Human medicines: regulatory information

This section of the website provides information on the regulation of medicines for human use in the European Union (EU). It particularly concerns the centralised procedure, where the European Medicines Agency (EMA) plays a key role.

The navigation menu contains three main sections corresponding to the key medicinal product lifecycle stages:

Regulatory information on herbal products is in a separate section, as these products are regulated differently in Europe.

For further information on EU legislation and procedures for the regulation of human medicines, see volumes 1-4 and 9-10 of the rules governing medicinal products in the EU.

United Kingdom’s (UK) withdrawal from the EU

EMA has published important information to help users of the centralised procedure prepare for the expected consequences of 'Brexit', including their obligations related to establishment within the European Economic Area (EEA). For more information, see UK’s withdrawal from the EU.