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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).
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10 March 2011 /Authorisation and supervision
Issuance of GMP certificates in relation to GMP inspection
The Danish Medicines Agency issues a GMP certificate or a statement of non-compliance with GMP within 90 days after a GMP inspection (inspection of good manufacturing practice). This is done in accordance with the agreed European procedures for inspectorates.
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08 March 2011 /Authorisation and supervision
Voluntary inspection of GLP activities of safety studies involving medical devices
Due to changes to the division of work between the Danish Accreditation and Metrology Fund (DANAK) and the Danish Medicines Agency related to inspections of good laboratory practice (GLP), the Danish Medicines Agency will in future be inspecting GLP trials of medical devices.
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03 March 2011 /Authorisation and supervision
DCP time slots for the first half of 2012
From 1 April 2011 to 30 April 2011, the Danish Medicines Agency resumes the allocation of DCP time slots for the first half of 2012.
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02 March 2011 /Authorisation and supervision
Compliance check of package leaflets and product labelling (winter 2011)
The companies are responsible for ensuring that the package leaflets and labelling of medicines comply with the Danish executive order on labelling. The Danish Medicines Agency regularly carries out random compliance checks of package leaflets and product labelling. Below, you can see which medicines we have checked during winter 2011. Our compliance check has meant that the labelling or package leaflets of a number of the medicines have been or will be changed.
