Legislation
Resolution

Resolution - RDC nº 92, of October 23, 2000

The Collegiate Board of Directors of the National Sanitary Surveillance Agency, in the use of the attributions vested in it under Article 11, item IV of the Regulation of ANVISA approved by Decree No. 3.029, of April 16, 1999, in a meeting held on October 18 , 2000,

WHEREAS
Articles VII and VIII of the Decree No. 3181, of 1999, which regulates the Law No. 9787, of 1999;
the need for setting the termination of the transitional period for the trademark adopted as the company name, prior to the name of the active substance;

the provisions of the Law No. 6.360, of September 23, 1976 and its regulation - Decree No. 79.094, of 1977, and Law No. 6.480, December 1, 1977.

the need for setting out the criteria for the labeling of all medicines,

the need for the differentiation of the labels between generic medicine and other medicines;
in compliance with Law No. 9787, of 1999 and Decree No. 3.181, of 1999, similar medicines can only be traded with a trademark;

the issues of labeling and packaging interfere with the safety requirements and the fight against medicine frauds;

Administrative Order ANVS/MS No. 802, of 1998, which establishes the norms and additional criteria for the safety of bottles and labeling of medicines;

adopted the following Resolution and I, the Chairman, determine its publication;

Article 1 - Resolution ANVS No. 510, of October 1, 1999, published in the Official Journal of the Union, enters into force with the language given by this Resolution.

Article 2 - All packaging, labels, directions, informative material, texts and any other advertising material and medical information, related to medicine, should stand out on the same display and in a legible manner, placed in the same printing space, immediately below the trade mark, in a size equal to 50% of these, the generic denomination of the active substance, employing the COMMON BRAZILIAN DENOMINATION- DCB, or the INTERNATIONAL NONPROPRIETARY NAMES - INN, or, for lack of these, the denomination described in the Chemical Abstract Substance (CAS), following this order of priority.

Only paragraph - When the concentration of the active principle is not expressed by the complete CBD (base + salt), such as, ERYTHROMYCIN Esterate or ESTOLATE, the name of the base substance with 50% the size of the trade mark immediately followed by the name of the salt, with a size equal to 50% of the that of the base may be adopted.

Article 3 - In case of association of two or more substances, the criteria present in the annex of this resolution must be adopted.

Article 4 - The companies which currently produce or trade similar medicine with or without a trade mark, or those which have adopted the company name prior to the name of the active substance, will have up to 6 (six) months, as of the date of publication of this resolution, to carry out the alterations needed for compliance with Law No. 9.787, of 1999, and with Decree No. 3.181, of 1999.

Paragraph 1- The lettering used to identify the trade mark for medicine as well as for generic denomination, must follow the proportionality between capital letters and low-case ones. It should also, in compliance with provisions of Article 3 of Decree No. 3181, of 1999, maintain due proportion in terms of distance between letters, with a view to easy reading and highlighting.

Paragraph 2 - Similar medicines can only be commercialized and identified by trade mark that distinguishes it from products of the same manufacturer or other manufacturers.

Paragraph 3 - The official laboratories acknowledged by the Ministry of Health, in order to acquire a trade name for their similar medicines, may adopt the name of the laboratory or another trade mark belonging to the laboratory, placed before the name of the active substance.

Paragraph 4 - Immunetherapeutical medicines cannot, under any circumstances, posses a brand name or designation , in compliance with article 5, paragraph 4, Law No. 6360, of September 23 , 1976, altered by Law No.6480, of December 1, 1977.

Paragraph 5 - Biological products, products derived from human plasma and blood, small volume parenteral solutions (SPPV) and unitary large volume parenteral solutions (SPGV) not containing pharmaceutical substances, such as water for injections, glucose solutions, sodium chloride, other electrolytic compounds or sugars, are allowed to use generic denomination, employing the DCB or INN, or, in its absence, the name described in the Chemical Abstract Substance (CAS), in this order of priority.

Paragraph 6 - The products obtained through biotechnology, with the exception of antibiotics and anti fungus, may also use generic denomination as set forth for the previous compounds.

Paragraph 7 - The labels or advertising of the products dealt with in Law No. 6360, of 1976, must not contain designations, geographical names, symbols, pictures, drawings or any indication that allows misinterpretation, mistake, self-medication or confusion as to the origin, source, nature, composition or quality of the product, or that attribute to the product purposes or characteristics other than those it really possesses.

Article 5 - Registration alterations aimed exclusively at adapting the names of similar medicines which, on the publication date of Decree No. 3181, of 1999, were not characterized and sold with the commercial name or trade mark, must be made by means of filling or of Petition Form 1 and 2 for each presentation of the product, together with registration and revalidation/renovation receipt, as well as commercialization receipt.

Paragraph 1 - Sanitary surveillance fees shall not be charged for undertaking the registration alterations provisioned for in the Caput of this article within the length of time set out in the Caput of article 3. Otherwise, the company must pay the corresponding fee.

