New rules for persons collaborating with the industry
As of 1 November 2014, new rules governing healthcare professionals' collaboration with pharmaceutical and medical companies take effect. The rules governing association will be extended to include...
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 ArticleEbola ruled out in patient hospitalised at Hvidovre Hospital
On Thursday night 2 October, a patient was hospitalised at Hvidovre Hospital and tested for Ebola virus. A blood sample tested at State Serum Institute ruled out the suspicion. ”The Danish Health and...
View ArticleDanish Pharmacovigilance Update, September 2014
News from the EU Denosumab (Prolia and Xgeva) and risk of osteonecrosis of the jaw and hypocalcaemia, page 2 Interferon beta and risk of serious adverse reactions, page 4 News from the DHMA Scopoderm®...
View ArticleMonthly report from the EU Pharmacovigilance Risk Assessment Committee...
The EU Pharmacovigilance Risk Assessment Committee (PRAC) convened on 6-9 October 2014. Topics discussed at the meeting: PRAC recommends strengthening the restrictions on the use of valproate in women...
View ArticlePatient to be examined for Ebola at Hvidovre Hospital
A patient has been admitted to Hvidovre Hospital in Copenhagen and is now being tested for Ebola infection according to the Danish Health and Medicines Authority's guidance on the management of Ebola...
View ArticlePRAC recommends strengthening the restrictions on the use of valproate in...
The EMA’s Pharmacovigilance and Risk Assessment Committee (PRAC) recommends strengthening the restrictions on the use of the antiepileptic valproate due to the risk of malformations and developmental...
View ArticleTechnical problems at DKMAnet
Due to technical problems, applications and other communication with the Danish Health and Medicines Authority via DKMAnet may have been lost in the period from 10.15 pm on Wednesday 15 October to...
View ArticleContinued technical problems at DKMAnet
DKMAnet is still unavailable due to technical issues. Applications and other communication with the Danish Health and Medicines Authority via DKMAnet may have been lost in the period from 10.15 pm on...
View ArticleUpdated guidelines on activities subject to a section 39 authorisation
We have updated our guidelines on activities subject to a section 39 authorisation or a company registration. The new version of the guidelines includes a description of the activities ”Transportation...
View ArticleDKMAnet is up and running
All services at DKMAnet are available again. Lost applications Unfortunately, applications and communication about applications submitted via DKMAnet to the Danish Health and Medicines Authority in...
View ArticleFocus on correct dose of Pro-Epanutin
The Danish Health and Medicines Authority encourages hospitals to pay special attention to the risk of dose errors of the anticonvulsant medicine Pro-Epanutin. The reason is that the National Agency...
View ArticleUpdated guidance on Ebola
We have updated our guidance to healthcare professionals on the management of patients with Ebola virus in Denmark. The updated guidance specifies how emergency service doctors, emergency rooms and...
View ArticleTechnical problems on DKMAnet: clinical trials
Due to technical problems, the clinical trial services on DKMAnet are not working. The system will inform you that your submission was not successful. So you should avoid using the clinical trial...
View ArticleBeware if your heart flutters
The combination of low-dose aspirins and anticoagulant medicines can cause severe bleeding. Consequently, we have published new material describing the risk of this combination to patients with heart...
View ArticleDanish Pharmacovigilance Update, October 2014
News from the EU EU's Pharmacovigilance Risk Assessment Committee (PRAC) recommends strengthening the restrictions on the use of the epileptic medicine valproate (Deprakine etc.) in women and girls,...
View ArticleDKMAnet clinical trial services up and running
We have solved the technical problems with the clinical trial services on DKMAnet, and you can use DKMAnet again. We are sorry for any inconvenience this may have caused.
View ArticleMonthly report from the EU Pharmacovigilance Risk Assessment Committee...
The EU Pharmacovigilance Risk Assessment Committee (PRAC) convened on 3-6 November 2014. Topics discussed at the meeting: PRAC recommends measures to reduce risk of heart problems with...
View ArticleAvailable time slots in Q1 2015 for DCP applications with Denmark as...
Companies wishing to apply for a marketing authorisation for a medicinal product can request a specified submission date (time slot). Time slots are available in the first quarter of 2015. Time slots...
View ArticleDeadline for clinical trial applications
Applications for authorisation of clinical trials in 2014 must reach us by midday on Monday 22 December 2014. All applications that we receive after this deadline will be considered received on 5...
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