0A4F4F9BD490A749D5437F821CF06DF1

Law Nº 6360/76

http://www.planalto.gov.br/ccivil_03/leis/l6360.htm

http://leaux.net/URLS/ConvertAPI Text Files/39E2ED8228895FD25C96C9F4E28473B4.en.txt

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This file was generated: 2020-07-15 04:05:52

Indicators in focus are typically shown highlighted in yellow;

Peer Indicators (that share the same Vulnerability association) are shown highlighted in pink;

"Outside" Indicators (those that do NOT share the same Vulnerability association) are shown highlighted in green;

Trigger Words/Phrases are shown highlighted in gray.

Link to Orphaned Trigger Words (Appendix (Indicator List, Indicator Peers, Trigger Words, Type/Vulnerability/Indicator Overlay)

Applicable Type / Vulnerability / Indicator Overlay for this Input

Vulnerability Type	Vulnerability	Indicator	# Matches
Political	criminal	criminal	1
Health	Drug Dependence	dependence	2
Health	Drug Usage	drug	18
Health	Drug Usage	substance	12
Health	Physically Ill	sick	1
Social	Child	children	1
Social	Incarcerated	restricted	4
Social	Infant	infant	1
Social	Linguistic Proficiency	language	1
Social	Marital Status	single	36
Social	Property Ownership	home	1
Social	Trade Union Membership	union	8
Social	education	education	1
Economic	Food Insecurity	hunger	1
General/Other	Relationship to Authority	authority	5

Political / criminal

Searching for indicator criminal:

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p.(None): Art. 63. Hygiene, cosmetic, perfume or similar products are considered fraudulent, falsified or adulterated when:
p.(None): I - it is presented with indications that induce error, mistake or confusion as to its origin, origin, composition or purpose;
p.(None): II - not observing the standards and paradigms established in this Law and regulation, or the specifications contained in the registration;
p.(None): III - the nature, composition, properties or characteristics that constitute the conditions of its registration have been modified, due to the effect of addition, reduction or
p.(None): withdrawal of raw materials or components.
p.(None): Single paragraph. This article includes inputs consisting of active, additive or complementary raw material, of a chemical nature,
p.(None): biochemical or biological, of natural or synthetic origin, or any other material intended for the manufacture, manipulation and improvement of hygiene products,
p.(None): cosmetics, perfumes and the like.
p.(None): Article 64. The reuse and use of containers traditionally used for food, drinks, soft drinks, diet products,
p.(None): medicines, drugs, chemicals, hygiene products, cosmetics and perfumes in the packaging of sanitizers and the like.
p.(None): Art. 65. The placing of new dates or repackaging in new product packages whose expiration date has expired, except for
p.(None): therapeutic sera that can be refilled and refiltered.
p.(None): Art. 66. Failure to comply with the precepts of this Law, its regulation and complementary rules sets up an infraction of a sanitary nature, making the offender subject
p.(None): to the process and penalties provided for in Decree-Law No. 785, of August 25, 1969, without prejudice to other applicable civil and criminal commissions.
p.(None): Single paragraph. The process referred to in this article may be initiated and judged by the Ministry of Health or by the health authorities of the States,
p.(None): Federal District and Territories, as appropriate.
p.(None): Art. 67. Regardless of those provided for in Decree-Law No. 785, of August 25, 1969, serious or very serious infractions are set up, under the terms of this Law, the
p.(None): following practices punishable by the sanctions indicated in that legal diploma:
p.(None): I - to label products under the regime of this Law or to advertise them without complying with the provisions of this Law and its regulations or contrary to
p.(None): respective registration and authorization terms and conditions;
p.(None): II - change the product manufacturing process, without the prior consent of the Ministry of Health;
p.(None): III - sell or display for sale a product whose expiration date has expired;
p.(None): IV - affixing new dates on products whose expiration date has expired or repackaging them in new packaging, except for therapeutic serums that
p.(None): they can be refilled and refiltered;
p.(None): V - industrialize products without the assistance of a legally qualified technician;
p.(None): VI - use, in the preparation of hormones, organs of animals that are not healthy, or that show signs of decomposition at the time of being
p.(None): handled, or from sick, fatigued or emaciated animals;
p.(None): VII - resell biological product not kept in a refrigerator, according to the indications determined by the manufacturer and approved by the Ministry of Health;
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Health / Drug Dependence

Searching for indicator dependence:

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p.(None): exceed one hundred and eighty days. (Paragraph included by Law No. 9,782, dated 1.26.1999)
p.(None): § 3 The registration, granted under the conditions of the previous paragraphs, will lose its validity, regardless of notification or interpellation, if the product does not
p.(None): is marketed within one year after the date of its concession, extendable for another six months, at the discretion of the health authority, upon written justification
p.(None): initiative of the interested company. (Paragraph included by Law No. 9,782, dated 1.26.1999)
p.(None): § 4 The request for a new product registration may be made two years after the verification of the fact that caused the loss of the previous validity
p.(None): granted, unless it is not attributable to the interested company. (Paragraph included by Law No. 9,782, dated 1.26.1999)
p.(None): Paragraph 5. The provisions of this article apply to products registered and manufactured in a Member State that is part of the Southern Common Market - MERCOSUR, for
p.(None): effect of its commercialization in the Country, if they correspond to a similar national already registered. (Paragraph included by Law No. 9,782, dated 1.26.1999)
p.(None): § 6 The similar medicine, manufactured or not in the country, must have its effectiveness, safety and quality proven in an equivalent way to that adopted for the
p.(None): Generic drug. (Included by Law No. 13,235, 2015) (Effective)
p.(None): Article 22 - Drugs, medications and pharmaceutical supplies that contain narcotic substances or determine physical or psychological dependence,
p.(None): being subject to the special control provided for in Decree-Law No. 753, of August 11, 1969, as well as in other legal diplomas, regulations and other rules
p.(None): pertinent, and medicines in general, will only be registered if, in addition to meeting the conditions, requirements and procedure established in this Law and
p.(None): regulations, packaging and labeling meet the standards approved by the Ministry of Health.
p.(None): Art. 22. Drugs, medications and pharmaceutical inputs that contain narcotic substances or determine physical or psychological dependence, Art.
p.(None): subject to the special control provided for in Decree-Law no. 753, of August 11, 1969, as well as in other legal diplomas, regulations and other rules
p.(None): pertinent, and medicines in general, will only be registered or will have their registrations renewed, if, in addition to meeting the conditions, requirements and
p.(None): procedure established in this Law and its regulation, packaging and labeling meet the standards approved by the Ministry of
p.(None): Health. (Wording given by Law nº 10.742, of 6.10.2003)
p.(None): Art. 23 - The following are exempt from registration:
p.(None): I - products whose formulas are registered in the Brazilian Pharmacopoeia, in the codex or in the forms accepted by the Ministry of Health;
p.(None): II - homeopathic preparations consisting of simple associations of tinctures or incorporation into solid substances;
p.(None): III - the concentrated solutes that serve for the extemporaneous obtaining of pharmaceutical and industrial preparations, considered as officinal products;
p.(None): IV - products equivalent to the official ones, whose formulas are not registered in the Pharmacopoeia or in the forms, but are approved and authorized by the
p.(None): Ministry of Health.
p.(None): Single paragraph. The provisions of this article do not exclude the obligation, for the marketing of the products referred to therein, for the company to
p.(None): Ministry of Health, information and explanatory data on injectable solutes. (Repealed by Law No. 10,742, dated 6.10.2003)
p.(None): Art. 24 - New medicines, exclusively for experimental use, under medical control, are also exempt from registration.
p.(None): imported with the express authorization of the Ministry of Health.
p.(None): Art. 24. New drugs, exclusively for experimental use, under medical control, are exempt from registration, and may even be
...

Health / Drug Usage

Searching for indicator drug:

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p.(None): active substances, isolated or in combination, that do not pose a risk to the life or health of man and warm-blooded useful animals, when applied in
p.(None): compliance with the recommendations contained in its presentation;
p.(None): c) disinfectants - destined to destroy, indiscriminately or selectively, microorganisms, when applied to inanimate objects or environments;
p.(None): d) detergents - designed to dissolve fats and the hygiene of containers and containers, and for domestic use.
p.(None): VIII - Label: printed or lithographed identification, as well as the words painted or engraved with fire, pressure or decal, applied directly on
p.(None): containers, containers, wrappers, wraps, cartridges or any other packaging protector;
p.(None): IX - Packaging: wrapper, container or any form of packaging, removable or not, intended to cover, package, fill, protect or maintain,
p.(None): specifically or not, the products covered by this Law;
p.(None): X - Registration: registration, in a proper book after the concessive order of the director of the Ministry of Health organ, under order number, of the products
p.(None): this Law deals with the indication of the name, manufacturer, origin, purpose and other elements that characterize them;
p.(None): XI - Manufacturing: all operations that are necessary to obtain the products covered by this Law;
p.(None): XII - Raw materials: active or inactive substances that are used in the manufacture of medicines and other products covered by this Law, both those that
p.(None): remain unchanged as to those subject to change;
p.(None): XIII - Lot or Departure: quantity of a drug or product covered by this Law, which is produced in a manufacturing cycle, and whose essential characteristic
p.(None): it is homogeneity;
p.(None): XIV - Lot Number: designation printed on the label of a drug and of products covered by this Law that allows the lot or departure to be identified
p.(None): that belong and, if necessary, locate and review all manufacturing and inspection operations carried out during production;
p.(None): XV - Quality Control: set of measures designed to guarantee, at any time, the production of batches of medicines and other products
p.(None): covered by this Law, which meet the standards of activity, purity, efficacy and safety;
p.(None): XVI - Semi-prepared product: any substance or mixture of substances still under the manufacturing process;
p.(None): XVII - Purity: degree to which a given drug contains other foreign materials.
p.(None): XVIII - Brazilian Common Denomination (DCB) - name of the drug or pharmacologically active principle approved by the federal agency responsible for
p.(None): health surveillance; (Item included by Law No. 9,787, dated 2.10.1999)
p.(None): XIX - International Common Denomination (INN) - name of the drug or pharmacologically active principle recommended by the World Health Organization
p.(None): Cheers; (Item included by Law No. 9,787, dated 2.10.1999)
p.(None): XX - Similar Medicines - those that contain the same or the same active ingredients, have the same concentration, pharmaceutical form, via
p.(None): administration, dosage and therapeutic, preventive or diagnostic indication of the reference drug registered with the federal agency responsible for surveillance
p.(None): health, and may differ only in characteristics related to the size and shape of the product, expiration date, packaging, labeling, excipients and vehicles,
p.(None): must always be identified by trade name or brand; (Item included by Law No. 9,787, dated 2.10.1999)
p.(None): XX - Similar Medicines - those that contain the same or the same active ingredients, have the same concentration, pharmaceutical form, via
p.(None): administration, dosage and therapeutic indication, which is equivalent to the medication registered with the federal agency responsible for health surveillance, and may differ
p.(None): only on characteristics related to the size and shape of the product, expiration date, packaging, labeling, excipients and vehicles, and must always be
p.(None): identified by trade name or brand; (Wording given by Provisional Measure No. 2,190-34, of 2001)
p.(None): XX - Similar Medicine - one that contains the same or the same active ingredients, that presents the same concentration, pharmaceutical form, via
p.(None): administration, dosage and therapeutic indication and which is equivalent to the medication registered with the federal agency responsible for health surveillance, and may differ
p.(None): only in terms of product size and shape, expiration date, packaging, labeling, excipients and vehicles, its effectiveness proven,
p.(None): safety and quality, and should always be identified by trade name or brand; (Wording given by Law No. 13,235, 2015) (Effective)
p.(None): XXI - Generic Medication - medication similar to a reference or innovative product, which is intended to be with this interchangeable one, generally produced
p.(None): after expiration or waiver of patent protection or other exclusive rights, its effectiveness, safety and quality proven, and designated by DCB
p.(None): or, in its absence, by DCI; (Item included by Law No. 9,787, dated 2.10.1999)
p.(None): XXII - Reference Medication - an innovative product registered with the federal agency responsible for sanitary surveillance and marketed in the Country, whose efficacy,
p.(None): safety and quality were scientifically proven by the competent federal agency, at the time of registration; (Item included by Law No. 9,787, of
p.(None): 10.2.1999)
p.(None): XXIII - Interchangeable Pharmaceutical Product - therapeutic equivalent of a reference medicine, substantially proven to have the same effects as
p.(None): effectiveness and safety; (Item included by Law No. 9,787, dated 2.10.1999)
p.(None): XXIV - Bioequivalence - consists of demonstrating pharmaceutical equivalence between products presented in the same pharmaceutical form, containing
p.(None): identical qualitative and quantitative composition of active ingredient (s), and which have comparable bioavailability, when studied under the same design
p.(None): experimental; (Item included by Law No. 9,787, dated 2.10.1999)
p.(None): XXV - Bioavailability - indicates the speed and extent of absorption of an active ingredient in a dosage form, from its curve
p.(None): concentration / time in the systemic circulation or its excretion in the urine. (Item included by Law No. 9,787, dated 2.10.1999)
p.(None): Single paragraph. In the case of imported generic drugs, whose bioequivalence tests were carried out outside the country, the
p.(None): comparative dissolution tests between the test drug, the international reference drug used in the bioequivalence study and the
p.(None): national reference. (Wording given by Provisional Measure No. 2,190-34, of 2001)
p.(None): Single paragraph. Until June 30, 2003, in the case of imported generic drugs, whose bioequivalence tests were carried out outside the country,
p.(None): comparative dissolution tests between the test drug, the international reference drug used in the
p.(None): bioequivalence and the national reference medicine. (Wording given by Law nº 10.669, of 14.5.2003)
p.(None): Art. 4º - The products destined for the infant use cannot contain caustic or irritating substances, they will have packages free of blunt parts and not
p.(None): may be presented in aerosol form.
p.(None): Single paragraph. The products referred to in the caput must have labeling and packaging characteristics that enable their immediate and precise distinction
p.(None): those intended for adult use. (Included by Law No. 13,236, 2015) (Effective)
p.(None): Art. 5 - The products referred to in this Law may not have names or designations that are misleading.
p.(None): Art. 5 - The products referred to in this Law may not have names or designations that are misleading. (Wording given by Law No. 6,480, of 1.12.1977)
p.(None): Art. 5 The products covered by this Law may not have names, designations, labels or packaging that are misleading. (Wording given by Law
p.(None): nº 13,236, of 2015) (Effective)
p.(None): § 1 - It is prohibited to adopt the same or similar name for products of different composition, even from the same manufacturer, ensuring the priority of the
p.(None): registration with the chronological order of entry of applications in the competent department of the Ministry of Health, when there is no previous registration.
p.(None): § 2 - The name of a product whose registration is subsequently required may be approved, provided that the previous registration application is denied, for reasons of order
p.(None): technical or scientific.
p.(None): § 3 - Once the brand collidence is confirmed, the name or designation of the product must be modified within 90 (ninety) days from the date of the
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p.(None): or its regulations.
p.(None): § 3 - Except as provided in arts. 17-A, 21 and 24-A, registration will be granted within a maximum period of ninety days, counting from the
p.(None): application, except in cases of non-compliance, by the applicant, with this Law or its r e g u l m e n t s. (Wording given by Law No. 13,411, of
p.(None): 2017) (Effective)
p.(None): § 4 - The acts related to the registration and the revalidation of the registration will only take effect from the date of publication in the "Official Gazette" of the Union.
p.(None): § 5 - The granting of the registration and its revalidation, and the prior and control analyzes, when applicable, are subject to the payment of public prices,
p.(None): referred to in Art. 82.
p.(None): § 6 - The revalidation of the registration must be requested in the first semester of the last year of the five-year period of validity, considering itself automatically revalidated,
p.(None): regardless of decision, if it has not been issued by the end of the decision.
p.(None): § 7 - The expiry of the registration of the product whose revalidation has not been requested within the period referred to in § 6 of this article will be declared.
p.(None): § 8 - The registration of the product that is not industrialized in the first period of validity will not be revalidated.
p.(None): § 8 - The registration will not be revalidated: (Wording given by Law nº 13.411, of 2017) (Effective)
p.(None): I - the product not classified as a medicine that has not been industrialized in the period of validity of the expired registration; (Included by Law nº
p.(None): 13,411, 2017) (Effective)
p.(None): II - of the drug that has not been marketed for at least the time corresponding to the final two thirds of the validity period of the registration
p.(None): expired. (Included by Law No. 13,411, of 2017) (Effective)
p.(None): § 9 - The formula for the composition of the product must be included in the registration referred to in this article, with the indication of the ingredients used and respective
p.(None): dosage.
p.(None): § 10 - Anvisa will define, by its own act, the mechanisms for publicizing the registration, post-registration alteration and registration renewal processes,
p.(None): the presentation of the following information is mandatory: (Included by Law No. 13,411, of 2017) (Term)
p.(None): I - status of the analysis; (Included by Law No. 13,411, of 2017) (Effective)
p.(None): II - deadline foreseen for the final decision on the process; (Included by Law No. 13,411, of 2017) (Effective)
p.(None): III - technical foundations of decisions about the process. (Included by Law No. 13,411, of 2017) (Effective)
p.(None): Art. 13 - Any modification of the formula, alteration of elements of composition or of their quantities, addition, subtraction or innovation introduced in the
p.(None): preparation of the product, will depend on prior and express authorization from the Ministry of Health and will be immediately registered in the registry.
p.(None): Art. 14 - The names or fancy designations of the licensed and industrialized products prior to the
p.(None): its validity.
p.(None): Art. 14 - The names or fancy designations of licensed and industrialized products prior to the
p.(None): its validity. (Wording given by Decree No. 6,480, of 1.12.1977)
p.(None): Art. 15 - The registration of the products referred to in this Law will be denied whenever the conditions, requirements and procedures for this purpose are not met
p.(None): provided for by law, regulation or instruction by the competent body.
p.(None): TITLE III
p.(None): Registration of Drugs, Medicines and Pharmaceutical Supplies
p.(None): Art. 16 - The registration of drugs, medications and pharmaceutical supplies, given their sanitary, medicated or prophylactic, curative,
p.(None): palliative or even for diagnostic purposes, is subject, in addition to meeting its own regulatory requirements, to the following specific requirements:
p.(None): Art. 16. The registration of drugs, medications, pharmaceutical inputs and related items, given their sanitary, medicated or prophylactic characteristics,
p.(None): curative, palliative, or even for diagnostic purposes, it is subject, in addition to meeting its own requirements, to the following specific requirements:
p.(None): (Wording given by Law nº 10.742, of 6.10.2003)
p.(None): I - that the product obeys the provisions of Art. 5, and its paragraphs;
p.(None): I - that the product obeys the provisions of article 5, and its paragraphs. (Wording given by Decree No. 6,480, of 1.12.1977)
p.(None): II - that the product, through scientific proof and analysis, be recognized as safe and effective for the intended use, and have the identity,
p.(None): necessary activity, quality, purity and safety;
p.(None): III - in the case of a new product, that ample information about its composition and use be offered, to assess its nature and determination
p.(None): the degree of security and effectiveness required;
p.(None): IV - presentation, when requested, of a sample for analyzes and experiences deemed necessary by the competent bodies of the Ministry of Health;
p.(None): V - when there is a new substance in the composition of the drug, delivery of a sample accompanied by the chemical and physical-chemical data that identify it;
p.(None): VI - when dealing with a drug or medication whose preparation requires technical and specific equipment, proof that the establishment is located
p.(None): properly equipped and maintains personnel qualified to handle or contract with third parties for this purpose.
p.(None): VII - presentation of the following economic information: (Included by Law No. 10,742, dated 10.6.2003)
p.(None): a) the price of the product practiced by the company in other countries; (Included by Law No. 10,742, dated 6.10.2003)
p.(None): b) the purchase price of the product's active substance; (Included by Law No. 10,742, dated 6.10.2003)
p.(None): c) the cost of treatment per patient using the product; (Included by Law No. 10,742, dated 6.10.2003)
p.(None): d) the potential number of patients to be treated; (Included by Law No. 10,742, dated 6.10.2003)
p.(None): e) the price list it intends to practice in the domestic market, with a breakdown of its tax burden; (Included by Law No. 10,742, dated 6.10.2003)
p.(None): f) the breakdown of the product's marketing proposal, including the expenses foreseen with the sales effort and with advertising and advertising;
p.(None): (Included by Law No. 10,742, dated 6.10.2003)
p.(None): g) the price of the product that has been modified, in the case of a change in formula or shape; and (Included by Law No. 10,742, dated 6.10.2003)
p.(None): h) the list of all substitute products on the market, accompanied by their respective prices. (Included by Law No. 10,742, of
p.(None): 6.10.2003)
p.(None): Single paragraph. The provisions of item I, do not apply to serums and vaccines or pharmaceutical products containing a single active substance
p.(None): known, at the discretion of the Ministry of Health. (Repealed by Law No. 6,480 of December 1, 1977)
p.(None): § 1 (Repealed as a single paragraph by Law No. 6,480, of December 1, 1977). (Included by Law No. 10,742, dated 6.10.2003)
p.(None): § 2 The presentation of the information contained in item VII may be waived, in part or in whole, in accordance with regulations
p.(None): specific. (Included by Law No. 10,742, dated 6.10.2003)
p.(None): Art. 17 - The registration of the products referred to in this Title will be denied whenever the conditions, requirements and procedures for that purpose are not met
p.(None): provided for by law, regulation or instruction of the competent body.
p.(None): Art. 17-A - The deadlines established for the final decision in the drug registration and post-registration alteration processes will take into account the following
p.(None): criteria: (Included by Law No. 13,411, of 2017) (Effective)
p.(None): I - technical complexity; (Included by Law No. 13,411, of 2017) (Effective)
p.(None): I - clinical, economic and social benefits of using the drug object of the application. (Included by Law No. 13,411, of 2017)
p.(None): (Validity)
p.(None): Paragraph 1 - The application of the criteria provided for in the caput, according to the methodology provided for in Anvisa's act, will determine the classification of the medication under
p.(None): evaluation in the following categories of precedence: (Included by Law No. 13,411, of 2017) (Term)
p.(None): I - priority; (Included by Law No. 13,411, of 2017) (Effective)
p.(None): II - ordinary. (Included by Law No. 13,411, of 2017) (Effective)
p.(None): Paragraph 2 - The maximum deadlines for the final decision in the registration and post-registration alteration processes for medication will be, respectively:
p.(None): (Included by Law No. 13,411, of 2017) (Effective)
p.(None): I - for the priority category, one hundred and twenty days and sixty days, counted from the date of the respective prioritization protocol; (Included
p.(None): by Law No. 13,411, of 2017) (Effective)
p.(None): II - for the ordinary category, three hundred and sixty-five days and one hundred and eighty days, counted from the date of the respective registration or registration protocol
p.(None): post-registration change. (Included by Law No. 13,411, of 2017) (Effective)
p.(None): § 3 - Except in cases where there is an appeal against a previous decision, the final decision in the post-registration alteration processes may be taken by approval
p.(None): conditional, presumed by Anvisa's contrary manifestation within the deadlines defined in § 2. (Included by Law No. 13,411, of 2017) (Effective)
p.(None): § 4 - The conditional approval referred to in § 3 may only occur in the event of post-registration alterations defined in the regulation and will be automatically
p.(None): reversed, at any time, in case the post-registration alteration is rejected by Anvisa. (Included by Law No. 13,411, of 2017) (Effective)
...

