Legislation
Law

Law nº 6.360, of September 23, 1976
OFFICIAL JOURNAL OF THE UNION OF SEPTEMBER 24, 1976

Deals with sanitary surveillance, to which medicines, drugs, pharmaceutical inputs and related products, and others are henceforth subject and enacts other provisions.

The President of the Republic
I let be known that the National Congress decrees and I sanction the following law:

TITLE I
Preliminary Provisions

Article 1 - Medicines, drugs, pharmaceutical inputs and related products, as defined in Law No. 5.991, of December 17, 1973, as well as the hygiene products, cosmetics, perfumes, household sanitizing products, products meant for aesthetic enhancement and others defined below, are henceforth subject to the norms of sanitary surveillance instituted by this Law.

Article 2 - Only companies duly authorized by the Ministry of Health and whose facilities have been licensed by the sanitary organizations of the Federal Units where they are located may extract, produce, manufacture, transform, synthesize, purify, fraction, pack, re-pack, import, export, store or remit products mentioned in Article 1.

Article 3 - For the purposes of this Law, in addition to definitions set forth in numerals I, II, III, IV, V and VII of Article 4 of Law No. 5.991, of December 17, 1973, the following definitions are adopted:

I. Diet Products: Products technically prepared in order to meet the dietary needs of people enjoying special physiological conditions;
II. Nutrients: Substances making up food with nutritional value, such as proteins, fats, carbohydrates, water, mineral elements and vitamins;
III. Hygiene Products: Products for external use, antiseptic or otherwise, meant for body cleaning or disinfecting, encompassing toilet soaps, shampoos, toothpaste, mouth-washes, antiperspirants, deodorants, shaving products and after-shave products, astringents and others;
IV. Perfumes: Products with aromatic composition obtained from natural or synthetic substances which, in the appropriate concentration levels and vehicles, may have as their main purpose the addition of pleasant odor to people or environments, including extracts, perfumed waters, cream perfumes, bath preparations, and room scenting products, presented in liquid, gelatinous, paste or solid form;
V. Cosmetics: Products for external use, meant to protect or embellish different parts of the body, such as face powder, talcum, beauty creams, hand-cream and similar products, face masks, beauty lotions, milky creamy and astringent solutions, hand lotions, foundation cream and cosmetic oils, rouge, blush, lipsticks, lip crayons, sun protectors, tan products and artificial tan products, mascara, eye-shadow, eyeliners, hair dyes, hair bleaching products, hair curling or straightening products, wave setting products, hair sprays, hair stuff and similar products, hair lotions, hair removing products, nail products and others;
VI. Colorants: Substances additional to medicines, diet products, cosmetics, perfumes, hygiene products and similar products, household sanitizing products and similar products, having the effect of giving color to those products and, in the case of certain types of cosmetics, that of transferring such color to the skin surface and to skin annexes;
VII. Household Sanitizing Products: Substances or preparations meant for household hygiene, disinfecting or pest-control, in collective and/or public environments, in places of shared use and in water treatment, encompassing;
VIII. a) insect-killing products - meant to fight, prevent and control insects in dwelling places, places and sites of shared use and their neighborhood; b) rat-killing products - meant to fight rats, mice and other rodents, in dwelling places, vessels and places and sites of shared use, containing active substances, isolated or associated, and not hazardous to human health or life or to those of useful warm-blooded animals when applied in compliance with recommendations contained in their packaging; c) disinfectants - meant to destroy micro-organisms, in a selective or indiscriminate manner, when applied to inanimate objects or to environments; d) detergents - meant to dissolve fats and for the hygiene of canisters and containers and for household applications.
IX. Labels: Printed or lithographed identification, as well as the wording painted or fire-engraved, pressure-engraved, pasted or directly applied on canisters and containers, packages or packaging, cartons or any other packaging protector;
X. Packaging: Container, canister, jar or any other type of packaging, susceptible of being removed or not, meant to cover, pack, bottle, protect or maintain, specifically or otherwise, products mentioned in this Law;
XI. Registration: The inscription, in the appropriate ledger, after the decision on licensing by the head of the relevant body within the Ministry of Health, under a serial number, of products mentioned in this Law, indicating their name, manufacturer, origin, purpose and other elements in their composition;
XII. Manufacturing: All operations necessary for obtaining products covered by this Law;
XIII. Raw Materials: Active or inactive substances used in the manufacture of medicines and other products covered by this Law, both those that remain unaltered and those susceptible of undergoing changes;
XIV. Lot or Shipment: Amount of a medicine or product covered by this Law, produced within one cycle of manufacturing and the essential characteristic of which is homogeneity;
XV. Lot Number: Designation printed in the label of a medicine or of a product covered by this Law allowing to identify the lot or shipment to which they belong, and, should it be necessary, to locate and review all manufacturing and inspection operations carried out during production;
XVI. Quality Control: Set of measures meant to guarantee, at any time, the production of lots of medicines and other products covered by this Law, satisfying the norms related to purity, efficacy and innocuity;
XVII. Semi-Elaborated Product: All substances or mixture of substances still under a manufacturing process;
XVIII. Purity: Degree at which a given drug contains other foreign materials.
XIX. Brazilian Common Denomination (DCB) - denomination of the pharmaceutical element or of the pharmaceutically active principle approved by the federal body in charge of sanitary surveillance;
XX. International Nonproprietary Name (INN) denomination of the pharmaceutical element or of the pharmaceutically active principle recommended by the World Health Organization
XXI. Similar Medicine - the one that contains the same active principle or principles, presenting the same degree of concentration, the same pharmaceutical for, the same vehicle, the same dosage and therapeutic, preemptive or diagnosis indications of the reference medicine registered at the federal body in charge of sanitary surveillance, apt to differ solely in terms of characteristics pertaining to the size and form the product, of its period of validity, packaging, labeling, excipients and vehicles, and having to be identified by a trademark;
XXII. Generic Medicine - a medicine similar to a reference product or to an innovative product intended to be interchangeable with the latter, normally produced after or foregoing of the patent protection or of other exclusivity rights, once its efficacy, safety and quality are verified and it is given by DCB or in its absence, by INN;
XXIII. Reference Medicine - an innovating product, registered at the federal body in charge of sanitary surveillance and marketed in the country, the efficacy and safety of which have been scientifically verified at the relevant federal body, on the occasion of its registration;
XXIV. Interchangeable Pharmaceutical Product - therapeutic equivalent of a reference medicine, having the same effects in terms of efficacy and safety essentially verified;
XXV. Bio-equivalence - the demonstration of the pharmaceutical equivalence amongst products presented under the same pharmaceutical form, containing identical qualitative and quantitative composition in terms of active principle or principles, with comparable bio-availability, when studied under the same experimental design;
XXVI. Bio-availability - it indicates the speed and the extent of absorption of an active principle in a form of dosage, starting from its time/concentration curb in the systemic circulation or in its excretion in urine (items added by Law No. 9.787, of February 10, 1999).