Paragraph 2 - The processes of medicine registration that are not concluded by the date of publication of this Resolution must present the documentation required in this Resolution.

Article 6 - When duplication of trade mark is verified, the priority of the denomination of the product is ensured to the holding company, according to chronological order of presentation of requests or of registration in the sanitary surveillance organ of the Ministry of Health.

Only paragraph - The company that has obtained registration of a product with a duplicated name must change it within 90 days, as from the date of its publication in the Official Journal of the Union, or otherwise be subject to cancellation of registration.

Article 7 - Generic medicines, in compliance with Law No. 9787, of 1999, and with ANVISA Resolution No. 391, of 1999, which are registered at the National Sanitary Surveillance Agency, must adopt, for their identification, solely the DCB, or for lack of it, the INN, the use of a trade mark being expressly forbidden.

Article 8 - The generic medicines dealt with in Article 6 of this Resolution must adopt, in their external packaging (box or external label), during the first period of validity of its registration, in a size equal to 30% of the size of the generic denomination, placed immediately underneath it and standing out in the same degree, the expression "Generic medicine Law No. 9787, of 1999".

Article 9 - The secondary and/or primary packaging (in case there is no secondary packaging) of all medicines must contain, as a further factor to prevent trade of falsified products, some sort of or safety seal, which should be unrecoverable after being opened and which make any attempt at opening evident, in order to ensure the inviolability of the packaging.

Paragraph 1 - The sealing of flaps, in case it is used, should ensure the requirements described in the Caput of this article in order to be considered as a safety seal.

Paragraph 2 - Adhesive seals, if used, in addition to the characteristics described in the Caput of this article, must not allow resealing and must contain the personalized identification of the laboratory.

Paragraph 3 - In the case of packaging that allows access to the product through more than one end, both ends should meet the requirements contained in the Caput of this article, in order to preserve the integrity and inviolability of the products.

Article 10 - In any position, apart from the main faces of the product, where the commercial name is placed in the secondary packaging, all applicable requirements contained in this resolution must be met, following the criteria of proportionality, this obligation being extended also to medicines that contain only one active principle or substance, in compliance with Decree No. 3181, of 1999.

Article 11 - The 10mm minimum limit at the base of the packaging, or at the end opposite the opening end, must be respected, as characterization of what is understood to be the footnote space of the box, after which the red strip of medicines sold under medical prescription must be adopted.

Paragraph 1 - For the red strip described in the Caput of this article, the reference color adopted should be pantone red n. 485C, according to standard color classification, the adoption of this same color not being allowed in any other part or composition of the label of medicines, including those sold without the requirement of medical prescription.

Article 12 - For phytotherapic medicines, the same determinations expressed in this regulation shall prevail, and their generic names should follow the official botanic designation.

Article 13 - Companies must meet the requirements of this Resolution within the period of time set out in the Caput of Article 3.

Article 14 - Article 6 of Administrative Order SVS/MS No. 802, of 1998, is hereby revoked.

Article 15 - Non-compliance with or disobedience of the provisions of this Resolution configures infraction of a sanitary nature, under the terms of Law No. 6437, of August 20, 1977, the infractor being subject to the penalties provisioned for in it.

Article 16 - This Resolution enters into force on the date of its publication.

GONZALO VECINA NETO

ANNEX

Medicines possessing two or more active substances in their formula should meet the determinations set out below, in compliance with Article 2 of this Resolution:
1) Medicines with up to two pharmaceutical substances/active principles: the generic name of each pharmaceutical substance should correspond to 50% of the size of the commercial name of the product.
2) Medicines with more than two and up to four pharmaceutical substances/active principles: the generic name of each pharmaceutical substance should correspond to a minimum of 30% of the size of the commercial name.
3) Medicines with more than four pharmaceutical substances/active principles: the generic name of each pharmaceutical substance should correspond to a minimum of 30% of the size of the commercial name or,
3.1) should display only the generic name of the pharmaceutical substance/active principle that justifies the therapeutic indication of the product, followed by the expression "+ ASSOCIATIONS".
Exception: When the type of identification described in item 3.1 is chosen, the complete formula of the product, with generic denominations of the active substances, should be placed on one of the faces of the secondary and/or primary packaging (if there is no secondary packaging), in a size that allows easy reading and identification.
4)Vitamin and/or mineral, and/or amino acid complexes should adopt the expressions Polivitamins and/or Poliminerals and/or Poliaminoacids, as generic designation, corresponding to 50% of the size of the commercial name of the product.
Exception: Also in these cases, the complete formula of the product, with generic denominations of the active substances, should be placed on one of the faces of the secondary and/or primary packaging (if there is no secondary packaging), in a size that allows easy reading and identification.
4) Phytotherapic medicines should use the official botanical designation, following the determinations below:
I place the commercial name of the product;
II use the official botanical designation (class and species) with 50% of the size of the commercial name;
III comply with all the other rules described in this annex.