EN PL

GMP: New WHO guidance on variations to multisource pharmaceutical products

08.09.2016
The World Health Organizaton recently published a new Annex 10: WHO general guidance on variations to multisource pharmaceutical products. The document is \"intended to serve as a guide for establishing national requirements for the regulation of post-approval changes.\" Proposed categories and reporting procedures are provided. Modifications may be justified in light of risk-benefit and legal considerations specific to each national medicines regulatory authority (NMRA).