Article 4 - Products meant for child use may not contain caustic or irritating substances, they must have packaging exempt from blunt parts and may not be presented in aerosol form.

Article 5 - Products mentioned in this Law may not have names or designations leading to error (Language given by Law No. 6.480, of December 1, 1977).

Paragraph 1 - The adoption of a name equal or similar for products having different compositions is forbidden, even if they are from the same manufacturer, and, in cases of filing requests at the relevant office of the Ministry of Health.

Paragraph 2 - The name of a product having its application for registration made afterwards may be approved, provided that the previous request for registration has been denied for technical or scientific reasons.

Paragraph 3 - Once the collision of brands is verified, the change of the product's name or designation must be requested within 90 (ninety) days from the date of publication of the decision in the Official Journal of the Union, under the penalty of registration denial.

Paragraph 4 - Without damage to the provisions of this Article, and, ad lib of the Ministry of Health, medicines containing a single widely known active substance and the immune-therapy products, drugs and pharmaceutical inputs must be identified by the denomination listed in the Brazilian Pharmacopoeia, and in no case should they bear fancy names or designations. (Added by Law No. 6.480, of December 1, 1977).

Article 6 - The verification that a given product, so far deemed useful, is harmful to health and does not meet requirements established by law means its immediate withdrawal from the market and the requirement that its composition formula and the language in its labels, instructions for use and packaging be changed, under the penalty of registration cancellation and of seizure of the product in the whole national territory.

Only Paragraph - The registration and licensing for use of medicines, as well as the approval or the requirement of change in their components belong solely to the Ministry of Health.

Article 7 - As a measure of sanitary safety and in view of reasons duly justified by the relevant body, the Ministry of Health may suspend, at any time, the manufacturing and sale of any of the products mentioned in this Law which, although registered, becomes suspect of having effects harmful for human health.

Article 8 - No establishment manufacturing or industrializing a product covered by this Law may operate without the assistance and effective responsibility of a legally certified technician.

Article 9 - Establishments covered by this Law making up Public Administration or created by the latter do not need licenses for operating, although they are subject to requirements pertaining to the appropriate facilities, equipment and machinery and to the technical assistance and responsibility.

Only Paragraph - For the purposes of sanitary control, as provided for in the legislation in force, communication to the Ministry of Health by the organizations referred to in this Article of the existence or installation of establishments mentioned in this Law is mandatory.

Article 10 - Imports of medicines, drugs, pharmaceutical inputs and other products mentioned in this Law, for industrial and commercial purposes and without a previous and express favorable opinion by the Ministry of Health, are forbidden.

Only Paragraph - The requirements provided for in this Article include acquisitions or donations involving persons of public and private law the amount and quality of which may jeopardize the execution of national health programs.

Article 11- Drugs, medicines and any related pharmaceutical inputs, hygiene products, cosmetics and household sanitizing products, imported or not, shall only be delivered for consumption in their original packaging or in other ones, previously authorized by the Ministry of Health.

Paragraph 1 - In order to fit the development of Federal Government plans and programs for the production and distribution to the use of special packaging or re-packaging allowing cost reduction without prejudice for the purity or efficacy of products.

