News about Licensing and supervision
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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.