Advanced therapies: post-authorisation

The European Medicines Agency's scientific and regulatory guidance on post-authorisation activities for human medicines marketed in the European Union apply to advanced therapy medicinal products (ATMPs). In addition, EMA has published specific guidance on pharmacovigilance for ATMPs.
Advanced therapies

Bulgarian is available via eTranslation, the European Commission's machine translation service.

Translate to Bulgarian | Important information about machine translation

For more information on post-authorisation activities, see Post-authorisation.

In this section

Share this page