Medida Provisória nº 91 de 23/12/2002. ALTERA A LEI 6.360, DE 23 DE SETEMBRO DE 1976, QUE DISPÕE SOBRE A VIGILANCIA SANITARIA A QUE FICAM SUJEITOS, AS DROGAS, OS INSUMOS FARMACEUTICOS E CORRELATOS, COSMETICOS, SANEANTES E OUTROS PRODUTOS.
MEDIDA PROVISÓRIA N. 91 – DE 23 DE DEZEMBRO DE 2002
Altera a Lei nº 6.360, de 23 de setembro de 1976, que dispõe sobre a vigilância sanitária a que ficam sujeitos, as drogas, os insumos farmacêuticos e correlatos, cosméticos, saneantes e outros produtos.
O PRESIDENTE DA REPÚBLICA, no uso da atribuição que lhe confere o art. 62 da Constituição, adota a seguinte Medida Provisória, com força de lei:
O parágrafo único do art. 3º da Lei 6.360, de 23 de setembro de 1976, passa a vigorar com a seguinte redação:
“Parágrafo único. Até 30 de junho de 2003, no caso de medicamentos genéricos importados, cujos ensaios de bioequivalência foram realizados fora do País, devem ser apresentados os ensaios de dissolução comparativos entre o medicamento-teste, o medicamento de referência internacional utilizado no estudo de bioequivalência e o medicamento de referência nacional.” (NR)
Esta Medida Provisória entrará em vigor na data de sua publicação.
Brasília, 23 de dezembro de 2002; 181º da Independência e 114º da República.
FERNANDO HENRIQUE CARDOSO
Barjas Negri
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