Paragraph 2 - Imported products, the marketing of which in the internal market does not need medical prescription shall have clarifying language on their composition, indications and mode of use, in Portuguese, added to the labels.

TITLE II

Registration

Article 12 - No product mentioned in this Law, including imported ones, may be industrialized, displayed for sale or delivered for consumption before registration at the Ministry of Health.

Paragraph 1 - Registration referred to in this Article shall be valid for 5 (five) years, and may be revalidated for equal and successive periods, the initial number of registration being maintained.

Paragraph 2 - The validity of registration and of registration re-validation of diet products, the period of which is of 2 (two) years, is an exception to the provisions of the previous paragraph.

Paragraph 3 - Registration shall be granted within at most 90 (ninety) days, counting from the date request is filed, except in cases of non compliance with this Law or with its regulations.

Paragraph 4 - Deeds pertaining to registration and registration re-validation shall produce effects only starting from the date of publication in the Official Journal of the Union.

Paragraph 5 - Granting of registration and its re-validation, and the previous and control analyses, if appropriate, are subject to the payment of public prices, referred to in Article 82.

Paragraph 6 - Re-validation of registration should be requested in the first semester of the last year of the five-year period of validity, and re-validation of registration shall be deemed automatically granted, irrespective of decision, should there be no pronouncement up to the date of termination of the validity in force.

Paragraph 7 - The registration of a product whose re-validation has not been requested within the period of time referred to in Paragraph 6 of this Article shall be declared expired.

Paragraph 8 - Registration of a product that is not industrialized within its first period of validity shall not be re-validated.

Paragraph 9 - The registration mentioned in this Article must contain the formula of the product's composition, indicating ingredients utilized and the respective dosage.

Article 13 - Any changes in the formula, change of composition elements or of their quantity, any addition, subtraction or innovation introduced in the preparation of the product shall depend upon previous and express authorization by the Ministry of Health , and such changes shall be immediately added to registration.

Article 14 - Fancy names and denominations of products licensed and industrialized prior to the entry into force of this Law are excluded from requirements provided for in this La. (Language given by Law No. 6.480, of December 1,1977).

Article 15 - Registration of products mentioned in this Law shall be denied whenever conditions, requirements and procedures for this purpose provided for in law, regulation or issued by the relevant bodies are not complied with.

TITLE III

Registration of Drugs, Medicines and Pharmaceutical Inputs

Article 16 - Registration of drugs, medicines and pharmaceutical inputs, given their sanitary, medicinal or prophylactic, curative, attenuating or diagnosis characteristics, is subject, in addition to meeting the appropriate regulatory requirements, to the following specific requirements:

I. that the product complies with the provisions of Article 5 and its paragraphs; (language given by law No. 6.480, of December 1, 1977).
II. That the product, by means of scientific verification and analysis, be recognized as safe and effective for the intended use and possess the necessary, activity, quality, purity and innocuity;
III. In cases of new products, that extensive information be provided on their composition and use, so that their nature be assessed and their necessary degree of safety and efficacy be determined;
IV. Presentation, when requested, of samples for analysis and experimenting deemed necessary by the relevant bodies of the Ministry of Health;
V. When there be new substances in the composition of medicines, the delivery of samples accompanied by chemical and physic-chemical data identifying them;
VI. When it is a drug or a medicine Whose preparation requires technical and specific machinery, evidence as to the fact that the establishment is duly equipped and maintains people able to handle such machinery or as to the out-sourcing of such activities;
Only Paragraph - ( Language given by Law No. 6.480, of December 1,1977).

Article 17 - Registration y of products mentioned in this Title shall be denied whenever conditions, requirements and procedures for such purposes provided for in law, regulations or instructions issued by relevant body are not complied with.

Article 18 - Registration of drugs, medicines and pharmaceutical inputs of foreign provenance shall depend, in addition to on the conditions, requirements and procedures provided for in this Law and in its regulation, on the verification that such products are already registered in their countries of origin.

Article 19 - Registration of drugs, medicines and pharmaceutical inputs shall be canceled whenever non authorized changes in their formula, dosage manufacturing conditions, indications for use and specifications announced in prospectuses, labels and advertisement material are introduced.

Only Paragraph - Should it become necessary to change the composition, the dosage or the therapeutic indications of a technically produced pharmaceutical product, the company would request the appropriate permission to the Ministry of Health, as provided for in the regulation of this Law.

Article 20 - Medicines whose preparation requires special care in terms of purification, dosage, sterilization or conservation shall only be registered when:

I. its composition contains new substance or substances;
II. its composition contains known substance or substances for to which a new or advantageous application in therapeutics may be given;
III. they present improvements in their formulae or forms, from the pharmaceutical and/or therapeutic points of view.

Only Paragraph- Medicines whose composition does not contain substance or substances known to be beneficial from the clinical or therapeutic points of view may not be registered. (Language given by Law No. 9.782, of January 26,1999).

Article 21 - The right to register medicines similar to others already registered is granted provided that they meet the requirements set forth in this Law.

"Paragraph 1 - Similar medicines to be manufactured in the Country are deemed registered after a period of time of one hundred and twenty days counted from the date the respective request is filed has elapsed, if so far a denial has not been issued.

