News about GMP/cGMP

22.02.2019

Swissmedic uses EU’s EudraGMDP database

As reported by the European Medicines Agency EMA, the Swiss Agency Swissmedic, has started in 2019 to enter information on GMP compliance as well as on manufacturing authorisations related to Swiss manufacturers into the European Union’s EudraGMDP database. This applies for all new or renewed manufacturing authorisations and the related GMP-certificates issued using new templates (similar to those of EMA). This will allow replacing the current practice of issuing paper documents, i.e. GMP and should lead to easier information-sharing and efficiency gains for all stakeholders.

This latest development is part of the mutual recognition agreement (MRA) between the EU and Switzerland, operational since June 2002 and most recently updated in August 2017. The latest amendment introduced the provisions on data entry to EudraGMDP by the Swiss authorities. Swissmedic has ‘read and write’ access to the data base and will be entering GMP compliance information on Swiss manufacturers, including those exporting to the EU. As a consequence, the regulatory requirement to provide original paper GMP certificates issued by EU or Swiss authorities will be replaced by either the provision of a reference to an entry in EudraGMDP or by means of a downloadable file or printout from the data base.


Source:

Swissmedic: Certificates

EMA: News



Comments

No comment has yet been written about this news


Write your comment about this news