Requirements for companies distributing and handling euphoriant substances
We have gathered information about the requirements for authorisations, storage, accounting and reporting of euphoriant substances: Guidelines for application for authorisation of activities with...
View ArticleElse Smith to resign as Director General of the DHMA
We confirm that as from 12 March 2015 Else Smith is no longer Director General of the Danish Health and Medicines Authority. More information Press release from the Ministry of Health (in Danish)
View ArticleDanish Pharmacovigilance Update, February 2015
The February issue of Danish Pharmacovigilance Update with news from the EU, the DHMA and short news: News from the EU EMA tightens guidelines for use of hydroxyzine-containing medicines (Atarax®,...
View ArticleThree Danish healthcare workers will not be quarantined for Ebola
The three healthcare workers who work for Defence Command Denmark and Danish Emergency Management Agency have been examined at Aarhus University Hospital in Skejby. The employees were sent back to...
View ArticleNew management at the DHMA
As from 13 March 2015, Jakob Cold has been appointed Acting Director General of the Danish Health and Medicines Authority. Jakob Cold has been a member of the Board of Directors of the DHMA since...
View ArticleNew advice on infant food
Infants should not be given cow's milk, but breast milk or infant formula throughout the first year of life. This is one of our new recommendations for infant food and nutrition for young children....
View ArticleNew guidelines on good distribution practice for APIs
The European Commission has published new guidelines on good distribution practice (GDP) for active substances (API) for medicinal products for human use. Distributors of active substances for...
View ArticleDanish Pharmacovigilance Update, March 2015
The March issue of Danish Pharmacovigilance Update with news from the EU, the DHMA and short news: News from the EU Restrictions on the use of codeine for cough and cold in children EU's list of...
View ArticleEMA's new assessment of the HPV vaccine: The benefits outweigh the risks
A causal relationship between the dizziness and fatigue syndrome, Postural Orthostatic Tachycardia Syndrome (POTS) and Gardasil can neither be confirmed nor denied. The EU's group of pharmacovigilance...
View ArticleAnnual Pharmacovigilance Report 2014
In our annual pharmacovigilance report 2014, you can read about the development in the number of ADR reports, learn about various focus areas and the European collaboration in the pharmacovigilance...
View ArticleDanish Pharmacovigilance Update, April 2015
The April issue of Danish Pharmacovigilance Update with news from the EU, the DHMA and short news: News from the EU High-dose ibuprofen/dexibuprofen may cause small increased cardiovascular risk, page...
View ArticleThe DHMA is closed on Friday 15 May
The Danish Health and Medicines Authority will be closed on 15 May, the day after Ascension Day. However, the Public Health Medical Officers operate a 24-hour emergency service and we process urgent...
View ArticleNational Clinical Guideline: prevention and treatment of dystocia
An English version of our national clinical guideline concerning primiparous women with dystocia is now available on our website. The guideline describes how to treat dystocia in first-time mothers....
View ArticleMany addictive drugs lacked statutory packaging seal
Our laboratory contacted 35 companies in the period from December 2014 to April 2015. The purpose was to examine whether the companies had made sure to seal their packages with addictive drugs (cf....
View ArticleDanish Pharmacovigilance Update, May 2015
The May issue of Danish Pharmacovigilance Update with news from the EU, the DHMA and short news: News from the EU EMA warns against using certain types of hepatitis C medicines and amiodarone...
View ArticleCUG certificates for login to DKMAnet must be replaced
The Danish Health and Medicines Authority has to replace the system used to issue Closed User Group (CUG) certificates to users of DKMAnet who cannot obtain a NemID employee certificate – i.e....
View ArticleGlobal operation against illicit medicines completed
A global medicine operation results in 156 arrests and shutdown of more than 2,400 websites. The Danish Health and Medicines Authority, the Danish customs and tax authorities (SKAT) and the Danish...
View ArticleGuide to individual case safety reporting
We have prepared a guide to companies on the electronic reporting of adverse drug reactions (ADR) to the Danish Health and Medicines Authority. The guide is in English and is a Best Practice guide to...
View ArticleClinical trial authorisation applications
In 2014, the Danish Health and Medicines Authority received 284 applications for authorisation of clinical trials of medicines in humans, which is a decline of 3% compared to 2013. Commercial sponsors...
View ArticleReduktion af klassificerede ftalater i medicinsk udstyr
Sundhedsstyrelsen har opdateret vejledningen til regioner og kommuner om, hvordan de kan reducere klassificerede ftalater, når de køber medicinsk udstyr. Flere udbydere af medicinsk udstyr tilbyder...
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