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Legislation
Law
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
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