p.(None): 2015) (Effective)
p.(None): Paragraph 2. The counting of the registration deadline will be interrupted until the satisfaction, by the interested company, of the requirement of the sanitary authority, and this cannot be
p.(None): exceed one hundred and eighty days. (Paragraph included by Law No. 9,782, dated 1.26.1999)
p.(None): § 3 The registration, granted under the conditions of the previous paragraphs, will lose its validity, regardless of notification or interpellation, if the product does not
p.(None): is marketed within one year after the date of its concession, extendable for another six months, at the discretion of the health authority, upon written justification
p.(None): initiative of the interested company. (Paragraph included by Law No. 9,782, dated 1.26.1999)
p.(None): § 4 The request for a new product registration may be made two years after the verification of the fact that caused the loss of the previous validity
p.(None): granted, unless it is not attributable to the interested company. (Paragraph included by Law No. 9,782, dated 1.26.1999)
p.(None): Paragraph 5. The provisions of this article apply to products registered and manufactured in a Member State that is part of the Southern Common Market - MERCOSUR, for
p.(None): effect of its commercialization in the Country, if they correspond to a similar national already registered. (Paragraph included by Law No. 9,782, dated 1.26.1999)
p.(None): § 6 The similar medicine, manufactured or not in the country, must have its effectiveness, safety and quality proven in an equivalent way to that adopted for the
p.(None): Generic drug. (Included by Law No. 13,235, 2015) (Effective)
p.(None): Article 22 - Drugs, medications and pharmaceutical supplies that contain narcotic substances or determine physical or psychological dependence,
p.(None): being subject to the special control provided for in Decree-Law No. 753, of August 11, 1969, as well as in other legal diplomas, regulations and other rules
p.(None): pertinent, and medicines in general, will only be registered if, in addition to meeting the conditions, requirements and procedure established in this Law and
p.(None): regulations, packaging and labeling meet the standards approved by the Ministry of Health.
p.(None): Art. 22. Drugs, medications and pharmaceutical inputs that contain narcotic substances or determine physical or psychological dependence, Art.
p.(None): subject to the special control provided for in Decree-Law no. 753, of August 11, 1969, as well as in other legal diplomas, regulations and other rules
p.(None): pertinent, and medicines in general, will only be registered or will have their registrations renewed, if, in addition to meeting the conditions, requirements and
p.(None): procedure established in this Law and its regulation, packaging and labeling meet the standards approved by the Ministry of
p.(None): Health. (Wording given by Law nº 10.742, of 6.10.2003)
p.(None): Art. 23 - The following are exempt from registration:
p.(None): I - products whose formulas are registered in the Brazilian Pharmacopoeia, in the codex or in the forms accepted by the Ministry of Health;
p.(None): II - homeopathic preparations consisting of simple associations of tinctures or incorporation into solid substances;
p.(None): III - the concentrated solutes that serve for the extemporaneous obtaining of pharmaceutical and industrial preparations, considered as officinal products;
...

p.(None): TITLE X
p.(None): Labeling and Advertising
p.(None): Art. 57. The Executive Branch will provide, in regulation, on labeling, package inserts, printed matter, labels and prospectuses referring to the products it deals with
p.(None): this Law.
p.(None): Single paragraph. Medicines bearing a trade name or brand will also be obligatorily with the same prominence and legibly in the
p.(None): parts referred to in the caput of this article, on packaging and promotional materials, the Brazilian Common Denomination or, failing that, the Common Denomination
p.(None): International in letters and characters whose size will not be less than one half the size of the letters and characters of the trade name or brand.
p.(None): (Paragraph included by Law No. 9,787, dated 2.10.1999)
p.(None): § 1 In addition to the trade name or brand, the medications must display, on the parts referred to in the caput of this article, on the packaging and
p.(None): promotional materials to the Brazilian Common Denomination or, when applicable, the International Common Denomination, in letters and characters with size never
p.(None): less than half the size of the letters and characters of the trade name or brand. (Wording given by Law No. 13,236, 2015) (Effective)
p.(None): § 2 The labels of medicines, drugs and related products must have characteristics that clearly differentiate them and that inhibit errors
p.(None): dispensation and administration, unwanted exchanges or misuse. (Included by Law No. 13,236, 2015) (Effective)
p.(None): Art. 58. Advertising, in any form of dissemination and means of communication, of products under the regime of this Law can only be promoted after
p.(None): authorization from the Ministry of Health, as provided by regulation.
p.(None): § 1 - When dealing with a drug, medication or any other product with the requirement to sell subject to medical or dental prescription, the advertisement
p.(None): will be restricted to publications that are intended exclusively for distribution to doctors, dentists and pharmacists.
p.(None): § 2 - The advertisement of over-the-counter medications, dietary products, household cleaners, cosmetics and hygiene products, will be
p.(None): subject to specific rules to be laid down in regulations.
p.(None): Art. 59. The designations, geographical names, symbols, figures, drawings or
p.(None): any indications that allow for false interpretation, error or confusion as to the origin, origin, nature, composition or quality, which they attribute to the product
p.(None): purposes or characteristics different from those it actually has.
p.(None): TITLE XI
p.(None): Packaging
p.(None): Art. 60. The approval, by the Ministry of Health, as required by regulation, of packaging, equipment and utensils prepared is mandatory
p.(None): or coated internally with substances that, in contact with the product, may alter its effects or produce damage to health.
p.(None): § 1 - The packaging destined for the packaging of drugs, medications, pharmaceutical supplies, hygiene products,
p.(None): cosmetics, perfumes and the like that do not contain a substance internally capable of altering the purity and effectiveness of the product.
p.(None): Paragraph 2 - The use of packaging designed to contain or pack drugs, medications or pharmaceutical inputs will not be authorized, as long as it is capable of
p.(None): directly or indirectly cause harmful health effects.
p.(None): § 3 - The approval of the type of packaging will be subject to prior analysis, when applicable.
p.(None): Art. 60-A. In order to contain or pack drugs, medication or related products, the use of packaging that may induce exchanges will not be authorized
p.(None): unwanted errors or errors in dispensing, using or administering these products. (Included by Law No. 13,236, 2015) (Effective)
p.(None): TITLE XII
p.(None): Means of Transport
p.(None): Art. 61. In the case of products that require special conditions of storage and storage, the vehicles used in their transportation must be equipped with
p.(None): of equipment that enables packaging and conservation capable of ensuring the conditions of purity, safety and efficacy of the product.
p.(None): Single paragraph. Vehicles used to transport drugs, medicines, pharmaceutical and related supplies, dietary and hygiene products, perfumes and
p.(None): similar activities must have the disinfection and hygiene conditions necessary to preserve human health ensured.
p.(None): TITLE XIII - Infractions and Penalties
p.(None): Art. 62. The medication, drug and pharmaceutical input are considered altered, adulterated or inappropriate for use:
p.(None): I - that has been mixed or conditioned with a substance that changes its therapeutic value or the purpose for which it is intended;
p.(None): II - when it has been removed or falsified, in whole or in part, an integral element of its normal composition, or replaced by another of inferior quality,
p.(None): or the dosage has been modified, or a foreign substance has been added to its composition, so that it becomes different from the formula in the record;
p.(None): III - whose volume does not correspond to the approved quantity;
p.(None): IV - when its conditions of purity, quality and authenticity do not satisfy the requirements of the Brazilian Pharmacopoeia or another Code adopted by
p.(None): Ministry of Health.
p.(None): Single paragraph. In the event of a change due to time, or a cause outside the responsibility of the technician or the company, the latter is obliged to withdraw
p.(None): immediately the product of the trade, for correction or replacement, under penalty of incurring a sanitary infraction.
p.(None): Art. 63. Hygiene, cosmetic, perfume or similar products are considered fraudulent, falsified or adulterated when:
p.(None): I - it is presented with indications that induce error, mistake or confusion as to its origin, origin, composition or purpose;
p.(None): II - not observing the standards and paradigms established in this Law and regulation, or the specifications contained in the registration;
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p.(None): IX - Packaging: wrapper, container or any form of packaging, removable or not, intended to cover, package, fill, protect or maintain,
p.(None): specifically or not, the products covered by this Law;
p.(None): X - Registration: registration, in a proper book after the concessive order of the director of the Ministry of Health organ, under order number, of the products
p.(None): this Law deals with the indication of the name, manufacturer, origin, purpose and other elements that characterize them;
p.(None): XI - Manufacturing: all operations that are necessary to obtain the products covered by this Law;
p.(None): XII - Raw materials: active or inactive substances that are used in the manufacture of medicines and other products covered by this Law, both those that
p.(None): remain unchanged as to those subject to change;
p.(None): XIII - Lot or Departure: quantity of a drug or product covered by this Law, which is produced in a manufacturing cycle, and whose essential characteristic
p.(None): it is homogeneity;
p.(None): XIV - Lot Number: designation printed on the label of a drug and of products covered by this Law that allows the lot or departure to be identified
p.(None): that belong and, if necessary, locate and review all manufacturing and inspection operations carried out during production;
p.(None): XV - Quality Control: set of measures designed to guarantee, at any time, the production of batches of medicines and other products
p.(None): covered by this Law, which meet the standards of activity, purity, efficacy and safety;
p.(None): XVI - Semi-prepared product: any substance or mixture of substances still under the manufacturing process;
p.(None): XVII - Purity: degree to which a given drug contains other foreign materials.
p.(None): XVIII - Brazilian Common Denomination (DCB) - name of the drug or pharmacologically active principle approved by the federal agency responsible for
p.(None): health surveillance; (Item included by Law No. 9,787, dated 2.10.1999)
p.(None): XIX - International Common Denomination (INN) - name of the drug or pharmacologically active principle recommended by the World Health Organization
p.(None): Cheers; (Item included by Law No. 9,787, dated 2.10.1999)
p.(None): XX - Similar Medicines - those that contain the same or the same active ingredients, have the same concentration, pharmaceutical form, via
p.(None): administration, dosage and therapeutic, preventive or diagnostic indication of the reference drug registered with the federal agency responsible for surveillance
p.(None): health, and may differ only in characteristics related to the size and shape of the product, expiration date, packaging, labeling, excipients and vehicles,
p.(None): must always be identified by trade name or brand; (Item included by Law No. 9,787, dated 2.10.1999)
p.(None): XX - Similar Medicines - those that contain the same or the same active ingredients, have the same concentration, pharmaceutical form, via
...

p.(None): may be presented in aerosol form.
p.(None): Single paragraph. The products referred to in the caput must have labeling and packaging characteristics that enable their immediate and precise distinction
p.(None): those intended for adult use. (Included by Law No. 13,236, 2015) (Effective)
p.(None): Art. 5 - The products referred to in this Law may not have names or designations that are misleading.
p.(None): Art. 5 - The products referred to in this Law may not have names or designations that are misleading. (Wording given by Law No. 6,480, of 1.12.1977)
p.(None): Art. 5 The products covered by this Law may not have names, designations, labels or packaging that are misleading. (Wording given by Law
p.(None): nº 13,236, of 2015) (Effective)
p.(None): § 1 - It is prohibited to adopt the same or similar name for products of different composition, even from the same manufacturer, ensuring the priority of the
p.(None): registration with the chronological order of entry of applications in the competent department of the Ministry of Health, when there is no previous registration.
p.(None): § 2 - The name of a product whose registration is subsequently required may be approved, provided that the previous registration application is denied, for reasons of order
p.(None): technical or scientific.
p.(None): § 3 - Once the brand collidence is confirmed, the name or designation of the product must be modified within 90 (ninety) days from the date of the
p.(None): publication of the order in the "Official Gazette" of the Union, under penalty of refusal of registration.
p.(None): § 4 - Without prejudice to the provisions of this article, drugs containing a single active substance well known, at the discretion of the Ministry of Health, and
p.(None): immunotherapeutics, drugs and pharmaceutical inputs must be identified by the name used in the Brazilian Pharmacopoeia, and under no circumstances
p.(None): have any fancy names or designations. (Included by Law No. 6,480, of 1.12.1977)
p.(None): § 5 The errors mentioned in the caput include dispensing and administering medications, drugs and related products.
p.(None): (Included by Law No. 13,236, 2015)
p.(None): § 5 The errors mentioned in the caput include dispensing and administering medications, drugs and related products.
p.(None): (Wording given by Law No. 13,236, 2015) (Effective)
p.(None): Art. 6 - The proof that a product, previously considered useful, is harmful to health or does not fulfill the requirements established by law, implies its
p.(None): immediate withdrawal from the trade and the requirement to change the formula of its composition and in the words of labels, package inserts and packages, under penalty of
p.(None): cancellation of the registration and seizure of the product, throughout the national territory.
p.(None): Single paragraph. It is the exclusive responsibility of the Ministry of Health to register and allow the use of medications, as well as the approval or requirement of
p.(None): modification of its components.
p.(None): Art. 7 - As a health security measure and in view of reasoned reasons from the competent body, the Ministry of Health may, at any time,
p.(None): suspend the manufacture and sale of any of the products covered by this Law, which, although registered, become suspected of having harmful effects on human health.
p.(None): Art. 8 - No establishment that manufactures or industrializes a product covered by this Law may operate without the effective assistance and responsibility of
p.(None): legally qualified technician.
...

