HEALTH
Title: APPROVES REGULATION OF THE NATIONAL SYSTEM OF CONTROL OF PHARMACEUTICAL PRODUCTS FOR USE
HUMAN
Version Type: With Deferred Validity by Date From: 26-12-2011 Beginning Validity: 12-26-2011
Id Standard 1026879
URL: http: //www.leychile.cl/N? I = 1026879 & f = 2011-12-26 & p =
APPROVES REGULATION OF THE NATIONAL SYSTEM OF CONTROL OF PHARMACEUTICAL PRODUCTS FOR HUMAN USE
No. 3.- Santiago, January 25, 2010.- Seen: the provisions of Books fourth and sixth and other provisions
Relevant of the Decree with Force of Law No. 725, of 1967, of the Ministry of Health, which approves the Sanitary Code.
Considering: The need to update, organize and complete the current regulations regarding the matter, and
Bearing in mind the powers conferred on me by Article 32 No. 6 of the Political Constitution of the Republic,
I dictate the following
Decree:
The following Regulations of the National Control System for Pharmaceutical Products for Human Use be approved:
PRELIMINARY TITLE:
SCOPE OF APPLICATION AND COMPETENT AUTHORITIES.
Article 1º.- This regulation includes the technical, administrative norms and other conditions or requirements that
must comply with registration, import, internationalization and export, production, storage and possession, distribution to
Free or onerous title, advertising and information on pharmaceutical products, as well as their use for
scientific research.
Article 2º.- It corresponds to the Ministry of Health, through the Undersecretariat of Public Health, to exercise a leading role
and regulator in pharmaceutical products, for which it must approve the national drug policy and
dictate the regulations and technical and administrative standards that public and private entities must comply with
that address the activities indicated in the previous article, which will be approved through the acts
administrative procedures that are relevant.
Article 3.- The Institute of Public Health is the health authority in charge of the entire national territory of the
sanitary control of pharmaceutical products and to ensure compliance with the provisions contained
in these regulations, in the Health Code, in its complementary regulations and in other legal norms
on the matter.
It corresponds to exercise the actions of quality control of pharmaceutical products in any of the phases
referred to in article 1, authorize the installation and operation of Pharmaceutical Laboratories, authorize
and register pharmaceutical products and others subject to these control modalities, control the conditions of
import and internment, export, manufacture, distribution, as well as the advertising and information of the
same products, control narcotic drugs and dependency-causing pharmaceuticals and other substances
psychotropic susceptible to supply analogous
effect, with respect to their import, export and their lawful use in the product manufacturing process
pharmacists and supervise compliance with the rules contained in these regulations and in the others that govern these
subjects.
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Article 4.- The Regional Ministerial Secretaries of Health, hereinafter the SEREMI, are the authorities
competent to authorize the admission of pharmaceutical products in accordance with the provisions of article 2 of
Law No.
18,164. In addition, they will be responsible for applying and supervising compliance with the rules contained in these regulations.
regarding its distribution, storage and possession, insofar as it is carried out by establishments of the
authorized pharmaceutical area, with the exception of the Pharmaceutical Laboratories.
Article 5.- For the purposes of these regulations, the following definitions shall apply:
1) Biological activity: Measurable response of activity or potency, in vivo or in vitro, that characterizes a
certain quantity of pharmaceutical product, with respect to a reference standard.
2) Administration: Act by which the medicine is placed in contact with the human being, so that it can
exert local action or be absorbed and exert systemic action.
3) Quality assurance: A planned and comprehensive system that aims to ensure that the processes and their
Results meet the quality requirements previously established for them.
4) Bioavailability: Amount of an active ingredient from a pharmaceutical form, which reaches the
systemic circulation and the speed with which this occurs.
5) Good Laboratory Practices (GLP): Set of rules, operating procedures and practices that guarantee
that the data generated by a quality control system is reproducible and representative, ensuring validity
and reliability of the results; These technical standards will be approved by Supreme Decree of the Ministry,
Institute proposal.
6) Good Manufacturing Practices (BPM): Minimum technical standards established for all procedures
intended to guarantee the uniform and satisfactory quality of pharmaceutical products, within the limits
accepted and valid for each of them; These technical standards will be approved by Supreme Decree of the Ministry,
at the proposal of the Institute.
7) Quality of a medicine: Fitness of the medicine for the use for which it is intended, which is determined
for its efficacy, safety and stability, in accordance with the characteristics of identity, potency, purity and others,
according to the respective sanitary registry.
8) Health registration certificate: Document issued by the health authority of the producing country or
provenance, at the request of the interested party, which must state:
- That the producer establishment meets the conditions required by the health legislation of their country to
elaborate, condition or package the registered product;
- That the product is registered in the country that issues the certificate according to current regulations, indicating
fully authorized formula;
- That its sale or distribution under any title is subject to some restrictive regime or special control of
sanitary type, if so.
9) Quality control: Activities that aim to ensure batches during all stages of manufacturing
product uniforms conforming to identity, potency, purity and other quality requirements
established in their respective monographs, authorized in the corresponding health registry.
10) Shelf control: Verification of quality of a product that is in its sale and delivery stage
to the public and which is carried out by the Institute or by the health authority with which it agrees, according to
programs established by the Ministry at the proposal of the Institute.
11) Key: Distinctive alphanumeric or numerical combination, which allows unique and unequaled identification in
any of the stages of manufacture, storage, distribution and sale of a pharmaceutical product, for
to ensure its traceability.
12) Counter sample: Finite portion of sample to be kept of the analyzed products, in the same terms
of reference or retention samples.
13) Quarantine: Transitory condition of physical isolation or by other means, of raw materials, materials and
intermediate, semi-finished, bulk, semi-finished or finished products, during which its
use or distribution, while the decision is made on its release, rejection or reprocessing, in accordance with the
Result of the respective quality control.
14) Dispensation: Act by which the pharmaceutical chemical professional
provides a medication to a person, generally to fulfill the prescription of a licensed professional, to
through which you are informed and guided about its use, influence of food, interactions with others
medicines,
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recognition of potential adverse reactions, storage conditions or other relevant information, all
this according to what is authorized in the registry.
15) Distribution: Distribution of the pharmaceutical product that is made between producing establishments, importers,
distributors, or other sanitary authorized to dispose of them.
16) Dosage: Interval of administration and period of treatment arranged for the dose of a medicine or
pharmaceutical product.
17) Dose: The total quantity of a drug or pharmaceutical product contained in the authorized pharmaceutical form and
that is administered at every opportunity.
18) Plant drug or plant material: The raw plant or parts of it, used for a medicinal purpose or
pharmacist.
19) Efficacy: Aptitude of a medicine or pharmaceutical product to produce the proposed therapeutic effects,
determined by scientific methods and clinical studies conducted in humans.
20) Insert: Cardboard sleeve or other material that protects the blister or strip and that contains the information of the brochure
patient and / or authorized graphic labeling.
21) Dissolution tests: "In vitro" tests that, through defined experimental conditions, allow determining
the dissolution rate of a solid active ingredient from a pharmaceutical form.
22) Dispenser container: That destined to pharmaceutical specialties of direct sale, allowed to be sold in
blister, strips, envelopes, inserts or other protective system of the primary container, according to the conditions
authorized in your registration.
23) Primary packaging: One that is used to contain a pharmaceutical product in its final pharmaceutical form
and who is in direct contact with her.
24) Secondary container: One that being inviolable, also allows containing, protecting and preserving the primary container.
25) Clinical packaging: Those intended for exclusive use in pharmacies or first-aid kits of establishments
medical-care, to be administered or delivered to patients who are treated therein, in accordance with the
dosage and prescribed form.
26) Pharmaceutical equivalents: Pharmaceutical products that contain identical amounts of the same principles
active ingredients or their same salts or esters, presented in the same pharmaceutical form and route of administration, but not
they necessarily contain the same excipients and that they meet the same or comparable quality specifications.
27) Therapeutic equivalents: Pharmaceutical equivalents that meet the same or comparable specifications for
quality and that when administered according to the conditions specified in its labeling, its effects, with respect to
efficacy and safety are essentially the same, all determined by appropriate studies.
28) Pharmaceutical specialty: Registered pharmaceutical product that is presented in a uniform and characteristic container,
conditioned for its use and designated with a generic name or another denomination. Those included shall be understood
elements or devices suitable for administration, in cases where they are so presented.
29) Specifications: Technical document that defines the attributes of a raw material, material, product, service or
other and that determines the variables that must be evaluated in them, describing all the tests, trials and analyzes
used for their determination and establishing the acceptance or rejection criteria.
30) Stability: Ability to maintain the original properties within the specified specifications and
authorized in the monograph of an active ingredient or of a finished pharmaceutical product, which allows to ensure its
physical, chemical, biological and microbiological properties, where applicable, within specified limits,
throughout its period of effectiveness.
31) Production status: manufacturing stage in which a pharmaceutical product is found in the process
productive, distinguishing semi-finished, bulk, semi-finished or finished products.
32) Therapeutic equivalence study: Comparative study (clinical, bioavailability, pharmacodynamic or "in
vitro ") between a reference or comparator pharmaceutical product and another under study.
33) Real-time stability study: Stability study carried out for the time proposed for the period of
efficacy and under storage conditions, temperature and humidity determined according to the nature of the product.
34) Accelerated stability study: Stability study designed to increase the degradation rate
chemical or physical changes of an active substance or a pharmaceutical product in its proposed primary packaging, using
severe storage conditions, temperature and humidity, as part of a formal storage program,
during a certain period of time according to the active ingredient under evaluation and whose results allow establishing
its stability by
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certain period.
35) Stability study: series of tests, trials and analyzes related to physical characteristics,
chemical, biological and microbiological characteristics of an active ingredient or a pharmaceutical product, to obtain information
on its stability, in order to define its period of effectiveness under certain packaging conditions and
storage.
36) Bioavailability studies: Pharmacokinetic studies that, through a pre-established experimental design,
allow to determine the bioavailability of an active principle.
37) Pharmacokinetic studies: "In vivo" tests that, through pre-established experimental designs, allow
establish the kinetics of the processes of absorption, distribution, metabolism and excretion of the active ingredients and
metabolites of a pharmaceutical product.
38) Evaluation of a pharmaceutical product: Systematic study of the background required of the interested party who
requests the sanitary registration, regarding the relevance of the administrative and technical background, such as
the pharmaceutical, pharmacological, toxicological, clinical and
therapeutic, in order to determine or verify if the product is suitable for use in the proposed indications.
39) Excipient: Any raw material used in the manufacture of the products referred to in this
regulation, which is not an active principle.
40) Sale: Retail sale of a pharmaceutical product to the user or consumer public.
41) Pharmacovigilance: Set of activities related to the detection, evaluation, understanding and prevention of
the adverse effects associated with the use of medications.
42) Expiration, expiration or expiration date: The one indicated by the month and calendar year and in some cases, in addition
for the day, as approved in the respective health registry; beyond which it cannot be expected that
product retain its stability.
43) Pharmaceutical form: Physical form in which a medication is presented, to facilitate its fractionation,
dispensing, dosing and administration or employment.
44) Standard formula or master formula: Document or set of documents that specify raw materials and their
quantities, as well as packaging packaging materials, along with a description of procedures and precautions
required to produce a specific quantity of a finished product, also including the instructions for
manufacturing and controls in process.
45) Import: It is the act by which a pharmaceutical product from abroad enters, enters and
it is in condition to be distributed, complying with current regulations.
46) Impurities: Any component that is not defined as constituent of the raw material or product.
47) Internment: It is the act by which a pharmaceutical product from abroad enters a place of
duly authorized storage, pending authorization for distribution and use.
48) License: Power or permission legally granted by a natural or legal person, which grants another the
authorization to request, modify or cancel a sanitary registry, as its owner.
49) Plant markers: They are chemically defined constituents of the active ingredients of the plant, of
interest for quality control purposes, regardless of whether or not they have therapeutic activity and that
can be used to calculate the amount of active ingredients of the vegetable in the final product, provided that they have
been quantified in the drug or vegetable preparation used as raw material in the preparation.
50) Tolerance margins: Percentages, maximum and minimum, officially allowed of an active principle declared in
a product.
51) Raw material: Any substance of defined quality that is directly involved in the manufacture of the form
pharmaceutical, whether it remains unchanged or is modified or eliminated in the course of the manufacturing process.
52) Packaging material: Material used as primary, secondary or insert packaging.
53) Monograph: Document containing the technical, pharmaceutical and scientific description of the characteristics and
properties of a product.
54) Medical sample: Unit of a pharmaceutical specialty, exclusively intended for free distribution to
professionals legally qualified for its prescription, whose labeling is identical to that of the registered product,
with the indication of your condition as a medical sample, which may include information to the professional.
55) Reference samples or retention samples: These are the samples collected from each batch of finished product that
must be maintained for up to one year after
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the expiration date, in its final container and stored under the conditions indicated in the health record.
56) Sample or legal counter sample: Sample that has been taken by the health authority in use of its powers
auditors, recording this fact in the respective act and under chain of custody conditions.
57) Generic name of a pharmaceutical product: Denomination accepted by the World Health Organization
(O.M.S.), under the distinctive and initials "International Common Denominations" (D.C.I.) or International Non
Proprietary Names (INN) and, failing that, in the officially recognized pharmacopoeias in the country.
58) Country of origin: One from which a pharmaceutical product is dispatched for import into our
country, without considering those territories through which it transits.
59) Country of production: The country in which the manufacturing establishment of a pharmaceutical product is located, in
any of the steps required to obtain a finished product.
60) Effective period: Period authorized by the Institute in the respective
sanitary registration, during which a product must maintain its stability under the conditions of packaging and
Storage defined in your stability study.
61) Potency: Therapeutic activity of a pharmaceutical product to produce a given effect, verified by tests
laboratory tests or controlled clinical data, obtained through the administration of the product in the
prescribed, recommended and approved employment conditions, which is expressed, according to the concentration of
active ingredients that make up the formula
of the product, in the weight / weight, weight / volume ratios, dose / volume unit or in units referred to a standard
recognized internationally.
62) Vegetable preparation: Plant or parts of pulverized plant, its extract, tincture, squeezed juice, fatty oil or
essential, rubber or resin or other product of a certain process, excluding its defined isolated constituents
chemically or their mixtures, without prejudice to the possibility of containing other components, such as solvents,
diluents or preservatives, which must be declared.
63) Active ingredient: Substance or mixture of substances with a specific pharmacological effect, or that without
possess pharmacological activity, being administered to the body they acquire it.
64) Standard Operating Procedure (POE): Written document containing updated instructions, numbered in
logical and continuous sequence, to carry out operations of a general nature, not necessarily limited to a
specific product or material, which must be designed, reviewed and updated by competent and authorized personnel
for its implementation by the technical professionals responsible for the establishment in which they are used, being
used to complement production documentation and for quality assurance and control.
65) Bulk product: Product that is in its final pharmaceutical form.
66) Pharmaceutical association product: One that contains two or more principles incorporated in a form
pharmaceutical.
67) Pharmaceutical combination product: One that consists of two or more pharmaceutical products that are
They include in a single package to be administered sequentially or simultaneously.
68) Pharmaceutical reference or comparator product: Product determined by the health authority as such,
compared to which another that requires evaluation of its therapeutic equivalence is compared.
69) Semi-finished product: Substance or mixture of partially processed substances, which precedes its form
pharmaceutical and requiring more manufacturing stages.
70) Semi-finished product: Product that is in its final pharmaceutical form and primary packaging.
71) Finished product: Product that is in its final container, labeled and ready for distribution to any
Title.
72) Production, production process, manufacturing, manufacturing or slaughter: set of operations involved in the
obtaining a pharmaceutical product, from the acquisition and receipt of materials, to the release,
storage and its corresponding quality controls.
73) Adverse Drug Reaction (ADR): The harmful and unintended reaction that occurs at doses used
normally in the human being.
74) Serious adverse reaction: Any adverse reaction that is life threatening or life threatening or that
implies serious disability or invalidity or that results in hospitalization or prolongation of the same.
75) Unexpected adverse reaction: Adverse reaction not mentioned in the product monograph,
information to the patient and the prescribing professional authorized in the respective health registry.
76) Medical prescription: Order signed by a professional legally authorized to
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This, in order for a quantity of one or more medications to be dispensed and administered as indicated in
she.
77) Health registration: Evaluation process of a pharmaceutical product that, being favorable, results in a
registration in a special role with correlative numbering maintained by the Institute, prior to its distribution and use.
78) Graphic labeling: Graphic representation that reproduces the officially authorized text in the respective registry
sanitary, for the different types of packaging approved for the product, as appropriate.
79) Series or Lot: A defined quantity of raw material, packaging material or processed product, which is carried out in
a single production cycle or through continuous stages, characterized by its homogeneity.
80) Subseries or Sublot: Specific and identified fraction of a batch.
81) Possession: It is the possession of a pharmaceutical product by a natural or legal person, whether or not it accredits a fair
title for it.
82) Health Record Holder: Natural or legal person, national or foreign, domiciled in Chile, whose
name is on a health record.
83) Traceability of analytical data: Property or characteristic that has the result of a measurement or the value of
a standard, which may be related to specified references, usually national standards or
international, through a continuous chain of comparisons all with specified uncertainties.
84) Traceability of a product: Ability to identify the origin and displacement of a specific unit of a
product in any of its manufacturing stages and / or a production batch, through the distribution chain,
as well as through the different entities that intervene, until they are dispensed, administered or used.
85) Sales unit: Authorized sales presentation to be dispensed and issued.
86) Validation: Documented action, carried out in accordance with the principles of the Good Practices of
Manufacturing and Laboratory, which demonstrate that the procedures, processes, activities or systems used in the
Production and quality control are conducive to the results provided, within established limits.
Article 6º.- The manufacture, import, possession, distribution and transfer, in any capacity, is prohibited.
of pharmaceutical products that are in any of the following conditions:
1. Contaminated pharmaceutical product: one that contains microorganisms or parasites or parts thereof, capable of
produce illnesses in people or illegal amounts of potentially toxic, carcinogenic or
mutagenic or other foreign materials.
