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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.
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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.
