EMA变更分类指南.pdf

12.12.2008 EN Official Journal of the European Union L 334/7 COMMISSION REGULATION (EC) No 1234/2008 of 24 November 2008 concerning the examination of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products (Text with EEA relevance) THE COMMISSION OF THE EUROPEAN COMMUNITIES, establish a simpler, clearer and more flexible legal framework, while guaranteeing the same level of public and animal health protection. Having regard to the Treaty establishing the European Community, (2) The procedures laid down in Regulations (EC) No 1084/2003 and (EC) No 1085/2003 should therefore be adjusted, without departing from the general prin­ Having regard to Directive 2001/82/EC of the European ciples on which those procedures are based. For Parliament and of the Council of 6 November 2001 on the reasons of proportionality, homeopathic and