News

15 April 2011 /Authorisation and supervision

The EDQM has suspended the Certificates of Suitability for the active substances buprenorphine hydrochloride, fentanyl, buprenorphine and naltrexone hydrochloride

The European Directorate for the Quality of Medicines and Healthcare (EDQM) has suspended the following Certificates of Suitability (CEP): buprenorphine hydrochloride, fentanyl, buprenorphine og naltrexone hydrochloride

14 April 2011 /Authorisation and supervision

EMA recommends resuming marketing of Octagam®

The European Medicines Agency (EMA) recommends resuming marketing of both strengths of the medicine Octagam®, 50 mg/ml and 100 mg/ml. Octagam® was recalled in autumn 2010 due to an unexpected increase in side effect reports of blood clots. The recommendation to resume marketing is based on a number of improvements in the manufacturing process.

12 April 2011 /Authorisation and supervision

Digital processing of application for company authorisation

In future, the Danish Medicines Agency will prefer to receive applications for company authorisations electronically as a signed, scanned PDF file. Not least, because we have migrated to digital processing, and consequently we scan all incoming post, which is then distributed electronically internally.

01 April 2011 /Authorisation and supervision

Requests for DCP time slots for the first half of 2012 now possible

Until 30 April 2011 , the Danish Medicines Agency is open for requests for DCP time slots for the first half of 2012.