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17 December 2010 /Authorisation and supervision
The EDQM has suspended the Certificate of Suitability for the active substance pyrazinamide
The European Directorate for the Quality of Medicines and Healthcare, EDQM, has suspended the following Certificate og Suitability. CEP R1-1998-070-Rev02 Pyrazinamide
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16 November 2010 /Authorisation and supervision
The EDQM has suspended the Certificate of Suitability for the active substance rifampicin
The European Directorate for the Quality of Medicines and Healthcare, EDQM, has suspended the Certificate of Suitability (CEP) for the active substance rifampicin
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16 November 2010 /Authorisation and supervision
The EDQM has suspended the Certificates of Suitability for the active substances oxytetracycline HCl and phenoxymethylpenicillin potassium
The European Directorate for the Quality of Medicines and Healthcare, EDQM, has suspended the Certificates of Suitability (CEP) for the active substances Oxytetracycline HCl (CEP 1999-162) abd Phenoxymethylpenicillin pottassium (CEP 2006-019)
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16 November 2010 /Authorisation and supervision
The EDQM has suspended the Certificates of Suitability for the active substances metronidazole and caffeine
The European Directorate for the Quality of Medicines and Healthcare, EDQM, has suspended the Certificates of Suitability (CEP) for the active substances metronidazole (R1-CEP 2002-119-Rev 00) and caffeine (R0-CEP 2005-116-Rev 01)
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09 July 2010 /Authorisation and supervision
Licensing of medicines – prioritisation and forecast processing times for the second half of 2010
We still find it important to maintain a high level of participation as rapporteur/co-rapporteur in applications under the centralised procedure as well as a high level of engagement in providing scientific advice to the EMA.
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05 July 2010 /Authorisation and supervision
Notification to medicines manufacturers about reduced testing of raw materials
The Danish Medicines Agency has become aware that there is some uncertainty about the possibility of using reduced testing of raw materials, including active pharmaceutical ingredients (API).
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15 June 2010 /Authorisation and supervision
Implementation of Braille (raised dots for the blind and partially sighted) on medicine packages
Please be advised that the name and strength in Braille (raised dots for the blind and partially sighted people) must appear on the outer packaging of medicine packages in Denmark, cf. section 12 of the Danish executive order on labelling
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21 April 2010 /Authorisation and supervision
The Danish Medicines Agency resumes the allocation of time slots for the second half of 2011
From 3 May 2010 to 31 May 2010 (both days included) the Danish Medicines Agency resumes the allocation of time slots for the second half of 2011.
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03 February 2010 /Authorisation and supervision
Licensing of medicines – prioritisation and forecast processing times for the first half of 2010
The changed administrative procedure that was introduced for national applications in the summer of 2009 now works routinely and according to plan.
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03 February 2010 /Authorisation and supervision
Compliance check of package leaflets and product labelling (winter 2009/2010)
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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26 January 2010 /Authorisation and supervision
New practice for authorisation of contract acceptors on section 39 authorisations
On 1 February 2010, a new practice will apply to the authorisation of contract acceptors on authorisations granted pursuant to section 39 of the Danish Medicines Act (a section 39 authorisation).
