GMP and MAHs
- 13 октября 2016
- 2019/6, EU, GMP, MAH, regulation, владелец регистрационного удостоверения лекарственного препарата, держатель регистрационного удостоверения лекарственного препарата, НПП,
Update [18/11/2021] On 29 July 2021, the European Medicines Agency (EMA) published final version of Reflection paper on Good Manufacturing Practice and Marketing Authorisation Holders. This Reflection Paper is focussed on the GMP-related responsibilities that apply to Marketing Authorisation Holder (MAH) companies and it seeks to provide clarity as to what the various responsibilities are