Decree No. 3841, Of 11 June 2001

Original Language Title: Decreto nº 3.841, de 11 de Junho de 2001

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Decree No. 3841, of 11 JUNE 2001 Gives new wording the provisions of the Decree No. 3675, 28 November 2000, which provides for special measures relating to the registration of generic medicines, which deals with the art. 4 of law No. 9787, of 10 February 1999.
The PRESIDENT of the REPUBLIC, in the use of the role that gives the art. 84, section IV, of the Constitution, and in view of the provisions of art. 4 of law No. 9787, of 10 February 1999, DECREES: Art. 1st The arts. 2, 3, 4 and 5 of Decree No. 3675, 28 November 2000, with the following wording: Art. 2 the special registration will be granted to registered generic medicines intended for public consumption, in one of the following: health authorities..................................................................................................................................................................................................
Sole paragraph. The special registration will also be granted to registered medicines as generics in Belgium, Denmark, Germany, Spain, France, Ireland, Italy, Netherlands, Austria, Finland, Sweden, Norway, United Kingdom and Portugal. " (NR)
? Art.3º................................................................................... .....................................................................................................
II. the use, in the said tests, reference drug to produce the same pharmaceutical form and dosage that the national reference product. " (NR)
"Art. 4 the special registration of generic drugs manufactured outside the country will be converted to registry on submission of bioequivalence studies, conducted in accordance with the rules adopted by the national health surveillance Agency. An-VISA, met the technical provisions issued by the Joint Board of the national health surveillance Agency and in accordance with the provisions of art. 2 of law No. 9787, February 10, 1999. " (NR)
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I? the company owns the record not present proof of product available for consumption throughout the country within 45 working days after the grant of the special registration;
II. within eight months, counted from the date of publication of the special registration, the company owns the record does not demonstrate that the necessary measures have been taken to the internalization of the production.
(1) proof of availability referred to in item I of the caput of this article consists of the monthly statement, signed by the company, stating: I? name of medicine, pharmaceutical form, concentration, presentation, therapeutic class and quantity sold;
II. business name of the client to whom they were sold the products, address, neighborhood, city, unit of the Federation, Postal code? Zip code and national registry of legal entities? CNPJ.
§ 2 The pharmaceutical equivalence and bioequivalence tests, carried out with the national reference medicinal product according to rules adopted by the ANVISA, must be submitted by manufacturers to start? if the manufacturing process. " (NR)
Art. 2 the numbers "1" and "2" of item "b" of section I of the annex to Decree No. 3675, 2000, shall take effect as follows: "1. Certificate of good manufacturing practices and control (BPFC/GMP) issued by Canada (Health Canada? Therapeutic Products Directorate), USA (FDA-Food and Drug Administration), for countries listed in the sole paragraph of art. 2nd or issued by health authorities of the countries in which they are installed productive plants. " (NR)
"2 ? Certificate of registration or authorization of Marketing of the medicinal product (generic), issued by one or more organs Health Canada (Health Canada-Therapeutic Products Directorate), USA (FDA? Food and Drug Administration) or countries listed in the sole paragraph of art. 2.? (NR)
Art. 3 this Decree shall enter into force on the date of its publication.
Brasilia, June 11 2001; 180 degrees of independence and 113 of the Republic.
FERNANDO HENRIQUE CARDOSO José Serra