Decreto-Lei n.º 289/94, de 14 de Novembro de 1994
Decreto-Lei n.° 289/94 de 14 de Novembro Face à evolução técnico-científica e à experiência entretanto adquirida torna-se necessário rever o regime do Decreto-Lei n.° 76/87, de 13 de Fevereiro, que estabelece o regime jurídico do fabrico, importação, comercialização e utilização de produtos biológicos para uso veterinário.
Importa ainda proceder à transposição para a ordem jurídica interna das Directivas n.os 90/677/CEE, do Conselho, de 13 de Dezembro, e 92/18/CEE, da Comissão, de 20 de Março, que estabelecem normas relativas a medicamentos veterinários imunológicos e requisitos especiais aplicáveis aos seusensaios.
Assim: Nos termos da alínea a) do n.° 1 do artigo 201.° da Constituição, o Governo decreta o seguinte: Artigo 1.° O presente diploma transpõe para a ordem jurídica interna as Directivas n.os 90/677/CEE, do Conselho, de 13 de Dezembro, e 92/18/CEE, da Comissão, de 20 de Março, que estabelecem normas para medicamentos veterinários imunológicos e requisitos especiais aplicáveis aos ensaios destes produtos de uso veterinário.
Art. 2.° As normas técnicas de execução do presente diploma são objecto de portaria do Ministro da Agricultura.
Art. 3.° Compete ao Instituto de Protecção da Produção Agro-Alimentar (IPPAA) e à Inspecção-Geral das Actividades Económicas (IGAE) assegurar a fiscalização do cumprimento das normas do presente diploma e respectiva regulamentação, sem prejuízo das competências atribuídas por lei a outras entidades.
Art. 4.° - 1 - Constituem contra-ordenações puníveis pelo presidente do conselho directivo do IPPAA, com coima cujo montante mínimo é de 100 000$ e máximo de 500 000$: a) A instalação de laboratórios fabricantes de medicamentos veterinários imunológicos sem a licença emitida pelo IPPAA; b) A importação e ou exportação de medicamentos veterinários imunológicos por agentes não possuidores da respectiva licença emitida pelo IPPAA; c) A inobservância das regras previstas para a introdução no mercado e comercialização dos medicamentos veterinários imunológicos; d) O incumprimento das normas relativas à prescrição e utilização dos medicamentos veterinários imunológicos.
2 - A tentativa e a negligência são puníveis.
3 - As coimas aplicadas às pessoas colectivas podem...
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