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01 November 2011 /Authorisation and supervision
Amendment of executive order on euphoriant substances
As of 27 October 2011, the substances 4-MEC, MPPP and N-ethylbuphedrone are comprised by the Danish executive order on euphoriant substances.
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28 October 2011 /Authorisation and supervision
Annual report on human tissues and cells shows continued rise in tissue establishment activity
The annual report on human tissues and cells is now available in English. It shows, among other things, that there were altogether 56 tissue establishments and 40 gynaecology clinics authorised to handle human tissues and cells in Denmark.
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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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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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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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02 May 2011 /Authorisation and supervision
New requirements for Qualified Persons in pharmaceutical companies
The Danish Medicines Agency has updated the guidelines on requirements and expectations for the Qualified Person in a pharmaceutical company, stating that a person cannot be approved as a Qualified Person on the authorisation if on leave.
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02 May 2011 /Authorisation and supervision
Electronic issuance of company authorisations
On 1 June 2011, the Danish Medicines Agency will switch to issuing company authorisations electronically as a signed PDF file. This means that, as from 1 June 2011, company authorisations will no longer be sent by ordinary post.
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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.
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16 March 2011 /Authorisation and supervision
Changes to authorisation to manufacture and import medicines and intermediates
The EMA has changed its practice on how import activities must be registered in the format for Manufacturer's and Importer's Authorisations (MIA). Import covers import of medicines and intermediates from a country outside the EU/EEA (third country).