2. Altered pharmaceutical product: That finished product that due to deficiency in storage, transport,
conservation or any other cause subsequent to its production:
to. has decreased its activity below the limits specified in the respective health registry or, in the
case of raw materials, in their quality specifications, referred to official texts,
b. it has lost its effectiveness or has undergone modifications that alter its quality,
c. is presented in a deteriorated container, or
d. is distributed or expended after the effectiveness period.
3. Adulterated pharmaceutical product: The one whose composition, specifications
or other conditions contemplated in the respective sanitary registry or, in the case of raw materials, in its
quality specifications referring to official texts, has been modified without prior authorization or without giving
compliance with said specifications.
4. Counterfeit pharmaceutical product: That pharmaceutical product that does not
has a sanitary registration or authorization or that has been manufactured or imported by someone who does not have authorization
sanitary for it. Counterfeit products will also be understood as those distributed or sold by those who do not
You have authorization for it.
The Institute will supervise the existence of pharmaceutical products in these situations, being able to apply the measures
sanitary that proceed and, previous the instruction of the corresponding summary, the sanctions that there are place.
The SEREMI will be responsible for supervising the sale and dispensing of products found in any of
the conditions described, with the same powers as the previous paragraph.
SEREMIs must inform the Institute of their findings related to the
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previous paragraph, in order for the latter to carry out the inspections, have
the measures and instruct the pertinent summaries regarding the holders of the sanitary registries, the
manufacturers, importers or distributors, as appropriate.
Likewise, the Institute or SEREMI, as the case may be, must make the respective complaint to the Public Ministry with
the purpose that it investigates and establishes the penal responsibilities that proceed.
TITLE I:
OF PHARMACEUTICAL PRODUCTS.
FIRST PARAGRAPH:
OF ITS DEFINITION.
Article 7º.- Pharmaceutical product or medicine is any substance, natural or synthetic, or a mixture of them, that
is intended for the human being for the purpose of curing, mitigating, treating, preventing or diagnosing diseases or
their symptoms, to modify physiological systems or mental state for the benefit of the person to whom it is
administered.
Active raw materials, pharmaceutical preparations, specialties are considered pharmaceutical products.
pharmaceutical and traditional herbal medicines.
Article 8º.- The Institute will be responsible for determining, through a well-founded resolution, the corresponding control regime
apply to all those products that are attributed or possess some of the properties indicated in the article
above and are labeled or advertised as food, being resolved as much binding
to those products that want to be distributed and sold for the first time, such as those that are in
circulation.
The determination of the control regime to be applied may be carried out ex officio or at the request of individuals or others
public bodies that in the exercise
of their inspection activities detect products in the conditions indicated in the first paragraph of this
Article.
For the determination of the applicable control regime requested by the SEREMI, they will send the Institute a
technical report and copy of all the antecedents in their possession, as well as, when appropriate, the
results of its inspection and inspection activities.
If the Institute determines that the control regime to be applied is that of a pharmaceutical product, the resolution
that it so determines will be published in the Official Gazette and the interested party will be notified in order to request their
health record, providing the background that the case requires, according to its category or classification, which
will be applicable to all those products that have the components to which activity has been attributed
therapy.
From the communication mentioned in the previous paragraph and while the sanitary registration for the product is not obtained,
that has been listed as a pharmaceutical product, it must be withdrawn from the market by whoever
distributed or distributed, without prejudice to the sanitary responsibilities that this may give rise to. Also arranged
will be applicable to the rest of the products that contain the declared component or components of a product
pharmacist.
In the event that the Institute determines that the control regime to be applied does not correspond to that of a product
pharmacist, will send the background together with a technical report that bases its evaluation to the Ministry for
your review.
Article 9.- The determination of the applicable control regime may also be made when there are doubts
about the classification of other products, such as cosmetics, household and sanitary pesticides, or
medical devices; the same procedure indicated above is applicable.
SECOND PARAGRAPH:
PHARMACEUTICAL SPECIALTIES AND THEIR CLASSIFICATION.
Article 10.- Pharmaceutical specialties, according to their nature, are classified into:
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a) Products of chemical origin or synthesis;
b) Biological products;
c) Radiopharmaceuticals;
d) Phytopharmaceuticals;
e) Homeopathic products;
f) Medicinal gases;
g) Others that, included in the concept of pharmaceutical specialty, are not included in some of the
previous categories.
Article 11º.- They are products of origin or chemical synthesis, those pharmaceutical specialties constituted by
one or more purified and identified active ingredients, obtained through a chemical synthesis process or
extraction.
Article 12º.- Biological products are those pharmaceutical specialties whose obtaining and / or production involves
to living organisms, as well as their fluids or tissues.
Organic products are classified as follows:
a) Vaccines: Biological products that have been formulated to provoke a specific active immunity.
b) Serums: Biological products that have been formulated to provoke passive immunity.
c) Blood products: Biological products derived from human blood or plasma, obtained by procedures
industrial, whose raw material is human blood or plasma. These medications include, especially, the
albumin, clotting factors and immunoglobulins of human origin, excluding whole blood, plasma
and blood cells of human origin.
d) Hormones: Biological products of protein type, amino acid derivative, spheroidal or lipid, which being
Natural origin, they are used to treat some disorders, either compensating or increasing their lack. Those of origin
Synthetic will be included in letter a) of article 10.
e) Biotechnological or Recombinant Drugs: Biological products of protein type developed by engineering
genetics, obtained by means of nucleic acid combination techniques (DNA, deoxyribonucleic acid and RNA,
recombinant ribonucleic acid), monoclonal antibodies, among others.
f) Antibiotics: They are biological products made up of substances secreted by a microorganism with capacity
antimicrobial. In the case of antibiotics of synthetic origin, these will be considered within letter a) of the
Article
10th.
g) Allergens: Biological product, intended to identify or cause a specific and acquired modification of the
immune response to an allergy agent.
h) Gene therapy: Biological product obtained through the set of processes intended to transfer a gene (DNA or
RNA) prophylactic, diagnostic or therapeutic, in vivo or ex vivo, to human or animal cells and their subsequent
expression in vivo.
Article 13.- Radiopharmaceuticals are those products or formulations marked with radionuclides or radioisotopes,
intended to be used in the diagnosis or treatment of diseases, whatever the route of administration
employee.
Article 14º.- Phytopharmaceuticals are those pharmaceutical specialties whose active ingredients come from the
aerial or underground parts of plants or other plant material and are properly standardized.
Article 15º.- Homeopathic products are those pharmaceutical specialties made up of substances
homeopathic and prepared from components or raw materials of plant, animal, mineral or chemical origin, of
according to a homeopathic manufacturing procedure, described in standards officially approved by supreme decrees
of the Ministry, which include the dilution and dynamisation processes of their mother tinctures,
which, in addition, must have been tested on healthy individuals and repertorized, to be prescribed or used
according to the law of similarity. A homeopathic product may contain one or more homeopathic substances.
Article 16.- They are medicinal gases, pharmaceutical specialties
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consisting of one or more gaseous components of known concentration, limited degree of impurity and made from
According to registered specifications, which is intended for administration to human beings, which will be governed by
the specific regulations that regulate them.
Article 17.- In addition to the groups indicated, they will be understood to be included within the pharmaceutical specialties,
any other product that is labeled, advertised or attributed by any means, with therapeutic properties, be these
curative, mitigation, treatment, diagnosis or prevention of diseases or their symptoms, or to modify
physiological systems or mental state for the benefit of the person to whom it is administered, and that are not
classifiable in any of the previous categories.
The following are understood to be included in this final group, among others:
a) Products for parenteral administration, whatever their composition, properties or effects.
b) Vitamins, minerals and other nutrients, in the therapeutic doses determined in the technical standard
respective approved by supreme decree of the Ministry.
c) Products of animal or mineral origin, as well as those that constitute vegetable drug associations and
vegetable preparations with active ingredients of different nature.
TITLE II:
OF THE SANITARY REGISTRY OF PHARMACEUTICAL SPECIALTIES AND OTHER PHARMACEUTICAL PRODUCTS
FIRST PARAGRAPH:
CONCEPT AND PURPOSE.
Article 18.- The health registration of a pharmaceutical specialty consists of an evaluation and study process.
systematic of its pharmaceutical, pharmacological, toxicological and clinical properties, intended to verify its
quality, safety and efficacy, which translates into an enrollment in a special role with correlative numbering that
maintains the Institute, which enables and authorizes its distribution and use in the country.
The sanitary registry does not exempt its owner or user to any title, from the obligation to comply with the
other legal or regulatory provisions that regulate the marketing of said products.
The health registration may be requested by any natural or legal person, national or foreign, duly
represented and domiciled in Chile.
Article 19.- The administrative act of sanitary registration is independent of commercial or property aspects.
intellectual or industrial of those who require or obtain it, in the terms provided for in article 49 of Law No.
19.039 on Industrial Property, whose consolidated, coordinated and systematized text was set by D.F.L. No. 3 of
2006, from the Ministry of Economy, Development and Reconstruction.
Article 20.- Any pharmaceutical product imported or manufactured in the country, to be distributed or used to
Any title in the national territory must previously have a health registry.
Article 21º.- Exceptionally, the Institute may authorize the sale or provisional use of certain
pharmaceutical products without sanitary registration, based on any of the following causes, which are stated by
exemplary according to the provisions of article 102 of the Health Code:
a) Epidemics or situations of emergency, urgency or catastrophe, which pose a serious risk to the health or life of
the habitants.
b) In the case of a pharmaceutical product that is required for an urgent medicinal purpose, without there being a
alternative when required.
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c) In the case of products to be used in scientific research or clinical trials, prior report
favorable of the corresponding ethics committee or committees, in accordance with the rules on clinical trials carried out on human beings
human, approved by the Ministry of Health.
Article 22 ° .- The requests presented by the interested parties, for sale
or provisional use of pharmaceutical products without prior health registration, based on letters a) and b) of the article
above will be presented to the Institute, and the authorization granted by the health authority of the
country
of origin or manufacturing as appropriate. In both cases the
authorizations granted to private parties may be required a second time before six
months, as long as the application for sanitary registration is presented or antecedents are provided that prove that the
Situation of emergency, urgency, catastrophe or urgent medicinal use has been maintained and they make their
grant.
Article 23.- Applications for the provisional use in scientific research or clinical trial of a product
pharmacist must appear before the Institute accompanied by the protocol approved by the ethics committee, in the
terms referred to in letter c) of article 21; the same document must be accompanied in the case of a
product that has a sanitary registration and its use is intended differently from that authorized.
Article 24 °. - In accordance with the collaboration agreements that are concluded between the Institute and the SEREMI of regions
that have border customs, carried out in accordance with the provisions of the Organic Constitutional Law of
General Bases of the State Administration, Law No. 18,575, whose consolidated, coordinated and systematized text was
fixed by D.F.L. Nº 1 of 2000 of the Ministry General Secretariat of the Presidency, the latter authority may
authorize the provisional use of pharmaceutical products without prior sanitary registration, when they are imported for
individual use, directly by the interested party or his agent, provided they are prescribed by a professional
enabled, to record the need and duration of treatment.
Likewise, said health authority may authorize the hospitalization of medications by nationals or foreigners
that carry them upon entering the country for treatment for a period not exceeding three weeks, unless it is
of chronic diseases or other treatments, duly founded and accredited. All excess will be withheld and
notified for subsequent confiscation.
The respective SEREMI shall inform the Institute monthly of the authorizations granted pursuant to this
Article.
Article 25.- For the purposes of the provisions of article 102 of the Health Code, pharmaceutical preparations
They will have an official sanitary registration number, which will be the one incorporated in the Official Registry of
Preparation, which will be considered as the official record of the Institute of Public Health.
Article 26º.- Active raw materials consisting of natural or synthetic drugs in bulk, shall be understood
registered by the mere fact of being included in the formula of a pharmaceutical specialty that has registration
sanitary or by the respective authorization of use and disposal, when these are imported by establishments
authorized for it.
Article 27º.- Traditional herbal medicines shall be understood as those constituted by the plants or parts of
plants, fresh or dried, whole or crushed, packaged and labeled by hand and labeled with the
denomination used by popular custom in the field of Chilean cultural traditions, which have been
recognized in the respective technical standard approved by supreme decree of the Ministry, referred to in the paragraph
following. They will be understood as registered for the purposes of their free sale and distribution, by the sole fact that SEREMI
competent authority has authorized the establishment where they are stored, processed, divided or packaged or other
activities of its processing, and must meet the following conditions:
a) They must be in a list contained in a technical standard approved by
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Supreme decree of the Ministry, issued in use of its legal, technical and regulatory powers, which will indicate the
denomination, therapeutic properties and uses of each of them, should be used as auxiliaries
symptomatic.
b) Be packed by hand as isolated, unmixed plant species.
c) Enter in their labels only those properties recognized in the aforementioned decree.
SECOND PARAGRAPH:
OF THE REQUIREMENTS OF THE SANITARY REGISTRY.
Article 28º.- Applications for health registration must be submitted to the Institute, complying with the
general and special requirements that are determined in this Title.
The general registration requirements include administrative aspects, technical information, quality
pharmaceutical and safety and clinical efficacy of the pharmaceutical product to be registered, which are commonly applied to
all the
records; for their part, the special requirements derive from their nature and from whose origin and veracity
The professional who signs the request must be held responsible.
1º Of the general requirements of the sanitary registry. A.- Administrative requirements.
Article 29.- Any request for health registration must comply with the following general requirements of a character
administrative and accompany the following information:
1. Identification and address of the interested party and his legal representative, in the case of legal persons.
2. Name of the technical director of the entity requesting the health registration or of the suitable professional, when not
technical direction is required, to assume
responsibility for the technical information provided.
3. Name of the pharmaceutical product, the following should be stated in this section:
a) Fantasy or generic name, corresponding to its international common name or, failing that, the name
pharmacopoeic or chemical;
b) Pharmaceutical form;
c) Unit dose per pharmaceutical form;
d) Administration route.
4. Therapeutic class or group, and the corresponding anatomical-therapeutic classification must also be indicated.
5. Manufacturing regime, distinguishing:
a) National manufacturing, for those products manufactured in a pharmaceutical laboratory, legally and technically
enabled for it, whether the manufacture is own or for others.
b) Imported products, distinguishing between:
b.1. Finished imported products that have been manufactured abroad, whether the import is carried out in
directly or through other authorized establishments.
b.2. Imported semi-finished products in their final primary packaging, to be conditioned in the country, either in
directly or through other authorized establishments.
b.3. Products imported in bulk in their final pharmaceutical form to be packaged in the country, whether this is
run directly or through other authorized establishments.
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b.4. Semi-finished imported products to carry out the other necessary production stages in the country
to obtain a finished product, either directly or through other authorized establishments.
6. Individualization of the licensor according to the name that appears on the license, if the process is done
in use of license.
7. Name and address of the producing establishment, if it is manufactured in the country or abroad.
8. Presentation of the product, describing it or the contents of the different packages: sale to the public, packages
clinical and / or as medical samples when appropriate; including those elements or devices that are incorporated
for your administration.
9. Physical description of the packaging material, indicating its type, both with respect to the primary packaging and
secondary, as well as those elements or devices that are incorporated for its administration, when appropriate.
10. Legal documents, in Spanish language or duly translated under the signature of the legal representative,
professional assigned for this purpose by the company or the Technical Director, when appropriate, made up of
following, depending on whether the products are imported or manufactured in the country:
a) In the case of imported products in any of its phases, it must be accompanied by:
a.1. Health registration certificate or Pharmaceutical product certificate or Health authorization certificate
o Official certification recommended by the World Health Organization, issued by the health authority of the
country of origin and that proves under legalized signature that the producer or warehouse establishment, if applicable,
meets the conditions required by the health legislation of your country; that the product is registered in your country of
according to current regulations, fully stating its authorized formula; and that your store is subject to some
restrictive regime or special sanitary control, if it were so.
a.2. Manufacturing agreement signed between the applicant and a foreign production pharmaceutical laboratory,
duly legalized.
a.3. Legalized license of the one who grants it, when appropriate.
a.4. Official certificate issued by the competent health authority of the country where the establishment is located
producer, proving that the foreign manufacturer is duly authorized in his country; that meets Good
Manufacturing practices, according to WHO recommendations, indicating the production areas or types of
products that it is authorized to manufacture, unless said accreditations are contained in the
document indicated in letter a1) of this article.
to 5. Import agreement authorized before a notary public or duly legalized, when appropriate.
a.6. National manufacturing and / or distribution agreement authorized by a notary, when appropriate, attaching the
sanitary authorization of each establishment.
a.7. Quality control agreement with a pharmaceutical laboratory authorized by the Institute, authorized before
notary, where appropriate.
b) Products manufactured in the country:
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b.1. National manufacturing and / or distribution agreement authorized by a notary, incorporating the authorization
of each establishment, when appropriate.
b.2. Legalized license of the one who grants it, if applicable.
b.3. Quality control agreement with a pharmaceutical laboratory authorized by the Institute, when appropriate.
Article 30 ° .- In the case of imported pharmaceutical products such as
Finished, semi-finished, bulk or semi-finished products, the applicant will be allowed to prove the
compliance with the manufacturer's Good Manufacturing Practices in accordance with the provisions of articles 192 °
and 193 °, in which case the requirements indicated in letter a.4 will not be applicable. of the preceding article.
B.- Technical Information Requirements.
Article 31.- Any application for health registration must meet the following general requirements regarding the
Technical information related to the pharmaceutical product, the following information being attached for this purpose:
1. Clinical and pharmacological monograph, in Spanish, signed by the technical director or technical advisor.
2. Graphic labeling project for all sales presentations to the public, clinic and medical sample, in language
Spanish.
3. Draft information brochure for professionals, backed by relevant scientific information and with the
declaration of bioavailability studies and their therapeutic equivalence, in the case of products
pharmacists whose active ingredients are subject to this requirement.
4. Draft patient information brochure, backed by relevant scientific information.
C.- Pharmaceutical Quality Requirements.
