News about company authorisations and registrations
| 01 October 2015 |
As of 1 October 2015, the Danish Health and Medicines Authority will change the practice for issuing Manufacturing and Importation Authorisations (MIAs) to pharmaceutical companies. This means that all manufacturing activities will be listed on the authorisation.
| 31 March 2015 |
The European Commission has published new guidelines on good distribution practice (GDP) for active substances (API) for medicinal products for human use.
| 11 March 2015 |
We have gathered information about the requirements for authorisations, storage, accounting and reporting of euphoriant substances.
| 09 March 2015 |
We can now transfer Wholesale Distribution Authorisations and Good Distribution Practice certificates to EudraGMDP, a Community database in the EU.
| 11 February 2015 |
We have updated our IT systems and are now able to transfer Manufacturing and Importation Authorisations (MIA) to EudraGMDP via EMA's latest XML form. This implies some changes to how we will issue MIAs in future.