Paragraph 2 - Counting of the period of time for registration shall be interrupted until the concerned company satisfies the requirement of the sanitary authority, and such period of time may not exceed one hundred and eighty days.

Paragraph 3 - Registration, when granted under the conditions set forth in the previous paragraphs, shall lose its validity, irrespective of notification or summons, if the product is not marketed within a one-year period after the date registration is granted. This period may be extended for six more months, ad lib of the sanitary authority, by means of written justification at the initiative of the company concerned.

Paragraph 4 - Request for a new registration of a product may be done two years after verification of the fact that gave cause for the loss of validity of the previously granted registration, except if the company concerned is not liable for it.

Paragraph 5 - Provisions of this Article apply to products registered and manufactured in State-Party making up the South Common Market - MERCOSUL, for the purposes of being marketed in the Country, if they correspond to a national, already registered, similar product. (Language given by Law No. 9.782,of January 26,1999).

Article 22 - Drugs, medicines and pharmaceutical inputs containing stupefacient substances or determining psychical dependence and that are subject to the special control provided for in Decree-Law No. 753, of August 11th , 1969,as well as other acts, regulations and other relevant norms, and medicines in general, shall only be registered if, in addition to meeting conditions, requirements and procedures set forth in this Law and in its regulation, their packaging and labeling fit standards approved by the Ministry of Health.

Article 23 - The following are registration exempt:

I. products whose formulae are listed in the Brazilian Pharmacopoeia, in the Codex or in forms accepted by the Ministry of Health;
II. homeopathic preparations made of simple associations of tinctures or by the incorporation of solid substances;
III. concentrated solutes used for the extemporaneous obtainment of pharmaceutical and industrial preparations deemed workshop products,
IV. products deemed equal to workshop ones, whose formulae are not listed in the Pharmacopoeia or in the forms, but are approved and authorized by the Ministry of Health.

Only Paragraph - provisions of this Article do not preclude the mandatory character, for the purpose of marketing products therein referred to, the need for the company to refer to the Ministry of Health the information and clarifying data on injectable solutes.

Article 24 - New medicines exclusively meant for experimental use, under medical control are equally exempt of registration, and can even be imported, by means of an express authorization by the Ministry of Health.

Only Paragraph - The exemption provided for in this Article shall be valid solely for a period of up to 3 (three) years, after expiry of which products must be registered, under the penalty of seizure determined by the Ministry of Health.

TITLE IV

Registration of Related Products

Article 25 - Appliances, instruments and accessories used in medicine, dentistry and related activities, as well as in the activities of physical education, embellishment of aesthetic correction, may only be manufactured, or imported, for delivery for consumption and sale display after the Ministry of Health issues an opinion on the mandatory or non mandatory character of registration.

Paragraph 1 - Instruments or accessories mentioned in this Article and contained in lists prepared by the Ministry of Health for this purpose are exempt from registration. For the other purposes of this Law and of its regulation, however, they remain subject to the regime of sanitary surveillance.

Paragraph 2 - Regulation of this Law shall prescribe the conditions, requirements and procedures concerning registration of machinery, instruments or accessories mentioned in this Article.

TITLE V

Registration of Cosmetics, Hygiene Products, Perfumes and Others

Article 26 - Only products meant for external use in environments shall be registered as cosmetics, products for personal hygiene, perfumes and others with similar nature and purpose, in consonance with their aesthetic, protecting, hygienic or odor-related purposes and provided that they do not bring about skin rashes or harm to health.

Article 27 - In addition to being subject its own regulatory requirements, registration of cosmetics, products meant for personal hygiene, perfumes and others having similar purposes shall depend upon meeting the following requirements:

I. to fit the list of substances declared innocuous, prepared by the relevant body of the Ministry of Health and published in the Official Journal of the Union, that shall contain the pertinent specifications for each category, as well as for medicines, inputs, raw materials, colorants, solvents and other products allowed to be used in their manufacturing;

II. if they do not fit the list referred to in the previous numeral, the innocuity of their respective formulae must be recognized, by means of conclusive opinions issued by the relevant analysis and technical bodies of the Ministry of Health.

Only Paragraph - The list of substances referred to in numeral I of this Article may be altered in order to exclude substances that may be deemed harmful to health, or to include others that may be approved.

Article 28 - Registration of cosmetics, products meant for personal hygiene and others having identical purposes, containing medicinal substances, although in does below therapeutic level, shall follow the norms contained in articles 16 and its numerals, 17,18 and 19 and its Only Paragraph, 20 and 21 and of the regulation of this Law.

Article 29 - Products referred to in Article 26 shall only be registered if they contain in their composition raw materials, solvents, colorants or pharmaceutical inputs contained in the list prepared by the relevant body of the Ministry of Health, published in the Official Journal of the Union, provided that restrictions to their use be expressly highlighted in labels and packaging, when appropriate, according to the area of the body on which they are to be applied.

Only Paragraph - When presented in the form of aerosol, products referred to in Article 26 shall only be registered if they follow the technical standards approved by the Ministry of Health and other specific requirements and norms.

