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02 December 2009 /Authorisation and supervision
Public access to EMA's community database EudraGMP
On 30 July 2009, EMA made it community database EudraGMP available to the public. With time, the database will contain all manufacturing and import authorisations (MIAs) for medicinal products issued to pharmaceutical companies within the EEA
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10 November 2009 /Authorisation and supervision
Information about variation applications from 1 January 2010
In a new regulation, the European Commission has established new rules that regulate variations of authorisations granted according to the Centralised Procedure, Decentralised Procedure (DCP) and the Mutual Recognition Procedure (MRP).
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02 October 2009 /Authorisation and supervision
Control of Granocyte®
The Danish Medicines Agency has analysed two different batches of Granocyte for the presence of the active substance lenograstim.
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02 October 2009 /Authorisation and supervision
Control of Neupogen® and Neupogen Novum®
The Danish Medicines Agency has analysed three different batches of Neupogen and Neupogen Novum for the presence of the active substance filgrastim.
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22 September 2009 /Authorisation and supervision
Medicines inspectors from 27 countries meet in Copenhagen on the use of blood, tissues and cells
This week, the Danish Medicines Agency is hosting an international conference that brings together specialists who carry out inspections of the use of human blood, tissues and cells at hospitals and in the pharmaceutical industry.
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30 June 2009 /Authorisation and supervision
Compliance check of package leaflets and product labelling (spring 2009)
In response to complaints and reports, etc. submitted to the Danish Patient Safety Database, the Danish Medicines Agency has examined different elements of the labelling of the below listed medicinal products to find out whether they comply with the provisions of the executive order on labelling.
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03 April 2009 /Authorisation and supervision
The Danish Medicines Agency resumes the allocation of time slots for the first half of 2011
Until 16 December 2009, the Danish Medicines Agency accepts time slot requests for the first half of 2011 for DCP procedures with Denmark as Reference Member State (RMS)
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12 March 2009 /Authorisation and supervision
Project on the monitoring of compliance with the rules by manufacturers of active pharmaceutical ingredients
Since December 2005, active pharmaceutical ingredients (API) used in medicinal products with a marketing authorisation in Denmark have been required to be manufactured under the EU-GMP.
