Asset Publisher

null Pharmaceutical plants and pharmaceutical wholesalers must register in the database of the European Medicines Agency by 28 January 2022

Pharmaceutical plants and pharmaceutical wholesalers must register in the database of the European Medicines Agency by 28 January 2022

6.10.2021

Pharmaceutical plants and pharmaceutical wholesalers – including manufacturers, importers, and distributors of active substances – must be registered in the European Medicines Agency's Organisation Management System (OMS) by 28 January 2022.

Registration will be a prerequisite for the issue of GMP/GDP certificates and operating licences and for the registration of manufacturers, importers, and distributors of active substances in the EudraGMDP database. EudraGMDP is an EU database on the manufacture and wholesale of pharmaceuticals, which publishes certificates of Good Manufacturing Practice (GMP) and Good Distribution Practices (GDP) or Non-Compliance reports, operating licenses for pharmaceutical plants and pharmaceutical wholesalers, and registrations of manufacturers, importers, and distributors of active substances.

The registration requirement applies to pharmaceutical plants and pharmaceutical wholesalers in the EU area and to pharmaceutical importers situated in the EU area, who must ensure that the places of manufacture of imported medicines in 3rd countries are also registered in the OMS.

The registration requirement is based on the development of the EMA databases and the changes to the EudraGMDP database as of 28 January 2022 following the entry into force of the EU Veterinary Medicines Regulation.

Read more:

Integration of EudraGMPD and OMS - Webinar for industry | European Medicines Agency (europa.eu)

EudraGMDP database

Ask more

  • Mirka Laavola, Senior Inspector, tel. + 358 29 522 3255
  • Mervi Saukkosaari, Senior Inspector, Head of Division, tel. + 358 29 522 3261
  • E-mail addresses are in the format firstname.lastname@fimea.fi