Article 32º.- Any request for health registration must comply with the general requirements accredited by the
pharmaceutical quality of the product, for which purpose you must enter the following information:
1. Quali-quantitative composition of the pharmaceutical product, expressed in the following order and with the following
rules:
a) Quali-quantitative statement of each of the active ingredients.
b) Quali-quantitative statement of each of the excipients.
c) Qualitative declaration of any excipient used and eliminated during the production process, when
proceed.
d) The quali-quantitative composition expressed in units of mass or volume of the decimal metric system, or units
of biological activity. Whenever possible, biological activity will be indicated per unit of mass or volume.
e) The active ingredients and excipients will be designated by their international common name (INN) or, failing that,
the existing pharmacopoeial name. In the case of non-pharmacopoeic substances, the chemical name will be used in
Spanish Language. No abbreviations or trademarks may be used for the name.
f) If there are colorants in the composition of the product, they must be specified with their generic names or, in the absence of
these, by their designation
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chemical or its equivalents that have in the Indices of Dyes Allowed and approved in the country by the standard
corresponding technique, approved by supreme decree of the Ministry; the same provision will be applicable when
use colored capsules.
2. Regarding the active ingredients used in the manufacture of pharmaceutical products, the information
following:
a) Specification and quality control method, adjusting to the requirements of pharmacopoeias or texts
Officials in force in Chile or pharmacopoeial-type monographs thereof, if not indicated in said texts
officers.
b) Declare supplier and manufacturer of the active ingredient (s), attaching the analysis bulletin with all the
parameters that characterize the active principle.
c) Origin of the primary reference standard, attaching the respective analysis certificate pointing to the
less its origin, potency, traceability and other pertinent tests that characterize it.
d) Spectrogram or chromatogram of the active ingredient and the standard by any instrumental method, when
it corresponds.
e) Storage conditions of the active ingredient as raw material.
3. Specifications and control methods of all its excipients, adjusting to the requirements set forth in the
pharmacopoeias or official texts in force in Chile or monographs thereof if not indicated in said texts.
4. Analytical methodology, in Spanish, signed by the technical professional who submits the request and by
the head of the quality control department, either the internal laboratory or the pharmaceutical control laboratory
external quality.
a) The analytical methodology must be complete, in order to characterize the pharmaceutical product and must include
all necessary controls to ensure product quality, depending on the pharmaceutical form produced.
b) The analytical methodology of all pharmaceutical products must include the following test methods
general: organoleptic description (appearance, dimensions, shape, color, odor, among others); ID
selective for the active ingredient (s), valuation, potency or activity of the active ingredient (s), the
determination of impurities when appropriate and the description of the type and material of packaging, both primary and
secondary.
c) The specific test methods according to the pharmaceutical form will be established according to technical regulations
Complementary in force, issued by the Institute.
d) The methodology must present its validation in all those cases in which they are not described in
officially recognized pharmacopoeias.
5. Special studies:
a) In the modified release pharmaceutical forms, such as delayed or enteric, prolonged and others, it should
declare this condition and verify it through pharmacokinetic studies, dissolution or diffusion tests or other
type of appropriate studies, duly supported.
b) Therapeutic equivalence and bioavailability studies, in the case of pharmaceutical products whose
Active ingredients are subject to this requirement.
6. Summary sheet, which includes the analytical parameters and their acceptance criteria with which the
product, document that once officialized, will become the finished product specifications, with the
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that the pharmaceutical specialty must comply throughout its period of effectiveness.
7. Proposal of the efficacy period and the storage and packaging conditions, both for the specialty
as for the reconstituted product if applicable, backed by the corresponding stability studies,
with the following details:
a) The stability history must include at least: studied formula, manufacturer identification and
responsible for the study of stability, temperature conditions, humidity, packaging material and series studied
(minimum 3 series or pilot lots), also include the programmed design and indicate the analytical procedures
used and finished product specifications; all of the above according to the Stability Guide of
Pharmaceutical Products, approved as a technical standard by supreme decree of the Ministry, on the proposal of the
Institute.
b) When the product requires dilution prior to administration, stability studies must be attached
for the formulation, the solvent (if included in the presentation) and the reconstituted product. In the event that the
product requires dilution and the solvent is not included in the presentation, the recommended solvents will be indicated and
it will also require the presentation of the stability studies of the formulation and of the reconstituted product.
c) If the product must be diluted for immediate administration, only the study of
compatibility with the corresponding diluents, exempting from the requirement established in the previous letter.
d) In the case of an active ingredient that is not incorporated in the authorized formula of another
Pharmaceutical specialty with health registration in the country, must include the results of the studies of
forced degradation and stress conditions, for the same, in addition to what is requested in number 2.
8. Technical information regarding manufacturing, key used in it, quality control and data
Physico-chemical, incorporated in a summary sheet with a flow diagram and the controls in process carried out.
Article 33º.- For the purposes of establishing identity, potency, purity, stability and other quality requirements
physical, chemical, microbiological and biopharmaceutical of the active ingredients and the pharmaceutical forms of the
medicines whose registration is requested, the Institute will adhere to the pertinent norms contained in the following
Pharmacopoeias and their supplements:
a) Chilean Pharmacopeia.
b) International Pharmacopoeia.
c) European Pharmacopoeia.
d) United States Pharmacopeia and The National Formulary.
e) British Pharmacopoeia.
f) French Pharmacopoeia.
g) German Pharmacopeia.
h) German Homeopathic Pharmacopoeia.
i) Wilmar Schwabe Pharmacopeia.
j) USA Homeopathic Pharmacopoeia.
k) Homeopathic Pharmacopoeia of Mexico.
l) Japanese Pharmacopeia.
m) Spanish Pharmacopeia.
n) Pharmacopoeia of Mexico.
For the purposes indicated above, in addition to the indicated pharmacopoeias, the series will also be recognized
of technical reports from the Expert Committee of the World Health Organization for biological patterns,
biotechnology, radioactive chemicals or others and Title 21 of the "Code of Federal Regulations" (C.F.R.), point 1.1 of
the United States of
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North America.
In the case of a pharmaceutical product that does not appear in any of the official texts indicated above, the
The Institute may well accept or reject, partially or totally, the technical information provided by the
interested.
Article 34º.- When the official texts referred to in the previous article do not indicate tolerance margins or other
specifications, these must be indicated in the registration application for the Institute to resolve about its
sufficiency.
Article 35º.- Given the nature, diversity and extent of the general pharmaceutical quality requirements, these
They may be detailed in complementary technical standards approved by the Supreme Decree of the Ministry, on the proposal of the
Institute.
D.- Safety and Efficiency Requirements.
Article 36º.- All requests for health registration must include safety and efficacy history, for which
The scientific information regarding:
1. Pharmaceutical product development studies, including chemical, pharmaceutical and biological studies,
as appropriate, of the proposed formula and its justification.
2. Preclinical studies, such as those studies that are carried out "in vitro" and / or in experimental animals,
generally designed for the purpose of obtaining the information necessary to decide whether further studies are warranted
wide in humans, without exposing them to unwarranted risks.
3. Selective pharmacological studies in animals.
4. Toxicological studies in animals, which will correspond to acute and chronic toxicity tests,
teratogenicity, embryotoxicity, fertility, mutagenesis and, where appropriate, carcinogenesis and, in general, those that
are necessary for a correct evaluation of the safety and tolerance of a pharmaceutical product.
5. Phase I, II and III clinical studies that guarantee the safety and efficacy of the product to be registered. I know
may present clinical studies of products that do not correspond to the formula to be registered, provided that
its pharmaceutical and therapeutic equivalence has been proven, through the
respective studies.
6. Pharmacokinetic studies, when appropriate.
7. Studies to demonstrate bioavailability or therapeutic equivalence of the intended pharmaceutical product
register, in the case of products whose active ingredients are subject to said requirement.
8. Chemical, pharmaceutical and biological report, including analytical, chemical, physical-chemical, biological or
microbiological and allow to conclude if the product to be registered is in accordance with the
declared composition, presents the adequate quality, the proposed control methods are adjusted to the state of the
Scientific knowledge, the formulation and pharmaceutical form are adequate for the proposed purposes and the packaging is
ideal for correct conservation.
9. Toxicological and pharmacological report, including preclinical tests or trials that allow reporting the
Product toxicity and what are its proven pharmacological properties.
10. Clinical report prepared by an external expert: The report must evaluate the studies provided by the
Applicant, insofar as they can guarantee that the product demonstrates an adequate tolerance, that the dosage
Recommended is correct, as well as any possible contraindications and side effects.
2º On the conditions and details of the registration of certain pharmaceutical specialties.
Article 37º.- For the registration of pharmaceutical products that constitute an association of active ingredients at doses
fixed, must also prove the
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following conditions:
a) Each active component must contribute to the therapeutic effect of the product and the association must contribute to
improve patient adherence to treatment;
b) The dose of each component, as well as the frequency of administration and duration of treatment, should confer
safety and efficacy to the association, avoiding the danger of promoting adverse reactions;
c) There must be compatibility between its ingredients, including the excipients used in the set,
from the chemical, pharmacological, pharmacokinetic and biopharmaceutical point of view, in vitro and in vivo, according to
correspond; and
d) The secondary, collateral or toxic effects must be of equal or less intensity than those that can
normally present each of the isolated active components.
Article 38.- Without prejudice to the foregoing, the application for sanitary registration of the products will be rejected.
Pharmaceuticals that constitute an association of active ingredients at fixed doses in the following situations:
a) They are indicated for diseases or symptoms that have a natural course different from that indicated in the registry for
each of its active components, unless proven otherwise; or
b) Any of the new components that are added do not have clinical, pharmacological and other tests subject to
evaluation.
Article 39º.- In the case of combination pharmaceutical products, whoever requests the sanitary registration shall
prove its safety and effectiveness in the use of the proposed set. In addition, it must be demonstrated that:
a) Each pharmaceutical specialty must contribute to the therapeutic effect of the combination product.
b) The dose of each specialty, as well as the frequency of administration and duration of treatment, must
confer safety and efficacy to the combination, without the danger of promoting adverse reactions.
c) There must be compatibility in the ingredients used in each pharmaceutical specialty, including those
excipients, from a chemical, pharmacological, pharmacokinetic and biopharmaceutical point of view, in vitro and in vivo,
as appropriate.
d) The secondary or collateral or toxic effects must be of equal or less intensity than those that can
normally present each of the pharmaceutical specialties in isolation.
Combination products may not include phytopharmaceuticals or homeopathic products, associated with each other or with other
proprietary medicines.
Article 40.- For the registration of phytopharmaceuticals, considering their nature, the following will be taken into consideration
precisions:
a) Safety must be guaranteed with the presentation of pre-clinical, toxicological studies in animals and clinics
phase I, while efficacy must be endorsed with phase II and III clinical studies. In cases where it exists
information from official literature of the different international or foreign organizations, such as
WHO, FDA or EMEA; at the time of requesting a health record, it will be accepted as valid in replacement of the
previous.
b) Registration applications must adhere to the provisions of the general registration requirements, with the
following special rules:
b.1. The submission of therapeutic equivalence studies will not be required at the time of registration or in their
subsequent modifications.
b.2. The description of the manufacturing process must be included.
b.3. Its generic name will correspond to the botanical taxonomic name of the plant that provides the
active ingredients.
b.4. The expression of its qualitative-quantitative formula must include: the type of vegetable preparation used, such
as dry extract, fluid extract, soft extract, powder or other; followed by
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the part or parts of the plant that are used, plus its scientific name with its concentration and its equivalence in a
vegetable marker, where applicable.
b.5. They may not include narcotic or psychotropic substances, nor mixtures with allopathic medicines.
b.6. The identity and purity of the components will be established according to what the pharmacopoeias or
international or foreign sources of scientific information, and the corresponding validation of
the proposed analytical methodology.
b.7. The analytical methodology for the evaluation of the finished product as well as its raw materials must appear
in any of the pharmacopoeias officially accepted in our country or in foreign scientific information sources
or the corresponding validation of the proposed analytical methodology must be presented.
b.8. They must comply with the specifications of the finished product according to the pharmaceutical form in which they
they are presented, however the valuation of the active ingredient (s) in the finished product may be excepted,
replacing it with the valuation of the specific plant marker.
b.9. Products containing isolated or synthetic active principles will not be considered as phytopharmaceuticals, although
are prepared from raw materials of plant origin.
Article 41º.- Regarding the sanitary registry of homeopathic products, considering their nature, they will be kept in
Consideration of the following details about the following matters:
a) Regarding the pharmaceutical quality history of the product:
a.1. The generic names of its active ingredients will be expressed in Latin, as established in the
recognized pharmacopoeias.
a.2. In qualitative-quantitative formulas, each homeopathic substance must be expressed with its Latin name
followed by its final degree of dilution, that is, in the finished product, plus its concentration.
a.3. There must be a clear and complete description of the raw material or materials of the heading used in the
preparation of the homeopathic substance, its characterization, method of preparation and physical-chemical controls
effected.
a.4. The description of the manufacturing method or methods used in the preparation of the product must be included.
finished.
to 5. Homeopathic pharmaceutical products must meet the finished product specifications according
to the pharmaceutical form in which they are presented, like any other type of medicine, with the exception of
valuation of the active ingredient (s) in the finished product.
a.6. When homeopathic products are administered in the form of conventional tablets, tests should be carried out
of disintegration to replace the dissolution test.
b) Regarding the presentation of antecedents that support the efficacy and safety of the product, they may be used
in addition to the texts expressly mentioned in article 33 of this decree, other pharmacopoeias, documents
issued by WHO expert committees or others recognized by supreme decree of the Ministry, issued under the
formula "By order of the President of the Republic",
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at the proposal of the Institute.
Article 42º.- In the case of sanitary registration of biological products, requests, in addition to complying with the
general requirements regarding the product to be registered, must observe the following details and
Accompany the background information regarding:
a) Name of the product, in the following order:
a.1. Fantasy name or in its case the generic name (INN) or pharmacopoeia. In the case of vaccines, the
Latin name according to the disease against which it protects.
a.2. The production process when the active ingredients are living or dead microorganisms; mentioning the
process as follows: "live", "attenuated", "conjugate" or "inactivated" or other.
a.3. The production method, in the case of an active principle that is produced by a living organism that has been
technologically modified, mentioning the process as follows: "recombinant".
a.4. Pharmaceutical form and dosage, if applicable.
b) Quali-quantitative composition, in the following order:
b.1. Qualitative-quantitative statement of each of the active ingredients.
b.2. Quali-quantitative statement of each of the excipients.
b.3. Qualitative-quantitative declaration of any adjuvant or adsorbent present, when appropriate.
b.4. The qualitative-quantitative composition must be expressed, if applicable, in units of mass or volume of the system
decimal metric. Protein content or units of biological activity shall be expressed per unit mass or
volume, or failing that they will be expressed in International Units.
b.5. In the case of products for active immunization, the composition should preferably be declared
quali – quantitative per unit dose.
b.6. The active ingredients will preferably be named by their International Nonproprietary Name (INN) or, in their
defect, by the existing pharmacopoeial name. For non-pharmacopoeic substances the name will be used
chemical or biological and in the case of vaccines, the Latin name according to the disease against which it protects. I dont know
may use abbreviations for the name.
b.7. The taxonomic name of the microorganisms shall be declared, without abbreviations, in addition the
strain, serotype or other appropriate sub-species signaling where appropriate.
b.8. The nature of any cellular system used in the production of the biological product must be declared,
as well as the use of recombinant DNA or RNA technology.
b.9. If one of the active substances is a living microorganism, the chemical component used in the
chemical inactivation method.
b.10. When the qualitative-quantitative statement includes adsorbent such as aluminum, the quantitative statement of its
Compounds should be declared in terms of the quantity per dose.
b.11. At the end of the formula, the preservatives will be quantitatively detailed when they are
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present and qualitatively the residues of antibiotics and antimicrobial agents used in the process of
manufacturing and inducing potential allergic reactions in certain individuals.
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
of these, by their chemical designation or their equivalents that they have in the Indices of Dyes allowed and approved
in the country by the corresponding technical standard, approved by the Supreme Decree of the Ministry. The same provision will be
applicable when using colored capsules.
c) Requirements for the active ingredient (s), including specification of quality and purity as well as the methods
control thereof, accompanying the following information:
c.1. Declare manufacturer and supplier of the active ingredient.
c.2. Declare supplier as well as the traceability, when appropriate, of the reference standard used for the
qualification of the active principle.
c.3. Storage conditions of the active ingredient: temperature, humidity and quality of the container.
c.4. Description of other desired elements and related compounds, their properties and characteristics:
structure, biological activity or other.
c.5. When describing active ingredients from human blood or blood products, the
procedures used to ensure the maximum absence of potentially pathogenic agents that may
be transmitted, including:
c.5.1. Donor selection protocol.
c.5.2. Plasma fractionation method.
c.5.3. All the tests carried out on the plasma, before and during the process, including the determination of
Hepatitis B surface antigens (HBV) and antibodies against Human Immunodeficiency Viruses (HIV)
and against the Hepatitis C virus (HCV) and others that proceed.
c.5.4. Storage temperature of the active ingredient and its controls.
c.5.5. Validity period and expiration date.
c.5.6. Inactivation methods for infectious contaminants that may be contained in the starting material, products
intermediates and final products.
d) Manufacturing method:
d.1. Description of the manufacturing method of the product, including the controls in process and its tolerance.
d.2. Description of the manufacturing process, which must include the description of the raw materials, stages
criticism and reprocessing, when appropriate, also include the way in which the controls to be used were selected
as routine in the control of the finished product.
d.3. Description of the source and starting materials for the preparation of the biological active ingredient.
d.4. Describe the actions taken to avoid or control contamination by adventitious agents, both viral
such as HIV, HBV, HCV, among others, as non-virals, such as agents
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of Transmissible Spongiform Encephalopathy (TSE), bacteria, mycoplasma or fungi.
d.5. Description and background of the validation process.
e) Excipient Control:
e.1. Attach the quality and purity specification as well as the control methods of the excipients to be used in
the formulation, adjusting to the requirements contemplated in official texts authorized in these regulations or
monographs thereof, if not indicated in said texts.
e.2. Attach accreditation about the absence of raw materials from animal species affected by
TSEs or other transferable.
f) Control of finished product:
f.1. You must include at least the following information:
. Description and appearance (physical state, color, odor, and clarity, where applicable);
. Selective identification for the active ingredient (s);
. Assessment, potency or activity of the active ingredient (s);
. Determination of impurities, when appropriate;
. Description of the nature and type of packaging material, both primary and secondary packaging, and accessories,
when the latter are in contact with the pharmaceutical product;
. Any other determined by resolution of the Institute, according to the nature and composition of the product
biological.
f.2. Indicate the acceptance criteria and maximum and minimum values ​​when they are determining factors.
f.3. Summary sheet, which includes the analytical parameters and their acceptance criteria with which the
biological product. This document, once official, will become the specifications of the finished product,
with which the biological product must comply throughout its period of effectiveness.
g) Packaging material:
g.1. Description of the nature and type of the packaging material, both primary, secondary and accessories, when
the latter are in contact with the pharmaceutical product.
g.2. You must include the information regarding the choice of the primary packaging material, considering the protection
of the light and humidity it provides, compatibility of the chosen material with the pharmaceutical form and its administration.
g.3. When the pharmaceutical form is sterile, it must include information on the integrity of the closure system of the
primary packaging to avoid microbial contamination.
h) Stability study for the formulation, the solvent and the reconstituted product, as appropriate:
h.1. Stability history should include as a minimum:
. Formula studied;
. Identification of the manufacturer and responsible for the stability study;
. Conditions of temperature, humidity, packaging material and series studied (minimum 3 series or pilot lots) and the
scheduled design, analytical procedures used and finished product specifications, all
as appropriate, according to the Product Stability Guide
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Pharmaceuticals referred to in article 32.
h.2. In the case of a biological product that contains an active ingredient that is incorporated for the first time in the
field of medicine in our country, must include the results of stability studies for degradation
forced and stressful conditions.
h.3. Proposition of the efficacy period and storage precautions, both supported by the study of
corresponding stability, also indicate the period of effectiveness for the reconstituted product, when appropriate.
h.4. If the product must be diluted prior to administration, the compatibility studies and
stability with corresponding diluents, as appropriate.
i) Safety and Efficiency Requirements.