Article 30 - Cosmetics, products for personal hygiene for adults and children, perfumes and related products may have their formulae of composition altered, provided that such changes be approved by the ministry of Health, based upon the relevant technical awards.

Article 31 - Changes in formulae shall be incorporated to the product's registration, as provided for in regulations.

Article 32 - The Ministry of Health shall cause to publish in the Official Journal of the Union the list of natural organic, artificial and synthetic colorants, including their slats and lacquers, as allowed for use in the manufacturing of products mentioned in articles 29, Only Paragraph, and 30.

Paragraph 1 - Any colorant presenting active or potential toxicity shall be excluded from the list referred to in this Article.

Paragraph 2 - Inclusion or exclusion of colorants and of their derivations shall follow provisions contained in the regulation.

TITLE VI

Registration of Household Sanitizing Products

Article 33 - Registration of household sanitizing products, of disinfectants and detergents shall follow the provisions of regulations and of specific complementary norms.

Article 34 - Insect killers may only be registered if:

I. they may be properly applied, in strict compliance with instructions contained in labels and other explanatory elements;
II. they do not represent any possibility of hazard for human health and for the health of domestic warm-blood animals in the forecast conditions of use;
III. they are not corrosive or harmful for surfaces on which they are applied.

Article 35 - Insect killers shall be registered only if:

I. they are presented according to norms provided for in the regulation of this Law;
II. if in their composition the insect-killing and the synergetic substances, natural or synthetic, comply with the appropriate concentration indexes as established by the Ministry of Health;
III. if their composition formulae observe the necessary caution, aimed at their handling and at the therapeutic measures in cases of accident, in view of the indispensable preservation of human life, according to the instructions of the ministry of Health.

Only Paragraph - Regulation of this Law shall set forth the requirements conditions and procedures pertaining to registration of insect killers.

Article 36 - For the purposes of insect-killer registration, substances making up the respective formulae shall be considered:

I. solvents and thinners, those used as vehicles in the preparation of insect killers;
II. propellants, the propulsion agents used in preparations under pressure.

Article 37 - The Ministry of Health shall prepare and cause to be published in the Official Journal of the Union the list of solvents, thinners and propellants allowed, with the respective maximal concentration levels.

Article 38 - Association of insect killers shall be allowed, and these must have the concentration levels of active elements proportionally reduced, when belonging to the same class.

Article 39 - Insect killer associations should satisfy the requirements provided for in Article 35 and its Only Paragraph, as to toxicity for animals subject to the efficiency test.

Article 40 - Registration of insect killers shall be permitted only when meant for:

I. the prompt application by any person for domestic purposes;
II. application and handling by specialized persons or organizations for professional purposes.

Article 41 - preparations whose composition formulae include active substances, isolated or in association, in different levels of concentration and under certain forms and types of presentation shall be registered as rat killers.

Only Paragraph - Associations of rat killing substances of a same class should be reduced proportionally to the concentration levels of their active principles.

Article 42 - Provisions of this Law apply to the registration of rat-killing preparations and substances, further specific requirements pertaining to this class of products remaining to be established in regulations and by the Ministry of Health.

Article 43 - Registration of disinfectants shall be carried out according to the provisions of the regulation to this Law and to instructions issued by the Ministry of Health.

Article 44 - For the purposes of this Law, detergents and disinfectants and their respective related products are deemed equal to household sanitizing products, when meant for application on inanimate objects and on environments, remaining subject to the same requirements and conditions in what regards registration, industrialization, delivery for consumption and inspection.

Article 45 - Sale of rat killers and their delivery for consumption shall remain restricted, exclusively, to products classified as having low and average toxicity, and it belongs exclusively to specialized companies or to organizations or bodies within the Direct and Indirect Public Administration to supply products classified as having high levels of toxicity and to control their application.

TITLE VII

Registration of Diet Products

Article 46 - Products meant for oral ingestion that, though not fitting the provisions of Decree-Law No. 986, of October 21, 1969,and its respective regulations have their use or sale subject to medical prescription, shall be registered as diet products, provided that meant for the purposes below:

I. to meet special dietary needs;
II. to supplement and enrich the usual nourishment with vitamins, amino-acids, minerals and other elements;
III. to disguise the sensations of hunger, of appetite and taste, replacing usual food in restriction diets.

Article 47 - Only products made up of the following substances shall be registered as diet products:

I. natural food modified in its composition or characteristics;
II. natural food, though not deemed usual food, containing nutrients or having nutrients added to it;
III. mineral or organic products, pure or associated, apt to contribute for the design of special diets;
IV. isolated or associated substances, without nutritional value, meant for restriction diets;
V. food complements containing vitamins, minerals or other nutrients;
VI. other products that, isolatedly or in association, may be characterized as diet products by the Ministry of Health.

Article 48 - Diet products mentioned in this Law may be presented under the usual forms of pharmaceutical products, in compliance with their names and their own characteristics.

Article 49 - In order to ensure the minimal dietary efficiency necessary and prevent confusion with therapeutic products, the amount of components of diet products justifying their indication for special diets should meet the standards internationally accepted, as per lists prepared by the Ministry of Health.
Paragraph 1 - If there are no established standards for the purposes of this Article, the rate of nutrients of diet products shall depend upon decision by the Ministry of Health.