p.(None): Art. 15 - The registration of the products referred to in this Law will be denied whenever the conditions, requirements and procedures for this purpose are not met
p.(None): provided for by law, regulation or instruction by the competent body.
p.(None): TITLE III
p.(None): Registration of Drugs, Medicines and Pharmaceutical Supplies
p.(None): Art. 16 - The registration of drugs, medications and pharmaceutical supplies, given their sanitary, medicated or prophylactic, curative,
p.(None): palliative or even for diagnostic purposes, is subject, in addition to meeting its own regulatory requirements, to the following specific requirements:
p.(None): Art. 16. The registration of drugs, medications, pharmaceutical inputs and related items, given their sanitary, medicated or prophylactic characteristics,
p.(None): curative, palliative, or even for diagnostic purposes, it is subject, in addition to meeting its own requirements, to the following specific requirements:
p.(None): (Wording given by Law nº 10.742, of 6.10.2003)
p.(None): I - that the product obeys the provisions of Art. 5, and its paragraphs;
p.(None): I - that the product obeys the provisions of article 5, and its paragraphs. (Wording given by Decree No. 6,480, of 1.12.1977)
p.(None): II - that the product, through scientific proof and analysis, be recognized as safe and effective for the intended use, and have the identity,
p.(None): necessary activity, quality, purity and safety;
p.(None): III - in the case of a new product, that ample information about its composition and use be offered, to assess its nature and determination
p.(None): the degree of security and effectiveness required;
p.(None): IV - presentation, when requested, of a sample for analyzes and experiences deemed necessary by the competent bodies of the Ministry of Health;
p.(None): V - when there is a new substance in the composition of the drug, delivery of a sample accompanied by the chemical and physical-chemical data that identify it;
p.(None): VI - when dealing with a drug or medication whose preparation requires technical and specific equipment, proof that the establishment is located
p.(None): properly equipped and maintains personnel qualified to handle or contract with third parties for this purpose.
p.(None): VII - presentation of the following economic information: (Included by Law No. 10,742, dated 10.6.2003)
p.(None): a) the price of the product practiced by the company in other countries; (Included by Law No. 10,742, dated 6.10.2003)
p.(None): b) the purchase price of the product's active substance; (Included by Law No. 10,742, dated 6.10.2003)
p.(None): c) the cost of treatment per patient using the product; (Included by Law No. 10,742, dated 6.10.2003)
p.(None): d) the potential number of patients to be treated; (Included by Law No. 10,742, dated 6.10.2003)
p.(None): e) the price list it intends to practice in the domestic market, with a breakdown of its tax burden; (Included by Law No. 10,742, dated 6.10.2003)
p.(None): f) the breakdown of the product's marketing proposal, including the expenses foreseen with the sales effort and with advertising and advertising;
p.(None): (Included by Law No. 10,742, dated 6.10.2003)
p.(None): g) the price of the product that has been modified, in the case of a change in formula or shape; and (Included by Law No. 10,742, dated 6.10.2003)
p.(None): h) the list of all substitute products on the market, accompanied by their respective prices. (Included by Law No. 10,742, of
p.(None): 6.10.2003)
p.(None): Single paragraph. The provisions of item I, do not apply to serums and vaccines or pharmaceutical products containing a single active substance
p.(None): known, at the discretion of the Ministry of Health. (Repealed by Law No. 6,480 of December 1, 1977)
p.(None): § 1 (Repealed as a single paragraph by Law No. 6,480, of December 1, 1977). (Included by Law No. 10,742, dated 6.10.2003)
p.(None): § 2 The presentation of the information contained in item VII may be waived, in part or in whole, in accordance with regulations
p.(None): specific. (Included by Law No. 10,742, dated 6.10.2003)
p.(None): Art. 17 - The registration of the products referred to in this Title will be denied whenever the conditions, requirements and procedures for that purpose are not met
p.(None): provided for by law, regulation or instruction of the competent body.
p.(None): Art. 17-A - The deadlines established for the final decision in the drug registration and post-registration alteration processes will take into account the following
p.(None): criteria: (Included by Law No. 13,411, of 2017) (Effective)
p.(None): I - technical complexity; (Included by Law No. 13,411, of 2017) (Effective)
p.(None): I - clinical, economic and social benefits of using the drug object of the application. (Included by Law No. 13,411, of 2017)
p.(None): (Validity)
p.(None): Paragraph 1 - The application of the criteria provided for in the caput, according to the methodology provided for in Anvisa's act, will determine the classification of the medication under
p.(None): evaluation in the following categories of precedence: (Included by Law No. 13,411, of 2017) (Term)
p.(None): I - priority; (Included by Law No. 13,411, of 2017) (Effective)
p.(None): II - ordinary. (Included by Law No. 13,411, of 2017) (Effective)
...

p.(None): Art. 18 - The registration of drugs, medications and pharmaceutical inputs of foreign origin will depend, in addition to the conditions, requirements and
p.(None): procedures provided for in this Law and its regulations, proof that it is already registered in the country of origin.
p.(None): § 1 If it is impossible to comply with the provisions of the caput of this article, proof of registration in force, issued by the
p.(None): of the country in which it is marketed or an international health authority and approved in a specific act of the Ministry of Health's National Health Surveillance Agency
p.(None): of Health. (Included by Provisional Measure No. 2,190-34, 2001)
p.(None): § 2 When registering a medication of foreign origin, the manufacturing company must present proof of compliance with the Good
p.(None): Manufacturing, recognized nationwide. (Included by Provisional Measure No. 2,190-34, of 2001)
p.(None): Art. 19 - The registration of drugs, medications and pharmaceutical supplies will be canceled, whenever any unauthorized modification of its formula is made,
p.(None): dosage, manufacturing conditions, indication of applications and specifications announced in package inserts, labels or advertising.
p.(None): Single paragraph. If there is a need to modify the composition, dosage or therapeutic indications of a pharmaceutical product technically
p.(None): prepared, the company will request the competent permission from the Ministry of Health, instructing the request as provided in the regulation of this Law.
p.(None): Art. 20 - Only the medicine whose preparation requires special care for purification, dosage, sterilization or conservation will be registered when:
p.(None): I - has a new substance in its composition;
p.(None): II - it has a known substance in its composition, which is given a new or advantageous application in therapy;
p.(None): III - present improvement of formula or form, from a pharmaceutical and / or therapeutic point of view.
p.(None): Single paragraph. The right to register medicines similar to those already registered is guaranteed, provided that they satisfy the requirements established in this
p.(None): Law.
p.(None): Single paragraph. The medication that does not have a clinically beneficial substance in its composition cannot be registered
p.(None): or therapeutic. (Wording given by Law No. 9,782, dated 1.26.1999)
p.(None): Art. 21 - A medication that does not have a substance that is known to be beneficial from a clinical or clinical point of view cannot be registered.
p.(None): therapeutic.
p.(None): Art. 21. The right to register medications similar to others already registered is guaranteed, as long as they satisfy the requirements established in this
p.(None): Law. (Wording given by Law No. 9,782, dated 1.26.1999)
p.(None): § 1 Similar medicines to be manufactured in the country, are considered registered after the end of one hundred and twenty days, counted from the presentation
p.(None): of the respective application, if it has not been rejected by then. (Paragraph included by Law No. 9,782, dated 1.26.1999)
p.(None): § 1 The similar medicine to be manufactured in the Country will be considered registered after the end of one hundred and twenty days after the presentation of the respective
p.(None): registration request, if the application has not been rejected by then and provided that the provisions of § 6 of this article are met. (Wording given by Law No. 13,235, of
p.(None): 2015) (Effective)
p.(None): Paragraph 2. The counting of the registration deadline will be interrupted until the satisfaction, by the interested company, of the requirement of the sanitary authority, and this cannot be
p.(None): exceed one hundred and eighty days. (Paragraph included by Law No. 9,782, dated 1.26.1999)
p.(None): § 3 The registration, granted under the conditions of the previous paragraphs, will lose its validity, regardless of notification or interpellation, if the product does not
p.(None): is marketed within one year after the date of its concession, extendable for another six months, at the discretion of the health authority, upon written justification
p.(None): initiative of the interested company. (Paragraph included by Law No. 9,782, dated 1.26.1999)
...

p.(None): dispensation and administration, unwanted exchanges or misuse. (Included by Law No. 13,236, 2015) (Effective)
p.(None): Art. 58. Advertising, in any form of dissemination and means of communication, of products under the regime of this Law can only be promoted after
p.(None): authorization from the Ministry of Health, as provided by regulation.
p.(None): § 1 - When dealing with a drug, medication or any other product with the requirement to sell subject to medical or dental prescription, the advertisement
p.(None): will be restricted to publications that are intended exclusively for distribution to doctors, dentists and pharmacists.
p.(None): § 2 - The advertisement of over-the-counter medications, dietary products, household cleaners, cosmetics and hygiene products, will be
p.(None): subject to specific rules to be laid down in regulations.
p.(None): Art. 59. The designations, geographical names, symbols, figures, drawings or
p.(None): any indications that allow for false interpretation, error or confusion as to the origin, origin, nature, composition or quality, which they attribute to the product
p.(None): purposes or characteristics different from those it actually has.
p.(None): TITLE XI
p.(None): Packaging
p.(None): Art. 60. The approval, by the Ministry of Health, as required by regulation, of packaging, equipment and utensils prepared is mandatory
p.(None): or coated internally with substances that, in contact with the product, may alter its effects or produce damage to health.
p.(None): § 1 - The packaging destined for the packaging of drugs, medications, pharmaceutical supplies, hygiene products,
p.(None): cosmetics, perfumes and the like that do not contain a substance internally capable of altering the purity and effectiveness of the product.
p.(None): Paragraph 2 - The use of packaging designed to contain or pack drugs, medications or pharmaceutical inputs will not be authorized, as long as it is capable of
p.(None): directly or indirectly cause harmful health effects.
p.(None): § 3 - The approval of the type of packaging will be subject to prior analysis, when applicable.
p.(None): Art. 60-A. In order to contain or pack drugs, medication or related products, the use of packaging that may induce exchanges will not be authorized
p.(None): unwanted errors or errors in dispensing, using or administering these products. (Included by Law No. 13,236, 2015) (Effective)
p.(None): TITLE XII
p.(None): Means of Transport
p.(None): Art. 61. In the case of products that require special conditions of storage and storage, the vehicles used in their transportation must be equipped with
p.(None): of equipment that enables packaging and conservation capable of ensuring the conditions of purity, safety and efficacy of the product.
p.(None): Single paragraph. Vehicles used to transport drugs, medicines, pharmaceutical and related supplies, dietary and hygiene products, perfumes and
p.(None): similar activities must have the disinfection and hygiene conditions necessary to preserve human health ensured.
p.(None): TITLE XIII - Infractions and Penalties
p.(None): Art. 62. The medication, drug and pharmaceutical input are considered altered, adulterated or inappropriate for use:
p.(None): I - that has been mixed or conditioned with a substance that changes its therapeutic value or the purpose for which it is intended;
p.(None): II - when it has been removed or falsified, in whole or in part, an integral element of its normal composition, or replaced by another of inferior quality,
p.(None): or the dosage has been modified, or a foreign substance has been added to its composition, so that it becomes different from the formula in the record;
p.(None): III - whose volume does not correspond to the approved quantity;
p.(None): IV - when its conditions of purity, quality and authenticity do not satisfy the requirements of the Brazilian Pharmacopoeia or another Code adopted by
p.(None): Ministry of Health.
p.(None): Single paragraph. In the event of a change due to time, or a cause outside the responsibility of the technician or the company, the latter is obliged to withdraw
p.(None): immediately the product of the trade, for correction or replacement, under penalty of incurring a sanitary infraction.
p.(None): Art. 63. Hygiene, cosmetic, perfume or similar products are considered fraudulent, falsified or adulterated when:
p.(None): I - it is presented with indications that induce error, mistake or confusion as to its origin, origin, composition or purpose;
p.(None): II - not observing the standards and paradigms established in this Law and regulation, or the specifications contained in the registration;
p.(None): III - the nature, composition, properties or characteristics that constitute the conditions of its registration have been modified, due to the effect of addition, reduction or
p.(None): withdrawal of raw materials or components.
p.(None): Single paragraph. This article includes inputs consisting of active, additive or complementary raw material, of a chemical nature,
p.(None): biochemical or biological, of natural or synthetic origin, or any other material intended for the manufacture, manipulation and improvement of hygiene products,
p.(None): cosmetics, perfumes and the like.
p.(None): Article 64. The reuse and use of containers traditionally used for food, drinks, soft drinks, diet products,
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Health / Physically Ill

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p.(None): to the process and penalties provided for in Decree-Law No. 785, of August 25, 1969, without prejudice to other applicable civil and criminal commissions.
p.(None): Single paragraph. The process referred to in this article may be initiated and judged by the Ministry of Health or by the health authorities of the States,
p.(None): Federal District and Territories, as appropriate.
p.(None): Art. 67. Regardless of those provided for in Decree-Law No. 785, of August 25, 1969, serious or very serious infractions are set up, under the terms of this Law, the
p.(None): following practices punishable by the sanctions indicated in that legal diploma:
p.(None): I - to label products under the regime of this Law or to advertise them without complying with the provisions of this Law and its regulations or contrary to
p.(None): respective registration and authorization terms and conditions;
p.(None): II - change the product manufacturing process, without the prior consent of the Ministry of Health;
p.(None): III - sell or display for sale a product whose expiration date has expired;
p.(None): IV - affixing new dates on products whose expiration date has expired or repackaging them in new packaging, except for therapeutic serums that
p.(None): they can be refilled and refiltered;
p.(None): V - industrialize products without the assistance of a legally qualified technician;
p.(None): VI - use, in the preparation of hormones, organs of animals that are not healthy, or that show signs of decomposition at the time of being
p.(None): handled, or from sick, fatigued or emaciated animals;
p.(None): VII - resell biological product not kept in a refrigerator, according to the indications determined by the manufacturer and approved by the Ministry of Health;
p.(None): VIII - apply rodenticides whose action is produced by gas or steam, in galleries, culverts, basements, attics or places of possible communication with homes or places
p.(None): frequented by humans or useful animals.
p.(None): TITLE XIV
p.(None): Inspection
p.(None): Art. 68. The health surveillance action will cover any and all products covered by this Law, including those exempt from registration, correlates,
p.(None): manufacturing, distribution, storage and sale establishments, and vehicles for the transportation of products.
p.(None): Single paragraph. The advertisement of products and brands, by any means of communication, advertising,
p.(None): labeling and labeling.
p.(None): Article 69. The inspection action is the responsibility of:
p.(None): I - the federal health agency:
p.(None): when the product is in transit from one to another federative unit, on a road by river, lake, sea or air, under the control of federal agencies;
p.(None): when it comes to imported or exported product;
p.(None): when it comes to taking samples for prior control and fiscal analysis;
p.(None): II - the state health agency, the Territories or the Federal District:
p.(None): when it is an industrialized product or delivered for consumption in the respective jurisdiction area;
p.(None): as for industrial or commercial establishments, installations and equipment;
p.(None): as for transport on roads and waterways or lakes, within their jurisdictional area;
p.(None): when it comes to taking samples for tax analysis.
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p.(None): allowed in its manufacture;
p.(None): II - not falling within the list referred to in the previous item, having recognized the innocuousness of the respective formulas, in conclusive opinions, issued by the
p.(None): competent, analysis and technical bodies of the Ministry of Health.
p.(None): Single paragraph. The list of substances referred to in item I of this article may be changed to exclude substances that may be judged
p.(None): harmful to health, or for the inclusion of others, which may be approved.
p.(None): Art. 28 - The registration of cosmetics, products for personal hygiene, and other similar purposes, containing medicinal substances,
p.(None): although in an infra-therapeutic dose, it will obey the norms contained in articles 16 and its subparagraphs, 17, 18 and 19 and its sole paragraph, 20 and 21 and its Regulation
p.(None): Law.
p.(None): Art. 29 - Only the product referred to in Art. 26 that contains in its composition raw material, solvent, dye or pharmaceutical inputs,
p.(None): contained in the list prepared by the competent body of the Ministry of Health, published in the "Official Gazette" of the Union, provided that they are expressly
p.(None): labels and packaging use restrictions, when applicable, in accordance with the area of the body where it should be applied.
p.(None): Single paragraph. When presented in aerosol form, the products referred to in Art. 26 will only be registered if they comply with technical standards
p.(None): approved by the Ministry of Health and other specific requirements and standards.
p.(None): Art. 30 - Cosmetics, personal hygiene products for adults and children, perfumes and the like may have altered their composition formulas provided that
p.(None): the changes are approved by the Ministry of Health, based on the relevant technical reports.
p.(None): Art. 31 - The formula changes will be registered in the product registration, as provided in the regulation.
p.(None): Art. 32 - The Ministry of Health will publish in the Union's "Official Gazette" the list of natural organic, artificial and synthetic dyes, including their salts and
p.(None): their lacquers, permitted in the manufacture of the products referred to in articles 29, sole paragraph, and 30.
p.(None): § 1 - Any and all dyes that present active or potential toxicity will be excluded from the list referred to in this article.
p.(None): § 2 - The inclusion and exclusion of dyes and their consequences will obey the provisions contained in regulations.
p.(None): TITLE VI
p.(None): From the Registry of Household Cleaners
p.(None): Art. 33 - The registration of sanitizing products, disinfectants and detergents will obey the provisions of regulation and complementary norms
p.(None): specific.
p.(None): Article 34 - Only insecticides that:
p.(None): I - can be applied correctly, in strict compliance with the instructions on the labels and other explanatory elements;
p.(None): II - do not offer any possibility of risk to human health and that of warm-blooded domestic animals, under the conditions foreseen for use;
p.(None): III - are not corrosive or harmful to the treated surfaces.
p.(None): Art. 35 - Only insecticides will be registered:
p.(None): I - presented according to the forms provided for in the Regulation of this Law;
p.(None): II - in whose composition the insecticidal and synergistic substances, natural or synthetic, observe the appropriate concentration indices established by the
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p.(None): proportionally.
p.(None): Art. 39 - Insecticide associations must satisfy the requirements set out in Art. 35 and its sole paragraph, regarding toxicity for animals submitted
p.(None): efficiency proof.
p.(None): Art. 40 - The registration of insecticides will only be allowed when it is intended:
p.(None): I - the prompt application by any person, for domestic purposes;
p.(None): II - the application and manipulation by a specialized person or organization for professional purposes.
p.(None): Art. 41 - Preparations whose composition formulas include active substances, isolated or in combination, in concentrations
p.(None): diverse and in certain forms and types of presentation.
p.(None): Single paragraph. Associations of rodenticides of the same class should be reduced in proportion to the concentrations of their active ingredients.
p.(None): Art. 42 - The provisions of this Law apply to the registration of preparations and rodenticide substances, fixing the regulations and instructions of the Ministry of Health
p.(None): other specific requirements related to this class of products.
p.(None): Art. 43 - The disinfectants will be registered according to the provisions of the Regulation of this Law and in instructions issued by the Ministry of Health.
p.(None): Art. 44 - For the purposes of this Law, detergents and disinfectants and their counterparts, intended for application, are equivalent to household products.
p.(None): in inanimate objects and environments, being subject to the same requirements and conditions regarding registration, industrialization, delivery to consumption and
p.(None): inspection.
p.(None): Art. 45 - The sale of rodenticides and their delivery for consumption will be restricted, exclusively, to products classified as low and medium toxicity, being
p.(None): private companies or bodies and entities of the Direct and Indirect Public Administration supply and control of the application of the
p.(None): high toxicity.
p.(None): TITLE VII
p.(None): Registration of Dietary Products
p.(None): Art. 46 - Those intended for oral intake will be registered as dietary products, which, not covered by the provisions of Decree-Law No. 986, of 21
p.(None): October 1969, and the respective regulations, have their use or sale subject to medical prescription and are intended:
p.(None): I - to meet special dietary needs;
p.(None): II - to supplement and enrich the usual diet with vitamins, amino acids, minerals and other elements;
p.(None): III - to avoid feelings of hunger, appetite and taste, replacing the usual foods in restricted diets.
p.(None): Art. 47 - Only products consisting of:
p.(None): I - natural foods modified in their composition or characteristics;
p.(None): II - natural products, although not considered to be usual foods, containing nutrients or added to them;
p.(None): III - mineral or organic products, pure or associated, able to contribute to the elaboration of special regimes;
p.(None): IV - isolated or associated substances, without nutritional value, intended for restricted diets;
p.(None): V - food supplements containing vitamins, minerals or other nutrients;
p.(None): VI - other products that, individually or in association, can be characterized as dietary by the Ministry of Health.
p.(None): Art. 48 - The dietary products referred to in this Law may be presented in the usual forms of pharmaceutical products, subject to nomenclature and
p.(None): their own characteristics.
p.(None): Art. 49 - To ensure the minimum necessary dietary efficiency and avoid being confused with therapeutic products, the content of the components of the
p.(None): dietary products, which justify their indication in special diets, must obey the internationally accepted standards, according to the relations elaborated by the
p.(None): Ministry of Health.
p.(None): § 1 - In the absence of a standard established for the purposes of this article, the nutrient rate of dietary products will depend on a pronouncement by the Ministry of Health.
p.(None): Cheers.
p.(None): § 2 - The proportion of vitamins to be added to the products will correspond to the standards established by the Ministry of Health.
p.(None): TITLE VIII
p.(None): Authorization of Companies and Licensing of Establishments
p.(None): Art. 50 - The operation of the companies covered by this Law will depend on authorization from the Ministry of Health, in view of the indication of industrial activity
p.(None): the nature and type of products and proof of technical, scientific and operational capacity, and other requirements set out in regulations and
p.(None): administrative acts by the same Ministry.
p.(None): Art. 50. The operation of the companies referred to in this Law will depend on authorization by Anvisa, granted upon request to register their
p.(None): activities, the payment of the respective Sanitary Surveillance Inspection Fee and other requirements defined in specific
...