In the cases of biotechnological products, by Supreme Decree of the Ministry, at the proposal of the Institute,
will establish the technical standard that will determine the active principles and their respective presentations, with respect to each
one of which the abbreviation of clinical studies destined to endorse efficacy and safety of the
product, based on the existence of another registered biotech product, using the same principles
active ingredients, unit dose, pharmaceutical form and route of administration.
Notwithstanding the foregoing, the interested party must accompany the comparative studies with the reference product,
that with respect to each active ingredient it is indicated, in order to appropriately characterize the product and demonstrate its
similar nature with the innovator or reference already mentioned.
THIRD PARAGRAPH:
OF THE PROCEDURE APPLICABLE TO THE REGISTRATION APPLICATION.
Article 43º.- The application for health registration, together with the background that must be accompanied according to the
type of pharmaceutical product, will be presented to the Institute of Public Health on the approved forms, upon payment
of the corresponding tariff.
Said request shall be recorded in a written or electronic file, in which the documents will be recorded.
presented by the interested parties, with expression of the time and date of presentation, granting a reference number
for admission and follow-up, upon payment of the fee corresponding to the first phase of admissibility of the
request.
Article 44º.- Within the term of ten working days, the Institute will carry out a review of the application form and
his background, issuing a pronouncement on his admissibility.
Article 45º.- In the case of resolving the admissibility of the request for the purposes of its evaluation and review
Regarding the merits, the interested party will be notified of the resolution that so determines, so that he or her
The representative appears to pay the fee corresponding to the next phase of the procedure.
If it is determined that the request is not admissible, the resolution that so establishes may only be based on the absence
of the background required by this regulation and its complementary regulations, according to the type of specialty
pharmaceutical, and will indicate the background that must be added to overcome the objection, granting a deadline for it
five business days, expired which
The Institute will proceed in the manner established in the first paragraph or it will declare no place for the request.
Article 46º.- When the admissibility of the registration procedure is declared, the antecedents will be sent to the
corresponding unit, which will proceed to the breakdown of the technical and administrative background, accompanied,
for analysis, separately.
In the case of the administrative background referred to in number 10
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of article 29, will be previously analyzed by the legal advisory unit.
The technical background referring to the requirements of technical information, pharmaceutical quality and
safety and efficacy, as well as those individuals who, depending on the case, are from the type of
pharmaceutical product and that correspond according to the previous paragraph, will be broken down and sent to the dependencies
specialized techniques, which will be evaluated in accordance with these regulations.
Article 47º.- If the evaluations carried out by the mentioned instances are favorable, and within the total term
of six months counted from the date of payment of the corresponding tariff, the sanitary registry of the
requested product, through the issuance of a resolution, which will be formally notified to who appears as
applicant.
Article 48º.- The resolution that grants the sanitary registry of a pharmaceutical specialty must contain at least
The next points:
to. Name and address of the holder.
b. Name and address of the manufacturer, originator, importer, Pharmaceutical Production Laboratory or
Conditioning, Quality Control, Distributor, and Licensor, where appropriate.
c. Registry number.
d. Name of the pharmaceutical specialty.
and. Complete quantitative and qualitative composition.
F. Pharmaceutical form.
g. Therapeutic Group.
h. Storage conditions and efficacy period.
i. Authorized packaging and presentations.
j. Authorized therapeutic indications.
k. Prescription and dispensing conditions, established according to the regulations issued by the Ministry.
l. If the product is subject to legal control, serial control or others, indicating its basis the conditions
in which it must be carried out.
m. Limitations of the authorization regarding the validity and vigilance requirement in the use of the product
registered.
n. Specific obligations of the registration holder.
or. Obligation to report the first production or import batch for distribution under any title, of
according to the provisions of article 71.
p. Others that are relevant, according to the nature and specific composition of each pharmaceutical product, as well
such as those related to production, import, quality control, storage, distribution or delivery to
any title and data protection of an "undisclosed" nature.
q. In one or more stamped annexes, which will be considered to form an integral part of the resolution, the
authorized graphic labeling, the patient information brochure or insert, the professional information brochure,
the finished product specifications and the finished product analysis methodology.
Article 49º.- In the event that the evaluation carried out recommends the denial of sanitary registration based on:
- Related or accessory questions: these will be brought to the attention of the applicant, who will have a period
15 working days to formulate the allegations it deems appropriate, after which the Institute will decide
about them in the final resolution.
- Insufficiency of the background or studies presented: the interested party will be notified in order to provide
greater antecedents within the term of 30 working days, and if said new antecedents are sufficient to
guarantee the conditions indicated above, the sanitary registration will be granted.
In the event that such new antecedents are not presented within the granted term or that, presented in
time, they were again evaluated as insufficient, the Institute will request directly and justly the Ministry of
Health your pronouncement regarding the refusal of registration.
The Ministry will have a period of 10 working days to issue its report on the proposed denial,
communicating it to the Institute so that it can issue the founded resolution that so establishes it, which will be
notified to the applicant.
Article 50: During the processing of the sanitary registry whoever has the
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Stakeholder in accordance with Law No. 19,880 may adduce allegations and provide documents or other elements
of judgment so that they are considered as antecedents for the concession or denial of the respective registration
sanitary.
Once the sanitary registration is granted, the resolution that grants it will be available on the official website
of the Institute of Public Health.
In the cases in which, by application of Law No. 19,039, such information has the nature of not
disclosed, it will be to the dispositions contained in said norm and its complementary regulation.
FOURTH PARAGRAPH:
OF SPECIAL REGISTRATION PROCEDURES.
1 of the abbreviated registration procedure.
Article 51º.- The ordinary sanitary registration procedure may be abbreviated in order to reduce the terms of
processing established, based on a resolution of the Ministry of Health, founded on the concurrence of any of
the following circumstances:
1) That the pharmaceutical product is necessary to be distributed to the population in compliance with plans or
health programs approved by the Ministry, which address certain situations of health risk or
specific pathologies and that are intended for certain groups of people, within the framework of health interests
national public.
2) That the pharmaceutical product has been included in the list of products included in the National Form
of Medicines, event in which the interested party must use the monographs of the Form to accelerate the
registration process.
The Institute will proceed to reduce the deadlines established for sanitary registration, attending the stage of
processing in which you are. In any case, the total procedure may not exceed four months.
2 of the simplified registration procedure.
Article 52º.- The ordinary sanitary registration procedure may be simplified, upon request of the
interested, omitting certain antecedents, in the cases and in the manner indicated below:
1. In the case of pharmaceutical products that contain the same active ingredient, in the same quantity per form
pharmaceutical and the same route of administration as another product that has or has had a health record
canceled by the Institute for public health reasons, in which case the presentation of the
antecedents that relate to safety and efficacy, except that for well-founded reasons and through resolution, the
Institute determines the need to have all or some of those records.
In the case of an unconventional release pharmaceutical product that is a pharmaceutical equivalent of one already
registered, the corresponding therapeutic equivalence studies must be attached.
2. In the case of sufficiently known and experienced active ingredients, so that their effectiveness,
safety of use and adverse reactions are stated in the scientific literature, the background may be substituted
related to pre-clinical studies, by the pertinent bibliography. Likewise, the
scientific information regarding the efficacy and safety of the product to be registered; on this last case
The application will be evaluated by the Institute, and the entire background may well be required.
3. In the case of a pharmaceutical product that is the pharmaceutical equivalent of one already registered and that is
find in the lists of active ingredients that have been required to demonstrate their therapeutic equivalence,
case in which the corresponding studies that the specific norm indicates must be presented.
4. In the case of a product manufactured in the country with the sole purpose of being exported, which according to the
Chilean regulations are considered as a product
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pharmacist and that proves that in the country of destination it is considered as a food product, by means of a document
issued by your health authority, the presentation of the background information that relates to the
safety and efficacy, unless the Institute determines through a founded resolution the need to have all or
some of that background.
Article 53º.- The cases indicated to
continuation:
a) The pharmaceutical product whose health registration is requested is incorporated for the first time in the field of
medicine in the country; except in the case indicated in article 52, second numeral;
b) The pharmaceutical product whose health registration is requested contains the same active ingredient as another already
registered, whose information or data have the protection established in paragraph 2 of Title VIII of the law
No. 19,039, granted according to the specific regulations governing the matter, or is based on data that count
with such protection;
c) The pharmaceutical product whose registration is requested includes a new therapeutic utility, dosage scheme,
extension of a previously approved route of administration or age group, with respect to one already registered;
d) The pharmaceutical product whose health registration is requested presents: a modification in the composition and
concentration of the active ingredients of an already registered formula; or contains new salts, esters, complexes or
isoforms of the active ingredients that make up a pharmaceutical specialty already registered; or constitutes
combinations of active ingredients at fixed doses, which separately or not have a health registry;
e) In all cases in which the pharmaceutical product, whose registration is requested is presented in a form
pharmaceutical different from another registered and that modifies the release of the active ingredient (s);
f) In the cases that a sanitary registration of a combination pharmaceutical product is requested for the first time;
g) When the sanitary registration of a biological product is requested.
Article 54º.- In the case of requests for health registration of homeopathic pharmaceutical products, they may only
use a simplified registration procedure when they copulatively meet the following conditions:
a) Route of oral or external administration;
b) Absence of a particular therapeutic indication in the graphic labeling project or in the draft brochure
information to the professional and the patient;
c) Be made up of a single homeopathic substance, in a degree of dilution that guarantees the safety of the
medication, and
d) The homeopathic substance that makes up the pharmaceutical must be
obtained from substances or raw materials of plant, animal, mineral or chemical origin found
described in recognized pharmacopoeias, according to a homeopathic manufacturing procedure that is also found
described in
said texts.
FIFTH PARAGRAPH:
VALIDITY, SUSPENSION AND CANCELLATION OF THE SANITARY REGISTRY.
Article 55º.- The sanitary registry of a pharmaceutical specialty will be valid for five years, counted from
the date of the resolution that grants it, and it may be renewed for equal and successive periods, provided there is no
been canceled and the following conditions are met:
1. Payment of the corresponding fee.
2. Overcoming of the observations made for the suspension of the sanitary registration within the term granted
for it. In the event that the validity of the sanitary registry expires pending that period, the
renewal within 15 days after the expiration of the period granted to overcome said observations.
3. Non-existence of fines pending payment or compliance with other sanitary measures or sanctions applied by the
Institute, if applicable, in relation to the registration to be renewed.
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The renewal of the sanitary registry must be denied when the non-compliance of some of the
obligations that correspond to the holder of the sanitary registry.
Article 56º.- The request for renewal of the health registration must be submitted to the Institute and, in the case of
imported products, must be accompanied by the Pharmaceutical Product Certificate or Registration Certificate or
Health authorization certificate or official certification recommended by the World Health Organization,
issued by the health authority of the country of origin and that proves that the producer or
warehouse, as appropriate, meets the conditions required by the health legislation of your country, that the product
is registered in the country according to regulations
in force, fully stating its authorized formula and that its sale is subject to some restrictive regime or
special sanitary control, if it were so.
Article 57º.- The sanitary registry renewal resolution must maintain the registry number assigned in
registration, adding the year of renewal and indicate the expiration date thereof.
Article 58º.- All health registration may be suspended for any of the following reasons:
1. If there are significant changes in the therapeutic indication or in the composition or in the forms of
dosage or in the application or other conditions announced in the labeling or in the information to the professional or the
advertising or others, which do not correspond to what is approved in the health registry.
2. If there are failures to product quality in two series.
The resolution that establishes the suspension of the sanitary registry will determine its scope and will set the term in which
the observations that motivated it must be satisfactorily corrected; in case of non-compliance, it will proceed to
cancellation.
Article 59º.- All sanitary registration may be canceled ex officio or by complaint of interested parties, with pronouncement
prior to the Ministry of Health, when one of the following causes occurs:
a) When through scientific background emanating from the World Organization
Health, national or foreign organizations or entities or their own research, the
Institute forms the conviction that a product is not safe or effective, as approved in the respective
sanitary registry, generating in his respect some of the following situations:
a.1. Manifest danger to public health.
a.2. Unfavorable therapeutic risk / benefit ratio.
a.3. Therapeutic ineffectiveness.
b) When it is verified that any of the data provided in the sanitary registration request has been
duly credited as false.
c) When the sanitary registration having been suspended, the reasons that founded it within the
term set for this purpose.
Article 60º.- The holder of the canceled or suspended sanitary registry will be responsible for taking the measures
necessary for the adequate collection, destruction or denaturation, when the Institute so determines, of the
units of the pharmaceutical product that are stored in its dependencies and those distributed, of
according to current regulations, to other establishments in the pharmaceutical or healthcare area and to inform the public
user who may be able to make personal use of the product in question.
Article 61º.- The suspension and cancellation of a sanitary registry must be determined by the Institute through
a well-founded resolution that will be notified to whoever appears as the owner thereof.
Article 62º.- Without prejudice to the provisions of article 59, the Institute may cancel the sanitary registration,
upon instruction of the summary
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corresponding sanitary, in addition to the fine that is applied, in accordance with the provisions of article 174 of the
Sanitary Code.
SIXTH PARAGRAPH:
OF THE MODIFICATIONS OF THE SANITARY REGISTRY.
1º Of the sanitary technical aspects.
Article 63º.- By founded resolution of the Institute, ex officio or at the request of the owner, some of
the mentions contained in the resolution of the sanitary registry of a pharmaceutical specialty.
Article 64º.- The Institute may require, by reasoned resolution,
make or demand that within a defined period the registry modifications that are necessary to
guarantee the quality, safety and efficacy in the use of one or more pharmaceutical specialties, when
scientific background emanating from the World Health Organization, national organizations or entities,
international or foreign or from their own research, the conviction is formed that any of the conditions of use
authorized presents a risk in its safety and effectiveness.
Article 65º.- At the request of the holder of the sanitary registry, the Institute, by resolution, may authorize
modifications, regarding its analytical, technical and legal aspects, and may include the following:
1. Expression of the formula, including the composition of the excipients.
2. Specifications of the finished product, the methods of control of the finished product and the period of effectiveness.
3. Presentation, content, type of container and devices or elements incorporated for administration.
Regarding the modification of the primary packaging, the respective stability studies must be attached, if
corresponds.
4. Condition of sale.
5. Denomination and graphic labeling.
6. Regimen, origin, conditioner, licensor, distributor, importer, pharmaceutical control laboratory
of quality, as well as the modification of the company name and the owner.
7. Information leaflets for professionals and patients.
8. Therapeutic indications, therapeutic schemes, age group modification and new route of administration, the
that will be submitted to the pertinent technical evaluation, in accordance with the ordinary sanitary registration procedure of
proprietary medicines.
9. Any other, with the exception of those that alter the nature and identity of the pharmaceutical specialty,
that is to say, those that relate to the active ingredient, its dosage, its pharmaceutical form or when the
modification alter your release system. In these latter cases, another registration will be required.
Article 66º.- The requests for modification of the sanitary registry of pharmaceutical specialties will be presented
before the Institute in the forms authorized for this purpose, attaching the technical-scientific background that
support what is requested and duly foliated.
The Institute will grant or not, by reasoned resolution, requests for modification of registration within a period not
greater than three months from the date of submission of the application, with the exception of those indicated in the
number 8 of the preceding article.
When during the evaluation of the modification request and the background provided, the
Insufficiency of the same to support the request, the user must be notified of such situation, indicating
specifically the objections and the background that must be added to overcome them, granting a deadline for
less than ten nor more than thirty business days.
2º Of the administrative aspects.
Article 67º.- Any modification of the sanitary registry that does not affect the
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technical aspects related to the quality, safety and efficacy of pharmaceutical specialties, should be
notified by the holder to the Institute of Public Health, who will proceed to update it.
Article 68º.- Changes in ownership of a health registry of a pharmaceutical specialty may be
requested from the Institute, provided that the new owner complies with the relevant requirements, keeping the others
conditions authorized in the registry or attaching the background to support your modification of the agreement
to the provisions of the previous articles.
The request must be supported with the corresponding legal instruments, duly legalized and translated
under the signature of the legal representative.
In the case of health records granted under a license, the provisions of the respective
document and in the absence of express mention the change of ownership can only be authorized with the consent of the
licensor, knowledge of the licensee and application for a new owner.
Article 69º.- In cases where the change of ownership and other registry modifications is required
sanitary, will proceed to solve them together, unless a change of manufacturer is required, in which case
You must request a new registration.
