News items 2015
The common portal for clinical trial applications on DKMAnet still postponed
| 10 February 2014 |
We plan to launch DKMAnet for clinical trial applications to both the research ethics committees and the Danish Health and Medicines Authority in the first half of 2014.
Danish Pharmacovigilance Update 28 November 2013
| 03 February 2014 |
In this issue of Danish Pharmacovigilance Update: Ciprofloxacin and the risk of tendon disorders, risk of blood clots from the use of the cancer medicine ponatinib and reporting of adverse reactions to the Danish Health and Medicines Authority.
Information to MAHs for new combined hormonal contraceptives
| 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.
Time slots for DCP procedures with Denmark as Reference Member State (RMS)
| 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).
Questions and answers to new good distribution practice guidelines
| 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.
Revocation of wholesale distribution and manufacturing authorisations granted to Singad Pharma ApS
| 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).