请教有关欧盟变更的事项

皮妈

请教各位前辈，欧盟兽药变更是否参照人用药变更的有关法规指南，近期查了一下有关法规：


成品涉及涉及  EMA Guidelines on the details of the various categories of variations, on the operation of the procedures laid down in Chapters II, IIa, III and IV of 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 and on the documentation to be submitted pursuant to those procedures (EC)_2013_2804_EN  

                        EMA. Guidelines on the details of the various categories of variations, on the operation of the procedures laid down in Chapters II, IIa, III  and IV of Commission Regulation (EC) No 1234/2008


COS 涉及EDQM发布的  GUIDELINEON REQUIREMENTS FOR REVISION/RENEWAL OF CERTIFICATES OFSUITABILITY TO THE EUROPEAN PHARMACOPOEIA MONOGRAPHS


我的问题，我们的原料药主要供兽药用，参考上面两个法规指南， 2008发布是总纲，2013年最新的指南，不知道是否理解正确？

海棠满枝

这个问题我不清楚，只能帮你顶一下

山顶洞人

做兽药的真少，出口的更少，等其他人来回答吧

依恋

您好，请问法规1和3的适用范围是一个是成品一个是原料药吗？

小金库

感谢分享