EMA recommends restrictions in the use of Trobalt
The Committee for Medicinal Products for Human Use (CHMP) under the European Medicines Agency (EMA) recommends restricting the use of the epilepsy medicine Trobalt® (retigabine) to only those patients...
View ArticleDKMAnet and indlaegsseddel.dk will be unavailable from 14 June at 13:00 to...
During the above period, we will be updating a number of systems, which means it will not be possible to log in or use any of the DKMAnet services or indlaegsseddel.dk. We apologise for any...
View ArticleDanish Pharmacovigilance Update, 23 May 2013
In this issue of Danish Pharmacovigilance Update: Cases of necrotising fasciitis associated with the use of bevacizumab (Avastin®) (front page) Tolvaptan (Samsca®) and potential risk of hepatic injury...
View ArticleImport of active substances from third countries after 2 July 2013
Importers can now apply to the Danish Health and Medicines Authority, requesting it to waive the requirement to obtain a written confirmation from the authorities in third-country in connection with...
View ArticleMonthly report from the EU Pharmacovigilance Risk Assessment Committee...
The EU Pharmacovigilance Risk Assesment Committee (PRAC) convened on 10-13 June 2013. Among the topics discussed at the meeting were: PRAC recommends restricting use of codeine when used for pain...
View ArticleImport of active substances from third countries after 2 July 2013
Read the Danish Health and Medicines Authority's answers to frequently asked questions about the rules on import of active substances. Requirements for import of active substances (API) - questions...
View ArticleNew version of the Danish GCP executive order
On 1 July 2013, a new version of the Danish executive order on good clinical practice in clinical trials of human medicines enters into force. Among the updates are: Pursuant to the present section...
View ArticleA legal requirement to use DKMAnet for submission of clinical trial...
During fall 2013, it becomes a requirement to submit applications via DKMAnet. With this change it also becomes easier to apply for authorisation of a clinical trial of human medicines: Companies and...
View ArticleNew version of the guidance document Voluntary Harmonisation Procedure for...
April saw the release of version 3 of the Voluntary Harmonisation Procedure (VHP), a voluntary procedure which makes it possible to obtain a coordinated assessment of an application for a clinical...
View ArticleVoluntary Harmonisation Procedure (VHP) for the assessment of multinational...
The Voluntary Harmonisation Procedure is a procedure which makes it possible to obtain a coordinated assessment of an application for a clinical trial that is to take place in several European...
View ArticleDanish Pharmacovigilance Update, 27 June 2013
In this issue of Danish Pharmacovigilance Update: The benefits of medicines for the treatment of acne (Diane® Mite and others) continue to outweigh the risks of use within the indication (front page)...
View ArticleNo access to e-forms on Monday 5 August 2013 from 22 to 23 pm
The Danish Health and Medicines Authority's e-forms cannot be accessed on Monday 5 August 2013 from 22 to 23 pm due to a system update and maintenance. The e-forms will return an error message if you...
View ArticleReference Safety Information – update from the Clinical Trials Facilition...
The Clinical Trial Facilitation Group (CTFG) has drawn up a document on Reference Safety Information (RSI). It describes the requirements for the RSI when submitting an application for a new trial,...
View ArticleDanish Pharmacovigilance Update, 29 august 2013
In this issue of Danish Pharmacovigilance Update: News from the EU Cases of acquired haemophilia following treatment with clopidogrel (Plavix® etc.) Change in indication and contraindication for...
View ArticleTransportation of medicinal products
A transportation provider that only transports medicinal products does not need an authorisation for wholesale distribution of medicinal products (a section 39 authorisation). Nor is a section 39...
View ArticleAmendment of executive order on euphoriant substances 30 Octobre 2013
As of 30 of October 2013, the substances below were included in annex 1 of executive order no. 557 of 31 May 2011 on euphoriant substances issued by the Danish Ministry of Health and Prevention. In...
View ArticleThe common portal for clinical trial applications on DKMAnet still postponed
We still plan to launch DKMAnet for clinical trial applications to both the ethics committee and the Danish Health and Medicines Authority in 2013. We have previously announced that DKMAnet must be...
View Article16 December is the final date for submission of clinical investigation...
The Danish Health and Medicines Authority is closed between Christmas and New Year. Therefore, applications for authorisation of clinical investigations of medical devices in 2013 must be received by...
View ArticleOur new website
The new website presents the contents from our previous websites in a simple design that adjusts to the screen size used, whether you access our website from a desktop, a mobile platform or a...
View ArticleFinal date for submission of clinical trial applications in 2013
The Danish Health and Medicines Authority is closed between Christmas and New Year. Therefore, applications for authorisation of clinical trials in 2013 must reach us by 20 December 2013. All...
View Article