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EMA to relocate to Amsterdam
| 21 November 2017 |
he Danish Medicines Agency congratulates Amsterdam on winning the hosting of the EMA and looks forward to a good and constructive cooperation.
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The European Commission has published three recommendations for the clinical trials regulation
| 14 November 2017 |
In cooperation with the clinical trials expert group, the European Commission is updating and issuing new recommendations as a result of the regulation on clinical trials on medicinal products for human use.
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New format requirements for marketing authorisation applications from 1 January 2018
| 10 November 2017 |
The NeeS submission format will be discontinued for applications submitted under the mutual recognition procedure (MRP). This change is related to medicinal products for human use. Parallel import and parallel distribution are not affected by this change.
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New Director of Division for Pharmacovigilance & Medical Devices
| 03 November 2017 |
Jens Piero Quartarolo has been appointed new Director of Division for Pharmacovigilance & Medical Devices and will form part of the Danish Medicines Agency's leadership team.