p.(None): this Law.
p.(None): Single paragraph. Medicines bearing a trade name or brand will also be obligatorily with the same prominence and legibly in the
p.(None): parts referred to in the caput of this article, on packaging and promotional materials, the Brazilian Common Denomination or, failing that, the Common Denomination
p.(None): International in letters and characters whose size will not be less than one half the size of the letters and characters of the trade name or brand.
p.(None): (Paragraph included by Law No. 9,787, dated 2.10.1999)
p.(None): § 1 In addition to the trade name or brand, the medications must display, on the parts referred to in the caput of this article, on the packaging and
p.(None): promotional materials to the Brazilian Common Denomination or, when applicable, the International Common Denomination, in letters and characters with size never
p.(None): less than half the size of the letters and characters of the trade name or brand. (Wording given by Law No. 13,236, 2015) (Effective)
p.(None): § 2 The labels of medicines, drugs and related products must have characteristics that clearly differentiate them and that inhibit errors
p.(None): dispensation and administration, unwanted exchanges or misuse. (Included by Law No. 13,236, 2015) (Effective)
p.(None): Art. 58. Advertising, in any form of dissemination and means of communication, of products under the regime of this Law can only be promoted after
p.(None): authorization from the Ministry of Health, as provided by regulation.
p.(None): § 1 - When dealing with a drug, medication or any other product with the requirement to sell subject to medical or dental prescription, the advertisement
p.(None): will be restricted to publications that are intended exclusively for distribution to doctors, dentists and pharmacists.
p.(None): § 2 - The advertisement of over-the-counter medications, dietary products, household cleaners, cosmetics and hygiene products, will be
p.(None): subject to specific rules to be laid down in regulations.
p.(None): Art. 59. The designations, geographical names, symbols, figures, drawings or
p.(None): any indications that allow for false interpretation, error or confusion as to the origin, origin, nature, composition or quality, which they attribute to the product
p.(None): purposes or characteristics different from those it actually has.
p.(None): TITLE XI
p.(None): Packaging
p.(None): Art. 60. The approval, by the Ministry of Health, as required by regulation, of packaging, equipment and utensils prepared is mandatory
p.(None): or coated internally with substances that, in contact with the product, may alter its effects or produce damage to health.
p.(None): § 1 - The packaging destined for the packaging of drugs, medications, pharmaceutical supplies, hygiene products,
p.(None): cosmetics, perfumes and the like that do not contain a substance internally capable of altering the purity and effectiveness of the product.
p.(None): Paragraph 2 - The use of packaging designed to contain or pack drugs, medications or pharmaceutical inputs will not be authorized, as long as it is capable of
p.(None): directly or indirectly cause harmful health effects.
p.(None): § 3 - The approval of the type of packaging will be subject to prior analysis, when applicable.
p.(None): Art. 60-A. In order to contain or pack drugs, medication or related products, the use of packaging that may induce exchanges will not be authorized
p.(None): unwanted errors or errors in dispensing, using or administering these products. (Included by Law No. 13,236, 2015) (Effective)
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Searching for indicator infant:

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p.(None): effectiveness and safety; (Item included by Law No. 9,787, dated 2.10.1999)
p.(None): XXIV - Bioequivalence - consists of demonstrating pharmaceutical equivalence between products presented in the same pharmaceutical form, containing
p.(None): identical qualitative and quantitative composition of active ingredient (s), and which have comparable bioavailability, when studied under the same design
p.(None): experimental; (Item included by Law No. 9,787, dated 2.10.1999)
p.(None): XXV - Bioavailability - indicates the speed and extent of absorption of an active ingredient in a dosage form, from its curve
p.(None): concentration / time in the systemic circulation or its excretion in the urine. (Item included by Law No. 9,787, dated 2.10.1999)
p.(None): Single paragraph. In the case of imported generic drugs, whose bioequivalence tests were carried out outside the country, the
p.(None): comparative dissolution tests between the test drug, the international reference drug used in the bioequivalence study and the
p.(None): national reference. (Wording given by Provisional Measure No. 2,190-34, of 2001)
p.(None): Single paragraph. Until June 30, 2003, in the case of imported generic drugs, whose bioequivalence tests were carried out outside the country,
p.(None): comparative dissolution tests between the test drug, the international reference drug used in the
p.(None): bioequivalence and the national reference medicine. (Wording given by Law nº 10.669, of 14.5.2003)
p.(None): Art. 4º - The products destined for the infant use cannot contain caustic or irritating substances, they will have packages free of blunt parts and not
p.(None): may be presented in aerosol form.
p.(None): Single paragraph. The products referred to in the caput must have labeling and packaging characteristics that enable their immediate and precise distinction
p.(None): those intended for adult use. (Included by Law No. 13,236, 2015) (Effective)
p.(None): Art. 5 - The products referred to in this Law may not have names or designations that are misleading.
p.(None): Art. 5 - The products referred to in this Law may not have names or designations that are misleading. (Wording given by Law No. 6,480, of 1.12.1977)
p.(None): Art. 5 The products covered by this Law may not have names, designations, labels or packaging that are misleading. (Wording given by Law
p.(None): nº 13,236, of 2015) (Effective)
p.(None): § 1 - It is prohibited to adopt the same or similar name for products of different composition, even from the same manufacturer, ensuring the priority of the
p.(None): registration with the chronological order of entry of applications in the competent department of the Ministry of Health, when there is no previous registration.
p.(None): § 2 - The name of a product whose registration is subsequently required may be approved, provided that the previous registration application is denied, for reasons of order
p.(None): technical or scientific.
p.(None): § 3 - Once the brand collidence is confirmed, the name or designation of the product must be modified within 90 (ninety) days from the date of the
p.(None): publication of the order in the "Official Gazette" of the Union, under penalty of refusal of registration.
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Searching for indicator language:

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p.(None): Single paragraph. For the purposes of sanitary control, provided for in the legislation in force, it is mandatory to communicate, by the bodies referred to in this article, to the Ministry of Health.
p.(None): Health, the existence or installation of establishments referred to in this Law.
p.(None): Art. 10 - The importation of medicines, drugs, pharmaceutical supplies and other products referred to in this Law, for industrial and commercial purposes, is prohibited without
p.(None): prior and express favorable statement by the Ministry of Health.
p.(None): Single paragraph. The requirements of this article include acquisitions or donations involving persons under public and private law, the amount and
p.(None): may compromise the implementation of national health programs.
p.(None): Art. 11 - Drugs, medications and any related pharmaceutical inputs, hygiene products, cosmetics and sanitizing products, imported or
p.(None): no, they will only be delivered for consumption in the original packaging or in others previously authorized by the Ministry of Health.
p.(None): § 1 - To assist the development of plans and programs of the Federal Government, of production and distribution of medicines to the population in need of
p.(None): resources, the Ministry of Health may authorize the use of special packaging or repackaging, which, without prejudice to the purity and efficacy of the product, allows the
p.(None): cost reduction.
p.(None): § 2 - Imported products, whose commercialization on the domestic market does not depend on a medical prescription, will have added, on the labeling,
p.(None): clarifying, in the Portuguese language, about its composition, its indications and how to use it.
p.(None): TITLE II
p.(None): From the Registry
p.(None): Art. 12 - None of the products covered by this Law, including imported ones, may be industrialized, exposed for sale or delivered for consumption before
p.(None): registered with the Ministry of Health.
p.(None): Paragraph 1 - The registration referred to in this article will be valid for 5 (five) years and may be revalidated for equal and successive periods, maintaining the number of
p.(None): initial registration.
p.(None): Paragraph 1 - The National Health Surveillance Agency - ANVISA - will define by its own act the deadline for renewing the registration of the products referred to in this Law,
p.(None): more than 10 (ten) years, considering the nature of the product and the health risk involved in its use. (Included by Law No. 13,097, 2015)
p.(None): Paragraph 2 - Except for the provisions of the preceding paragraph, the validity of the registration and the revalidation of the registration of dietary products, whose term is 2 (two) years.
p.(None): Paragraph 3 - Registration will be granted within a maximum period of 90 (ninety) days, counting from the date of submission of the application, except in cases of non-compliance with this Law
p.(None): or its regulations.
p.(None): § 3 - Except as provided in arts. 17-A, 21 and 24-A, registration will be granted within a maximum period of ninety days, counting from the
p.(None): application, except in cases of non-compliance, by the applicant, with this Law or its r e g u l m e n t s. (Wording given by Law No. 13,411, of
p.(None): 2017) (Effective)
p.(None): § 4 - The acts related to the registration and the revalidation of the registration will only take effect from the date of publication in the "Official Gazette" of the Union.
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Searching for indicator single:

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p.(None): safety and quality, and should always be identified by trade name or brand; (Wording given by Law No. 13,235, 2015) (Effective)
p.(None): XXI - Generic Medication - medication similar to a reference or innovative product, which is intended to be with this interchangeable one, generally produced
p.(None): after expiration or waiver of patent protection or other exclusive rights, its effectiveness, safety and quality proven, and designated by DCB
p.(None): or, in its absence, by DCI; (Item included by Law No. 9,787, dated 2.10.1999)
p.(None): XXII - Reference Medication - an innovative product registered with the federal agency responsible for sanitary surveillance and marketed in the Country, whose efficacy,
p.(None): safety and quality were scientifically proven by the competent federal agency, at the time of registration; (Item included by Law No. 9,787, of
p.(None): 10.2.1999)
p.(None): XXIII - Interchangeable Pharmaceutical Product - therapeutic equivalent of a reference medicine, substantially proven to have the same effects as
p.(None): effectiveness and safety; (Item included by Law No. 9,787, dated 2.10.1999)
p.(None): XXIV - Bioequivalence - consists of demonstrating pharmaceutical equivalence between products presented in the same pharmaceutical form, containing
p.(None): identical qualitative and quantitative composition of active ingredient (s), and which have comparable bioavailability, when studied under the same design
p.(None): experimental; (Item included by Law No. 9,787, dated 2.10.1999)
p.(None): XXV - Bioavailability - indicates the speed and extent of absorption of an active ingredient in a dosage form, from its curve
p.(None): concentration / time in the systemic circulation or its excretion in the urine. (Item included by Law No. 9,787, dated 2.10.1999)
p.(None): Single paragraph. In the case of imported generic drugs, whose bioequivalence tests were carried out outside the country, the
p.(None): comparative dissolution tests between the test drug, the international reference drug used in the bioequivalence study and the
p.(None): national reference. (Wording given by Provisional Measure No. 2,190-34, of 2001)
p.(None): Single paragraph. Until June 30, 2003, in the case of imported generic drugs, whose bioequivalence tests were carried out outside the country,
p.(None): comparative dissolution tests between the test drug, the international reference drug used in the
p.(None): bioequivalence and the national reference medicine. (Wording given by Law nº 10.669, of 14.5.2003)
p.(None): Art. 4º - The products destined for the infant use cannot contain caustic or irritating substances, they will have packages free of blunt parts and not
p.(None): may be presented in aerosol form.
p.(None): Single paragraph. The products referred to in the caput must have labeling and packaging characteristics that enable their immediate and precise distinction
p.(None): those intended for adult use. (Included by Law No. 13,236, 2015) (Effective)
p.(None): Art. 5 - The products referred to in this Law may not have names or designations that are misleading.
p.(None): Art. 5 - The products referred to in this Law may not have names or designations that are misleading. (Wording given by Law No. 6,480, of 1.12.1977)
p.(None): Art. 5 The products covered by this Law may not have names, designations, labels or packaging that are misleading. (Wording given by Law
p.(None): nº 13,236, of 2015) (Effective)
p.(None): § 1 - It is prohibited to adopt the same or similar name for products of different composition, even from the same manufacturer, ensuring the priority of the
p.(None): registration with the chronological order of entry of applications in the competent department of the Ministry of Health, when there is no previous registration.
p.(None): § 2 - The name of a product whose registration is subsequently required may be approved, provided that the previous registration application is denied, for reasons of order
p.(None): technical or scientific.
p.(None): § 3 - Once the brand collidence is confirmed, the name or designation of the product must be modified within 90 (ninety) days from the date of the
p.(None): publication of the order in the "Official Gazette" of the Union, under penalty of refusal of registration.
p.(None): § 4 - Without prejudice to the provisions of this article, drugs containing a single active substance well known, at the discretion of the Ministry of Health, and
p.(None): immunotherapeutics, drugs and pharmaceutical inputs must be identified by the name used in the Brazilian Pharmacopoeia, and under no circumstances
p.(None): have any fancy names or designations. (Included by Law No. 6,480, of 1.12.1977)
p.(None): § 5 The errors mentioned in the caput include dispensing and administering medications, drugs and related products.
p.(None): (Included by Law No. 13,236, 2015)
p.(None): § 5 The errors mentioned in the caput include dispensing and administering medications, drugs and related products.
p.(None): (Wording given by Law No. 13,236, 2015) (Effective)
p.(None): Art. 6 - The proof that a product, previously considered useful, is harmful to health or does not fulfill the requirements established by law, implies its
p.(None): immediate withdrawal from the trade and the requirement to change the formula of its composition and in the words of labels, package inserts and packages, under penalty of
p.(None): cancellation of the registration and seizure of the product, throughout the national territory.
p.(None): Single paragraph. It is the exclusive responsibility of the Ministry of Health to register and allow the use of medications, as well as the approval or requirement of
p.(None): modification of its components.
p.(None): Art. 7 - As a health security measure and in view of reasoned reasons from the competent body, the Ministry of Health may, at any time,
p.(None): suspend the manufacture and sale of any of the products covered by this Law, which, although registered, become suspected of having harmful effects on human health.
p.(None): Art. 8 - No establishment that manufactures or industrializes a product covered by this Law may operate without the effective assistance and responsibility of
p.(None): legally qualified technician.
p.(None): Article 9 - Establishments covered by this Law that are members of the Public Administration or instituted by it, regardless of the operating license,
p.(None): however, they are subject to the requirements of the appropriate facilities, equipment and equipment and to technical assistance and responsibility.
p.(None): Single paragraph. For the purposes of sanitary control, provided for in the legislation in force, it is mandatory to communicate, by the bodies referred to in this article, to the Ministry of Health.
p.(None): Health, the existence or installation of establishments referred to in this Law.
p.(None): Art. 10 - The importation of medicines, drugs, pharmaceutical supplies and other products referred to in this Law, for industrial and commercial purposes, is prohibited without
p.(None): prior and express favorable statement by the Ministry of Health.
p.(None): Single paragraph. The requirements of this article include acquisitions or donations involving persons under public and private law, the amount and
p.(None): may compromise the implementation of national health programs.
p.(None): Art. 11 - Drugs, medications and any related pharmaceutical inputs, hygiene products, cosmetics and sanitizing products, imported or
p.(None): no, they will only be delivered for consumption in the original packaging or in others previously authorized by the Ministry of Health.
p.(None): § 1 - To assist the development of plans and programs of the Federal Government, of production and distribution of medicines to the population in need of
p.(None): resources, the Ministry of Health may authorize the use of special packaging or repackaging, which, without prejudice to the purity and efficacy of the product, allows the
p.(None): cost reduction.
p.(None): § 2 - Imported products, whose commercialization on the domestic market does not depend on a medical prescription, will have added, on the labeling,
p.(None): clarifying, in the Portuguese language, about its composition, its indications and how to use it.
p.(None): TITLE II
p.(None): From the Registry
p.(None): Art. 12 - None of the products covered by this Law, including imported ones, may be industrialized, exposed for sale or delivered for consumption before
p.(None): registered with the Ministry of Health.
p.(None): Paragraph 1 - The registration referred to in this article will be valid for 5 (five) years and may be revalidated for equal and successive periods, maintaining the number of
p.(None): initial registration.
p.(None): Paragraph 1 - The National Health Surveillance Agency - ANVISA - will define by its own act the deadline for renewing the registration of the products referred to in this Law,
...

