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29 July 2011 /Authorisation and supervision
New guidelines on submittable formats for applications for marketing authorisation, variations, etc.
The Danish Medicines Agency has formulated new guidelines on submittable formats for applications for marketing authorisation, variations, update prior to MRP, renewal, follow-up and referral to CMD. In addition, the guidelines on submission of paper applications have been revised. The new guidelines are intended to make it easier for companies to submit applications electronically and to ease our electronic processing of applications.
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26 July 2011 /Authorisation and supervision
New labelling order effective on 28 July 2011
A new executive order no. 869 of 21 July 2011 on the labelling etc. of medicinal products (labelling order) enters into force on 28 July 2011. Most provisions of the new labelling order are unaltered compared to executive order no. 1210 of 7 December 2005 on labelling etc. of medicinal products.
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22 July 2011 /Authorisation and supervision
Annual report 2010 of the Danish Medicines Agency's laboratory control activities
The Danish Medicines Agency's Laboratory has published an annual report for 2010 that describes our activities within the European network called the Official Medicines Control Laboratories (OMCL).
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18 July 2011 /Authorisation and supervision
Update for tissue establishments about the West Nile Virus and quarantine
In cooperation with the Danish National Board of Health, the Danish Medicines Agency wishes to inform tissue establishments in Denmark about the risk of exposure to the West Nile Virus.
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14 July 2011 /Authorisation and supervision
Licensing of medicines prioritisation and forecast processing times for the second half of 2011
Every six months, we prioritise and forecast processing times for the authorisation of medicines. Our forecast for the second half of 2011 and status on the first half of 2011 are now ready.
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13 July 2011 /Authorisation and supervision
Danish translations of the PhVWP recommendations for the wording of product information are now available on our website
The Danish Medicines Agency has translated a series of recommendations for the wording of summaries of product characteristics and package leaflets, prepared by the European Pharmacovigilance Working Party, PhVWP. The Danish translations are now available on our website.
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13 July 2011 /Authorisation and supervision
Generic substitution terminated for oral medicines containing cyclosporine or tacrolimus
With regard to generic medicines for oral use that contain cyclosporine or tacrolimus, it has so far been possible to label these as generically substitutable if the medicines were assessed to be therapeutically interchangeable. Provided, however, that bioequivalence between the generic version and the original product is established based on stringent criteria. Following a reassessment, the Danish Medicines Agency now considers that generic substitution should no longer be possible for these to active substances.
