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07 October 2011 /Authorisation and supervision
The EDQM has suspended the Certificate of Suitability for the active substance oxytetracycline
The European Directorate for the Quality of Medicines and Healthcare, has suspended the Certificate of Suitability for oxytetracycline.
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03 October 2011 /Authorisation and supervision
Changed practice for authorisations for wholesale distribution of medicines within the EU/EEA
The Danish Medicines Agency has changed its practice with respect to the format of authorisations for wholesale distribution of medicines within the EU/EEA. The change concerns the application form's Annex A.1 in which applicants are now only to indicate activities that the company carries out at its own address. Likewise, Annex A.1 of the wholesale dealer's authorisation will only list the activities performed at the company's own address.
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30 September 2011 /Authorisation and supervision
New guidelines on applications for company authorisations
The Danish Medicines Agency has prepared a number of new guidelines on applications for company authorisations.
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06 May 2011 | Updated 30 September 2011 /Authorisation and supervision
Errors found at more than one in five alternative practitioners
More than one in five alternative practitioners visited by the Danish Veterinary and Food Administration and the Danish Medicines Agency in a series of joint on-site inspections last year were unfamiliar with the regulations for the food supplements and medicines on their shelves. This is the result of a report based on more than 50 on-site inspections at alternative practitioners across Denmark.
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20 September 2011 /Authorisation and supervision
The EDQM has suspended the Certificate of Suitability for the active substance theophylline
The European Directorate for the Quality of Medicines and Healthcare (EDQM) has suspended Theophylline.
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20 September 2011 /Authorisation and supervision
The EDQM has suspended the Certificates of Suitability for the active substances ribavirin and tiamulin
The European Directorate for the Quality of Medicines and Healthcare (EDQM) has suspended Tiamulin Hydrogen for veterinary use and Ribavirin.
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26 August 2011 /Authorisation and supervision
Danish translation of the PhVWP's recommendation for hydrochlorothiazide product information
The European Pharmacovigilance Working Party, PhVWP, has prepared a recommendation for the wording of the product information for hydrochlorothiazide. The Danish Medicines Agency has now translated this recommendation into Danish. The text is to be used when preparing new product information for medicines containing hydrochlorothiazide.
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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.
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14 June 2011 /Authorisation and supervision
The EDQM has suspended the Certificate of Suitability for the active substance mesalazine
EDQM, the European Directorate for the Quality of Medicines and Healthcare, has suspended the following Certificates of Suitability (CEP): CEP 2005-277 / Mesalazine
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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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12 May 2011 /Authorisation and supervision
Entry into force of extended deadline for implementation of changes to labelling and package leaflets
The new 12-month deadline for implementation of changes to labelling and package leaflets enters into force on 16 May 2011. As part of the implementation of the new deadline, a new Danish executive order on submission of package leaflets to the Danish Medicines Agency has been issued. Equally, the 'Guideline on variations to marketing authorisations for medicinal products' (the variation guideline) has been updated.
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03 May 2011 | Updated 05 May 2011 /Authorisation and supervision
Antidepressants for treatment of children and adolescents
In continuation of a report on Danish television in ‘DR 21’ on Sunday 1 May 2011 on the risk of suicide from using SSRIs to treat children and adolescents, the Danish Medicines Agency has the following comments.