p.(None): VI - when dealing with a drug or medication whose preparation requires technical and specific equipment, proof that the establishment is located
p.(None): properly equipped and maintains personnel qualified to handle or contract with third parties for this purpose.
p.(None): VII - presentation of the following economic information: (Included by Law No. 10,742, dated 10.6.2003)
p.(None): a) the price of the product practiced by the company in other countries; (Included by Law No. 10,742, dated 6.10.2003)
p.(None): b) the purchase price of the product's active substance; (Included by Law No. 10,742, dated 6.10.2003)
p.(None): c) the cost of treatment per patient using the product; (Included by Law No. 10,742, dated 6.10.2003)
p.(None): d) the potential number of patients to be treated; (Included by Law No. 10,742, dated 6.10.2003)
p.(None): e) the price list it intends to practice in the domestic market, with a breakdown of its tax burden; (Included by Law No. 10,742, dated 6.10.2003)
p.(None): f) the breakdown of the product's marketing proposal, including the expenses foreseen with the sales effort and with advertising and advertising;
p.(None): (Included by Law No. 10,742, dated 6.10.2003)
p.(None): g) the price of the product that has been modified, in the case of a change in formula or shape; and (Included by Law No. 10,742, dated 6.10.2003)
p.(None): h) the list of all substitute products on the market, accompanied by their respective prices. (Included by Law No. 10,742, of
p.(None): 6.10.2003)
p.(None): Single paragraph. The provisions of item I, do not apply to serums and vaccines or pharmaceutical products containing a single active substance
p.(None): known, at the discretion of the Ministry of Health. (Repealed by Law No. 6,480 of December 1, 1977)
p.(None): § 1 (Repealed as a single paragraph by Law No. 6,480, of December 1, 1977). (Included by Law No. 10,742, dated 6.10.2003)
p.(None): § 2 The presentation of the information contained in item VII may be waived, in part or in whole, in accordance with regulations
p.(None): specific. (Included by Law No. 10,742, dated 6.10.2003)
p.(None): Art. 17 - The registration of the products referred to in this Title will be denied whenever the conditions, requirements and procedures for that purpose are not met
p.(None): provided for by law, regulation or instruction of the competent body.
p.(None): Art. 17-A - The deadlines established for the final decision in the drug registration and post-registration alteration processes will take into account the following
p.(None): criteria: (Included by Law No. 13,411, of 2017) (Effective)
p.(None): I - technical complexity; (Included by Law No. 13,411, of 2017) (Effective)
p.(None): I - clinical, economic and social benefits of using the drug object of the application. (Included by Law No. 13,411, of 2017)
p.(None): (Validity)
p.(None): Paragraph 1 - The application of the criteria provided for in the caput, according to the methodology provided for in Anvisa's act, will determine the classification of the medication under
p.(None): evaluation in the following categories of precedence: (Included by Law No. 13,411, of 2017) (Term)
p.(None): I - priority; (Included by Law No. 13,411, of 2017) (Effective)
p.(None): II - ordinary. (Included by Law No. 13,411, of 2017) (Effective)
p.(None): Paragraph 2 - The maximum deadlines for the final decision in the registration and post-registration alteration processes for medication will be, respectively:
p.(None): (Included by Law No. 13,411, of 2017) (Effective)
p.(None): I - for the priority category, one hundred and twenty days and sixty days, counted from the date of the respective prioritization protocol; (Included
p.(None): by Law No. 13,411, of 2017) (Effective)
p.(None): II - for the ordinary category, three hundred and sixty-five days and one hundred and eighty days, counted from the date of the respective registration or registration protocol
p.(None): post-registration change. (Included by Law No. 13,411, of 2017) (Effective)
p.(None): § 3 - Except in cases where there is an appeal against a previous decision, the final decision in the post-registration alteration processes may be taken by approval
p.(None): conditional, presumed by Anvisa's contrary manifestation within the deadlines defined in § 2. (Included by Law No. 13,411, of 2017) (Effective)
p.(None): § 4 - The conditional approval referred to in § 3 may only occur in the event of post-registration alterations defined in the regulation and will be automatically
p.(None): reversed, at any time, in case the post-registration alteration is rejected by Anvisa. (Included by Law No. 13,411, of 2017) (Effective)
p.(None): Paragraph 5 - The terms mentioned in Paragraph 2 may be extended by up to one third of the original term, only once, upon a reasoned decision by Anvisa
p.(None): issued at least fifteen business days before the original term expires. (Included by Law No. 13,411, of 2017) (Effective)
p.(None): Paragraph 6 - Anvisa's requests for clarification or rectification must be consolidated into a single order, except if they are necessary to
p.(None): clarify or rectify information related to the request previously answered by the requesting company, and will suspend the counting of the deadlines determined in this
p.(None): until they are met. (Included by Law No. 13,411, of 2017) (Effective)
p.(None): § 7 - Unjustified non-compliance with the deadlines provided for in this article implies an assessment of the functional responsibility of the server or servers
p.(None): cause, under the terms of Law No. 8,112, of December 11, 1990. (Included by Law No. 13,411, of 2017) (Effective)
p.(None): § 8 - Anvisa will regulate the provisions of this article, in particular the specification of the criteria referred to in the caput, with a view to
p.(None): priority categories. (Included by Law No. 13,411, of 2017) (Effective)
p.(None): Paragraph 9 - The period of one hundred and eighty days after the beginning of the effectiveness of this article has expired without the regulation provided for in Paragraph 8 having been published, and
p.(None): as long as the matter remains unregulated, the maximum term for the final decision will be three hundred and sixty-five days in the registration and
p.(None): one hundred and eighty days in post-registration alterations. (Included by Law No. 13,411, of 2017) (Effective)
p.(None): Art. 18 - The registration of drugs, medications and pharmaceutical inputs of foreign origin will depend, in addition to the conditions, requirements and
p.(None): procedures provided for in this Law and its regulations, proof that it is already registered in the country of origin.
p.(None): § 1 If it is impossible to comply with the provisions of the caput of this article, proof of registration in force, issued by the
p.(None): of the country in which it is marketed or an international health authority and approved in a specific act of the Ministry of Health's National Health Surveillance Agency
p.(None): of Health. (Included by Provisional Measure No. 2,190-34, 2001)
p.(None): § 2 When registering a medication of foreign origin, the manufacturing company must present proof of compliance with the Good
p.(None): Manufacturing, recognized nationwide. (Included by Provisional Measure No. 2,190-34, of 2001)
p.(None): Art. 19 - The registration of drugs, medications and pharmaceutical supplies will be canceled, whenever any unauthorized modification of its formula is made,
p.(None): dosage, manufacturing conditions, indication of applications and specifications announced in package inserts, labels or advertising.
p.(None): Single paragraph. If there is a need to modify the composition, dosage or therapeutic indications of a pharmaceutical product technically
p.(None): prepared, the company will request the competent permission from the Ministry of Health, instructing the request as provided in the regulation of this Law.
p.(None): Art. 20 - Only the medicine whose preparation requires special care for purification, dosage, sterilization or conservation will be registered when:
p.(None): I - has a new substance in its composition;
p.(None): II - it has a known substance in its composition, which is given a new or advantageous application in therapy;
p.(None): III - present improvement of formula or form, from a pharmaceutical and / or therapeutic point of view.
p.(None): Single paragraph. The right to register medicines similar to those already registered is guaranteed, provided that they satisfy the requirements established in this
p.(None): Law.
p.(None): Single paragraph. The medication that does not have a clinically beneficial substance in its composition cannot be registered
p.(None): or therapeutic. (Wording given by Law No. 9,782, dated 1.26.1999)
p.(None): Art. 21 - A medication that does not have a substance that is known to be beneficial from a clinical or clinical point of view cannot be registered.
p.(None): therapeutic.
p.(None): Art. 21. The right to register medications similar to others already registered is guaranteed, as long as they satisfy the requirements established in this
p.(None): Law. (Wording given by Law No. 9,782, dated 1.26.1999)
p.(None): § 1 Similar medicines to be manufactured in the country, are considered registered after the end of one hundred and twenty days, counted from the presentation
p.(None): of the respective application, if it has not been rejected by then. (Paragraph included by Law No. 9,782, dated 1.26.1999)
p.(None): § 1 The similar medicine to be manufactured in the Country will be considered registered after the end of one hundred and twenty days after the presentation of the respective
p.(None): registration request, if the application has not been rejected by then and provided that the provisions of § 6 of this article are met. (Wording given by Law No. 13,235, of
p.(None): 2015) (Effective)
p.(None): Paragraph 2. The counting of the registration deadline will be interrupted until the satisfaction, by the interested company, of the requirement of the sanitary authority, and this cannot be
p.(None): exceed one hundred and eighty days. (Paragraph included by Law No. 9,782, dated 1.26.1999)
...

p.(None): being subject to the special control provided for in Decree-Law No. 753, of August 11, 1969, as well as in other legal diplomas, regulations and other rules
p.(None): pertinent, and medicines in general, will only be registered if, in addition to meeting the conditions, requirements and procedure established in this Law and
p.(None): regulations, packaging and labeling meet the standards approved by the Ministry of Health.
p.(None): Art. 22. Drugs, medications and pharmaceutical inputs that contain narcotic substances or determine physical or psychological dependence, Art.
p.(None): subject to the special control provided for in Decree-Law no. 753, of August 11, 1969, as well as in other legal diplomas, regulations and other rules
p.(None): pertinent, and medicines in general, will only be registered or will have their registrations renewed, if, in addition to meeting the conditions, requirements and
p.(None): procedure established in this Law and its regulation, packaging and labeling meet the standards approved by the Ministry of
p.(None): Health. (Wording given by Law nº 10.742, of 6.10.2003)
p.(None): Art. 23 - The following are exempt from registration:
p.(None): I - products whose formulas are registered in the Brazilian Pharmacopoeia, in the codex or in the forms accepted by the Ministry of Health;
p.(None): II - homeopathic preparations consisting of simple associations of tinctures or incorporation into solid substances;
p.(None): III - the concentrated solutes that serve for the extemporaneous obtaining of pharmaceutical and industrial preparations, considered as officinal products;
p.(None): IV - products equivalent to the official ones, whose formulas are not registered in the Pharmacopoeia or in the forms, but are approved and authorized by the
p.(None): Ministry of Health.
p.(None): Single paragraph. The provisions of this article do not exclude the obligation, for the marketing of the products referred to therein, for the company to
p.(None): Ministry of Health, information and explanatory data on injectable solutes. (Repealed by Law No. 10,742, dated 6.10.2003)
p.(None): Art. 24 - New medicines, exclusively for experimental use, under medical control, are also exempt from registration.
p.(None): imported with the express authorization of the Ministry of Health.
p.(None): Art. 24. New drugs, exclusively for experimental use, under medical control, are exempt from registration, and may even be
p.(None): imported with the express authorization of the Ministry of Health. (Wording given by Law nº 10.742, of 6.10.2003)
p.(None): Single paragraph. The exemption provided for in this article will only be valid for a period of up to 3 (three) years, at the end of which the product will be required to register, under penalty of
p.(None): apprehension determined by the Ministry of Health.
p.(None): Art. 24-A. Simplified Renewal of the Registration of Medicines is established for medicines that are registered with the Brazilian health agency
p.(None): for a period equal to or greater than 10 (ten), who have not had reports of ineffectiveness and / or significant adverse events and which are adequate to the requirements
p.(None): current sanitary conditions, regardless of their sales classification. (Included by Law No. 13,097, 2015)
p.(None): Single paragraph. The definition of the period referred to in the caput will be made by Anvisa based on criteria that involve the therapeutic class of the product,
p.(None): changes made in its formulation, indications and dosage and in the production process, as well as the route of administration, the pharmaceutical form and the effective
p.(None): product exposure to use. (Included by Law No. 13,097, 2015)
p.(None): Art. 24-B. For the purposes of renewing the registration of medications referred to in art. 24-A, the requirements to be observed by those interested in the act will be
p.(None): defined by Anvisa in regulation. (Included by Law No. 13,097, 2015)
p.(None): TITLE IV
p.(None): From the Registry of Correlates
p.(None): Art. 25 - The devices, instruments and accessories used in medicine, dentistry and related activities, as well as those of physical education, beautification or
p.(None): aesthetic correction, can only be manufactured, or imported, for delivery to consumption and exposure to sale, after the Ministry of Health
p.(None): on whether registration is mandatory or not.
p.(None): § 1 - The devices, instruments or accessories referred to in this article, which are in relationships for this purpose, prepared by the
p.(None): Ministry of Health, being, however, subject, for the other purposes of this Law and its Regulations, to the health surveillance regime.
p.(None): § 2 - The regulation of this Law will prescribe the conditions, requirements and procedures related to the registration of devices, instruments or accessories
p.(None): of this article.
p.(None): TITLE V
p.(None): Registration of Cosmetics, Hygiene Products, Perfumes and others
p.(None): Art. 26 - Only personal hygiene products, perfumes and other products of similar nature and purpose will be registered as cosmetics, the products that are
p.(None): intended for external use or in the environment, depending on their aesthetic, protective, hygienic or odorous purposes, without causing skin irritation or damage to health.
p.(None): Art. 27 - In addition to being subject to specific regulatory requirements, the registration of cosmetics, products for personal hygiene, perfumes and others,
p.(None): of similar purpose, will depend on the satisfaction of the following requirements:
p.(None): I - fit in the list of substances declared innocuous, prepared by the competent body of the Ministry of Health and published in the "Official Gazette" of the Union,
p.(None): which will contain the specifications relevant to each category as well as drugs, inputs, raw materials, dyes, solvents and other
p.(None): allowed in its manufacture;
p.(None): II - not falling within the list referred to in the previous item, having recognized the innocuousness of the respective formulas, in conclusive opinions, issued by the
p.(None): competent, analysis and technical bodies of the Ministry of Health.
p.(None): Single paragraph. The list of substances referred to in item I of this article may be changed to exclude substances that may be judged
p.(None): harmful to health, or for the inclusion of others, which may be approved.
p.(None): Art. 28 - The registration of cosmetics, products for personal hygiene, and other similar purposes, containing medicinal substances,
p.(None): although in an infra-therapeutic dose, it will obey the norms contained in articles 16 and its subparagraphs, 17, 18 and 19 and its sole paragraph, 20 and 21 and its Regulation
p.(None): Law.
p.(None): Art. 29 - Only the product referred to in Art. 26 that contains in its composition raw material, solvent, dye or pharmaceutical inputs,
p.(None): contained in the list prepared by the competent body of the Ministry of Health, published in the "Official Gazette" of the Union, provided that they are expressly
p.(None): labels and packaging use restrictions, when applicable, in accordance with the area of the body where it should be applied.
p.(None): Single paragraph. When presented in aerosol form, the products referred to in Art. 26 will only be registered if they comply with technical standards
p.(None): approved by the Ministry of Health and other specific requirements and standards.
p.(None): Art. 30 - Cosmetics, personal hygiene products for adults and children, perfumes and the like may have altered their composition formulas provided that
p.(None): the changes are approved by the Ministry of Health, based on the relevant technical reports.
p.(None): Art. 31 - The formula changes will be registered in the product registration, as provided in the regulation.
p.(None): Art. 32 - The Ministry of Health will publish in the Union's "Official Gazette" the list of natural organic, artificial and synthetic dyes, including their salts and
p.(None): their lacquers, permitted in the manufacture of the products referred to in articles 29, sole paragraph, and 30.
p.(None): § 1 - Any and all dyes that present active or potential toxicity will be excluded from the list referred to in this article.
p.(None): § 2 - The inclusion and exclusion of dyes and their consequences will obey the provisions contained in regulations.
p.(None): TITLE VI
p.(None): From the Registry of Household Cleaners
p.(None): Art. 33 - The registration of sanitizing products, disinfectants and detergents will obey the provisions of regulation and complementary norms
p.(None): specific.
p.(None): Article 34 - Only insecticides that:
p.(None): I - can be applied correctly, in strict compliance with the instructions on the labels and other explanatory elements;
p.(None): II - do not offer any possibility of risk to human health and that of warm-blooded domestic animals, under the conditions foreseen for use;
p.(None): III - are not corrosive or harmful to the treated surfaces.
p.(None): Art. 35 - Only insecticides will be registered:
p.(None): I - presented according to the forms provided for in the Regulation of this Law;
p.(None): II - in whose composition the insecticidal and synergistic substances, natural or synthetic, observe the appropriate concentration indices established by the
p.(None): Ministry of Health;
p.(None): III - whose composition formula meets the necessary precautions, with a view to its handling and therapeutic measures in the event of an accident, for the
p.(None): preservation of human life, according to the instructions of the Ministry of Health.
p.(None): Single paragraph. The regulation of this Law will establish the requirements, conditions and procedures related to the registration of insecticides.
p.(None): Article 36 - For the purpose of registering insecticides, the substances that make up the respective formulas will be considered:
p.(None): I - solvents and thinners, those used as vehicles in insecticidal preparations;
p.(None): II - propellants, the propellants used in pressed preparations.
p.(None): Art. 37 - The Ministry of Health will prepare and publish in the "Official Gazette" of the Union the list of solvents, thinners and propellants allowed, with the
p.(None): maximum concentrations.
p.(None): Art. 38 - The association of insecticides will be allowed, which should have, when in the same class, the concentrations of active elements reduced
p.(None): proportionally.
p.(None): Art. 39 - Insecticide associations must satisfy the requirements set out in Art. 35 and its sole paragraph, regarding toxicity for animals submitted
p.(None): efficiency proof.
p.(None): Art. 40 - The registration of insecticides will only be allowed when it is intended:
p.(None): I - the prompt application by any person, for domestic purposes;
p.(None): II - the application and manipulation by a specialized person or organization for professional purposes.
p.(None): Art. 41 - Preparations whose composition formulas include active substances, isolated or in combination, in concentrations
p.(None): diverse and in certain forms and types of presentation.
p.(None): Single paragraph. Associations of rodenticides of the same class should be reduced in proportion to the concentrations of their active ingredients.
p.(None): Art. 42 - The provisions of this Law apply to the registration of preparations and rodenticide substances, fixing the regulations and instructions of the Ministry of Health
p.(None): other specific requirements related to this class of products.
p.(None): Art. 43 - The disinfectants will be registered according to the provisions of the Regulation of this Law and in instructions issued by the Ministry of Health.
p.(None): Art. 44 - For the purposes of this Law, detergents and disinfectants and their counterparts, intended for application, are equivalent to household products.
p.(None): in inanimate objects and environments, being subject to the same requirements and conditions regarding registration, industrialization, delivery to consumption and
p.(None): inspection.
p.(None): Art. 45 - The sale of rodenticides and their delivery for consumption will be restricted, exclusively, to products classified as low and medium toxicity, being
p.(None): private companies or bodies and entities of the Direct and Indirect Public Administration supply and control of the application of the
p.(None): high toxicity.
p.(None): TITLE VII
p.(None): Registration of Dietary Products
p.(None): Art. 46 - Those intended for oral intake will be registered as dietary products, which, not covered by the provisions of Decree-Law No. 986, of 21
p.(None): October 1969, and the respective regulations, have their use or sale subject to medical prescription and are intended:
p.(None): I - to meet special dietary needs;
p.(None): II - to supplement and enrich the usual diet with vitamins, amino acids, minerals and other elements;
...

