News items 2015
| 29 January 2014 |
After the most recent EU review of a number of new combined contraceptives under Article 31 of Directive 2001/83/EC, it was decided that marketing authorisation holder (MAHs) for these products must send out DHPCs and guidance material to doctors.
| 28 January 2014 |
The Danish Health and Medicines Authority wishes to inform future applicants of the possibility to request for a time slot to applications for marketing authorisations through the decentralised procedure (DCP) where Denmark is acting as reference member state (RMS).
| 27 January 2014 |
The guidelines on good distribution practice of medicinal products for human use came into force on 7 September 2013. Read our questions and answers to the guidelines.
| 15 January 2014 |
On 20 December 2013 and on 10 January 2014, the Danish Health and Medicines Authority decided to revoke the section 39 authorisations for wholesale distribution and manufacturing of medicinal products with the authorisation IDs 25081 and 25082 granted to Singad Pharma ApS (company number 255894).