Paragraph 2 - The proportion of vitamins to be added to products shall co-respond to the standards established by the Ministry of Health.

TITLE VIII
Authorization of Companies and Licensing of Establishments

Article 50 - Operation of companies mentioned in this Law shall depend upon authorization by the Ministry of Health, in view of indication of the respective industrial activity, of the nature and kind of the products and of the verification of the technical, scientific and operational capability, and of other requirements provided for in regulations and administrative deeds by the same Ministry.

Only Paragraph - The authorization mentioned in this Article shall be valid for the whole national territory, and should be renewed whenever there are changes or inclusion of activities, or changes of partners or directors in charge of the legal representation of the company.

Article 51 - Licensing, by the local authority, of industrial or commercial establishments carrying out activities mentioned in this Law, shall depend upon operation of the company having been authorized by the Ministry of Health and upon being met, by each establishment, the technical and sanitary requirements set forth in regulations and instructions issued by the Ministry of Health, including in what concerns the effective assistance of accredited technical responsible officials to the different sectors of activity.

Only Paragraph - Each establishment shall have a specific and independent license although there be more than one establishment in the same town, belonging to the same company.

Article 52 - Supplementary local legislation shall set forth the requirements and conditions for licensing establishments referred to in this Law, in compliance with the following provisions:

I. When a single establishment industrializes or markets products heading different natures or purposes, it shall be mandatory to have separate facilities for manufacturing and packaging materials, substances and finished goods;
II. Appropriate location of facilities and the interdiction of residences or dwelling places in the buildings allocated to the above mentioned activities and in nearby areas;
III. Previous approval, by the State health organization, of projects and blueprints of buildings and inspection of compliance with same.

TITLE IX
Technical Responsibility

Article 53 - Companies carrying out activities provided for in this Law are obliged to maintain legally accredited technical responsible officials in an amount and with qualifications enough for the appropriate coverage of the different types of production, in each establishment.

Article 54 - It will belong to the technical responsible official to prepare the report to be presented to the Ministry of Health, for the purposes of product registration, as well as to lend effective technical assistance to the sector under his or her professional responsibility.

Article 55 - Although the delivery of technical assistance to the establishment may be discontinued, or should the latter cease operating, the responsibility of the technical professional for activities carried out so far shall remain in force for a one-year period counted as from termination of activities.

Article 56 - Irrespective of other legal typifications, including criminal ones, for which technical and administrative responsible officials may be made accountable, the company shall be liable both from the administrative and civil points of views for sanitary misconduct deriving from non-compliance with this Law and its regulations as well as with other complementary.
TITLE IX

Labeling and Advertising

Article 57 - The Executive Branch shall decide by means of regulation, on labeling, prospectuses, printed material, labels and other information material pertaining to products mentioned in this Law.

"Only paragraph - In addition to the commercial name or brand, medicine must display, in the items referred to in the heading of this Article, in packaging and promotional material, the Brazilian Common Denomination or, when appropriate, the International Nonproprietary Name, in letters and characters never smaller than the size of letters and characters appearing in the commercial". (Paragraph added by provisional Measure No. 1912-7,of August 27, 1999.

Article 58 - Advertisement, under any form of publicizing and means of communication, of products under the regime of this Law may only be carried out after authorization by the Ministry of Health, as to be provided for in regulation.

Paragraph 1 - In cases of drugs, medicines or any other product under the requirement of sale according to medical or dental prescription, advertisement shall be restricted to publications exclusively meant for distribution to physicians, dentists and chemists.

Paragraph 2 - Advertisement of free-sale medicines, diet products, household sanitizing products, cosmetics and hygiene products shall be subject to specific norms to be provided for in regulations.

Article 59 - Geographical names, symbols, images, drawings or any indication leading to false interpretation, error or confusion as to origin, provenance, nature, composition or quality, attributing to the product purposes or characteristics other than those it really possesses may not appear either in labeling or in advertising of products mentioned in this Law.

TITLE XI

Packaging

Article 60 - Approval by the Ministry of Health, as may be provided for in regulations, of packaging, equipment and utensils prepared or internally coated with substances that, in contact with the product, may alter its effects or bring about harm to health, is mandatory.

Paragraph 1 - Packaging meant for containing drugs, medicines, pharmaceutical inputs, hygiene products, cosmetics, perfumes and related products that do not internally contain substances capable of altering the purity and efficacy conditions of the product shall not depend upon approval.

Paragraph 2 - The use of packaging meant for containing or packaging drugs, medicines or pharmaceutical inputs shall not be authorized if apt to bring about direct or indirect hazard to health.

Paragraph 3 - Approval of types of packaging shall be preceded by previous analysis, when appropriate.

TITLE XII

Means of Transportation

Article 61 - In cases of products requiring special storage and safekeeping conditions, vehicles used for their transportation should count on equipment allowing packaging and preservation conditions apt to ensure the purity, safety and efficacy conditions of products.

