Danish Pharmacovigilance Update, August 2014
The August issue of Danish Pharmacovigilance Update. News from the EU Restrictions on the use of bromocriptine (Parlodel®) to inhibit lactation, page 3 EU's list of recommendations on safety signals,...
View ArticleMonthly report from the EU Pharmacovigilance Risk Assessment Committee...
The EU Pharmacovigilance Risk Assessment Committee (PRAC) convened on 8-11 September 2014. Topics discussed at the meeting: PRAC concludes review of Valdoxan/Thymanax (agomelatine). Two years of focus...
View ArticleConsultation procedure about medicinal products and safety measure...
On 5 September 2014, the Danish Health and Medicines Authority submitted a draft list of the medicinal products comprised by the new safety measures rules (Directive 2001/83) for consultation. The...
View ArticleDanish Pharmacovigilance Update, December 2014
The December issue of Danish Pharmacovigilance Update with news from the EU, the DHMA and short news: Danish Pharmacovigilance Update, December 2014 News from the EU EU's list of recommendations on...
View ArticleUpdating of summaries of product characteristics due to changed ATC codes...
Marketing authorisation holders of medicinal products authorised under the National Procedure, the Decentralised Procedure as well as the Mutual Recognition Procedure, should be aware that some ATC...
View ArticleConsultation on transparency in clinical trials
The European Medicines Agency (EMA) has launched a public consultation on how to implement the transparency requirements of the new EU Clinical Trials Regulation. The requirements must be implemented...
View ArticleDKMAnet Clinical trials – Problems with submission to the research ethics...
Clinical trial submissions via DKMAnet are not forwarded to the research ethics committees. Unfortunately, clinical trial submissions via DKMAnet are not forwarded to the research ethics committees...
View ArticleDanish Pharmacovigilance Update, August 2014
The August issue of Danish Pharmacovigilance Update. News from the EU Restrictions on the use of bromocriptine (Parlodel®) to inhibit lactation, page 3 EU's list of recommendations on safety signals,...
View ArticleMonthly report from the EU Pharmacovigilance Risk Assessment Committee...
The EU Pharmacovigilance Risk Assessment Committee (PRAC) convened on 8-11 September 2014. Topics discussed at the meeting: PRAC concludes review of Valdoxan/Thymanax (agomelatine). Two years of focus...
View ArticleDigitisation of procedure for issuing export certificates for medicinal...
We are simplifying the procedure for issuing export certificates for medicinal products. Previously, an export certificate was sent back and forth between the company and us by ordinary post. We are...
View ArticleOff-label use of medicines
In a new report, the Danish Health and Medicines Authority highlights the monitoring of the safety of off-label use of medicines in Denmark. Off-label use of medicines may include giving a medicinal...
View ArticleNew director at the DHMA
On 1 February 2015, Anne-Marie Vangsted, Acting Head of Division, took up the position as Director with responsibility for supervision at the Danish Health and Medicines Authority. The new position as...
View ArticleDanish Pharmacovigilance Update, January 2015
The January issue of Danish Pharmacovigilance Update with news from the EU, the DHMA and short news: News from the EU Chlorhexidine may cause skin damage to newborns, page 2 Small risk of severe...
View ArticleMIA format updated according to EMA's community procedures
We have updated our IT systems and are now able to transfer Manufacturing and Importation Authorisations (MIA) to EudraGMDP via EMA's latest XML form. This implies some changes to how we will issue...
View ArticleSend Danish package leaflet when applying for changes to product information
When applying for changes to the product information, marketing authorisation holders must always send a Danish version of the package leaflet to the Danish Health and Medicines Authority, whether the...
View ArticleNew Head of Division for Public Health Medical Officers East & Supervision
The Danish Health and Medicines Authority has appointed Anette Lykke Petri as new Head of Division for Supervision as from 1 March 2015. Anette Lykke Petri will be forming the new management team for...
View ArticleThe MMR vaccine is a safe vaccine
We have reviewed the reported adverse reactions from the MMR vaccine during the past five years. As a result of the current media coverage of the MMR vaccine, we have reviewed all reports of suspected...
View ArticleWholesale Distribution Authorisations and GDP certificates can now be...
We can now transfer Wholesale Distribution Authorisations (WDA) and Good Distribution Practice (GDP) certificates to EudraGMDP, a Community database in the EU. We have updated our IT systems so that...
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Warning against Slimex 15 and Slimex 15 New Formula
The Danish Health and Medicines Authority warns against taking the weight-loss products Slimex 15 and Slimex 15 New Formula that are sold on the internet. The weight-loss products contain sibutramine...
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