p.(None): Art. 48 - The dietary products referred to in this Law may be presented in the usual forms of pharmaceutical products, subject to nomenclature and
p.(None): their own characteristics.
p.(None): Art. 49 - To ensure the minimum necessary dietary efficiency and avoid being confused with therapeutic products, the content of the components of the
p.(None): dietary products, which justify their indication in special diets, must obey the internationally accepted standards, according to the relations elaborated by the
p.(None): Ministry of Health.
p.(None): § 1 - In the absence of a standard established for the purposes of this article, the nutrient rate of dietary products will depend on a pronouncement by the Ministry of Health.
p.(None): Cheers.
p.(None): § 2 - The proportion of vitamins to be added to the products will correspond to the standards established by the Ministry of Health.
p.(None): TITLE VIII
p.(None): Authorization of Companies and Licensing of Establishments
p.(None): Art. 50 - The operation of the companies covered by this Law will depend on authorization from the Ministry of Health, in view of the indication of industrial activity
p.(None): the nature and type of products and proof of technical, scientific and operational capacity, and other requirements set out in regulations and
p.(None): administrative acts by the same Ministry.
p.(None): Art. 50. The operation of the companies referred to in this Law will depend on authorization by Anvisa, granted upon request to register their
p.(None): activities, the payment of the respective Sanitary Surveillance Inspection Fee and other requirements defined in specific
p.(None): Anvisa. (Wording given by Law No. 13,097, of 2015)
p.(None): Single paragraph. The authorization referred to in this article will be valid for the entire national territory and must be renewed whenever there is a change or inclusion
p.(None): activity or change of the partner or director who is in charge of the legal representation of the company.
p.(None): Single paragraph. The authorization referred to in this article will be valid for the entire national territory and must be updated according to the specific regulation of the
p.(None): Anvisa. (Wording given by Law No. 13,097, of 2015)
p.(None): Art. 51 - The licensing, by the local authority, of industrial or commercial establishments that carry out the activities referred to in this Law, will depend on
p.(None): the operation of the company has been authorized by the Ministry of Health and the technical and
p.(None): established in regulation and instructions of the Ministry of Health, including with regard to the effective assistance of qualified technical
p.(None): activity sectors.
p.(None): Single paragraph. Each establishment will have a specific and independent license, even if there is more than one in the same location, belonging to the same
p.(None): company.
p.(None): Art. 52 - The local supplementary legislation will fix the requirements and conditions for the licensing of the establishments referred to in this Law, observing the following
p.(None): precepts:
p.(None): I - when a single establishment industrializes or markets products of a different nature or purpose, the existence of facilities will be mandatory
p.(None): separate for the manufacture and packaging of materials, substances and finished products;
p.(None): II - adequate location of the premises and prohibition of residences or housing in the properties destined for them and in the adjacent areas;
p.(None): III - prior approval by the state health agency of the projects and plans of the buildings and inspection of the respective compliance.
p.(None): TITLE IX
p.(None): Technical Responsibility
p.(None): Art. 53 - Companies that carry out the activities provided for in this Law are obliged to maintain sufficient legally qualified technical officers,
p.(None): qualitatively and quantitatively, for the adequate coverage of the different species of production, in each establishment.
p.(None): Art. 54 - It will be the responsibility of the technical responsible to prepare the report to be presented to the Ministry of Health, for the purposes of product registration, and to provide technical assistance.
p.(None): the sector under its professional responsibility.
p.(None): Art. 55 - Although assistance to the establishment will cease, or it will cease to function, it will last for one year, counting from the cessation, the
p.(None): responsibility of the technical professional for the acts performed until then.
p.(None): Art. 56 - Regardless of other legal agreements, including penal ones, of which the technical and administrative responsible are liable, the company
p.(None): it will answer administratively and civilly for health infraction resulting from the non-observance of this Law and its regulations and other complementary norms.
p.(None): TITLE X
p.(None): Labeling and Advertising
p.(None): Art. 57. The Executive Branch will provide, in regulation, on labeling, package inserts, printed matter, labels and prospectuses referring to the products it deals with
p.(None): this Law.
p.(None): Single paragraph. Medicines bearing a trade name or brand will also be obligatorily with the same prominence and legibly in the
p.(None): parts referred to in the caput of this article, on packaging and promotional materials, the Brazilian Common Denomination or, failing that, the Common Denomination
p.(None): International in letters and characters whose size will not be less than one half the size of the letters and characters of the trade name or brand.
p.(None): (Paragraph included by Law No. 9,787, dated 2.10.1999)
p.(None): § 1 In addition to the trade name or brand, the medications must display, on the parts referred to in the caput of this article, on the packaging and
p.(None): promotional materials to the Brazilian Common Denomination or, when applicable, the International Common Denomination, in letters and characters with size never
p.(None): less than half the size of the letters and characters of the trade name or brand. (Wording given by Law No. 13,236, 2015) (Effective)
p.(None): § 2 The labels of medicines, drugs and related products must have characteristics that clearly differentiate them and that inhibit errors
p.(None): dispensation and administration, unwanted exchanges or misuse. (Included by Law No. 13,236, 2015) (Effective)
p.(None): Art. 58. Advertising, in any form of dissemination and means of communication, of products under the regime of this Law can only be promoted after
p.(None): authorization from the Ministry of Health, as provided by regulation.
p.(None): § 1 - When dealing with a drug, medication or any other product with the requirement to sell subject to medical or dental prescription, the advertisement
p.(None): will be restricted to publications that are intended exclusively for distribution to doctors, dentists and pharmacists.
...

p.(None): purposes or characteristics different from those it actually has.
p.(None): TITLE XI
p.(None): Packaging
p.(None): Art. 60. The approval, by the Ministry of Health, as required by regulation, of packaging, equipment and utensils prepared is mandatory
p.(None): or coated internally with substances that, in contact with the product, may alter its effects or produce damage to health.
p.(None): § 1 - The packaging destined for the packaging of drugs, medications, pharmaceutical supplies, hygiene products,
p.(None): cosmetics, perfumes and the like that do not contain a substance internally capable of altering the purity and effectiveness of the product.
p.(None): Paragraph 2 - The use of packaging designed to contain or pack drugs, medications or pharmaceutical inputs will not be authorized, as long as it is capable of
p.(None): directly or indirectly cause harmful health effects.
p.(None): § 3 - The approval of the type of packaging will be subject to prior analysis, when applicable.
p.(None): Art. 60-A. In order to contain or pack drugs, medication or related products, the use of packaging that may induce exchanges will not be authorized
p.(None): unwanted errors or errors in dispensing, using or administering these products. (Included by Law No. 13,236, 2015) (Effective)
p.(None): TITLE XII
p.(None): Means of Transport
p.(None): Art. 61. In the case of products that require special conditions of storage and storage, the vehicles used in their transportation must be equipped with
p.(None): of equipment that enables packaging and conservation capable of ensuring the conditions of purity, safety and efficacy of the product.
p.(None): Single paragraph. Vehicles used to transport drugs, medicines, pharmaceutical and related supplies, dietary and hygiene products, perfumes and
p.(None): similar activities must have the disinfection and hygiene conditions necessary to preserve human health ensured.
p.(None): TITLE XIII - Infractions and Penalties
p.(None): Art. 62. The medication, drug and pharmaceutical input are considered altered, adulterated or inappropriate for use:
p.(None): I - that has been mixed or conditioned with a substance that changes its therapeutic value or the purpose for which it is intended;
p.(None): II - when it has been removed or falsified, in whole or in part, an integral element of its normal composition, or replaced by another of inferior quality,
p.(None): or the dosage has been modified, or a foreign substance has been added to its composition, so that it becomes different from the formula in the record;
p.(None): III - whose volume does not correspond to the approved quantity;
p.(None): IV - when its conditions of purity, quality and authenticity do not satisfy the requirements of the Brazilian Pharmacopoeia or another Code adopted by
p.(None): Ministry of Health.
p.(None): Single paragraph. In the event of a change due to time, or a cause outside the responsibility of the technician or the company, the latter is obliged to withdraw
p.(None): immediately the product of the trade, for correction or replacement, under penalty of incurring a sanitary infraction.
p.(None): Art. 63. Hygiene, cosmetic, perfume or similar products are considered fraudulent, falsified or adulterated when:
p.(None): I - it is presented with indications that induce error, mistake or confusion as to its origin, origin, composition or purpose;
p.(None): II - not observing the standards and paradigms established in this Law and regulation, or the specifications contained in the registration;
p.(None): III - the nature, composition, properties or characteristics that constitute the conditions of its registration have been modified, due to the effect of addition, reduction or
p.(None): withdrawal of raw materials or components.
p.(None): Single paragraph. This article includes inputs consisting of active, additive or complementary raw material, of a chemical nature,
p.(None): biochemical or biological, of natural or synthetic origin, or any other material intended for the manufacture, manipulation and improvement of hygiene products,
p.(None): cosmetics, perfumes and the like.
p.(None): Article 64. The reuse and use of containers traditionally used for food, drinks, soft drinks, diet products,
p.(None): medicines, drugs, chemicals, hygiene products, cosmetics and perfumes in the packaging of sanitizers and the like.
p.(None): Art. 65. The placing of new dates or repackaging in new product packages whose expiration date has expired, except for
p.(None): therapeutic sera that can be refilled and refiltered.
p.(None): Art. 66. Failure to comply with the precepts of this Law, its regulation and complementary rules sets up an infraction of a sanitary nature, making the offender subject
p.(None): to the process and penalties provided for in Decree-Law No. 785, of August 25, 1969, without prejudice to other applicable civil and criminal commissions.
p.(None): Single paragraph. The process referred to in this article may be initiated and judged by the Ministry of Health or by the health authorities of the States,
p.(None): Federal District and Territories, as appropriate.
p.(None): Art. 67. Regardless of those provided for in Decree-Law No. 785, of August 25, 1969, serious or very serious infractions are set up, under the terms of this Law, the
p.(None): following practices punishable by the sanctions indicated in that legal diploma:
p.(None): I - to label products under the regime of this Law or to advertise them without complying with the provisions of this Law and its regulations or contrary to
p.(None): respective registration and authorization terms and conditions;
p.(None): II - change the product manufacturing process, without the prior consent of the Ministry of Health;
p.(None): III - sell or display for sale a product whose expiration date has expired;
p.(None): IV - affixing new dates on products whose expiration date has expired or repackaging them in new packaging, except for therapeutic serums that
p.(None): they can be refilled and refiltered;
p.(None): V - industrialize products without the assistance of a legally qualified technician;
p.(None): VI - use, in the preparation of hormones, organs of animals that are not healthy, or that show signs of decomposition at the time of being
p.(None): handled, or from sick, fatigued or emaciated animals;
p.(None): VII - resell biological product not kept in a refrigerator, according to the indications determined by the manufacturer and approved by the Ministry of Health;
p.(None): VIII - apply rodenticides whose action is produced by gas or steam, in galleries, culverts, basements, attics or places of possible communication with homes or places
p.(None): frequented by humans or useful animals.
p.(None): TITLE XIV
p.(None): Inspection
p.(None): Art. 68. The health surveillance action will cover any and all products covered by this Law, including those exempt from registration, correlates,
p.(None): manufacturing, distribution, storage and sale establishments, and vehicles for the transportation of products.
p.(None): Single paragraph. The advertisement of products and brands, by any means of communication, advertising,
p.(None): labeling and labeling.
p.(None): Article 69. The inspection action is the responsibility of:
p.(None): I - the federal health agency:
p.(None): when the product is in transit from one to another federative unit, on a road by river, lake, sea or air, under the control of federal agencies;
p.(None): when it comes to imported or exported product;
p.(None): when it comes to taking samples for prior control and fiscal analysis;
p.(None): II - the state health agency, the Territories or the Federal District:
p.(None): when it is an industrialized product or delivered for consumption in the respective jurisdiction area;
p.(None): as for industrial or commercial establishments, installations and equipment;
p.(None): as for transport on roads and waterways or lakes, within their jurisdictional area;
p.(None): when it comes to taking samples for tax analysis.
p.(None): Single paragraph. The competence referred to in this article may be delegated, by agreement, reciprocally, by the Union, the States and the District
p.(None): Federal, except for the hypothesis of non-delegable powers, expressly provided for by law.
p.(None): Art. 70. The health surveillance action will be carried out permanently, constituting a routine activity of the health agencies.
p.(None): Art. 71. The powers and prerogatives of the inspection agents will be established in the regulation of this Law.
p.(None): Art. 72. The determination of infractions, under the terms of this Law, will be done through the seizure of samples and interdiction of the product or establishment, as
p.(None): regulation.
p.(None): § 1 - The proof of the infraction will give reason, depending on the case, for the seizure and destruction of the product, throughout the national territory, for the cancellation of the registration
p.(None): and the revocation of the establishment's license, which will only become effective after the publication of the irrevocable condemnatory decision in the Federal Official Gazette.
p.(None): Paragraph 2 - Any changes made as a result of natural causes, circumstances and events will also give rise to apprehension, interdiction and disabling
p.(None): unpredictable, causing product damage, deterioration or contamination, rendering them ineffective or harmful to health.
p.(None): Art. 73. For the purpose of sanitary inspection, the tests aimed at verifying the formula's efficiency will be carried out according to the standards set by the
p.(None): Ministry of Health.
p.(None): Art. 73. Fiscal and control analyzes, for purposes of inspection and monitoring of products subject to the health surveillance regime, shall be carried out
p.(None): by an official laboratory, instituted within the scope of the Union, the States, the Federal District or the Municipalities, or by public or private laboratories accredited for such purpose
p.(None): end. (Wording given by Law No. 13,097, of 2015)
p.(None): Single paragraph. The accreditation referred to in the caput will be carried out by Anvisa or by the official laboratories themselves, under the terms of regulation
p.(None): specific edited by Anvisa. (Included by Law No. 13,097, 2015)
p.(None): Art. 74. They cannot exercise in health inspection bodies and control laboratories public servants who are partners, shareholders or interested parties, Art.
p.(None): in any way, from companies that carry out activities subject to the regime of this Law, or provide services with or without employment relationship.
p.(None): TITLE XV
p.(None): Quality Control of Medicines
p.(None): Art. 75. The Ministry of Health will set standards and improve mechanisms to guarantee the quality of medicines to consumers, taking into account the
p.(None): identity, activity, purity, efficacy and safety of the products and covering the quality specifications and production supervision.
p.(None): Single paragraph. The standards referred to in this article will determine the quality specifications of raw materials and semi-finished products
p.(None): used in the manufacture of medicines, as well as their quality specifications, and will accurately describe the criteria for their acceptance.
p.(None): Art. 76. No raw materials or semi-elaborated products may be used in the manufacture of medicines without having been verified to have
p.(None): acceptable quality, according to evidence that will be the subject of Ministry of Health standards.
p.(None): Art. 77. The inspection of the production of medicines will have, as a priority, the following aspects:
p.(None): I - manufacturing, taking into account unfavorable intrinsic and extrinsic factors, including the possibility of contamination of raw materials, products
p.(None): semi-finished products and the finished product;
p.(None): II - the finished product, in order to check the compliance with the relevant requirements to the technicians responsible for the manufacture and inspection of the products, to the places
p.(None): and equipment, sanitation, raw materials and systems for inspection and self-inspection and registration of medicines.
p.(None): Art. 78. Without prejudice to the control and inspection under the responsibility of the Public Authorities, every establishment intended for the production of medicines must have
p.(None): technical quality inspection department, which operates autonomously in its sphere of competence, with the purpose of verifying the quality of
p.(None): raw materials or substances, monitor the qualitative aspects of the operations of the drugs produced and perform the other necessary tests.
p.(None): Single paragraph. The pharmaceutical industrial laboratories are allowed to carry out the controls provided for in this article, in official institutes or laboratories, by means of
p.(None): agreement or contract.
p.(None): Art. 79. All reports about accidents or harmful reactions caused by medications will be transmitted to the competent health authority.
p.(None): Single paragraph. Changes in the quality of medicines and any changes in their physical characteristics will be investigated with all
p.(None): details and, once proven, will be subject to the appropriate corrective measures.
p.(None): TITLE XVI
p.(None): Health Surveillance Organs
p.(None): Art. 80. The health surveillance activities referred to in this Law will be carried out:
p.(None): I - at the federal level, by the Ministry of Health, in the form of legislation and regulations;
p.(None): II - in the States, Territories and the Federal District, through their own bodies, observing the relevant federal rules and local supplementary legislation.
p.(None): TITLE XVII
p.(None): Of the final and transitional provisions
p.(None): Art. 81. Companies that already operate the activities covered by this Law will have a period of 12 (twelve) months for changes and adaptations necessary to the
p.(None): compliance with and what is available in it.
p.(None): Art. 82. The services provided by the Ministry of Health, related to this Law, will be remunerated by the public price regime, being the Minister of
p.(None): State to establish the respective values and to discipline their collection. (Repealed by Provisional Measure No. 2,190, of 2001)
p.(None): Art. 83. Drugs, chemicals and ﬁ nal products will be sold in their original packaging and may only be fractionated, for resale, in
p.(None): commercial establishments, under the direct responsibility of the respective technical responsible.
p.(None): Art. 84. The provisions of this Law do not exclude the application of the other rules to which the activities covered by it are subject, in relation to aspects object of
p.(None): specific legislation.
p.(None): Art. 85. To the products mentioned in article 1, governed by special rules, the provisions of this Law apply, as appropriate.
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p.(None): vitamins;
p.(None): III - Hygiene Products: products for external use, antiseptic or not, intended for cleanliness or body disinfection, including soaps,
p.(None): shampoos, toothpastes, mouthwashes, antiperspirants, deodorants, shaving and after shaving products, styptic and others;
p.(None): IV - Perfumes: products of aromatic composition obtained based on natural or synthetic substances, which, in appropriate concentrations and vehicles, have
p.(None): main purpose is the odor of people or environments, including extracts, perfumed waters, creamy perfumes, prepared for bathing and
p.(None): room odorants, presented in liquid, gelled, pasty or solid form;
p.(None): V - Cosmetics: products for external use, intended for the protection or beautification of different parts of the body, such as facial powders, talc, creams.
p.(None): beauty, hand cream and the like, facial masks, beauty lotions, milky, creamy and astringent solutions, hand lotions, makeup bases and
p.(None): cosmetic oils, wrinkles, blushes, lipsticks, lip pencils, anti-sun preparations, suntans and simulators, mascara, shadows, eyeliner, hair dye,
p.(None): hair bleaching agents, prepared for curling and straightening hair, hair fixers, hairspray, shiny and similar, capillary lotions, depilatories and
p.(None): epilatories, prepared for nails and others;
p.(None): VI - Dyes: additional substances to medicines, diet products, cosmetics, perfumes, hygiene products and the like, sanitizing products and
p.(None): similar, with the effect of giving them color and, in certain types of cosmetics, transferring it to the skin surface and skin appendages;
p.(None): VII - Household sanitizers: substances or preparations intended for home hygiene, disinfection or disinfection, in collective environments and / or
p.(None): public places of use and water treatment including:
p.(None): a) insecticides - intended to combat, prevent and control insects in houses, enclosures and places for public use and their surroundings;
p.(None): b) rodenticides - intended to combat rats, mice and other rodents, in households, boats, enclosures and places for public use, containing
p.(None): active substances, isolated or in combination, that do not pose a risk to the life or health of man and warm-blooded useful animals, when applied in
p.(None): compliance with the recommendations contained in its presentation;
p.(None): c) disinfectants - destined to destroy, indiscriminately or selectively, microorganisms, when applied to inanimate objects or environments;
p.(None): d) detergents - designed to dissolve fats and the hygiene of containers and containers, and for domestic use.
p.(None): VIII - Label: printed or lithographed identification, as well as the words painted or engraved with fire, pressure or decal, applied directly on
p.(None): containers, containers, wrappers, wraps, cartridges or any other packaging protector;
p.(None): IX - Packaging: wrapper, container or any form of packaging, removable or not, intended to cover, package, fill, protect or maintain,
p.(None): specifically or not, the products covered by this Law;
p.(None): X - Registration: registration, in a proper book after the concessive order of the director of the Ministry of Health organ, under order number, of the products
p.(None): this Law deals with the indication of the name, manufacturer, origin, purpose and other elements that characterize them;
p.(None): XI - Manufacturing: all operations that are necessary to obtain the products covered by this Law;
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Searching for indicator union:

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p.(None): Art. 4º - The products destined for the infant use cannot contain caustic or irritating substances, they will have packages free of blunt parts and not
p.(None): may be presented in aerosol form.
p.(None): Single paragraph. The products referred to in the caput must have labeling and packaging characteristics that enable their immediate and precise distinction
p.(None): those intended for adult use. (Included by Law No. 13,236, 2015) (Effective)
p.(None): Art. 5 - The products referred to in this Law may not have names or designations that are misleading.
p.(None): Art. 5 - The products referred to in this Law may not have names or designations that are misleading. (Wording given by Law No. 6,480, of 1.12.1977)
p.(None): Art. 5 The products covered by this Law may not have names, designations, labels or packaging that are misleading. (Wording given by Law
p.(None): nº 13,236, of 2015) (Effective)
p.(None): § 1 - It is prohibited to adopt the same or similar name for products of different composition, even from the same manufacturer, ensuring the priority of the
p.(None): registration with the chronological order of entry of applications in the competent department of the Ministry of Health, when there is no previous registration.
p.(None): § 2 - The name of a product whose registration is subsequently required may be approved, provided that the previous registration application is denied, for reasons of order
p.(None): technical or scientific.
p.(None): § 3 - Once the brand collidence is confirmed, the name or designation of the product must be modified within 90 (ninety) days from the date of the
p.(None): publication of the order in the "Official Gazette" of the Union, under penalty of refusal of registration.
p.(None): § 4 - Without prejudice to the provisions of this article, drugs containing a single active substance well known, at the discretion of the Ministry of Health, and
p.(None): immunotherapeutics, drugs and pharmaceutical inputs must be identified by the name used in the Brazilian Pharmacopoeia, and under no circumstances
p.(None): have any fancy names or designations. (Included by Law No. 6,480, of 1.12.1977)
p.(None): § 5 The errors mentioned in the caput include dispensing and administering medications, drugs and related products.
p.(None): (Included by Law No. 13,236, 2015)
p.(None): § 5 The errors mentioned in the caput include dispensing and administering medications, drugs and related products.
p.(None): (Wording given by Law No. 13,236, 2015) (Effective)
p.(None): Art. 6 - The proof that a product, previously considered useful, is harmful to health or does not fulfill the requirements established by law, implies its
p.(None): immediate withdrawal from the trade and the requirement to change the formula of its composition and in the words of labels, package inserts and packages, under penalty of
p.(None): cancellation of the registration and seizure of the product, throughout the national territory.
p.(None): Single paragraph. It is the exclusive responsibility of the Ministry of Health to register and allow the use of medications, as well as the approval or requirement of
p.(None): modification of its components.
p.(None): Art. 7 - As a health security measure and in view of reasoned reasons from the competent body, the Ministry of Health may, at any time,
...

p.(None): TITLE II
p.(None): From the Registry
p.(None): Art. 12 - None of the products covered by this Law, including imported ones, may be industrialized, exposed for sale or delivered for consumption before
p.(None): registered with the Ministry of Health.
p.(None): Paragraph 1 - The registration referred to in this article will be valid for 5 (five) years and may be revalidated for equal and successive periods, maintaining the number of
p.(None): initial registration.
p.(None): Paragraph 1 - The National Health Surveillance Agency - ANVISA - will define by its own act the deadline for renewing the registration of the products referred to in this Law,
p.(None): more than 10 (ten) years, considering the nature of the product and the health risk involved in its use. (Included by Law No. 13,097, 2015)
p.(None): Paragraph 2 - Except for the provisions of the preceding paragraph, the validity of the registration and the revalidation of the registration of dietary products, whose term is 2 (two) years.
p.(None): Paragraph 3 - Registration will be granted within a maximum period of 90 (ninety) days, counting from the date of submission of the application, except in cases of non-compliance with this Law
p.(None): or its regulations.
p.(None): § 3 - Except as provided in arts. 17-A, 21 and 24-A, registration will be granted within a maximum period of ninety days, counting from the
p.(None): application, except in cases of non-compliance, by the applicant, with this Law or its r e g u l m e n t s. (Wording given by Law No. 13,411, of
p.(None): 2017) (Effective)
p.(None): § 4 - The acts related to the registration and the revalidation of the registration will only take effect from the date of publication in the "Official Gazette" of the Union.
p.(None): § 5 - The granting of the registration and its revalidation, and the prior and control analyzes, when applicable, are subject to the payment of public prices,
p.(None): referred to in Art. 82.
p.(None): § 6 - The revalidation of the registration must be requested in the first semester of the last year of the five-year period of validity, considering itself automatically revalidated,
p.(None): regardless of decision, if it has not been issued by the end of the decision.
p.(None): § 7 - The expiry of the registration of the product whose revalidation has not been requested within the period referred to in § 6 of this article will be declared.
p.(None): § 8 - The registration of the product that is not industrialized in the first period of validity will not be revalidated.
p.(None): § 8 - The registration will not be revalidated: (Wording given by Law nº 13.411, of 2017) (Effective)
p.(None): I - the product not classified as a medicine that has not been industrialized in the period of validity of the expired registration; (Included by Law nº
p.(None): 13,411, 2017) (Effective)
p.(None): II - of the drug that has not been marketed for at least the time corresponding to the final two thirds of the validity period of the registration
p.(None): expired. (Included by Law No. 13,411, of 2017) (Effective)
p.(None): § 9 - The formula for the composition of the product must be included in the registration referred to in this article, with the indication of the ingredients used and respective
p.(None): dosage.
p.(None): § 10 - Anvisa will define, by its own act, the mechanisms for publicizing the registration, post-registration alteration and registration renewal processes,
p.(None): the presentation of the following information is mandatory: (Included by Law No. 13,411, of 2017) (Term)
...

p.(None): TITLE IV
p.(None): From the Registry of Correlates
p.(None): Art. 25 - The devices, instruments and accessories used in medicine, dentistry and related activities, as well as those of physical education, beautification or
p.(None): aesthetic correction, can only be manufactured, or imported, for delivery to consumption and exposure to sale, after the Ministry of Health
p.(None): on whether registration is mandatory or not.
p.(None): § 1 - The devices, instruments or accessories referred to in this article, which are in relationships for this purpose, prepared by the
p.(None): Ministry of Health, being, however, subject, for the other purposes of this Law and its Regulations, to the health surveillance regime.
p.(None): § 2 - The regulation of this Law will prescribe the conditions, requirements and procedures related to the registration of devices, instruments or accessories
p.(None): of this article.
p.(None): TITLE V
p.(None): Registration of Cosmetics, Hygiene Products, Perfumes and others
p.(None): Art. 26 - Only personal hygiene products, perfumes and other products of similar nature and purpose will be registered as cosmetics, the products that are
p.(None): intended for external use or in the environment, depending on their aesthetic, protective, hygienic or odorous purposes, without causing skin irritation or damage to health.
p.(None): Art. 27 - In addition to being subject to specific regulatory requirements, the registration of cosmetics, products for personal hygiene, perfumes and others,
p.(None): of similar purpose, will depend on the satisfaction of the following requirements:
p.(None): I - fit in the list of substances declared innocuous, prepared by the competent body of the Ministry of Health and published in the "Official Gazette" of the Union,
p.(None): which will contain the specifications relevant to each category as well as drugs, inputs, raw materials, dyes, solvents and other
p.(None): allowed in its manufacture;
p.(None): II - not falling within the list referred to in the previous item, having recognized the innocuousness of the respective formulas, in conclusive opinions, issued by the
p.(None): competent, analysis and technical bodies of the Ministry of Health.
p.(None): Single paragraph. The list of substances referred to in item I of this article may be changed to exclude substances that may be judged
p.(None): harmful to health, or for the inclusion of others, which may be approved.
p.(None): Art. 28 - The registration of cosmetics, products for personal hygiene, and other similar purposes, containing medicinal substances,
p.(None): although in an infra-therapeutic dose, it will obey the norms contained in articles 16 and its subparagraphs, 17, 18 and 19 and its sole paragraph, 20 and 21 and its Regulation
p.(None): Law.
p.(None): Art. 29 - Only the product referred to in Art. 26 that contains in its composition raw material, solvent, dye or pharmaceutical inputs,
p.(None): contained in the list prepared by the competent body of the Ministry of Health, published in the "Official Gazette" of the Union, provided that they are expressly
p.(None): labels and packaging use restrictions, when applicable, in accordance with the area of the body where it should be applied.
p.(None): Single paragraph. When presented in aerosol form, the products referred to in Art. 26 will only be registered if they comply with technical standards
p.(None): approved by the Ministry of Health and other specific requirements and standards.
p.(None): Art. 30 - Cosmetics, personal hygiene products for adults and children, perfumes and the like may have altered their composition formulas provided that
p.(None): the changes are approved by the Ministry of Health, based on the relevant technical reports.
p.(None): Art. 31 - The formula changes will be registered in the product registration, as provided in the regulation.
p.(None): Art. 32 - The Ministry of Health will publish in the Union's "Official Gazette" the list of natural organic, artificial and synthetic dyes, including their salts and
p.(None): their lacquers, permitted in the manufacture of the products referred to in articles 29, sole paragraph, and 30.
p.(None): § 1 - Any and all dyes that present active or potential toxicity will be excluded from the list referred to in this article.
p.(None): § 2 - The inclusion and exclusion of dyes and their consequences will obey the provisions contained in regulations.
p.(None): TITLE VI
p.(None): From the Registry of Household Cleaners
p.(None): Art. 33 - The registration of sanitizing products, disinfectants and detergents will obey the provisions of regulation and complementary norms
p.(None): specific.
p.(None): Article 34 - Only insecticides that:
p.(None): I - can be applied correctly, in strict compliance with the instructions on the labels and other explanatory elements;
p.(None): II - do not offer any possibility of risk to human health and that of warm-blooded domestic animals, under the conditions foreseen for use;
p.(None): III - are not corrosive or harmful to the treated surfaces.
p.(None): Art. 35 - Only insecticides will be registered:
p.(None): I - presented according to the forms provided for in the Regulation of this Law;
p.(None): II - in whose composition the insecticidal and synergistic substances, natural or synthetic, observe the appropriate concentration indices established by the
p.(None): Ministry of Health;
p.(None): III - whose composition formula meets the necessary precautions, with a view to its handling and therapeutic measures in the event of an accident, for the
p.(None): preservation of human life, according to the instructions of the Ministry of Health.
p.(None): Single paragraph. The regulation of this Law will establish the requirements, conditions and procedures related to the registration of insecticides.
p.(None): Article 36 - For the purpose of registering insecticides, the substances that make up the respective formulas will be considered:
p.(None): I - solvents and thinners, those used as vehicles in insecticidal preparations;
p.(None): II - propellants, the propellants used in pressed preparations.
p.(None): Art. 37 - The Ministry of Health will prepare and publish in the "Official Gazette" of the Union the list of solvents, thinners and propellants allowed, with the
p.(None): maximum concentrations.
p.(None): Art. 38 - The association of insecticides will be allowed, which should have, when in the same class, the concentrations of active elements reduced
p.(None): proportionally.
p.(None): Art. 39 - Insecticide associations must satisfy the requirements set out in Art. 35 and its sole paragraph, regarding toxicity for animals submitted
p.(None): efficiency proof.
p.(None): Art. 40 - The registration of insecticides will only be allowed when it is intended:
p.(None): I - the prompt application by any person, for domestic purposes;
p.(None): II - the application and manipulation by a specialized person or organization for professional purposes.
p.(None): Art. 41 - Preparations whose composition formulas include active substances, isolated or in combination, in concentrations
p.(None): diverse and in certain forms and types of presentation.
p.(None): Single paragraph. Associations of rodenticides of the same class should be reduced in proportion to the concentrations of their active ingredients.
p.(None): Art. 42 - The provisions of this Law apply to the registration of preparations and rodenticide substances, fixing the regulations and instructions of the Ministry of Health
p.(None): other specific requirements related to this class of products.
p.(None): Art. 43 - The disinfectants will be registered according to the provisions of the Regulation of this Law and in instructions issued by the Ministry of Health.
p.(None): Art. 44 - For the purposes of this Law, detergents and disinfectants and their counterparts, intended for application, are equivalent to household products.
p.(None): in inanimate objects and environments, being subject to the same requirements and conditions regarding registration, industrialization, delivery to consumption and
...

p.(None): VIII - apply rodenticides whose action is produced by gas or steam, in galleries, culverts, basements, attics or places of possible communication with homes or places
p.(None): frequented by humans or useful animals.
p.(None): TITLE XIV
p.(None): Inspection
p.(None): Art. 68. The health surveillance action will cover any and all products covered by this Law, including those exempt from registration, correlates,
p.(None): manufacturing, distribution, storage and sale establishments, and vehicles for the transportation of products.
p.(None): Single paragraph. The advertisement of products and brands, by any means of communication, advertising,
p.(None): labeling and labeling.
p.(None): Article 69. The inspection action is the responsibility of:
p.(None): I - the federal health agency:
p.(None): when the product is in transit from one to another federative unit, on a road by river, lake, sea or air, under the control of federal agencies;
p.(None): when it comes to imported or exported product;
p.(None): when it comes to taking samples for prior control and fiscal analysis;
p.(None): II - the state health agency, the Territories or the Federal District:
p.(None): when it is an industrialized product or delivered for consumption in the respective jurisdiction area;
p.(None): as for industrial or commercial establishments, installations and equipment;
p.(None): as for transport on roads and waterways or lakes, within their jurisdictional area;
p.(None): when it comes to taking samples for tax analysis.
p.(None): Single paragraph. The competence referred to in this article may be delegated, by agreement, reciprocally, by the Union, the States and the District
p.(None): Federal, except for the hypothesis of non-delegable powers, expressly provided for by law.
p.(None): Art. 70. The health surveillance action will be carried out permanently, constituting a routine activity of the health agencies.
p.(None): Art. 71. The powers and prerogatives of the inspection agents will be established in the regulation of this Law.
p.(None): Art. 72. The determination of infractions, under the terms of this Law, will be done through the seizure of samples and interdiction of the product or establishment, as
p.(None): regulation.
p.(None): § 1 - The proof of the infraction will give reason, depending on the case, for the seizure and destruction of the product, throughout the national territory, for the cancellation of the registration
p.(None): and the revocation of the establishment's license, which will only become effective after the publication of the irrevocable condemnatory decision in the Federal Official Gazette.
p.(None): Paragraph 2 - Any changes made as a result of natural causes, circumstances and events will also give rise to apprehension, interdiction and disabling
p.(None): unpredictable, causing product damage, deterioration or contamination, rendering them ineffective or harmful to health.
p.(None): Art. 73. For the purpose of sanitary inspection, the tests aimed at verifying the formula's efficiency will be carried out according to the standards set by the
p.(None): Ministry of Health.
p.(None): Art. 73. Fiscal and control analyzes, for purposes of inspection and monitoring of products subject to the health surveillance regime, shall be carried out
p.(None): by an official laboratory, instituted within the scope of the Union, the States, the Federal District or the Municipalities, or by public or private laboratories accredited for such purpose
p.(None): end. (Wording given by Law No. 13,097, of 2015)
p.(None): Single paragraph. The accreditation referred to in the caput will be carried out by Anvisa or by the official laboratories themselves, under the terms of regulation
p.(None): specific edited by Anvisa. (Included by Law No. 13,097, 2015)
p.(None): Art. 74. They cannot exercise in health inspection bodies and control laboratories public servants who are partners, shareholders or interested parties, Art.
p.(None): in any way, from companies that carry out activities subject to the regime of this Law, or provide services with or without employment relationship.
p.(None): TITLE XV
p.(None): Quality Control of Medicines
p.(None): Art. 75. The Ministry of Health will set standards and improve mechanisms to guarantee the quality of medicines to consumers, taking into account the
p.(None): identity, activity, purity, efficacy and safety of the products and covering the quality specifications and production supervision.
p.(None): Single paragraph. The standards referred to in this article will determine the quality specifications of raw materials and semi-finished products
p.(None): used in the manufacture of medicines, as well as their quality specifications, and will accurately describe the criteria for their acceptance.
p.(None): Art. 76. No raw materials or semi-elaborated products may be used in the manufacture of medicines without having been verified to have
p.(None): acceptable quality, according to evidence that will be the subject of Ministry of Health standards.
p.(None): Art. 77. The inspection of the production of medicines will have, as a priority, the following aspects:
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Searching for indicator education:

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p.(None): imported with the express authorization of the Ministry of Health. (Wording given by Law nº 10.742, of 6.10.2003)
p.(None): Single paragraph. The exemption provided for in this article will only be valid for a period of up to 3 (three) years, at the end of which the product will be required to register, under penalty of
p.(None): apprehension determined by the Ministry of Health.
p.(None): Art. 24-A. Simplified Renewal of the Registration of Medicines is established for medicines that are registered with the Brazilian health agency
p.(None): for a period equal to or greater than 10 (ten), who have not had reports of ineffectiveness and / or significant adverse events and which are adequate to the requirements
p.(None): current sanitary conditions, regardless of their sales classification. (Included by Law No. 13,097, 2015)
p.(None): Single paragraph. The definition of the period referred to in the caput will be made by Anvisa based on criteria that involve the therapeutic class of the product,
p.(None): changes made in its formulation, indications and dosage and in the production process, as well as the route of administration, the pharmaceutical form and the effective
p.(None): product exposure to use. (Included by Law No. 13,097, 2015)
p.(None): Art. 24-B. For the purposes of renewing the registration of medications referred to in art. 24-A, the requirements to be observed by those interested in the act will be
p.(None): defined by Anvisa in regulation. (Included by Law No. 13,097, 2015)
p.(None): TITLE IV
p.(None): From the Registry of Correlates
p.(None): Art. 25 - The devices, instruments and accessories used in medicine, dentistry and related activities, as well as those of physical education, beautification or
p.(None): aesthetic correction, can only be manufactured, or imported, for delivery to consumption and exposure to sale, after the Ministry of Health
p.(None): on whether registration is mandatory or not.
p.(None): § 1 - The devices, instruments or accessories referred to in this article, which are in relationships for this purpose, prepared by the
p.(None): Ministry of Health, being, however, subject, for the other purposes of this Law and its Regulations, to the health surveillance regime.
p.(None): § 2 - The regulation of this Law will prescribe the conditions, requirements and procedures related to the registration of devices, instruments or accessories
p.(None): of this article.
p.(None): TITLE V
p.(None): Registration of Cosmetics, Hygiene Products, Perfumes and others
p.(None): Art. 26 - Only personal hygiene products, perfumes and other products of similar nature and purpose will be registered as cosmetics, the products that are
p.(None): intended for external use or in the environment, depending on their aesthetic, protective, hygienic or odorous purposes, without causing skin irritation or damage to health.
p.(None): Art. 27 - In addition to being subject to specific regulatory requirements, the registration of cosmetics, products for personal hygiene, perfumes and others,
p.(None): of similar purpose, will depend on the satisfaction of the following requirements:
p.(None): I - fit in the list of substances declared innocuous, prepared by the competent body of the Ministry of Health and published in the "Official Gazette" of the Union,
p.(None): which will contain the specifications relevant to each category as well as drugs, inputs, raw materials, dyes, solvents and other
p.(None): allowed in its manufacture;
...