Only Paragraph - vehicles used in the transportation of drugs, medicines, pharmaceutical inputs and related products, diet, hygiene products, perfumes and similar products must be granted the necessary disinfection and hygiene conditions necessary for the preservation of human health.

TITLE XIII

Infractions and Penalties

Article 62 - A medicine, drug or pharmaceutical input is deemed altered, adulterated or unfit:

I. If it has been mixed or packed with substances apt to modify its therapeutic value or the purpose it is meant for,
II. When an integral element of its normal composition has been withdrawn or falsified, wholly or partly, or when such element has been replaced by another one of lower quality or when the dosage has been modified, or if a substance foreign to its composition has been added to it, so that it becomes different from the formula contained in the registration;
III. When its volume does not correspond to the approved amount;
IV. When its purity, quality and authenticity do not meet the requirements of Brazilian Pharmacopoeia or of other code adopted by the Ministry of Health.

Only Paragraph - should there occur changes due to the passage of time or to causes beyond the responsibility of the technician or of the company the latter would be compelled to immediately withdraw the product from the market, for the appropriate correction or replacement, under the risk of incurring in sanitary infraction.

Article 63 - A hygiene product, cosmetic, perfumes or similar product is deemed forged, falsified or adulterated when:

I. it is presented with indications leading to error, deception or confusion as to its provenance origin, composition or purpose;
II. it does not meet the standards and paradigms set forth in this Law and in regulations, or the specifications contained in registration;
III. its nature, composition, properties or characteristics instrumental for its registration are modified due to addition, reduction or withdrawal of raw materials or components.

Only Paragraph - Inputs made up of active, additional or complementary raw material, of a chemical, bio-chemical or biological nature, of natural or synthetic origin, or any other material meant for manufacturing, handling and processing hygiene products, perfumes and similar products are included in the provisions of this Article.

Article 64 - It is forbidden to reutilize containers traditionally used for food, beverages, soft drinks, diet products, medicines, drugs, chemicals, hygiene products, cosmetics and perfumes for packaging sanitizing and similar products.
must be granted the necessary disinfection and hygiene conditions necessary for the preservation of human health.

Article 65 - It is forbidden to enter new dates or to re-pack in new packaging products whose period of validity has expired, except for therapeutic serums susceptible of being red-dosed and re-filtered.

Article 66 - Non-compliance with provisions of this Law, of its regulation and of complementary norms implies sanitary infraction, infractors being subject to prosecution and to the penalties provided for in decree-Law No. 785, of August 25, 1969, without prejudice for the other applicable civil and criminal typifications.(Note: Decree-Law No. 785, of August 25, 1969, was revoked by Law No. 6.437, of August 20, 1977).

Only Paragraph - The lawsuit referred to in this Article may be initiated and judged by the Ministry of Health or by the sanitary authorities of the States, the Federal District and the Territories, as appropriate.

Article 67 - Irrespective of infractions provided for in Decree-Law No. 785, of August 25,1969, the following practices susceptible of punishment by sanctions indicated in that legal instrument constitute serious or most serious infractions: (Decree-Law No. 785, of August 25, 1969, was revoked by Law No. 6.437, of August 20, 1977).

I. To label products under the regime of this Law or to advertise them without complying with provisions of this Law and of its regulations or in a manner contrary to the terms and conditions of Health;
II. To alter the manufacturing process of products without previous assent by the Ministry of Health;
III. To sell or display for sale a product whose period of validity has expired;
IV. To enter new dates in products whose period of validity has expired or to pack them in new containers, except for therapeutic serums apt to be re-dosed and re-filtered;
V. To industrialize products without the assistance of a legally accredited technical responsible official;
VI. To use ,in the preparation of hormones, organs of animals that are not sound, or presenting signs of decay the moment they are to be manipulated, or coming from ill or exhausted animals, or from animals having undergone loss of weight;
VII. To re-sell a biological product that has not been kept under refrigeration, in compliance with indications determined by the manufacturer and approved by the Ministry of Health;
VIII. To use rat killers whose action be performed through gas or steam in galleries, drainpipes, basements, cellars or places having possible communication with residences or places frequented by human beings or useful animals.

TITLE XIV

Inspection

Article 68 - Sanitary surveillance activities shall encompass all and any product mentioned in this Law, including those for which registration is waived and related products, manufacturing, distribution, storage and sale establishments and the vehicles meant for transportation of such products.

Only Paragraph - Advertisement of products and brand names, through any means of communication, publicity, labeling and labels are also subject to surveillance activities.

Article 69 - Inspection activities belong to:

I. The federal health organization;
a) when the product is in transit from one federal unit to another, by road, through rivers, lakes, sea or air, under the control of federal organizations;
b) when it is an imported or exported product;
c) when it is the case of sample collection for control, previous and fiscal analysis.
II. The State, Territory or Federal District health organizations:
a) when it an industrialized product, or when it is delivered for consumption in the respective area of jurisdiction;
b) as to industrial or commercial establishments, facilities or equipment;
c) as to transport through roads, rivers and lakes within their jurisdictional areas;
d) when it is the case of sample collection for fiscal analysis.

