Printed 23/05/2012

Url http://laegemiddelstyrelsen.dk/en/topics/authorisation-and-supervision/licensing-of-medicines/news

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Authorisation and supervision

News about licensing of medicines

14 May 2012

Announcement of time slots for decentralised procedures in 2013

The Danish Health and Medicines Authority announces allocation periods for time slots in 2013 for decentralised procedures (DCP) with Denmark as Reference Member State (RMS).
01 May 2012

Clarification regarding parallel imported medicines when the directly imported medicinal product has been deregistered

Generally, it is the parallel importer's responsibility to maintain the authorised summary of product characteristics (SPC) and the package leaflet (PL) when the directly imported medicinal product has been deregistered. Therefore any changes to the SPC and PL, including regular updates to the safety information, must be submitted as variation applications by the parallel importer.
30 April 2012

Submission of package leaflets and product labelling in connection with parallel import
17 April 2012

Translation of the PhVWP's recommendation for product information – proton-pump inhibitors' class effects on magnesium blood levels from long-term use
17 April 2012

Translation of the PhVWP's recommendation for product information – prescription-only proton-pump inhibitors and risk of fractures of the hip, wrist and spine
11 April 2012

Danish translation of the PhVWP's recommendation for the product information of topiramate
15 March 2012

Danish translation of the PhVWP's recommendation for product information – antiepileptics and possible risk of bone disorder
15 March 2012

Revised Danish translation of the PhVWP's recommendation for the product information of rosuvastatin (Crestor)
01 March 2012

Danish translation of the PhVWP's recommendation for the product information ketoprofen and ketorolac
22 February 2012

Danish translation of the PhVWP's recommendation for the product information of escitalopram
17 February 2012

Danish translation of the PhVWP's recommendation for the product information of gonadotropin-releasing hormone agonists
17 February 2012

Danish translation of the PhVWP's recommendation for the product information of methotrexate
17 February 2012

Danish translation of the PhVWP's recommendation for the product information of HMG-CoA reductase inhibitors (statins)
15 February 2012

DCP time slots for the period July-October 2012 still available
08 February 2012

Danish translation of the PhVWP's recommendation for the product information of tibolone (Livial)
31 January 2012

New revised Danish translation of the PhVWP's recommendation for the product information of ophthalmic beta-blockers
25 January 2012

Danish translation of the PhVWP's recommendation for the product information of Strattera (atomoxetine)
20 January 2012

Updating of summaries of product characteristics prompted by changed ATC codes for 2012
13 January 2012 | Updated 17 January 2012

Obligations regarding updates of Active Substance Master Files (ASMF/DMF)
10 January 2012

Danish Medicines Agency resumes allocation of DCP time slots for the period July-October 2012

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