Article 70º.- The changes will be registered in the corresponding registry, in the same terms and conditions indicated in
Article 66º for the other modifications of the sanitary registry.
SEVENTH PARAGRAPH:
FROM COMMON OBLIGATIONS TO ANY HEALTH REGISTRY HOLDER.
Article 71º.- The holder of the health registry is ultimately responsible for the safety and efficacy of the medication.
Without prejudice to the specific obligations established in attention to the nature of each specialty
pharmaceutical, all health record holder will be obliged to:
1) Respect and enforce the authorization conditions contemplated in the respective sanitary registry and the
others indicated by these regulations.
2) Comply with the obligations imposed by Title X on Health Surveillance.
3) Immediately communicate to the Institute and to the Undersecretariat of Public Health the recalls of products from the market that
practice, adequately reporting the reasons and measures taken for this purpose.
4) Inform the Ministry, the Institute and the Supply Center of the National System of Health Services
the intention to temporarily or permanently suspend the distribution of the product, with an advance of 3 to 6
months respectively.
5) Keep the sanitary registry updated, in accordance with the state of science and technique, especially in
in relation to quality control methods, as well as the safety and efficacy of the pharmaceutical specialty.
6) Communicate to the Institute the changes in your administrative information within 30 days.
7) The owner of a registered pharmaceutical product must inform the Institute of the date of manufacture of the first
industrial lot and attach the validation schedule of the production process.
8) The others that the regulation indicates.
TITLE III:
OF CONTAINERS AND LABELING.
Article 72º.- All pharmaceutical specialty must be presented in a primary and secondary container, both of which must
guarantee its inviolability as a finished product and also contain the patient information brochure.
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At the request of the owner of the registry, the Institute may exceptionally exempt it from the requirement of the container
secondary or patient information booklet, when the primary alone guarantees that it can preserve the
quality of the pharmaceutical form and the inclusion of all the indications that the labeling requires for the secondary packaging
or for the patient information brochure.
Article 73º.- The primary packaging of pharmaceutical specialties must be suitable and suitable for conservation
of its content, in accordance with the
stability studies presented for the same in the registry or its subsequent modifications.
Article 74º.- The labeling of the secondary containers will be in the Spanish language, clearly marked
visible and must indicate, at least, the mentions expressed below, the legends being prohibited
advertising or promotional:
1. Name of the pharmaceutical specialty.
2. Pharmaceutical form and unit dose in the case of monodrugs.
3. In the case of non-conventional release pharmaceutical forms, this circumstance must be registered in
the container, as declared in the respective registry.
4. Number of dosage units.
5. Composition of the formula: active ingredient or ingredients indicated qualitatively and quantitatively and excipients
qualitatively listed.
6. Name and address of the owner and the manufacturer, conditioner or importer laboratory, as appropriate.
7. Route of administration.
8. Approved sales condition, expressed in the corresponding acronym or with its full text.
9. Expiration date. In the case of extemporaneously prepared products, the solvent will also be indicated, including
or recommended and the period of effectiveness once reconstituted, if applicable.
10. Registration number granted by the Institute, preceded by the acronym of individualization "Reg. I.S.P:".
11. The product key. If the finished product is imported, it will keep the origin key.
12. Storage and conservation conditions.
13. Incorporation of the legend: "More information on www.ispch.cl" and of the others referred to in article 87,
as appropriate.
14. Any other indication that is specially and additionally required in these regulations or that the Institute considers
fundamentally necessary when granting the registration or that is determined later.
Article 75º.- The primary packaging must bear printed, at least the mentions indicated in numbers 1, 2, 7,
9, 10 and 11 of the previous article.
Article 76º.- In the case of the pharmaceutical specialties that are available in a medical sample presentation,
must also inscribe the mention: "MEDICAL SAMPLE FORBIDDEN SALE", both in the primary and secondary packaging,
clearly, indelibly and visibly.
Article 77º.- The labels must be printed or attached on the outside of the containers and without contact with their
content. The letter must use Arial characters or others of similar rectilinear type and with a minimum body size
6.
Article 78.- Exceptionally, the graphic labeling of a finished imported pharmaceutical product may include
texts in other languages, in addition to Spanish, provided that it does not alter the text authorized by the Institute.
Article 79º.- Holders of health records may include in the labels, under their sole responsibility
with respect to third parties, the mentions that, in relation to industrial property rights, are required by law, to enable
the exercise of the rights conferred by it.
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Article 80º.- All the graphic labels and the information brochure for the patient and the professional, presented to the
At the time of requesting the health registration, they must correspond to the final text that they will have once authorized,
without prejudice to the modifications that the Institute may introduce to them.
For the patient information brochures, the rule of article 77 regarding the size and type of
letter in which they must be incorporated in the secondary packaging.
The same requirements shall apply for subsequent modifications of such graphic labeling and information brochure to
patient and professional.
Article 81º.- The pharmaceutical specialties whose condition of sale is direct, must carry in the brochure of
information to the patient or on their labels, in addition to the indications described in article 74, which are mentioned
then:
a) Instructions regarding the usual dosage for each indication, according to what is authorized in the respective
registry.
b) Warnings necessary for safe and effective use, pointing out contraindications, interactions and
adverse reactions, when appropriate, all as determined by the Institute when granting the sanitary registration.
The presentation of these products may be made in dispensing containers provided that each blister or strip is
contained in an insert or other unit, containing the full text of the approved legend on the packaging
secondary and in the patient information brochure, in the event that I do not attach it.
Article 82º.- The name of a pharmaceutical specialty will correspond to its generic or fantasy name.
Notwithstanding the foregoing, if it is a pharmaceutical specialty with a different identification than its name
generic and containing only one active ingredient, it must be identifiable by its generic name printed on
clearly legible characters, in terms that meet the following conditions:
a) Be located on the bottom line and immediately after the authorized name.
b) Keep the color of the letters and the same background of the authorized name.
c) Have a dimension of not less than fifty percent of said denomination, with a size that is not less
to that indicated in article 77 of these regulations.
d) Be printed in capital letters.
Article 83º.- A pharmaceutical specialty may not be designated with a fantasy name, in the cases that
indicate:
a) That it is the same or similar to an international common name, or to its own chemical or generic name or
other than that referring to the active ingredient (s) that comprise it.
b) That it can lead to confusion, being the same or similar to the name of another product registered with a principle
different active or different therapeutic properties.
c) That the name has served to identify a product whose registration has been canceled or has expired, except
that 10 years or more have passed in the case of direct sales products and 5 years or more in the other cases, with
different therapeutic properties; unless it is proven that the product was never marketed in the country.
d) That the name covers or is similar to the name of a food, cosmetic or some other product subject to control
sanitary.
e) That the name induces the wrong use or stimulates self-medication.
Notwithstanding all the foregoing, the owner of a registration may name a series with the same fantasy name.
of registered pharmaceutical specialties provided that in their compositions they maintain at least the same principle
active on which the main therapeutic action is determined and its condition of sale is direct.
Article 84.- The containers of all parenteral solutions of 100 ml or more, must bear a label that must indicate,
in addition to the mentions of article 74, its date of manufacture in a clear, indelible and visible way,
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indicating day, month and year and the warning to discard in case of turbidity or precipitate, unless these conditions
are indicated as specifications of the finished product and authorized in the respective registry.
In the case of solutions for parenteral use that contain electrolytes in monodrug, in addition to what is indicated in the
previous paragraph, this must be indicated in the inscription of the label in letters of a defined color or, failing that,
with a
badge of the corresponding color. The Institute will establish the colors for each cation of the active principle of the
respective solutions.
Article 85º.- The quantity of pharmaceutical product must be expressed in weight, volume or unit, as the case may be.
In the case of ampoules or vial-ampoules, each one shall bear the indications indicated for the primary containers and the
amount of the active ingredient (s), unless by the size of the container, the Institute through resolution
consider it appropriate to exempt, totally or partially, from some of these requirements.
Article 86º.- The composition of the product must be reproduced in its active components, according to what is approved in
registration shall be granted and shall also indicate the equivalence of the active ingredient (s) in its base drug and the
qualitative list of all excipients.
The composition of the formula will be expressed in percentages and in the respective unit dose in the case of syrups,
solutions, emulsions, powders, ointments, creams and gels and other pharmaceutical forms of a similar nature.
In the case of ampoules, capsules, tablets, dragees, ovules and suppositories, the composition formulas are
will express for each unit dose.
Those solid or liquid pharmaceutical forms that do not appear in units such as tablets, dragees, ovules
or others similar, will also express the active principle or principles contained in the administration measures
current or usual.
Article 87º.- The labels must prominently indicate, when appropriate, the following legends:
- "SUBJECT TO CONTROL OF NARCOTICS"
- "SUBJECT TO PSYCHOTROPIC CONTROL"
- "NATIONAL FORM"
- "CLINICAL PACKAGE FOR MEDICAL AND CARE ESTABLISHMENTS ONLY"
- "CLINICAL PACK FOR SALE IN AUTHORIZED PHARMACEUTICAL ESTABLISHMENTS"
-    "EXTERNAL USE"
- "USE UNDER MEDICAL SUPERVISION"
- "MEDICAL SAMPLE FORBIDDEN SALE"
- R = Simple Recipe, RR = Retained Recipe, RCH = Recipe Check, VD = Direct Selling
Article 88.- Any series or batch or sub-series or sublot of a pharmaceutical product will be identified by means of a password.
that will allow it to be individualized in any of the stages, from its production to its dispensation or use.
The structure of the code, for the purposes of its interpretation, must be informed to the Institute by the holder of the
respective sanitary registry. In the same way it will proceed for its modifications and for different keys that
can be used.
Article 89º.- The keys must be reproduced on the labels of the primary and secondary packaging of the specialty
pharmaceutical.
Article 90º.- The keys will consist of numbers or combinations of letters and numbers, and must reproduce the
month and year of manufacture and the serial number corresponding to the item, in correlative and chronological order.
Failing that, any alpha-numeric combination may be used as a key but must jointly state:
the production date in month and year, on all labels, in addition to the general labeling requirements.
Article 91º.- In the case of finished imported pharmaceutical products, the owner of the registry must declare the
code of the country of origin at the time of requesting registration, indicating its interpretation.
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Article 92º.- If a pharmaceutical product from the same batch or series is finished in discontinuous stages, each of
they will constitute a sublot and must be individualized with an addition to the original serial number.
TITLE IV:
OF THE IMPORT AND INTERNATION OF PHARMACEUTICAL PRODUCTS.
FIRST PARAGRAPH:
GENERAL DISPOSITION.
Article 93º.- The importation of a pharmaceutical specialty can only be carried out when it has
Sanitary registration in force and that its import has not been suspended, without prejudice to cases and conditions
provided for in the First Paragraph of Title II of this regulation.
Article 94º.- Exceptionally a pharmaceutical specialty to be imported as a finished product by
Any natural or legal person will not require a new sanitary registry for its import and distribution.
by persons other than those who obtained said registration, when accredited, through the registration certificate,
pharmaceutical product certificate or health authorization or official certification recommended by the Organization
World Health, granted by the health authority in accordance with the provisions of article 29, number 10, of
this regulation, indicating that the pharmaceutical product, in addition to having the same formula, generic name or
denomination, comes from the same producer laboratory and country of origin as the pharmaceutical specialty
previously registered.
Once the above is accredited, the Institute will authorize, by resolution, the import of a quantity
determined and will authorize its use and disposal with the sole merit of the authorization and the respective bulletins
corresponding to the analyzes carried out by a quality control laboratory at the interned items.
SECOND PARAGRAPH:
OF IMPORT AND INTERNATION.
Article 95.- The importation of pharmaceutical specialties may be carried out by laboratories.
authorized pharmacists, pharmacies, drugstores and warehouses for pharmaceutical products and, in general, by anyone
natural or legal person, in accordance with the rules established in current legislation.
Article 96º.- Any natural or legal person may import pharmaceutical specialties, as well as materials
raw materials for their production. Notwithstanding the foregoing, for admission to the national territory,
will require having a duly authorized place for its storage, processing or subsequent distribution,
such as: pharmaceutical laboratories, pharmacies, drugstores and warehouses of pharmaceutical products, as appropriate
to the nature and purpose of the imported material.
Article 97º.- Only the pharmaceutical production laboratories may enter pharmaceutical products in any
of its production stages.
The conditioning pharmaceutical laboratories may enter semi-finished pharmaceutical products.
Regarding the pharmaceutical specialties that enter as a finished product, they can only be received and
stored by establishments duly authorized for it.
Raw materials destined for the manufacture of medicines or their marketing to producing establishments
Of these, they may only be admitted by drug stores and pharmaceutical production laboratories.
THIRD PARAGRAPH:
OF THE PROCESS OF INTERNATION OF PHARMACEUTICAL PRODUCTS.
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Article 98º.- For the hospitalization of all pharmaceutical products, a Certificate of Destination must be requested
Customs office at SEREMI corresponding to the customs office of entry of the product, having to attach the background
pertinent, in which the interned material, its quantity and its nature, as well as the
route and means of transport to carry out your transfer from the customs premises to an authorized establishment for
it.
SEREMI must rule on the request referred to in the preceding paragraph, within three
business days counted from the filing date of the petition and, in case of rejection, must do so by
founded resolution.
The SEREMI, through the Ministry, may sign agreements with other public entities for the issuance of the
designated certificates, signed in accordance with the provisions of the Organic Constitutional Law of Bases
Of the State Administration, Law No. 18,575, whose consolidated, coordinated and systematized text was set
by D.F.L. Nº 1, from 2000, of the Ministry General Secretariat of the Presidency.
Article 99.- To study any customs destination for pharmaceutical products, the interested party must present to the
National Customs Service the certificate issued by the respective SEREMI.
Once the processing of the customs destination document has been completed and the products have been removed from the
customs, they will be deposited under the responsibility of the consignee, who will not be able to use, consume, sell,
assign or dispose of them under any title, without obtaining the approval of the Institute by granting their authorization for use and
provision, denying it or setting a period of
security to practice the corresponding sanitary controls, during which time the products cannot be
used or distributed under any circumstances.
Said authorization will be requested from the Public Health Institute attaching the documentation related to the import.
(invoice and shipping document), the customs destination certification and the control control analysis protocol of
quality of the producing country or, failing that, the analysis protocol carried out in the country, except for samples of
pharmaceutical products intended exclusively for analysis and development or for obtaining their health registration,
the authorization must be issued within three business days from the date the interested party
notify the authority of the entry of the products to the warehouse.
The granting of the use and disposal authorization will not exempt applicants from the obligation to comply
in parallel with the other legal, regulatory or administrative requirements that are required to authorize its use or
distribution, as well as the observance of the rights of third parties established by law.
The National Customs Service will inform the Institute monthly about the pharmaceutical products that have
been imported into the country, as well as their quantity and the name of the importer.
In any case, in the case of pharmaceutical specialties, the warehouse or deposit establishment declared by the
importer must have the authorization of the corresponding SEREMI of Health.
TITLE V:
EXPORT OF PHARMACEUTICAL SPECIALTIES.
Article 100.- Only pharmaceutical products that have a valid health registration in
Chile, after notifying the Institute.
Article 101.- Pharmaceutical specialties destined for export that are labeled "Products for the
Export "the regulatory requirements regarding packaging, graphic labeling, brochure will not be applicable to them
information to the patient, except for the identification of the finished product, which must have the
following mentions:
A. Name of the product, including its generic name.
B. Pharmaceutical form.
C. I.S.P.
D. Name of the manufacturing establishment.
E. Serial number and expiration date.
Article 102.- They will be applicable to the elaboration, quality control and
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storage of products intended exclusively for export, the Good Practice standards of
Manufacturing and Laboratory.
Article 103 ° .- Pharmaceutical products destined exclusively for export must be packed,
stored and transported appropriately to their nature.
Article 104º.- The owner of the registry may request the Institute to issue a Product Certificate
Pharmacist, which must be issued within 10 days from the receipt of the corresponding
request.
Article 105º.- The distribution and use of labeled products in any country in the country is prohibited.
in accordance with the provisions of article 101 of these regulations or registered exclusively for export.
TITLE VI:
PHARMACEUTICAL LABORATORIES.
FIRST PARAGRAPH:
GENERAL DISPOSITION.
Article 106 ° .- The manufacture of pharmaceutical specialties will correspond exclusively to laboratories
regulated and authorized pharmacists in accordance with these regulations. Pharmacies may only prepare
pharmaceutical, magisterial and officinal preparations according to the norms established in the regulations
specific.
Article 107 ° .- Pharmaceutical Laboratory is any establishment destined for the import, production, packaging,
conditioning or quality control of the products referred to in these regulations. According to their
Activities are classified into the following categories:
a) Pharmaceutical Production Laboratory: It will be any establishment in which the manufacture, import,
fractionation, packaging or packaging, as well as any other activity related to production and control
of quality of pharmaceutical products. These establishments may also manufacture, import or distribute
raw materials used in the pharmaceutical industry.
b) Pharmaceutical Conditioning Laboratory: It will be any establishment exclusively dedicated to processes that do not
alter the integrity of the primary packaging of a pharmaceutical product to make it a finished product.
c) Pharmaceutical Quality Control Laboratory: It will be any establishment that in dependencies or sections
exclusively for this purpose, carry out analysis, testing, research and development of analytical methodology
and other analytical studies related to the products subject to these regulations or others, such as those
establishments that, among others, carry out Therapeutic Equivalence studies in vitro, at the request of any
natural or legal person, through the respective agreement. In the case of the quality control departments of
Pharmaceutical production laboratories, wishing to provide quality control services to third parties,
will require an additional authorization, granted by the Institute.
Article 108 ° .- Every Pharmaceutical Laboratory must observe the regulation contained in the Good Practices of
Manufacturing and Laboratory, as appropriate to the activities for which it is authorized.
SECOND PARAGRAPH:
SANITARY AUTHORIZATION OF LABORATORIES
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Article 109 ° .- The installation of a pharmaceutical laboratory, whatever its category, must be authorized in
expressly by resolution of the Institute, regarding its installation, operation and eventual transfer.
The expansion, modification of the physical plant or the lines of
activities within each category of establishments.
Article 110 °. - The authorization of installation and operation granted by the Institute, will have a validity of 3
years and will be renewed in accordance with the ninth paragraph of this title.
