News items 2015
Consultation on transparency in clinical trials
| 21 January 2015 |
The European Medicines Agency (EMA) has launched a public consultation on how to implement the transparency requirements of the new EU Clinical Trials Regulation. Deadline on 18 February.
Updating of summaries of product characteristics due to changed ATC codes for 2015
| 16 January 2015 |
Marketing authorisation holders of medicinal products authorised under the National Procedure, the Decentralised Procedure, as well as the Mutual Recognition Procedure, should be aware that some ATC codes have been changed in 2015.
Danish Pharmacovigilance Update, December 2014
| 12 January 2015 |
The December issue of Danish Pharmacovigilance Update with news from the EU, the DHMA and short news.
Fees for medical devices in 2015
| 05 January 2015 |
The fees for medical devices have been adjusted in accordance with Danish Government regulations, including the fees for registration of manufacturers and devices, importers and distributors, assessment of applications for the authorisation for clinical investigation of medical devices, and amendments to investigations, as well as supervision and control of notified bodies in Denmark.