Law nº 9.787, of February 10, 1999

Alters Law No. 6.360, of September 23, 1976, concerning sanitary surveillance, establishes the generic drug, decides upon the use of generic names in pharmaceutical products, among other procedures.

THE PRESIDENT OF THE REPUBLIC
I hereby make public that the National Congress decrees and I herein sanction the following Law:

Article 1 - Law No. 6.360, of September 23, 1976 is hereby enforced with the following alterations:

"Article 3
"XVIII - Brazilian Common Denomination (DCB) - denomination of the drug substance or the pharmaceutically active principle approved by the federal agency in charge of sanitary surveillance:
XIX - International Nonproprietary Name (INN) - denomination of the drug substance or the pharmaceutically active principle recommended by the World Health Organization:
XX - Similar Drug product - that which contains the same drug(s), presents the same concentration, dosage form, route of administration, strength and therapeutic indication, preventive or diagnostic, of the reference drug product registered at the federal agency in charge of sanitary surveillance, being allowed to differ only in characteristics related to size and form of the product, expiry date, packaging, labeling, excipients and vehicles, always being identified by its trade mark:
XXI - Generic Drug- drug product similar to a reference or innovative product, expected to be interchangeable with the latter, usually produced after the expiration or waiver of patent protection or of other exclusiveness rights, its effectiveness, safety and quality being proven, and designated by DCB or, in its absence, by INN;
XXII - Reference Drug product - innovative product registered at the federal agency in charge of the sanitary surveillance and marketed in the country, for which effectiveness, safety and quality have been scientifically proven to the competent federal agency, upon its registration;
XXIII - Interchangeable Pharmaceutical Product - therapeutic equivalent to a reference drug product, the same effectiveness and safety effects being essentially proven;
XXIV - Bioequivalence - consists of the demonstration of pharmaceutical equivalence between products presented under the same dosage form, containing identical qualitative and quantitative composition of drug(s), and that have comparable bioavailability when studied under the same experimental design;
XXV - Bioavailability - indicates the rate and the extension of absorption of a drug in a dosage form, based upon its concentration/time curve in the systemic circulation or its excretion in urine.

Article 57
"Only Paragraph. The drug products displaying trade mark must also display, with the same highlight and legible form, in the pieces referred to in the Caput of this article, in the packaging and promotional material, the Brazilian Common Denomination or, in its absence, the International Nonproprietary Name in lettering and characters which size shall not be inferior to half the size of the lettering and characters of the trade mark."

Article 2 - The federal agency in charge of sanitary surveillance shall regulate, within ninety days:

I - the criteria and conditions for the registration and quality control of generic drugs;
II - the criteria for bioavailability tests of pharmaceutical products in general;
III - the criteria for the assessment of therapeutic equivalence, through bioequivalence tests of generic drugs, in order to characterize their interchangeability.
IV - the criteria for dispensing generic drugs in government and private pharmaceutical services, the expressed decision of the prescribing professional for not interchanging being respected.

Article 3 - The acquisition of drug products, under any purchase modality, and medical and dental drug product prescriptions, within the range of the Unified Health System - SUS, must adopt the Brazilian Common Denomination (DCB) or, in its absence, the International Nonproprietary Name (INN).

Paragraph 1 - The federal agency in charge of sanitary surveillance shall edit, periodically, the list of drug products registered in the country, according to the pharmacological classification of the National List of Essential Drug products (Rename) in force and following the Brazilian Common Denomination or, in its absence, the International Nonproprietary Name, followed by the trade marks and the corresponding manufacturing companies.

Paragraph 2 - In the acquisition of drug products referred to in the Caput of this article, the generic drug, when available, shall be given preference over others in the same conditions of price equality.

Paragraph 3 - In announcements, bidding proposals and contracts of acquisition of drug products, within the scope of SUS, the technical specifications of the products, the respective quality control methods and the systematic for compliance certification shall be required when applicable.

Paragraph 4 - The delivery of the acquired drug products shall be accompanied by the respective quality reports.

Article 4 - The Federal Executive Branch is allowed to issue special measures concerning registration, production, taxation system, distribution and dispensation of generic drugs, object of this Law, with a view to encouraging their adoption and use in the country.
Only Paragraph. The Ministry of Health shall provide means and ways to assure wide communication, information and education on generic drugs.

Article 5 - The Ministry of Health shall promote technical-scientific development support programs applied to improvement of drug product quality.
Only Paragraph. The cooperation of national and international institutions related to the assessment of the quality of drug products shall be sought.

Article 6 - Laboratories that produce and market drug products with or without trade mark shall carry out alterations and adaptations needed to comply with this Law within six months.

Article 7 - This Law enters into force on the date of its publication.

Brasília, February 10th 1999, 178th of the Independence and 111st of the Republic.

FERNANDO HENRIQUE CARDOSO
José Serra