Article 111.- Any natural or legal person who acquires a pharmaceutical laboratory or takes charge of its
exploitation or administration on its own account or that of others, must notify the Institute within 30 days,
accompanying the instruments that prove their right, identifying the legal representative and attaching the payroll of
professionals in charge of the Technical Directorate, Production Headquarters, Quality Assurance and Control of
Quality, which correspond according to the type of establishment.
Article 112 ° .- The Institute may inspect the establishment to verify the conditions of its operation,
in accordance with the provisions of these regulations and Good Manufacturing and Laboratory Practices.
THIRD PARAGRAPH:
INSTALLATION AND OPERATION AUTHORIZATION PROCEDURE.
Article 113º.- The installation of a pharmaceutical laboratory must be done in an independent location.
Article 114º.- The laboratory installation authorization must be made by resolution of the Institute, within
of the term of 30 working days, counted from the time the interested party presents the following to the Institute in full
documents:
a) Individualization of the applicant.
b) Legal instruments that prove the title invoked for the possession of the establishment and denomination
commercial.
c) Architectural plan, in duplicate of the premises, together with flow charts or personnel displacement,
critical support materials and systems when applicable as well as technical specifications of the establishment,
regarding the areas and their distribution, in accordance with Good Manufacturing and Laboratory Practices, according to
it corresponds.
d) Laboratory category and production lines, analyzes and / or activities to be carried out.
e) Proof of payment of customs duty.
Prior to requesting authorization to install the premises, interested parties may request the Institute,
upon payment of the corresponding fee, the evaluation of the flow diagrams indicated above.
Article 115º.- Once the establishment in question is installed, the interested party will request the Institute, prior to
require operating authorization, on-site verification of conformity between the information delivered to the
At the time of requesting the installation authorization, what was developed and the Good Manufacturing Practices and
Laboratory, as applicable; leaving record of the non-conformities.
Article 116º.- The authorization of the operation of a pharmaceutical laboratory must be made by resolution
of the Institute within the term
30 days from when the interested party fully accompanies the following information:
a) List of facilities and equipment that the establishment has,
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duly qualified, as appropriate to the category.
b) Declarations signed by the professionals who will assume the technical direction, production management,
quality assurance and quality control, as appropriate; without prejudice to special provisions
that this regulation contemplates.
c) Activities, production lines or quality control to be carried out.
d) Description of the key or keys that will be used in accordance with the provisions of these regulations, when
Try pharmaceutical production labs.
e) Any other information that the Institute has justly requested.
Article 117.- Once the application for operating authorization has been received, the Institute will declare its
admissibility or inadmissibility within 15 days of submission, based on the background
enunciated in the previous article. Declared inadmissible, the Institute will inform the interested party of the background
missing so that in a period of 5 working days he can accompany them, under the warning of having him for their
request.
If the background information is insufficient, or does not comply with what has been developed and what is required in the regulations
in force, the Institute will issue within 30 days, a founded resolution that will reject the request for
functioning.
If the accompanied background is sufficient, the Institute will issue within 30 days, a resolution
authorizing the operation of the laboratory, which will contain the following mentions:
1. Name, category and address of the pharmaceutical laboratory.
2. Legal representative and professionals who assume technical responsibilities.
3. Lines of activities, production and / or authorized analysis.
FOURTH PARAGRAPH:
PHYSICAL PLANT REQUIREMENTS OF PHARMACEUTICAL LABORATORIES.
Article 118 ° .- All pharmaceutical laboratories will be specially designed and their size and construction must comply
with the provisions of these regulations and Good Manufacturing and Laboratory Practices, as appropriate to its
category. The location should be such that it is not close to
establishments that, due to the activities they carry out, are a source of contamination, nor that in turn originate it in their
environment.
Article 119 ° .- The laboratory must have special and independent rooms for the storage of
flammable or explosive, corrosive, toxic and polluting risks substances. These enclosures
They will strictly comply with the security measures determined by the competent bodies.
Article 120 ° .- The laboratory that manufactures or packages pharmaceutical products that have active ingredients
narcotic, psychotropic or others subject to special controls, must have storage areas
independent and restricted access.
Article 121 ° .- The establishments that import, manufacture, package, condition or distribute under any title
biological products or others that require special storage conditions, according to what is authorized in the
respective sanitary registry, they must ensure the conservation of temperature and keep records of them until
its distribution.
1º Of the Pharmaceutical Production Laboratories.
Article 122 ° .- The physical plant of a pharmaceutical production laboratory must consider, at least the
following areas, which will be
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clearly specified in the diagrams presented and approved by the Institute:
a) Reception and sampling of materials and products.
b) Quarantine of materials and products.
c) Sampling of raw materials.
d) Fractionation of raw materials.
e) Storage of approved materials.
f) Storage of rejected materials.
g) Manufacturing.
h) Washing and drying of utensils and materials.
i) Primary packaging and labeling.
j) Secondary packaging and labeling.
k) Quarantine of finished products and those subject to serial control, when appropriate.
l) Storage of approved finished products.
m) Storage of reference samples and counter samples.
n) Storage of recalled products.
o) Storage of rejected products.
p) Storage of returned products.
q) Storage of products in process.
r) Quality control laboratory.
s) Areas for quality control operations of products in process.
t) Manufacture and sterile and aseptic fractionation of pharmaceutical products, in accordance with Good Practices
Manufacturing, when applicable.
u) Expedition or dispatch.
v) Maintenance.
w) Offices for responsible professionals.
x) Bathroom and changing rooms for the use of personnel, prior to entering or leaving the plant, as appropriate.
In the cases of the zones described in letters b), e), k) and l), no physically separate sections will be required,
if there is an electronic system that allows adequate control of the different states of the materials.
The Pharmaceutical Production Laboratories may outsource, in independent premises, the areas of
storage of finished products. If the independent premises are owned by the laboratory, it will constitute a
expansion of its plant; whereas if it belongs to a third party, the latter must have the authorization
corresponding sanitary, issued by the respective SEREMI, which must supervise the activity that it
develop, in accordance with the general storage requirements provided in these regulations.
Article 123 ° .- The area corresponding to production must be structured, equipped and enabled, according to the forms
Pharmaceuticals that are manufactured and controlled to prevent cross contamination.
Article 124 ° .- The manufacturing and packaging areas may constitute a single unit, when systems are used
serial production technicians, who do not allow separating the different stages of product development and always
that the necessary measures be taken to avoid cross contamination.
Article 125 ° .- The manufacture and packaging of sterile pharmaceutical products can only be carried out in rooms
specially enabled for this purpose, also complying with the necessary conditions to execute:
a) The sterile fractionation of non-sterilizable products in final containers.
b) The aseptic fractionation of sterilizable products in final containers.
Article 126 ° .- When laboratory animals are used, they must be kept in isolated enclosures and
specially authorized for said effects, in the form and conditions authorized by the Institute.
Article 127 ° .- The facilities, equipment and other implements used in a production laboratory must
have the design, size and manufacturing materials in accordance with Good Manufacturing Practices ensuring, at
less, the following:
a) Continuous and orderly stages of manufacturing and quality control.
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b) Maintaining the necessary hygienic conditions.
c) Verification of the correct operation of the equipment, facilities and instruments, as well as
corresponding qualification of the same.
Article 128.- The production laboratories that carry out research and product development actions in their
establishments must have equipment and qualified personnel for such purposes.
Article 129 ° .- The manufacture of raw materials or drugs of biological origin that are obtained by processes of this
nature, intended for the elaboration of biological products, can only be carried out in laboratories especially
enabled and equipped for it or in sections thereof and separate from the production laboratories,
requiring, in any case, the corresponding authorization from the Institute.
These venues, in addition to complying with the provisions of this Title, must have a system that includes
exclusive facilities and equipment that allows the decontamination, neutralization, inactivation and incineration of
risky materials.
Article 130 °. - Only in rooms properly conditioned and equipped to minimize the risk of contamination,
may:
a) Manipulate microorganisms, toxins, cell cultures and others determined by the Institute.
b) Prepare and package biological products that contain microorganisms, toxins, cell cultures and others.
In any case, the packaging of the processed products must be carried out in areas of controlled contamination.
2nd Of the Pharmaceutical Conditioning Laboratories.
Article 131 ° .- The physical plant of the Conditioning Pharmaceutical Laboratories must consider, at least, the
following areas:
a) Reception and sampling of materials and products.
b) Quarantine of materials and products.
c) Storage of approved materials and products.
d) Conditioning.
e) Quarantine of finished products and those subject to serial control, when appropriate.
f) Storage of approved finished product.
g) Storage of rejected and withdrawn materials and products, duly circumscribed.
h) Storage of returned finished products.
i) Storage of reference samples and counter samples.
j) Expedition or dispatch.
k) Maintenance: if applicable.
l) Quality control regarding the production line or lines that are developed, including at least
an area for the analysis of labeling material, packaging and finished product with respect to its graphic labeling.
m) Office for the responsible professional or professionals.
n) Bathrooms and changing rooms.
In the cases of the zones described in letters b), c) e) and f), no physically separate sections will be required, if
There is an electronic system that allows adequate control of the different states of the materials.
3rd Of the Pharmaceutical Quality Control Laboratories.
Article 132 ° .- The External Quality Control Pharmaceutical Laboratory, or the quality control department of
a Pharmaceutical Production Laboratory,
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You must have the following areas, as appropriate to your lines of activities:
a) Reception and storage of samples.
b) Storage of counter samples.
c) Physical-chemical analysis.
d) Material washing.
e) Instrument room.
f) Microbiology, as appropriate.
g) Analysis of packaging materials.
h) Biological tests.
i) Bioterios.
j) Office (s) for the professional (s) responsible (s).
k) Bathrooms and changing rooms.
l) Storage of reagents.
These sections must have a sufficient number of rooms or areas to ensure that the testing systems
are isolated from each other.
Article 133 ° .- The quality control department of a Pharmaceutical Production Laboratory must have
the areas indicated in the previous article, in what corresponds to their line of activities.
In cases where a microbiology area is available, there must be separate sterility rooms, counting
and washing.
This service may be contracted externally, except in the case of quality controls carried out in the process.
from production to the primary packaging stage inclusive, in the manufacture of injectable products and those
that are made by aseptic filling.
4º Considerations common to all the physical plants of a Pharmaceutical Laboratory.
Article 134 ° .- All physical plants must comply with the requirements established in the Good Practices of
Manufacturing and Laboratory.
Article 135 ° .- The manufacture of products with highly active principles, such as hormones, cytostatics,
Beta-lactams, radiopharmaceuticals, and immunosuppressants contained in international or other authorized or
recognized by the Institute through a well-founded resolution, must be carried out in special facilities and
independent or isolated as appropriate, from those used in the elaboration of the other products, taking
the special measures required for personnel handling such products, in terms of clothing and items
protectors that avoid health risks, as determined in the technical standards approved by decree
supreme of the Ministry, dictated under the formula "By order of the President of the Republic" at the proposal of the Institute.
By founded resolution of the Institute, the lists of highly active principles that may be established will also be established.
be manufactured or conditioned in common areas, using the campaign work system, with validated methods
cleaning areas and equipment.
Article 136 ° .- The production and quality control areas will be physically separated, without prejudice to the
quality control applied in the same production process.
FIFTH PARAGRAPH:
THE PROCEDURES AND RECORDS.
Article 137 °. - Of each one of the operations carried out in the production stage, a record must be made
written, which must faithfully correspond to the standard production operating procedure and Good
Manufacturing practices.
Article 138 ° .- There must be a master formula for each product
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and batch size to be manufactured, which corresponds faithfully to the qualitative-quantitative unit formula, authorized in the
respective sanitary registry.
Article 139 ° .- The production process of each series or batch of a product must be consigned in documents
sheets called "Manufacturing form" and "Container-packaging or conditioning form", which must
stay permanently updated. In the case of pharmaceutical conditioning laboratories, only
the "Conditioning sheet" will apply.
Article 140 ° .- The manufacturing worksheet is the foliated document based on the pertinent parts of the formula
updated teacher. It must include, at least, the following information:
a) Product individualization.
b) Quantity to manufacture.
c) Serial number assigned according to the authorized key.
d) Manufacturing start and end dates.
e) Qualitative and quantitative formula, which must correspond proportionally to the formula authorized in the
Health Register.
f) Raw materials used in the manufacture of the product.
g) Number of analysis bulletins of raw materials used in the manufacture of the product.
h) Performance that theoretically can be expected from operations at different stages of manufacturing, limits
of admissible performance and actual performance obtained.
i) Standard manufacturing operating procedure that includes, at least:
1. Detailed instructions and precautions to be observed in the manufacturing process.
2. Individualization of all tests and analyzes necessary for quality inspection during each of
the production phases, indicating the names of the people who carried out these tests and analyzes.
j) Product analysis bulletins.
k) All other information on special problems, including details, with the authorized signature for any
deviation from the registered formula.
l) Name and signature of the professional responsible for production.
Article 141 ° .- Container-packaging form is the foliated document based on the relevant parts of the formula
approved or current master package or packaging instructions, which must include at least the following
data:
a) Individualization of the product and its presentation.
b) Serial number assigned according to a declared and approved code, individualizing with one or more other numbers or letters
the different sub-lots of the series, in accordance with the provisions of these regulations.
c) Start and end date of the packaging process.
d) Name and quantity of the inputs used in accordance with what is authorized in the sanitary registry.
e) Number of analysis bulletins of the materials used.
f) Theoretical performance, limits of admissible performance and actual performance obtained, with the comments
relevant.
g) Standard packaging-operating operating procedure, including at least:
1. Detailed instructions and precautions to be observed during the process.
2. Individualization of all tests and analyzes necessary for quality inspection during each of
the packaging-packaging phases, indicating the names of the people who carried out these tests and analyzes, be
of the own analysis laboratory or that authorized for external quality control, according to the corresponding stage.
h) Reconciliation of bulk materials, of printed packaging materials used in the process, destroyed,
returned, among others.
i) All other relevant antecedents in the packaging-packaging process, such as samples of used printed materials,
including serial number, expiration date and any other printing and notation of special problems, which
understand
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details for any deviations from the packaging instructions.
j) Name and signature of the professional responsible for the process.
In the case of pharmaceutical conditioning laboratories, the form described in the previous paragraph is
It will denominate "Conditioning sheet" to which the same mentions previously indicated in
how much they correspond.
Article 142.- All pharmaceutical production and conditioning laboratories must maintain a "General Registry of
production ", with the following annotations per day and in chronological order, regarding each product, as
correspond:
a) Planning date, product name and assigned serial number.
b) Number of the "Manufacturing Return".
c) Start and end dates of the production of the bulk product.
d) Theoretical and practical performance of the bulk product.
e) Number of Container-packaging or conditioning form.
f) Start and end dates of the packaging-packaging or conditioning process.
g) Theoretical and practical performance of the finished product.
h) Numbers of analysis bulletins of the finished product.
i) Number and date of the resolution that authorizes the series or batch, in the case of products subject to the
serial control, in accordance with the provisions of the regulations.
j) Product expiration date, which must be established based on the product's manufacturing date and the
efficacy period authorized in the respective health registry.
k) Names and signatures of the production manager.
Article 143 ° .- Pharmaceutical laboratories that handle narcotic drugs, psychotropic products and others subject to
special controls, must maintain official records in the form and conditions that the regulations
corresponding demand.
Article 144 ° .- Pharmaceutical laboratories must carry out activities
of quality control to ensure compliance with the technical specifications of the product, authorized in the
respective sanitary registry.
The analytical methodologies and quality specifications will be those that have been authorized in the respective
monographs when granting the sanitary registration or in the modifications approved later.
There must also be a quality assurance system, which must be developed in accordance with the notion of
integrated security, understood as such,
the set of planned and systematized rules and procedures necessary to guarantee product quality
finished.
Article 145 ° .- The pharmaceutical laboratory must keep records of
each of the operations and analyzes carried out on each series or batch manufactured and their corresponding materials
raw materials and packaging-packaging material, for one year beyond the expiration date of the product.
The records mentioned will include: raw material analysis bulletins, packaging materials, products
in process and finished products, production equipment qualification protocols; technique validation
analytical;
operating resumes, calibrations, maintenance of facilities, equipment and instruments and others, all
This in accordance with Good Manufacturing Practices and Good Laboratory Practices.
Article 146 ° .- The records referred to in this paragraph must be kept permanently updated, be easy
access and record any changes.
These records may be kept in a computer system to the extent that it meets the stated requirements.
Article 147º.- In the case of conditioning laboratories, the provisions of the articles shall apply
above, regarding the process that
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performed, and the process must be approved by signing the professional responsible for quality.
SIXTH PARAGRAPH:
OF PERSONNEL AND RESPONSIBILITIES
Article 148º.- Pharmaceutical production laboratories must have suitable personnel for the performance of
the following charges:
1.- Technical Director. 2.- Production Manager.
3.- Head of Quality Control.
4.- Head of Quality Assurance.
Notwithstanding the provisions, the Institute may authorize, by means of a founded resolution, the complexity of the
laboratory in question, that the same professional assume the Technical Direction and the Production Headquarters, and / or that
the same professional assumes the Head of Quality Control and Quality Assurance.
In the case of conditioning laboratories, the professional in charge of the Technical Directorate may also assume the
roles and responsibilities of the Production Manager; for his part, the Head of Quality Control may assume those of the
Head of Quality Assurance.
Notwithstanding the provisions of the preceding paragraph, these positions must be held by chemical professionals
pharmacists, independently, being technically responsible for the obligations that these regulations
it imposes on them.
Article 149 ° .- External quality control laboratories will function under the responsibility of a Director
Technician, by profession a pharmaceutical chemist.
Article 150 ° .- The technical management of pharmaceutical laboratories that exclusively manufacture raw materials or
drugs of biological origin, which are obtained by processes of the same nature, may also correspond to a biochemist
or a doctor-surgeon with a specialization in microbiology.
Article 151 ° .- The positions of Technical Director, Head of Production, Head of Quality Control and Head of
Quality Assurance, must be exercised continuously and permanently throughout the time of
operation of the
laboratory, and the Institute must be informed, within a period of 30 days from the date they assume, the
name and address to which notifications will be validly made.
