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Legislation
Decree Decree
nº 3.841, of June 11, 2001
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Alters
the dispositions stated on Decree No.
3.675, of November 28, 2000, concerning special measures
in relation to the registration of generic medicine, under
art. 4th of Law no 9.787, of February 10, 1999.
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THE PRESIDENT OF THE REPUBLIC, in the use of the attribution vested in him under
article 84, item IV of the Constitution, and, in view of provisions in article
4 of the Law No. 9.787, of February 10, 1999,
DECREES:
Article 1 - Articles
2, 3, 4 and 5 of Decree No. 3.675, of November 28, 2000, comes into force with
the following reading :
"Article 2 Special registration shall be granted
to registered generic medicine, aimed to the public consumption, within one of
the following sanitary authorities:
..............................................................................
Only Paragraph. Special registration shall also be granted to medicines registered
as generic in Belgium, Denmark, Germany, Spain, France, Ireland, Italy, Holland,
Austria, Finland, Sweden, Norway, United Kingdom and in Portugal." (NR)
"Article 3 ..............................................................................
..............................................................................
II - the use, at referred trials, of reference medicine which shall present the
same pharmaceutical form and dosage of the product of national reference."
(NR)
"Article 4 Special registration of generic medicine manufactured
out of the country shall converted into registration by means the presentation
of bioequivalence studies, performed in compliance to the regulations approved
by the National Sanitary Surveillance Agency - ANVISA, being met all technical
dispositions issued by the Collegiate Board of Directors of the National Sanitary
Surveillance Agency and in compliance to the provisions of article 2 of Law No.
9.787, of February 10, 1999." (NR)
"Article 5 ..............................................................................
I - the company holder of the registration shall not present proof of availability
of the product for consumption within all national territory in a maximum of forty-five
working days after the granting of the special registration;
II - nearing
the deadline of eight months, from the date of the issuing of the special registration,
the company holder of the registration that shall prove that al the necessary
measures have been taken towards the internal marketing of the production.
Paragraph 1 The proof of availability mentioned to in item I of the caput of this
article consists on the monthly statement of sales, signed by the company, which
shall contain:
I - the name of the medicine, pharmaceutical form, concentration,
presentation, therapeutic class and amount sold;
II - corporate name of the
consumers to whom the products have been sold, the address, neighbourhood, city,
state, zip code and National Private Corporation Register - CNPJ.
Paragraph
2 Trails of pharmaceutical equivalence and bioequivalence, performed with the
national reference medicine in compliance with the regulations approved by ANVISA,
shall be presented by the manufacturing companies at the beginning of the manufacturing
process." (NR)
Article 2 Numbers "1" and "2" of line
"b" of item I of the Annex to the Decree No. 3.675, of 2000, shall come
into force with the following reading :
"1 - Certificate of Good Practice
of Manufacturing and Control (BPFC/GMP) issued by Canada (Health Canada - Therapeutic
Products Directorate), USA (FDA - Food and Drug Administration), by countries
stated on only paragraph of article 2 or issued by sanitary authorities of the
countries where the productive facilities are installed ." (NR)
"2
- Certificate of Registration or Authorisation for the Commercialization of the
Medicine (generic), issued by one or more sanitary entities in Canada (Health
Canada - Therapeutic Products Directorate), USA (FDA - Food and Drug Administration)
or by countries stated on only paragraph of article 2." (NR)
Art. 3o
This Decree enters into force on the date of its publication.
Brasília,
June 11th 2001; 180th of the Independence and 113th of the Republic.
FERNANDO HENRIQUE CARDOSO
José Serra
This text does not substitute the text published in the Official Journal of the
Union of June 12, 2001
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