Only Paragraph - Competence mentioned in this Article may be devolved, by means of agreement, in a reciprocal manner, by the Union, the States and Federal District, except for the hypotheses of non-transferable powers, as expressly provided for in law.

Article 70 - Sanitary surveillance activities shall be carried out on a permanent basis, being a routine activity of health organizations.

Article 71 - Functions and prerogatives of inspection agents shall be established in regulations to this Law.

Article 72 - Assessment of infractions, under this Law, shall be done by means of seizure of samples and interdiction of the product or of the establishment, as provided for regulation.

Paragraph 1 - Verification of infraction shall give grounds, as appropriate, for seizure and destruction of the product, all over the national territory, for cancellation of registration and cashiering the establishments license, steps that shall only become effective after publication of the condemning decision in the Official Journal of the Union.

Paragraph 2 - Changes due to unpredictable causes, circumstances or natural events apt to determine damage, deterioration or contamination of products, rendering them ineffective or harmful to health shall also provide grounds for seizure, interdiction and destruction.

Article 73 - For the purposes of sanitary surveillance, experiments meant for verifying the efficiency of formulae shall be carried out in compliance with norms set forth by the Ministry of Health.

Article 74 - Civil servants who are partners, shareholders of, or have an interest of any kind in companies carrying out activities subject to the regime of this Law, or who deliver services to such organizations or in control laboratories.

TITLE XV

Quality Control of Medicines

Article 75 - The Ministry of Health shall enact norms and improve mechanisms meant to ensure consumers the quality of medicines, bearing in mind the identity, activity, purity, efficacy and innocuity of products, and encompassing quality specifications and production inspection.

Only Paragraph - Norms referred to in this Article shall, determine the quality specifications of raw materials and of semi-processed products used in the manufacture of medicines, as well as the quality specifications of the latter, and shall accurately describe the criteria for the respective acceptance.

Article 76 -No raw material or semi-processed product may be used in the manufacture of medicines without the verification that they posses acceptable quality, according to evidence that shall be dealt with in norms issued by the Ministry of Health.

Article 77 - Inspection of the production of medicines shall bear in mind, on a priority basis, the following aspects:

I. manufacturing, bearing in mind unfavorable intrinsic and extrinsic factors, including the possibility of contamination of raw materials, of semi-processed products and of the finished product;
II. the finished product, in order to check whether in meets requirements pertaining to the technical officials in charge of manufacturing and inspection of products, to the sites and equipment, to the sanitation of the environment, to raw materials and to inspection and self-inspection systems and to the registration of medicines.

Article 78 -Without prejudice for control and inspection carried out by the public powers, any establishment meant for the production of medicines shall posses a technical department for quality inspection, operating in an autonomous manner within its sphere of competence, aimed at checking the quality of raw materials or substances, at surveying qualitative aspects of manufacturing operations and the stability of medicines produced, as well as at carrying out other necessary tests.
Only Paragraph - Industrial pharmaceutical laboratories are allowed to carry out controls provided for in this Article in official institutes or laboratories, by means of agreements or contracts.

Article 79 - All reports on accidents or harmful reactions caused by medicines shall be transmitted to the relevant sanitary authority.

Only Paragraph - Changes in the quality of medicines and any change in their physical characteristics shall be investigated in all details, and once verified, shall be subject to the appropriate corrective measures.

TITLE XVI

Sanitary Surveillance Organizations

Article 80 - Sanitary surveillance activities mentioned in this Article shall be carried out:

I. at federal level, by the Ministry of Health, as provided for in legislation and regulations;
II. in the States, Territories and in the Federal District, through their own organizations, in compliance with the relevant federal norms and with the local supplementary legislation.

TITLE XVII

Final and Transitory Provisions

Article 81 - Companies already exploiting activities mentioned in this Law shall have a twelve-month period to carry out the changes and adaptations necessary for compliance with its provisions.

Article 82 - (Revoked by Provisional Measure No. 1912-7, of August27, 1999).

Article 83 - Drugs, chemicals and workshop products shall be sold in their original packaging and may only be fractionated for re-sale, in commercial establishments, under the direct responsibility of the respective technical official in charge.
Article 84 - Provisions of this Law do not preclude the enforcement of other norms covering activities mentioned herein as to aspects mentioned in specific legislation.

Article 85 - Provisions of this law apply to products mentioned in Article 1, governed by special norms, as appropriate.

Article 86 - Sanitizing phyto-sanitary and zoo-sanitary products, those of exclusive veterinarian use and those meant for fighting rats and other rodents in agriculture are excluded from the regime of this Law, since they are meant for use for purposes different from those herein set forth.

Article 87 - The Executive Branch shall enact the regulation and the deeds necessary for the accurate compliance with this law.

Only Paragraph - While regulation and other deeds provided for in this Article are not enacted, the current ones that do not conflict with provisions of this Law shall remain in force.

Article 88 - This Law enters into force 95 (ninety-five) days after its publication, and provisions contrary to it are hereby revoked.

Brasilia, September 23, 1976; 155 of Independence and 88 of the Republic.

Ernesto Geisel
Paulo de Almeida Machado