In the absence of the owner, they must be immediately replaced by others of the same profession and for the time
your absence lasts. In any case, the responsibility of the processes already started will always affect the owner, without
prejudice of the one that exists with respect to the substitute.
In the case of professionals who assume such positions as substitutes, it must be recorded in all
existing forms and records, as well as being informed monthly to the Institute.
If the holder's absence is prolonged for a period of more than 48 hours, it must be made up under the conditions
previously indicated and also communicated to the Institute. The same communication must be made at the end of your
functions or suspension thereof.
Article 152 ° .- The Technical Director will be responsible for representing the establishment before the health authority, for
purposes of compliance with these regulations regarding the following aspects:
a) Guarantee the veracity of the information declared in the health registry.
b) Keep a file with the product registration resolutions, their modifications, the information to the
professional, advertising and all documentation sent or received from the Institute.
c) Timely forward all the information that, pursuant to this
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regulations, must be sent to the Institute or that the latter requires and that no other person has been appointed.
d) Ensure that the advertising and information of pharmaceutical products complies with the provisions of the
health registration and current health regulations.
e) Exercise the other functions assigned to it by laws and regulations.
Article 153.- The Production Manager will correspond, in general, the organization and development of the components of the
production process in the technical order, being especially responsible for the following aspects:
a) Guarantee the conformity of the formula of the products that are manufactured, packaged or imported with what has been declared and
approved in the registry specifications.
b) Observe and enforce Good Manufacturing Practices.
c) Ensure correct compliance with the instructions related to the manufacturing, packaging and
storage, including process controls.
d) Monitor the maintenance of the department in general, facilities and equipment.
e) Exercise the other functions assigned to it by laws and regulations.
Article 154 ° .- The following functions will correspond to the Head of Quality Control of the establishment:
a) Guarantee that the specifications and analytical methodology, for each of the raw materials,
container-packaging, products in process and finished products, correspond to what is authorized in the respective registry
health, executing or taking responsibility for the representative sampling of each of them, in accordance with the
plans established and designed with statistical criteria.
b) Approve or reject raw materials, products in process, finished products and packaging materials of
according to the specifications and methodologies authorized in the respective sanitary registry, proposing its
rectification, reprocessing or destruction when appropriate, leaving a record for
writing of the relevant observation.
c) Execute stability studies and other analyzes for each of the finished products.
d) Inform the head of quality assurance, in a timely and truthful manner, of all the information required to
the release of a batch or series of a product, and must expressly indicate any observation that influences the
same.
e) Plan, establish and control the performance of laboratory work, ensuring compliance with
the rules on Good Laboratory Practice.
f) To ensure the adequate maintenance of reference samples and / or counter samples of raw materials, of
products in process and finished products.
g) Guarantee the reliability of the analytical results of the quality controls carried out in its
laboratory, in the products that are elaborated, packaged or imported for their own account or for others.
h) Exercise the other functions assigned by the laws and regulations, regarding their professional activity in
the establishment.
Article 155 °. - The Head of Quality Assurance will correspond, in general, to carry out the activities inherent to the
adopted quality system and efforts to ensure that pharmaceutical products have the required quality
in accordance with the respective sanitary registry and especially must:
a) Verify that the elaboration of the products is carried out in accordance with Good Manufacturing Practices and
Laboratory and supervise its compliance at all levels.
b) Ensure the adequate establishment of data in each of the records that every pharmaceutical laboratory must
keep in accordance with current regulations.
c) Release for distribution to the market each production series or batch, which should refer, among others, to
the evaluation of compliance with the specifications of the sanitary registry, compliance with Good Practices of
Manufacturing and Laboratory, production process, analysis results practiced, documentation review
of the batch or series, controls in process and
analysis of deviations, without prejudice to the responsibilities that affect the Head of Production or Control of
Quality, as appropriate.
d) Establish the validation programs, both of the manufacturing processes that may be responsible for causing
variation in the characteristics of products in process and finished products, such as the methodologies of
analysis.
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e) Register and analyze complaints and claims about the quality of products that have been reported or
returned by users or investigated by the health authority and take the necessary measures to correct the
deficiencies found.
f) Establish and enforce the calibration and qualification programs of the equipment and instruments of the
pharmaceutical laboratory, as appropriate.
g) Study and carry out stability studies.
h) Design and execute a program to verify the reliability of the methods used in the inspection and
analysis of the quality characteristics of materials and products.
i) Design and execute the programs for self-inspections and audits of suppliers and service providers
external.
j) Exercise the other functions assigned by the laws and regulations, regarding their professional activity in
the establishment.
Article 156 ° .- Corresponds to the Technical Director of the External Quality Control Pharmaceutical Laboratory
represent the establishment before the health authority for the purposes of complying with these regulations and,
in particular, carry out the following functions:
a) Issue the analysis bulletins of raw materials, products in process or finished according to the
methodologies and specifications, as appropriate, established in the respective health registers,
deciding on their approval or rejection.
b) Establish and periodically enforce the programs established to calibrate and qualify the instruments and
laboratory equipment, as appropriate.
c) Design and execute a program to verify the reliability of the methods used in sampling, inspection
and analysis of the quality characteristics of products.
d) Plan, establish and control the performance of laboratory work, ensuring compliance with
the rules of Good Laboratory Practice.
e) Guarantee the reliability of the analytical results of
quality that are made in your laboratory in the products that are manufactured, packaged or imported, whose analyzes have
been entrusted.
f) Carry out the sampling of the products to be analyzed, according to a procedure that ensures their
representativeness.
Article 157 ° .- The natural or legal person who owns the establishment, when appropriate, must provide the
Professionals indicated the technical and financial resources that they need to respond to the requirements
established in this regulation.
Article 158 ° .- The responsibilities that affect the Technical Director, the Production Manager, the Control Manager of
Quality and the Head of Quality Assurance, will always reach the natural or legal person, owner of the
establishment, when appropriate, according to the general rules that govern the matter.
Article 159 ° .- The natural or legal person who owns the
establishment, when appropriate, will respond together with the Technical Director of the correct distribution or sale, to
any title, of the products that the establishment manufactures or imports, as well as advertising and information
to be made of them.
Article 160 ° .- The owner's natural or legal person and the technical director of the establishment will be responsible for the
acquisition, maintenance, possession and use of narcotic drugs, psychotropic products and others subject to
special controls, in the form and conditions established by the corresponding regulations.
SEVENTH PARAGRAPH:
OF THE CONTRACTING OF SERVICES TO THIRD PARTIES
Article 161 °. - The holders of a sanitary registry may purchase services related, among others, to the
manufacturing, packaging and
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analysis and specific quality control tests, to a pharmaceutical laboratory, provided that this is stated in the
respective agreement and thus has been authorized in the corresponding sanitary registry or in its modifications
later.
Article 162 ° .- The agreement for the manufacture or packaging of pharmaceutical products, in any of its stages,
It must include the technical aspects of the stage to which it refers, in accordance with the Good Practices of
Manufacture.
Article 163 ° .- The quality control agreement must establish
clearly entrusted activities, considering the requirements established in the Good Practices of
Laboratory.
Likewise, the agreement must contain the obligation of the contractor to deliver all the necessary information to
carry out the respective analyzes in accordance with the Good Laboratory Practices and specifications of the
Health Register.
Article 164 °. - In any case, those who carry out activities in compliance with an agreement must comply with them.
requirements and requirements for the activity that develops and will be subject to the same responsibilities as
this regulation establishes with respect to it.
EIGHTH PARAGRAPH:
SPECIAL PRODUCTION ESTABLISHMENTS
Article 165 ° .- The production of phytopharmaceuticals, homeopathic products and those referred to in the article
17 of this Regulation,
It must satisfy the needs of their manufacturing processes, according to the Good Practices of
Manufacture or in accordance with the technical standards approved by supreme decree of the Ministry, issued to
Institute proposal.
Article 166 °. - The establishments that elaborate traditional herbal medicines, are excepted from the
standards indicated in this title and will be authorized and supervised by the corresponding SEREMI, within the scope of
your competition.
By supreme decree of the Ministry, the technical standard that will establish the requirements for the
establishments that traditionally store, divide, package or carry out other operations related to
development of traditional herbal medicines.
PARAGRAPH NINE:
OF THE VALIDITY, CANCELLATION AND SUSPENSION OF THE OPERATION AUTHORIZATION
Article 167 ° .- The authorization to operate a pharmaceutical laboratory will be valid for three years
counted from the date of its granting and may be automatically renewed for equal and successive periods, in
both do not incur any of the grounds for cancellation established in these regulations and
compliance with the manufacturing standards and specifications of the Good Manufacturing and Laboratory Practices.
For these purposes, the Institute may inspect and supervise the operating conditions of the laboratories.
pharmacists and verify compliance with current regulations.
Article 168 ° .- The authorization to operate a pharmaceutical laboratory may be canceled, through
founded resolution of the Institute, in the following cases:
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a) The owner or his legal representative, communicate his will not to continue his activities.
b) The authorized establishment suspends its operation for a period of six months.
Article 169.- Without prejudice to the provisions of the previous article, the authorization of the operation of a
pharmaceutical laboratory may also be canceled, according to the merit of the health summary that must be instructed,
among others, in the following cases:
a) No analysis of raw materials and finished products, as appropriate.
b) One or more counterfeit, contaminated, altered or adulterated products are manufactured.
c) There are repeated failures in the quality of the products manufactured or conditioned by the establishment,
related to efficacy and safety, in more than three series of products that correspond to the same sanitary registry
or more than four series that correspond to different products within the 1-year period.
d) When the establishment has been totally or partially suspended, the same infractions will be verified
that motivated its suspension.
Article 170º.- The work stoppage or suspension of activities will proceed when any of the
following conditions:
a) That a pharmaceutical laboratory operates without a Technical Director, Production Manager, Quality Control Manager or
Head of Quality Assurance, as appropriate.
b) That the observed deficiencies that have been notified to it have not been corrected, within the terms that the
Institute would have pointed out to him.
c) That the manufacturing standards and specifications of the Good Manufacturing Practices and
Laboratory, in what corresponds to the category and lines of establishment activities, that put at risk the
efficacy, safety and quality of products.
The suspension or suspension may be total or partial.
Article 171 °. - In the case of suspension or suspension, the conditions and the term in which
they must be fulfilled for the resumption of the tasks to be arranged.
Article 172 ° .- Every owner must notify the Institute, within the
30 days following, the temporary or permanent closure of your pharmaceutical laboratory.
In the case of temporary closure that exceeds 6 months or that involves any change in the physical plant, its
facilities or its line of activities, the corresponding authorization must be requested to resume tasks or
activities.
TITLE VII:
OF QUALITY
FIRST PARAGRAPH:
GENERAL DISPOSITION
Article 173 ° .- All pharmaceutical products manufactured or imported into the country must be subject to quality control,
except for the exceptions established in these regulations.
The responsibility for the quality of the products will correspond to the manufacturers, importers, distributors,
vendors or holders of any title, as appropriate and where appropriate.
Article 174 ° .- Any natural or legal person, owner of an establishment that acts as a manufacturer of
pharmaceutical products, you must adopt a quality control system that ensures compliance with the
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production specifications, raw materials and finished product, through the realization of the
corresponding analyzes.
The same obligation will affect natural or legal persons, who
act as importers of pharmaceutical products in any of their production stages, as appropriate.
For their part, natural or legal persons acting as importers of raw materials intended for the
elaboration of pharmaceutical products, must have a system that accredits their quality.
Article 175 ° .- All health registration holders must prove that the manufacturing, national or foreign, of the
pharmaceutical products conforms to the concept of quality assurance, in the sense of demonstrating that the methods
analysis and manufacturing have validation and are conducive to obtaining products that comply with
the quality requirements established in the respective sanitary registry, according to the general guidelines
established in the Good Manufacturing and Laboratory Practices.
Notwithstanding the foregoing, in the case of validations of pharmaceutical manufacturing processes, you may
accept a compliance schedule.
Article 176 ° .- The Institute may suspend, by reasoned resolution, the distribution of a pharmaceutical product
that does not prove or comply with the requirements of the previous article. In this case, the owner may make the
pertinent adjustments to ensure that the processes are validated, being able to restore the authorization for the
distribution, after resolution of the Institute.
Article 177 ° .- Any natural or legal person who has authorization to provisionally use a product
pharmacist without prior health registration, according to letters a) and b) of article 21 of this regulation, will have
the obligation to have instruments that guarantee product quality and to carry out tests and analyzes of
quality control, to be determined in the resolution that authorized it.
SECOND PARAGRAPH:
QUALITY REQUIREMENTS
Article 178 ° .- The quality requirements of pharmaceutical specialties will be established in the
Product specifications and control methods to be used will be those approved when granting the respective
sanitary registry or in its subsequent modifications.
Article 179º.- The quality requirements of the raw materials destined to the manufacture of products
pharmacists, will be those declared in the specifications of the health registry, being the responsibility of
pharmaceutical laboratories for drug production, quality control and compliance with the others
requirements, before distribution.
Any change in the manufacturer of the active ingredient (s) that occurs after the granting of the
sanitary registry, must be informed to the Institute, providing the background showing that the modification of
origin does not affect the quality, efficacy and stability of the product, without prejudice to the power of the Institute to
carry out a selective sampling in order to verify the specifications with which the registration was granted, for which
which may request further information.
THIRD PARAGRAPH:
OF THE SERIAL CONTROL
Article 180.- Without prejudice to the general quality control provisions indicated above, the
Institute, by means of a founded resolution, may subject serial control, temporarily or permanently, to any
product, taking into account its nature, the variability of the analysis methods used in its control or
other reasons duly substantiated.
Article 181 °. - For series control, the Institute of Public Health
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determine, by resolution, the performance of all or part of the tests or analyzes included in the specifications
of finished product, authorized in the respective sanitary registry and its frequency for each product.
Article 182 ° .- The approval of the lot or sublot does not exempt the holder of the sanitary registry from the obligation of
carry out the quality controls established by this regulation and its complementary regulations.
Article 183 ° .- All biological products must undergo the serial control procedure.
Article 184 ° .- The request for series control must correspond to a fully finished lot or sublot.
individualized with a different alphanumeric code each time the respective request is presented; owing
attach the following:
a) Batch release certificate issued by the Head of Quality Assurance in the case of production
national or by the manufacturer or health authority of your country, in the case of imported, finished or
semi-finished, as appropriate.
b) The respective Analysis Bulletin made in Chile or the analysis bulletin of the manufacturing country in the case of
finished, semi-finished or bulk imported products.
c) Standards necessary to carry out the analysis.
Article 185 ° .- To carry out the serial control procedure, the Institute will proceed to take two samples, one of
which will be sealed and
documented in the premises where the sampling is carried out, under the responsibility of the Technical Director. The size
of each sample will be enough to carry out two complete analyzes, according to the product specifications
completed authorized in the respective sanitary registry and will be carried out through sampling procedures
determined by resolution of the Institute.
Article 186 ° .- The approval or rejection of a lot or sublot under series control, will be made within the
20 business days, counted from the time they are received according to the background described in article 184 of this
regulations, with the exception of vaccines, whose serial control will be carried out within 40 working days.
Notwithstanding the foregoing, the Institute may for reasonable reasons increase the term indicated in the preceding paragraph.
Once the serial control is rejected, the manufacturer or importer must proceed to the immediate destruction of the product, the
which will be effective in authorized places, in the presence of the Technical Director and a minister of public faith
designated by the Institute, drawing up a record of everything done.
Exceptionally, the Institute may authorize the reprocessing of the rejected product, after a well-founded request from the
interested, in which case the respective resolution will set the conditions under which it will be carried out.
FOURTH PARAGRAPH:
OF THE EXEMPTION OF QUALITY CONTROL AND SERIAL CONTROL.
Article 187 ° .- The Institute may exempt finished imported products from quality and / or serial control,
in all or part of them, in the case of products with very low turnover and high unit cost, and requests and
justify by the holder of the sanitary registry.
For these purposes, the interested party must provide sufficient information about the validation of the methods.
analytical used in the release of the batch in the country of manufacture, analysis bulletin of the country of origin and
cold chain maintenance records, where applicable.
Article 188 ° .- The resolution granting the exemption or denial must be founded. In case of being favorable
It will contain the following mentions:
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1. Name of the pharmaceutical specialty.
2. Maximum authorized quantity and frequency of importation.
3. Exempt analyzes.
4. Number of counter samples to be kept.
5. Validity of the resolution granting the exemption.
FIFTH PARAGRAPH:
OBLIGATIONS RELATED TO QUALITY CONTROL.
Article 189 ° .- The holder of the sanitary registry will be responsible for keeping counter samples of each batch of
Pharmaceutical products manufactured locally or on each import made, in sufficient quantity to make, to
at least two complete analyzes of the product, according to the specifications approved in the respective registry
sanitary, suitably labeled and stored, under the custody of the Chief of Quality Control, whether this is his own
pharmaceutical laboratory or the one that provides services externally by agreement.
The counter samples and corresponding documentation must be kept for one year beyond the expiration date.
of the product.
SIXTH PARAGRAPH:
QUALITY INSPECTION.
Article 190 ° .- The Public Health Institute is the health authority in charge of supervising the quality of the
pharmaceutical products through inspection, shelf control or other actions in establishments
manufacturers, importers, conditioners, distributors, vending machines and healthcare services.
These activities may be extended to bioavailability studies and to those intended to demonstrate equivalence
therapeutic according to the provisions of Title X of these regulations.
Article 191 °: Any failure of quality of pharmaceutical products or claim on it, must be notified to the
Institute, which will be responsible for evaluating them and determining the appropriate actions in their case.
If this failure occurs due to storage, distribution through drugstores or retail, the background
will be forwarded to the corresponding SEREMI, so that it can make the responsibility of those who proceed, through
of the respective sanitary summary.
Article 192 ° .- In the case of importers of products manufactured abroad as finished products,
semi-finished, made in bulk or semi-finished, it will be the responsibility of the Institute to verify compliance, by
of the producer laboratory located abroad, of the Good Manufacturing Practices according to the lines of
corresponding production.
For the purposes of verification in foreign laboratories, the Institute may contract consultancies and services
external or sign agreements with national or foreign entities, public or private, that are necessary for their
realization in accordance with the required quality standards.
