New format requirements for applications for authorisation of medicinal...
On 1 July 2015, the rules governing applications for marketing authorisations for medicinal products were amended in three areas as a result of new requirements from the European Medicines Agency...
View ArticleDanish Pharmacovigilance Update, June 2015
The June issue of Danish Pharmacovigilance Update with news from the EU, the DHMA and short news: News from the EU SGLT2 (sodium-glucose co-transporter 2) inhibitors and development of atypical...
View ArticleIncrease in clinical trial applications
An increasing number of clinical trial applications, improved production and assessment performance, but also longer assessment times. In the first half of 2015, the Danish Health and Medicines...
View ArticleAsthma inhaler recalled
Pharmaceutical company AstraZeneca recalls a batch of Bricanyl Turbuhaler. One inhaler of this batch is empty and contains no medicine. The recalled inhaler is Bricanyl Turbuhaler 0.5 mg per dose, 100...
View ArticleNew organisation structure of DHMA
The Danish Medicines Agency to be re-established as an independent agency. From the turn of the year 2015/2016, the Danish Health and Medicines Authority will be split into four agencies: A health...
View ArticleExecutive order on euphoriant substances – nine new substances
On 25 August 2015, new substances were included in annex 1 of executive order no. 557 of 31 May 2011 on euphoriant substances issued by the Danish Ministry of Health. The information is primarily...
View ArticleChristian Schneider appointed new NIBSC director
Christian Schneider, Medical Head of Division, has been appointed new director of the National Institute for Biological Standards and Control (NIBSC), which is located north of London, England....
View ArticleDanish Pharmacovigilance Update, August 2015
News from the EU EU's list of recommendations on safety signals News from the DHMA The DHMA has requested the EMA to further clarify the safety profile of HPV vaccines Dialogue conference on HPV...
View ArticleInformation about MERS-CoV for travellers
The Danish Health and Medicines Authority has prepared a leaflet for travellers visiting areas with outbreaks of MERS-CoV. The leaflet describes recommended precautions for travellers to areas with...
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2nd generation contraceptive pills associated with the lowest risk of blood...
Scientific evidence shows that the older 2nd generation contraceptive pills are associated with a lower risk of blood clots compared to the newer 3rd and 4th generation contraceptive pills....
View ArticleNew practice for MIAs
As of 1 October 2015, the Danish Health and Medicines Authority will change the practice for issuing Manufacturing and Importation Authorisations (MIAs) to pharmaceutical companies. This means that...
View ArticleDanish Pharmacovigilance Update, September 2015
News from the EU Mirabegron (Betmiga): New recommendations regarding the risk of increase in blood pressure News from the DHMA Childhood vaccinations and reported suspected adverse reactions in Q2 of...
View ArticleThe Danish Ministry of Health has appointed three new Director Generals
In August, Minister for Health Sophie Løhde announced that she will strengthen the focus on core tasks, case handling and the development of the health area by establishing four new agencies under the...
View ArticleSummary of product characteristics and package leaflet to be updated after...
Following the establishment of the Danish Medicines Agency (DKMA) on 8 October 2015, the section on the reporting of side effects must be updated in the summary of product characteristics (section...
View ArticleDanish Pharmacovigilance Update, October 2015
News from the EU New warning regarding cardiac failure caused by Xalkori (crizotinib) use EU's list of recommendations on safety signals News from the Danish Medicines Agency Interaction between...
View ArticleDanish Medicines Agency over Christmas and New Year 2015
The Danish Medicines Agency will be closed over Christmas and New Year, from 24 December 2015 to 3 January 2016 inclusive. We will not read faxes and post sent to the Danish Medicines Agency’s main...
View ArticleDanish Pharmacovigilance Update, November 2015
News from the EU Available data do not suggest an association between HPV vaccination and the syndromes POTS and CRPS according to new EMA review Serious risk of teratogenicity from the use of...
View ArticleNew application forms mandatory from 1 January
From 1 January 2016, it will be mandatory to use the eAF to apply for marketing authorisations, renewals and variations. This applies to both human and veterinary medicinal products, and it applies to...
View ArticleDecreasing prevalence of illicit drugs
The prevalence of illicit drugs is decreasing according to this year's report on the drug situation in Denmark 2013 prepared by the Danish Health and Medicines Authority. New figures show that...
View ArticleRecommendations for organ donation
More people should decide whether they wish to become a potential organ donor and the hospitals should introduce pathways. These are two of the recommendations of a working group headed by the Danish...
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