Deadline for applications for clinical investigations of medical devices
Applications for clinical investigations of medical devices in 2014 must reach us by 17 December 2014. All applications that we receive after this date will be considered received on 5 January 2015....
View ArticleDeadline for applications for marketing authorisation of medicinal products
Applications for marketing authorisation of medicinal products in 2014 must reach us by 19 December 2014. All applications that we receive after this date will be considered received on 5 January...
View ArticleNaming of medicinal products
In future, we will comment on medicinal product names applied for (names of human medicines applied for under the mutual recognition (MRP) and decentralised procedures (DCP)) on Day 50 for MRP and on...
View ArticleDanish Pharmacovigilance Update, November 2014
Five years ago, we issued Danish Pharmacovigilance Update for the first time. We are delighted to celebrate the newsletter's fifth anniversary with more than 3,000 subscribers to the Danish and the...
View ArticleNew procedure for follow up on adverse drugs reaction reports as of 15...
The Danish Health and Medicines Authority wants a targeted and relevant process for collecting additional information to reports on adverse drug reactions. Therefore, we are by 15 December 2014...
View ArticleMonthly report from the EU Pharmacovigilance Risk Assessment Committee...
PRAC held its last meeting for this year on 1-4 December 2014 During its December meeting, the PRAC did not initiate or conclude a safety referral. The Committee focused on the broad spectrum of its...
View ArticleFollow up requests via DKMA-net
Monday 15 December the DHMA will upgrade the technical solution for receiving follow up requests via the DKMAnet. Until the deployment is completed we will not be able to retrieve follow up requests....
View ArticleDanish Pharmacovigilance Update, November 2014
Five years ago, we issued Danish Pharmacovigilance Update for the first time. We are delighted to celebrate the newsletter's fifth anniversary with more than 3,000 subscribers to the Danish and the...
View ArticleApplications for compassionate use permits on weekdays between Christmas and...
The Danish Health and Medicines Authority reviews urgent applications for compassionate use (application for the dispensing of medicines not marketed in Denmark) on weekdays between Christmas and New...
View ArticleChanges to the Danish childhood vaccination programme
From 1 January 2015, children will be offered the previous childhood vaccination programme again, because Statens Serum Institut (SSI) can now provide vaccines again after one year with technical...
View ArticleThe DHMA over Christmas and New Year
We will be closed from 24 December 2014 to 4 January 2015 inclusive. Read about compassionate use permits and see the information below about how to contact the National Institute of Radiation...
View ArticleThe drug situation in Denmark
We have prepared our national report about the drug situation in Denmark in 2014. According to the report, the number of drug-related deaths is stable, while the number of poisonings is increasing....
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 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 ArticleNew 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 ArticleDanish Pharmacovigilance Update, September 2014
The September issue of Danish Pharmacovigilance Update. 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...
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 ArticleFees for medical devices in 2015
The fees for medical devices have been adjusted in accordance with Danish Government regulations, including the fees for registration of manufacturers and devices, importers and distributors,...
View ArticleItalian case about stolen medicine affects Denmark
21 stolen packages of medicine from Italy have probably been sold on the Danish and German markets. The Danish Health and Medicines Authority has asked the company to recall the medicine (the batch)....
View ArticleConsultation: rules of procedure for public hearings in the EMA
The European Medicines Agency (EMA) has launched a public consultation on draft rules of procedures for public hearings held by its Pharmacovigilance Risk Assessment Committee (PRAC). See the Draft...
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