欧盟免疫兽用药品的许可程序。

Licensing procedures for immunological veterinary medicinal products in the European Union.

作者信息

Pastoret P P, Falize F

机构信息

Department of Immunology-Vaccinology, Faculty of Veterinary Medicine, University of Liège, Sart Tilman, Belgium.

出版信息

Adv Vet Med. 1999;41:595-607. doi: 10.1016/s0065-3519(99)80045-7.

DOI:10.1016/s0065-3519(99)80045-7

PMID:9890046

Abstract

With the adoption of the new authorization system, all regulatory needs for veterinary medicinal products have been fulfilled with the European Union. This system, indeed, provides access to a continent-wide market to innovative products, in particular vaccines, and facilitates access to the markets of the Member States for other products. This should have a clearly favorable impact on the veterinary vaccines industry.

摘要

随着新授权体系的采用，兽用药品的所有监管要求在欧盟均已得到满足。事实上，该体系为创新产品，尤其是疫苗，提供了进入全欧洲市场的机会，并便利了其他产品进入成员国市场。这对兽用疫苗行业应会产生明显的有利影响。