Article 193 ° .- Notwithstanding the foregoing, the Institute may accept international accreditation and certification
of pharmaceutical specialties and production plants, to the extent that the technical standards of production and control
of quality applied by the sanitary authority of the manufacturing country or the
country recognized as accreditation, have been declared homologated by resolution of the Ministry of Health or that
they appear in International Treaties.
In case they are not homologated, the Institute will proceed in the manner indicated in the previous article at the expense of the
Applicant for health registration or its owner, when appropriate.
Article 194 °. - In the event that through the respective sanitary summary,
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check for quality failures of three or more batches of different pharmaceutical products from the same line of
production of a certain manufacturing laboratory, the Institute will modify the sanitary authorization, excluding the
production line corresponding to said products or will proceed to the suspension of import and distribution
authorized in the health registers of all those pharmaceutical specialties whose authorized manufacturer
include that production line.
TITLE VIII:
OF THE ºDISTRIBUTION.
Article 195 ° .- The distribution of the products will be done by the pharmaceutical production laboratories and
conditioners, drugstores and
warehouses for pharmaceutical products for human and dental use, under the conditions that for each of them are
establish in the respective sanitary registry and only sanitary authorized establishments for their
reception.
Article 196 ° .- The sale to the public of pharmaceutical specialties may only be made in pharmacies, warehouses
pharmaceuticals and warehouses of dental or other pharmaceutical products, under the conditions that for each of them
are statutorily established.
Pharmaceutical laboratories and drug stores may sell their products, manufactured or imported, to the public in
separate enclosures within its physical plant and specially enabled for these purposes, under the conditions of
approved outlets in the health registry. These venues will function under the responsibility of the Technical Director
of the establishment or the chemical-pharmaceutical professional appointed. These venues must have the
approval, regarding its location and operation, granted by the competent Institute or SEREMI of Health,
respectively.
Also, these establishments may sell such products to the public,
in the approved sales conditions, in independent premises, separated from its physical plant, in charge of a
chemical-pharmaceutical professional, prior
authorization of the corresponding SEREMI of Health.
Article 197 ° .- The condition of sale to the public of a pharmaceutical specialty will be determined in the respective
health registration and in the case of use authorizations without health registration, in the respective resolution; for
both cases will consider the therapeutic indications and authorized mode of use, as well as adverse reactions and
product interactions.
Article 198 °. - The condition of sale of a pharmaceutical specialty must be strictly observed in its
sale or delivery to any title to users and may not be freely distributed anywhere, by any
medium, or under any pretext or condition.
Those units labeled and distributed directly and exclusively are excepted from the provisions of the preceding paragraph.
professionals legally empowered to prescribe, as medical samples, in their consultations or at meetings
scientific in which they participate, which must be provided directly by the professional to the patient.
Notwithstanding the foregoing, the donation of pharmaceutical specialties and those products to which
referred to in article 21, letter a), to public or private healthcare establishments, with a minimum advance notice
one year to maturity or six months in the latter case, with prior authorization from the Institute, which must include
in its packaging with a legend referring to its condition of free distribution, to be dispensed in the same
condition to patients.
The establishment receiving the donation must deliver them free of charge.
TITLE IX:
ADVERTISING AND INFORMATION.
FIRST PARAGRAPH:
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GENERAL DISPOSITION.
Article 199 ° .- Advertising and information, to the patient and the professional, related to specialties
pharmaceutical companies, will be governed by the rules of this Title, for which it will be understood as:
a) Advertising: Set of procedures or activities used to publicize, highlight, distinguish directly or
indirectly to the public, through any means or method of dissemination, its own characteristics,
conditions of distribution, sale and use of the products referred to in these regulations.
b) Information for professionals: Set of procedures and activities, aimed at professionals legally
authorized to prescribe or dispense pharmaceutical products, in order to make them known to the products
referred to in these regulations, adjusting to what is authorized in the respective sanitary registry.
c) Professional information brochure: Document that will contain at least the characteristics of the specialty
pharmaceutical; pharmacokinetic, pharmacodynamic and toxicological aspects thereof; as well as the indications,
dosage, age group to which it is directed, contraindications, interactions, precautions and / or warnings,
adverse reactions, within which it is necessary to point out those that may occur during pregnancy, lactation
or in special populations; the measures to be taken in cases of overdose and other aspects, determined by the
authority based on the nature and scientific information available of a pharmaceutical product, in order to
inform professionals legally empowered to prescribe or dispense pharmaceutical products.
d) Patient information brochure: Document intended to inform the patient about a specialty
pharmaceutical. It will contain at least the information regarding the authorized indication, warnings,
contraindications, interactions with other products, precautions and all other information that the health authority
determine in the registry, to ensure its correct use. The Pharmaceutical Products for Sale brochure
direct, you must also indicate information
about the usual dosage for particular use and how they are approved for use in the registry.
Article 200.- The advertising of the direct sale pharmaceutical specialties may be carried out without authorization.
prior to the Institute, having to do so, reproduce the exact content, total or partial, authorized in the brochures
of information to the patient and labels, which have been approved in the respective health registry.
You can only refer to therapeutic recommendations that have been approved by the Institute in the respective
sanitary registry and, in no case, may contain titles, figures, indications, effects, allusions or mentions,
do not settle for it.
Advertising that is contrary to the aforementioned will be sanctioned, prior sanitary summary.
Article 201 °. - It will not be possible to advertise the specialties whose condition of sale is simple recipe, recipe
withheld or prescription check.
They may, however, advertise to professionals qualified for their prescription and dispensation, publicly without
prior approval of the Institute, through notices intended exclusively to publicize its introduction or existence
in the market, containing only the approved official name, with its identification on the main label, the
name of the manufacturer or importer and distributor laboratory and the hallmark of the establishment, if any.
Article 202.- The donation, delivery or free distribution of medicines for advertising purposes will be prohibited.
This purpose will be presumed in any free, massive or individual delivery, donation or distribution that is not found.
protected by article 198 °.
Article 203 °. - The Institute may suspend or prohibit, by reasoned resolution, advertising and information to the
professional, of pharmaceutical specialties that do not comply with the provisions of this Title, without
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prejudice to the corresponding sanitary summary instruction.
For these purposes, the Institute will require the corresponding parties, the texts of the publicity and information of such
products.
Article 204 °. - When the information to the professional proves not to correspond to that approved in the registry, the
Institute, by founded resolution, may suspend the sanitary registration and, in addition, order the withdrawal of all
brochures.
Article 205 °. - The modifications of the information leaflets to the patient and the professional authorized in the
registration, may be requested by the owner, must be approved or rejected by reasoned resolution.
Likewise, the Institute may, by means of a founded resolution, modify the authorized brochures with prior notice to
to take the appropriate measures.
Article 206 ° .- The holders of sanitary registration, importers, manufacturers or distributors and vendors who
advertise or carry out information activities to the prescribing professional, by itself or through third parties, with
infringement of the provisions of these regulations, will be sanctioned upon instruction of the corresponding summary
sanitary.
Article 207 °. - Publications, projections, transmissions or any other propaganda system are prohibited.
audiovisual by means of which any product that has not been
authorized or recognized as such by the authority.
The health authority may resolve the immediate cessation of said activity, under the terms of article 178
of the Sanitary Code, without prejudice to the sanitary responsibility that may affect the offender, as determined
in the corresponding summary.
SECOND PARAGRAPH:
FROM INFORMATION TO PROFESSIONAL.
Article 208 °. - The information to the professional of the pharmaceutical specialties of sale under simple prescription, will be
aimed exclusively at professionals legally empowered to prescribe, and chemical-pharmacists
in charge of dispensing.
Article 209 ° .- The information given to the professional must be
true, exact, complete and testable, must be in accordance with the therapeutic use, properties and
content of the professional information brochure, as approved in the corresponding registry.
You must also indicate the formula, indications, interactions, contraindications, precautions and
Warnings, adverse reactions, side effects, dosage and toxicity risks, as well as their treatment.
The texts and graphic expressions must conform to the type of pharmaceutical product, without alterations, distortions or
qualifying of any other nature and be exact, true and subject to verification.
Article 210 °. - In the professional information brochure, the information regarding the
bioavailability or therapeutic equivalence demonstrated in cases where these are mandatory.
Article 211 ° .- When the information refers to clinical, pharmacological or other antecedents
scientists, must be duly individualized and the citations must correspond to the faithful transcription of
they. These studies must be fully available to professionals who request it, according to
proceed.
Studies that do not refer to the pharmaceutical specialty in question may not be attributed as their own. Whether
use graphics, tables or references of the product, the bibliography, reference source and
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the name of the product and the owner of its registration, clearly visible.
Article 212 ° .- The general characteristics that others possess cannot be attributed as exclusive to a product.
Comparison with other drugs registered with the same active ingredient should be demonstrated with studies.
that endorse them.
All scientific information not recognized in the respective health registry, referring to therapeutic indications and
Dosages other than those authorized, may be delivered to professionals authorized to prescribe,
expressly indicating such condition and being the eventual use of that one, of exclusive responsibility of the professional.
Article 213 ° .- Incentives of any kind such as money, goods, services or other directed may not be used
to the professionals responsible for prescribing or dispensing, as well as to the people in charge of dispensing it,
to stimulate the prescription, dispensing or sale of some products or companies over others.
THIRD PARAGRAPH:
ADVERTISING IN PHARMACEUTICAL ESTABLISHMENTS.
Article 214 ° .- Only specialties may be announced in manufacturing and distribution establishments
pharmaceutical companies whose condition of sale is direct, indicating their authorized name and approved packaging and the
producer or distributor badge, if any.
Notwithstanding the foregoing, vending companies may announce the price of pharmaceutical specialties,
Whatever its condition of sale, by means of the exact reproduction of its labels in the places of sale.
Products subject to special controls, such as psychotropic, are exempt from these provisions.
and narcotics.
Article 215.- In these establishments, advertising procedures that may induce the
purchase, use or unspecified choice of medicines, such as raffles, raffles, donation of samples or other forms
that stimulate consumption, misuse or self-medication, if applicable. Likewise, the sale of
pharmaceutical products through incentives of any kind aimed at pharmacy staff.
TITLE X:
OF HEALTH SURVEILLANCE.
FIRST PARAGRAPH:
OF PHARMACOVIGILANCE.
Article 216 °. - The Institute is the sanitary authority in charge of the security surveillance of the specialties
Registered and non-registered pharmaceutical companies have been authorized for use in research
scientific or provisional.
Article 217 ° .- Health professionals have the duty to communicate to the Institute, all suspicions of
Adverse reactions of which they are aware and which could have been caused by a certain product
pharmacist.
The same obligation will fall on the Technical Director of the healthcare establishments, which must maintain
an updated record of these events.
The communication of the information referred to in this article, must be made on the forms that for this purpose
determine the Institute of Public Health, by resolution.
In the case of suspicion of a serious adverse drug reaction, the communication must be made within
72 hours after taking
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knowledge of the fact. In all other cases, you must communicate within the
30 days.
Article 218 °. - The holders of sanitary registrations or authorizations must implement and maintain a system of
pharmacovigilance, own or outsourced, being its Technical Advisor, responsible for:
a) Create, adopt and maintain a documented system to collect and process information on a single file
all suspected adverse reactions.
b) Prepare and submit quarterly to the Institute of Public Health, information about suspicions of
adverse reactions in the authorized forms, unless by means of a founded resolution the Institute determines a
lower term.
c) Ensure that a prompt and complete response is given to any request for additional information that the
Institute of Public Health and that is necessary to evaluate the benefits and risks of a pharmaceutical specialty,
within the terms established by that entity.
In qualified cases, the Institute of Public Health, by founded resolution, may also provide special measures of
pharmacovigilance for certain products.
Article 219 °. - The holders of sanitary registry of pharmaceutical specialties will be obliged to maintain
updated the information on product safety and a continuous evaluation of the risk-benefit ratio of the
same, in accordance with the provisions of the Seventh Paragraph of Title II of this regulation.
Article 220 ° .- The Institute will analyze the surveillance information
available and, where appropriate, will require the necessary studies to evaluate the safety of a pharmaceutical specialty,
in the authorized conditions of use. You can also propose the necessary measures to minimize risks
associated with the use of pharmaceutical specialties and to maintain an adequate balance in the risk-benefit ratio
from the same.
Without prejudice to the provisions of Law No. 19,628, on Protection of Personal Data, the background, the
evaluation and the measures indicated above, will have the character of public information, and may be given to
know by any means of diffusion.
SECOND PARAGRAPH:
OF THERAPEUTIC EQUIVALENCE.
Article 221 ° .- By Supreme Decree of the Ministry, issued at the proposal of the Institute, the technical standard will be approved
that will determine the lists of
active ingredients contained in pharmaceutical products that require to demonstrate their therapeutic equivalence and the
list of pharmaceutical products that will serve as a reference for them.
Likewise, by resolution of the Ministry, the criteria and the technical norm that establish the criteria will be approved.
necessary to determine the pharmaceutical products that require demonstration of therapeutic equivalence.
The rules and other procedures for conducting bioavailability studies, as well as studies of
therapeutic equivalence, in the corresponding cases, will be established by resolution of the Ministry, at the proposal
from high school.
TITLE XI:
OF THE PROCEDURES, SANCTIONS AND REMEDIES.
Article 222 °. - The administrative procedures, notifications and calculation of terms to which the application of the
these regulations, will be governed by
provisions of law No. 19,880, on the basis of the administrative procedures governing the acts of the organs
of the state administration.
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Article 223 °. - The infractions to the dispositions of the present regulation will be sanctioned by the Institute, previous
instruction of the respective sanitary summary, in accordance with the provisions of this decree and in accordance with the provisions
in Book X of the Sanitary Code and complementary sanitary legislation.
Of the sanctions applied, they can only be judicially claimed in the manner established in article 171 of the Code.
Sanitary.
The provisions, whose oversight has been filed in the SEREMI will be sanctioned by them in accordance with the
preceding paragraphs.
Article 224 °. - In use of its powers of sanitary inspection, the Institute, in justified cases, may
apply emergency measures, without the need for a prior sanitary summary. The same measures may be applied by
the minister of faith designated by the Institute, with the sole merit of the act that it draws up, when there is a risk
imminent for health. The same attributions will have the SEREMI or their ministers of faith, regarding the inspection
that these regulations expressly instruct them.
Article 225 ° .- Except as provided in the second paragraph of article 223, of the actions and resolutions it adopts
the Director of the Institute in the exercise of his functions, in relation to the matters referred to in this
regulation, an appeal may be filed before the Ministry of Health, within five days
business days counted from the date of the notification of the respective resolution in your case.
In the event that the affected party requires a longer time to present antecedents that support their claim, they must
request it within the deadline, from the Ministry of Health,
the one who will decide about it.
Once the appeal is presented, the Ministry must request the background from the Institute and will rule on the
claim within ten days
upon receipt of said documents, unless technically it requires a longer period for said effect.
If an appeal for reversal is filed before the same Institute, the claim referred to in this article may
interpose within the same term and subsidiarily. In this case the resolution that resolves the replacement will serve as
report for the purposes indicated in the preceding paragraph.
FINAL TITLE: VALIDITY.
Article 226 ° .- These regulations will come into effect 6 months later
of its publication in the Official Gazette, the date on which Supreme Decree No. 1,876 of 1995 of the
Ministry of Health, as well as any other norm, resolution or provision that is contrary or incompatible with the
contained in this regulatory decree.
Without prejudice to the provisions of the preceding paragraph, the provisions contained in article 175 of this
regulations, will come into effect from its publication in the Official Gazette.
TRANSITIONAL ITEMS
FIRST TRANSITORY Article:
OF THE SANITARY RECORDS.
The health records granted under the Supreme Decree No. 1,876 of 1995 of the Ministry of Health, which
This act is repealed, they will remain valid and valid. All in all, the Institute of Public Health, through resolution
founded, may require the background that it deems pertinent for updating health records, with
In order to comply with the provisions of this regulation, granting a term for it, which may not be
less than a year.
The provisions that this regulation provides regarding labeling will be required the following year counted from its
validity.
The health registration requests that are in process as of the effective date of this
Regulations must be withdrawn within the
30 following days, being able to be readmitted within the following 5 months, without
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tariff collection, complying with the requirements and formalities that this regulation establishes. Those requests
that are not withdrawn within the established period, will be denied outright.
SECOND TRANSITORY Article:
OF SANITARY AUTHORIZATIONS.
The sanitary authorizations granted under the Supreme Decree No. 1,876, of 1995, of the Ministry of Health, which
by this act it is repealed, they will keep their validity and validity. However, the Pharmaceutical Laboratories authorized to this
date must comply with the regulations according to the following schedule:
- Physical Structure Requirements: Within 2 years
- Personnel and Administrative Requirements: Within 1 year
- Technical Requirements and Methodology: Within 1 year
The authorizations for the installation and operation of Pharmaceutical Laboratories that are in process at the
The effective date of these Regulations must be withdrawn within the following 30 days, and may
be re-entered within the following 5 months, without tariff collection, complying with the requirements and formalities
that this regulation establishes. Those requests that are not withdrawn within the established period will be
flatly denied.
Sign up, take reason and publish yourself.- Michelle Bachelet Jeria, President of the Republic.- Alvaro Erazo Latorre,
Health Minister.
I am transcribing for your knowledge Affect Decree No. 3, dated 25-01-2010.- Regards you, María Soledad Carvallo
Holtz, Assistant Secretary for Public Health (S).
OFFICE OF THE COMPTROLLER GENERAL OF THE REPUBLIC
Legal Division
Attended by Decree No. 3 of 2010 from the Ministry of Health No. 27,949.- Santiago, May 4, 2011.
This Control Entity has processed the document of the item, through which the system regulations are approved
national control of pharmaceutical products for human use, as it is adjusted to law, but complies with
make it clear that this Comptroller General understands that the aspects indicated in the second and third paragraphs
of its article 221 must be regulated by a supreme decree issued through the Ministry of Health, and not by
resolution,
as expressed there.
With the foregoing scope, the administrative act of the heading has been taken into account.
Yours sincerely, Ramiro Mendoza Zúñiga, Comptroller General of the Republic.
Mr
Minister of Health Present
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