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14 May 2012 /Authorisation and supervision
Announcement of time slots for decentralised procedures in 2013
The Danish Health and Medicines Authority announces allocation periods for time slots in 2013 for decentralised procedures (DCP) with Denmark as Reference Member State (RMS).
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10 May 2012 /Side effects and trials
Drug Analysis Prints with data from more than 14,000 side effect reports
In February, the Danish Health and Medicines Authority published the first 14 of approximately 1,000 adverse reactions prints, called Drug Analysis Prints, of suspected adverse drug reactions (ADRs) reported by doctors, patients and relatives. We have now published the rest.
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01 May 2012 /Side effects and trials
Questions and answers from the Clinical Trial Facilitation Group on trial designs and DSUR
The Clinical Trial Facilitation Group (CTFG) has drawn up a Q&A document on specific trial designs and a document on Development Safety Update Report (DSUR). The CTFG was formed in 2004 by the Heads of Medicines Agencies (HMA), one of the purposes being to obtain a more uniform interpretation of the EU regulatory requirements.
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01 May 2012 /Authorisation and supervision
Clarification regarding parallel imported medicines when the directly imported medicinal product has been deregistered
Generally, it is the parallel importer's responsibility to maintain the authorised summary of product characteristics (SPC) and the package leaflet (PL) when the directly imported medicinal product has been deregistered. Therefore any changes to the SPC and PL, including regular updates to the safety information, must be submitted as variation applications by the parallel importer.
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01 May 2012 /Side effects and trials
Monthly report from the EU Pharmacovigilance Working Party, PhVWP – April 2012
The EU Pharmacovigilance Working Party (PhVWP) convened on 16-18 April 2012. Among the topics discussed at the meeting were:
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01 May 2012 /Side effects and trials
Monthly report from the EU Pharmacovigilance Working Party, PhVWP – March 2012
The EU Pharmacovigilance Working Party (PhVWP) convened on 12-14 March 2012. Among the topics discussed at the meeting were:
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30 April 2012 /Authorisation and supervision
Submission of package leaflets and product labelling in connection with parallel import
The Danish Health and Medicines Authority reminds companies submitting parallel import applications to enclose the package leaflet and labelling on an A4 sheet in a readable font size. The font size used must be size 11 or more.
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25 April 2012 /Retail and online sale
MaxiMenPills – an illegal potency-enhancing product
An analysis performed by the Danish Health and Medicines Authority of the potency-enhancing product MaxiMenPills, previously marketed by a Danish online shop, has established that the product contains two active substances, which are not declared on the package.
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25 April 2012 /Side effects and trials
Use of EU register facilitates publication of clinical research
Researchers who author articles based on clinical trial results can now avoid having to publish the same study in two different public registers. They can avoid double-registration because the EU Clinical Trials Register has now been recognised by the World Health Organization (WHO’s International Clinical Trials Registry Platform) as a so-called 'primary registry' like its US counterpart ClinicalTrials.gov.
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24 April 2012 /Authorisation and supervision
The EDQM has withdrawn the Certificate of Suitability for the active substance Acetylsalicylic acid
EDQM, the European Directorate for the Quality of Medicines and Healthcare, has withdrawn the following Certificate of Suitability (CEP): R0-CEP 2006-195-Rev 00 / Acetylsalicylic acid.
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24 April 2012 /Authorisation and supervision
The EDQM has suspended the Certificate of Suitability for the active substance Stanozolol Micronised
EDQM, the European Directorate for the Quality of Medicines and Healthcare, has suspended the following Certificate of Suitability (CEP): R1-CEP 2002-222-Rev 01 / Stanozolol Micronised.
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24 April 2012 /Authorisation and supervision
The EDQM has withdrawn the Certificate of Suitability for the active substance Oxaliplatin
EDQM, the European Directorate for the Quality of Medicines and Healthcare, has withdrawn the following Certificate of Suitability (CEP): R0-CEP 2005-158-Rev 00 / Oxaliplatin.
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23 April 2012 /Side effects and trials
Gilenya (fingolimod) – new recommendations to reduce risk of adverse effects on the heart
The European Medicines Agency has recommended new advice to healthcare professionals to reduce the risk of adverse effects on the heart associated with the use of the multiple sclerosis treatment Gilenya (fingolimod).
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18 April 2012 /Authorisation and supervision
The EDQM has withdrawn Certificates of Suitability for the active substance Diclofenac Sodium
EDQM, the European Directorate for the Quality of Medicines and Healthcare, has withdrawn the following Certificates of Suitability (CEP): R0-CEP 2006-304-Rev 00 Diclofenac Sodium and R1-CEP 2000-133-Rev 02 Diclofenac Sodium.
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17 April 2012 /Authorisation and supervision
Translation of the PhVWP's recommendation for product information – proton-pump inhibitors' class effects on magnesium blood levels from long-term use
The European Pharmacovigilance Working Party, PhVWP, has prepared a recommendation for the wording of the product information concerning the class effects of proton-pump inhibitors (dexlansoprazole, esomeprazole, lansoprazole, omeprazole, rabeprazole, pantoprazole) on magnesium blood levels from long-term use.
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17 April 2012 /Authorisation and supervision
Translation of the PhVWP's recommendation for product information – prescription-only proton-pump inhibitors and risk of fractures of the hip, wrist and spine
The European Pharmacovigilance Working Party, PhVWP, has prepared a recommendation for the wording of the product information for prescription-only proton-pump inhibitors (omeprazole esomeprazole/naproxen, omeprazole/ketoprofen, esomeprazole, lansoprazole, pantoprazole, rabeprazole) and risk of fractures of the hip, wrist and spine.
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17 April 2012 /Authorisation and supervision
The EDQM has withdrawn Certificates of Suitability from CSPC Innovation Pharmaceutical Co., Ltd.
EDQM, the European Directorate for the Quality of Medicines and Healthcare, has withdrawn a number of Certificates of Suitability (CEP) from CSPC Innovation Pharmaceutical Co., Ltd.
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13 April 2012 /Side effects and trials
Risk-adapted assessment of clinical trials of already marketed medicinal products
The Danish Health and Medicines Authority has looked into the possibility of assessing clinical trials of already marketed medicinal products based on risk adaptation. We now offer shorter assessment times for clinical trials where the risk involved for patients is not higher than the risk of exposing the trial participant to standard treatment.
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11 April 2012 /Authorisation and supervision
Danish translation of the PhVWP's recommendation for the product information of topiramate
The European Pharmacovigilance Working Party, PhVWP, has prepared a recommendation for the wording of the product information for topiramate-containing medicines. The Danish Health and Medicines Authority has now translated this recommendation into Danish.
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11 April 2012 /Authorisation and supervision
The EDQM has suspended the Certificate of Suitability for the active substance Trimetazidine dihydrochloride
EDQM, the European Directorate for the Quality of Medicines and Healthcare, has suspended the following Certificates of Suitability (CEP): RO-CEP 2007-245-Rev 01 Trimetazidine dihydrochloride.
