EEC MARKETING AUTHORIZATION OF MEDICINAL PRODUCTS

被引：0

作者：

MIKHAIL, M

机构：

来源：

TIERARZTLICHE UMSCHAU | 1992年 / 47卷 / 05期

关键词：

VETERINARY MEDICINAL PRODUCTS; MARKETING AUTHORIZATION; EEC LEGAL REQUIREMENTS; APPLICATION FOR MARKETING AUTHORIZATION; COMMITTEE FOR VETERINARY MEDICINAL PRODUCTS CVMP; PRESCRIPTION ONLY MEDICINE POM; EUROPEAN AGENCY; PHARMACOVIGILANCE; PREMIXES; HIGHTECH MEDICINAL PRODUCTS; MAXIMAL RESIDUE LIMITS MRL; HARMONIZATION;

D O I：

暂无

中图分类号：

S85 [动物医学（兽医学）];

学科分类号：

0906 ;

摘要：

An overview of the legal requirements imposed by the EEC for the marketing authorization of a medicinal product is given which highlights those for veterinary medicinal products. These include the EC directives 81/851, 81/852 and their amendments for the application for marketing authorization, the Committee for Veterinary Medicinal Products COM 90/C 330 on establishing a European Agency and on pharmaco vigilance, 90/167 on pre-mixes, 90/676 on prescription requirements, 87/22 on medicinal products produced by high technology methods and 2377/90 on Maximum Residue Limits (MRL's). Areas which are of concern include the future registration system and the future distribution channels with respect to a harmonised EEC-wide prescription only medicine (POM) policy.

引用

页码：387 / &

共 50 条

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