Economic / Food Insecurity

Searching for indicator hunger:

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p.(None): Art. 42 - The provisions of this Law apply to the registration of preparations and rodenticide substances, fixing the regulations and instructions of the Ministry of Health
p.(None): other specific requirements related to this class of products.
p.(None): Art. 43 - The disinfectants will be registered according to the provisions of the Regulation of this Law and in instructions issued by the Ministry of Health.
p.(None): Art. 44 - For the purposes of this Law, detergents and disinfectants and their counterparts, intended for application, are equivalent to household products.
p.(None): in inanimate objects and environments, being subject to the same requirements and conditions regarding registration, industrialization, delivery to consumption and
p.(None): inspection.
p.(None): Art. 45 - The sale of rodenticides and their delivery for consumption will be restricted, exclusively, to products classified as low and medium toxicity, being
p.(None): private companies or bodies and entities of the Direct and Indirect Public Administration supply and control of the application of the
p.(None): high toxicity.
p.(None): TITLE VII
p.(None): Registration of Dietary Products
p.(None): Art. 46 - Those intended for oral intake will be registered as dietary products, which, not covered by the provisions of Decree-Law No. 986, of 21
p.(None): October 1969, and the respective regulations, have their use or sale subject to medical prescription and are intended:
p.(None): I - to meet special dietary needs;
p.(None): II - to supplement and enrich the usual diet with vitamins, amino acids, minerals and other elements;
p.(None): III - to avoid feelings of hunger, appetite and taste, replacing the usual foods in restricted diets.
p.(None): Art. 47 - Only products consisting of:
p.(None): I - natural foods modified in their composition or characteristics;
p.(None): II - natural products, although not considered to be usual foods, containing nutrients or added to them;
p.(None): III - mineral or organic products, pure or associated, able to contribute to the elaboration of special regimes;
p.(None): IV - isolated or associated substances, without nutritional value, intended for restricted diets;
p.(None): V - food supplements containing vitamins, minerals or other nutrients;
p.(None): VI - other products that, individually or in association, can be characterized as dietary by the Ministry of Health.
p.(None): Art. 48 - The dietary products referred to in this Law may be presented in the usual forms of pharmaceutical products, subject to nomenclature and
p.(None): their own characteristics.
p.(None): Art. 49 - To ensure the minimum necessary dietary efficiency and avoid being confused with therapeutic products, the content of the components of the
p.(None): dietary products, which justify their indication in special diets, must obey the internationally accepted standards, according to the relations elaborated by the
p.(None): Ministry of Health.
p.(None): § 1 - In the absence of a standard established for the purposes of this article, the nutrient rate of dietary products will depend on a pronouncement by the Ministry of Health.
p.(None): Cheers.
p.(None): § 2 - The proportion of vitamins to be added to the products will correspond to the standards established by the Ministry of Health.
p.(None): TITLE VIII
p.(None): Authorization of Companies and Licensing of Establishments
...

General/Other / Relationship to Authority

Searching for indicator authority:

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p.(None): clarify or rectify information related to the request previously answered by the requesting company, and will suspend the counting of the deadlines determined in this
p.(None): until they are met. (Included by Law No. 13,411, of 2017) (Effective)
p.(None): § 7 - Unjustified non-compliance with the deadlines provided for in this article implies an assessment of the functional responsibility of the server or servers
p.(None): cause, under the terms of Law No. 8,112, of December 11, 1990. (Included by Law No. 13,411, of 2017) (Effective)
p.(None): § 8 - Anvisa will regulate the provisions of this article, in particular the specification of the criteria referred to in the caput, with a view to
p.(None): priority categories. (Included by Law No. 13,411, of 2017) (Effective)
p.(None): Paragraph 9 - The period of one hundred and eighty days after the beginning of the effectiveness of this article has expired without the regulation provided for in Paragraph 8 having been published, and
p.(None): as long as the matter remains unregulated, the maximum term for the final decision will be three hundred and sixty-five days in the registration and
p.(None): one hundred and eighty days in post-registration alterations. (Included by Law No. 13,411, of 2017) (Effective)
p.(None): Art. 18 - The registration of drugs, medications and pharmaceutical inputs of foreign origin will depend, in addition to the conditions, requirements and
p.(None): procedures provided for in this Law and its regulations, proof that it is already registered in the country of origin.
p.(None): § 1 If it is impossible to comply with the provisions of the caput of this article, proof of registration in force, issued by the
p.(None): of the country in which it is marketed or an international health authority and approved in a specific act of the Ministry of Health's National Health Surveillance Agency
p.(None): of Health. (Included by Provisional Measure No. 2,190-34, 2001)
p.(None): § 2 When registering a medication of foreign origin, the manufacturing company must present proof of compliance with the Good
p.(None): Manufacturing, recognized nationwide. (Included by Provisional Measure No. 2,190-34, of 2001)
p.(None): Art. 19 - The registration of drugs, medications and pharmaceutical supplies will be canceled, whenever any unauthorized modification of its formula is made,
p.(None): dosage, manufacturing conditions, indication of applications and specifications announced in package inserts, labels or advertising.
p.(None): Single paragraph. If there is a need to modify the composition, dosage or therapeutic indications of a pharmaceutical product technically
p.(None): prepared, the company will request the competent permission from the Ministry of Health, instructing the request as provided in the regulation of this Law.
p.(None): Art. 20 - Only the medicine whose preparation requires special care for purification, dosage, sterilization or conservation will be registered when:
p.(None): I - has a new substance in its composition;
p.(None): II - it has a known substance in its composition, which is given a new or advantageous application in therapy;
p.(None): III - present improvement of formula or form, from a pharmaceutical and / or therapeutic point of view.
p.(None): Single paragraph. The right to register medicines similar to those already registered is guaranteed, provided that they satisfy the requirements established in this
p.(None): Law.
p.(None): Single paragraph. The medication that does not have a clinically beneficial substance in its composition cannot be registered
p.(None): or therapeutic. (Wording given by Law No. 9,782, dated 1.26.1999)
p.(None): Art. 21 - A medication that does not have a substance that is known to be beneficial from a clinical or clinical point of view cannot be registered.
p.(None): therapeutic.
p.(None): Art. 21. The right to register medications similar to others already registered is guaranteed, as long as they satisfy the requirements established in this
p.(None): Law. (Wording given by Law No. 9,782, dated 1.26.1999)
p.(None): § 1 Similar medicines to be manufactured in the country, are considered registered after the end of one hundred and twenty days, counted from the presentation
p.(None): of the respective application, if it has not been rejected by then. (Paragraph included by Law No. 9,782, dated 1.26.1999)
p.(None): § 1 The similar medicine to be manufactured in the Country will be considered registered after the end of one hundred and twenty days after the presentation of the respective
p.(None): registration request, if the application has not been rejected by then and provided that the provisions of § 6 of this article are met. (Wording given by Law No. 13,235, of
p.(None): 2015) (Effective)
p.(None): Paragraph 2. The counting of the registration deadline will be interrupted until the satisfaction, by the interested company, of the requirement of the sanitary authority, and this cannot be
p.(None): exceed one hundred and eighty days. (Paragraph included by Law No. 9,782, dated 1.26.1999)
p.(None): § 3 The registration, granted under the conditions of the previous paragraphs, will lose its validity, regardless of notification or interpellation, if the product does not
p.(None): is marketed within one year after the date of its concession, extendable for another six months, at the discretion of the health authority, upon written justification
p.(None): initiative of the interested company. (Paragraph included by Law No. 9,782, dated 1.26.1999)
p.(None): § 4 The request for a new product registration may be made two years after the verification of the fact that caused the loss of the previous validity
p.(None): granted, unless it is not attributable to the interested company. (Paragraph included by Law No. 9,782, dated 1.26.1999)
p.(None): Paragraph 5. The provisions of this article apply to products registered and manufactured in a Member State that is part of the Southern Common Market - MERCOSUR, for
p.(None): effect of its commercialization in the Country, if they correspond to a similar national already registered. (Paragraph included by Law No. 9,782, dated 1.26.1999)
p.(None): § 6 The similar medicine, manufactured or not in the country, must have its effectiveness, safety and quality proven in an equivalent way to that adopted for the
p.(None): Generic drug. (Included by Law No. 13,235, 2015) (Effective)
p.(None): Article 22 - Drugs, medications and pharmaceutical supplies that contain narcotic substances or determine physical or psychological dependence,
p.(None): being subject to the special control provided for in Decree-Law No. 753, of August 11, 1969, as well as in other legal diplomas, regulations and other rules
p.(None): pertinent, and medicines in general, will only be registered if, in addition to meeting the conditions, requirements and procedure established in this Law and
p.(None): regulations, packaging and labeling meet the standards approved by the Ministry of Health.
p.(None): Art. 22. Drugs, medications and pharmaceutical inputs that contain narcotic substances or determine physical or psychological dependence, Art.
...

p.(None): Cheers.
p.(None): § 2 - The proportion of vitamins to be added to the products will correspond to the standards established by the Ministry of Health.
p.(None): TITLE VIII
p.(None): Authorization of Companies and Licensing of Establishments
p.(None): Art. 50 - The operation of the companies covered by this Law will depend on authorization from the Ministry of Health, in view of the indication of industrial activity
p.(None): the nature and type of products and proof of technical, scientific and operational capacity, and other requirements set out in regulations and
p.(None): administrative acts by the same Ministry.
p.(None): Art. 50. The operation of the companies referred to in this Law will depend on authorization by Anvisa, granted upon request to register their
p.(None): activities, the payment of the respective Sanitary Surveillance Inspection Fee and other requirements defined in specific
p.(None): Anvisa. (Wording given by Law No. 13,097, of 2015)
p.(None): Single paragraph. The authorization referred to in this article will be valid for the entire national territory and must be renewed whenever there is a change or inclusion
p.(None): activity or change of the partner or director who is in charge of the legal representation of the company.
p.(None): Single paragraph. The authorization referred to in this article will be valid for the entire national territory and must be updated according to the specific regulation of the
p.(None): Anvisa. (Wording given by Law No. 13,097, of 2015)
p.(None): Art. 51 - The licensing, by the local authority, of industrial or commercial establishments that carry out the activities referred to in this Law, will depend on
p.(None): the operation of the company has been authorized by the Ministry of Health and the technical and
p.(None): established in regulation and instructions of the Ministry of Health, including with regard to the effective assistance of qualified technical
p.(None): activity sectors.
p.(None): Single paragraph. Each establishment will have a specific and independent license, even if there is more than one in the same location, belonging to the same
p.(None): company.
p.(None): Art. 52 - The local supplementary legislation will fix the requirements and conditions for the licensing of the establishments referred to in this Law, observing the following
p.(None): precepts:
p.(None): I - when a single establishment industrializes or markets products of a different nature or purpose, the existence of facilities will be mandatory
p.(None): separate for the manufacture and packaging of materials, substances and finished products;
p.(None): II - adequate location of the premises and prohibition of residences or housing in the properties destined for them and in the adjacent areas;
p.(None): III - prior approval by the state health agency of the projects and plans of the buildings and inspection of the respective compliance.
p.(None): TITLE IX
p.(None): Technical Responsibility
p.(None): Art. 53 - Companies that carry out the activities provided for in this Law are obliged to maintain sufficient legally qualified technical officers,
p.(None): qualitatively and quantitatively, for the adequate coverage of the different species of production, in each establishment.
...

p.(None): Art. 76. No raw materials or semi-elaborated products may be used in the manufacture of medicines without having been verified to have
p.(None): acceptable quality, according to evidence that will be the subject of Ministry of Health standards.
p.(None): Art. 77. The inspection of the production of medicines will have, as a priority, the following aspects:
p.(None): I - manufacturing, taking into account unfavorable intrinsic and extrinsic factors, including the possibility of contamination of raw materials, products
p.(None): semi-finished products and the finished product;
p.(None): II - the finished product, in order to check the compliance with the relevant requirements to the technicians responsible for the manufacture and inspection of the products, to the places
p.(None): and equipment, sanitation, raw materials and systems for inspection and self-inspection and registration of medicines.
p.(None): Art. 78. Without prejudice to the control and inspection under the responsibility of the Public Authorities, every establishment intended for the production of medicines must have
p.(None): technical quality inspection department, which operates autonomously in its sphere of competence, with the purpose of verifying the quality of
p.(None): raw materials or substances, monitor the qualitative aspects of the operations of the drugs produced and perform the other necessary tests.
p.(None): Single paragraph. The pharmaceutical industrial laboratories are allowed to carry out the controls provided for in this article, in official institutes or laboratories, by means of
p.(None): agreement or contract.
p.(None): Art. 79. All reports about accidents or harmful reactions caused by medications will be transmitted to the competent health authority.
p.(None): Single paragraph. Changes in the quality of medicines and any changes in their physical characteristics will be investigated with all
p.(None): details and, once proven, will be subject to the appropriate corrective measures.
p.(None): TITLE XVI
p.(None): Health Surveillance Organs
p.(None): Art. 80. The health surveillance activities referred to in this Law will be carried out:
p.(None): I - at the federal level, by the Ministry of Health, in the form of legislation and regulations;
p.(None): II - in the States, Territories and the Federal District, through their own bodies, observing the relevant federal rules and local supplementary legislation.
p.(None): TITLE XVII
p.(None): Of the final and transitional provisions
p.(None): Art. 81. Companies that already operate the activities covered by this Law will have a period of 12 (twelve) months for changes and adaptations necessary to the
p.(None): compliance with and what is available in it.
p.(None): Art. 82. The services provided by the Ministry of Health, related to this Law, will be remunerated by the public price regime, being the Minister of
p.(None): State to establish the respective values and to discipline their collection. (Repealed by Provisional Measure No. 2,190, of 2001)
p.(None): Art. 83. Drugs, chemicals and ﬁ nal products will be sold in their original packaging and may only be fractionated, for resale, in
p.(None): commercial establishments, under the direct responsibility of the respective technical responsible.
p.(None): Art. 84. The provisions of this Law do not exclude the application of the other rules to which the activities covered by it are subject, in relation to aspects object of
p.(None): specific legislation.
p.(None): Art. 85. To the products mentioned in article 1, governed by special rules, the provisions of this Law apply, as appropriate.
...

Orphaned Trigger Words

Appendix

Indicator List

Indicator	Vulnerability
authority	Relationship to Authority
children	Child
criminal	criminal
dependence	Drug Dependence
drug	Drug Usage
education	education
home	Property Ownership
hunger	Food Insecurity
infant	Infant
language	Linguistic Proficiency
restricted	Incarcerated
sick	Physically Ill
single	Marital Status
substance	Drug Usage
union	Trade Union Membership

Indicator Peers (Indicators in Same Vulnerability)

Indicator	Peers
drug	['substance']
substance	['drug']

Trigger Words

capacity

consent

protect

protection

risk

Applicable Type / Vulnerability / Indicator Overlay for this Input

Vulnerability Type	Vulnerability	Indicator	# Matches
Political	criminal	criminal	1
Health	Drug Dependence	dependence	2
Health	Drug Usage	drug	18
Health	Drug Usage	substance	12
Health	Physically Ill	sick	1
Social	Child	children	1
Social	Incarcerated	restricted	4
Social	Infant	infant	1
Social	Linguistic Proficiency	language	1
Social	Marital Status	single	36
Social	Property Ownership	home	1
Social	Trade Union Membership	union	8
Social	education	education	1
Economic	Food Insecurity	hunger	1
General/Other	Relationship to Authority	authority	5

Law Nº 6360/76

Applicable Type / Vulnerability / Indicator Overlay for this Input

Political / criminal

Health / Drug Dependence

Health / Drug Usage

Health / Physically Ill

Social / Child

Social / Incarcerated

Social / Infant

Social / Linguistic Proficiency

Social / Marital Status

Social / Property Ownership

Social / Trade Union Membership

Social / education

Economic / Food Insecurity

General/Other / Relationship to Authority

Orphaned Trigger Words

Appendix

Indicator List

Indicator Peers (Indicators in Same Vulnerability)

Trigger Words

Applicable Type / Vulnerability / Indicator Overlay for this Input