European Medicines Agency
Founded in 1995, the European Medicines Agency (EMA) is a decentralized agency of the European Union (EU). The EMA regulates medicines, medical devices and herbal products for human use under ‘Human Regulatory’.
The EU legal framework for the authorization, manufacture and distribution can be found in Regulation (EC) No 726/2004 and Directive 2001/83/EC.
EUR-Lex
EUR-Lex is a website that provides access to European Union (EU) law. It includes EU legislation, case law, and other legal documents. EUR-Lex offers a wide range of options to search within its various collections as well as numerous functions catering to different needs.
EUR-Lex / Legal Acts: In this section, you can find the main types of EU legal acts: regulations, directives, decisions, recommendations and opinions. You can also search for certain other documents issued by EU institutions or bodies