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10 June 2011 | Updated 14 June 2011 /Side effects and trials
Diabetes medicine withdrawn in France while awaiting EU review
Since March 2011, the EU has been engaged in reviewing the benefits and risks of diabetes medicines which contain the substance pioglitazone. Pioglitazone is being investigated due to suspicion of an increased risk of urinary bladder cancer. The French drug regulatory authorities have chosen to temporarily remove diabetes medicines that contain pioglitazone from the market, while we are awaiting the outcome of the EU review. In Denmark, the Danish Medicines Agency is awaiting an early, common EU decision on pioglitazone. Danish patients should not change their treatment at the present time.
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09 June 2011 /Authorisation and supervision
New executive order on euphoriant substances (no. 557 of 31 May 2011)
The Danish Ministry of Interior and Health has issued a new executive order on euphoriant substances. The new executive order on euphoriant substances no. 557 of 31 of May 2011 came into force on 3 June 2011.
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08 June 2011 /Authorisation and supervision
Contract manufacturers and contract laboratories do no longer need to be pre-approved by the Danish Medicines Agency
As of 1 June 2011, the Danish Medicines Agency changed its practice so we no longer need to pre-approve contract acceptors as regards Annexes 3 and 4 on section 39 authorisations for manufacture and import of medicines and intermediates (Manufacturer's and Importer's Authorisation, MIA).
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01 June 2011 /Authorisation and supervision
Format change of authorisations for wholesale distribution of medicines within the EU/EEA
On 1 June 2011, the Danish Medicines Agency changed the format of the authorisation for wholesale distribution within the EU/EEA. Medicines for human or veterinary use are no longer divided and product types (A.1.2) have been changed to storage conditions (A.1.2).
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01 June 2011 /News - miscellaneous
Danish Pharmacovigilance Update, May 2011
Among the articles in this issue of Danish Pharmacovigilance Update is a status on adverse reaction reports for contraceptive pills.
