News

New version of the guidance document Voluntary Harmonisation Procedure for clinical trials

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 trial that is to take place in several European countries.

New European list of medicines under additional monitoring

The European Medicines Agency (EMA) has published a list of medicines that are subject to additional monitoring. From the autumn of 2013, these medicines will display an inverted black triangle in their package leaflet and the summary of product characteristics with information for patients and healthcare professionals.

Nyt Om Bivirkninger 25 april 2013

Danish Pharmacovigilance Update, 21 February 2013

In this issue of Danish Pharmacovigilance Update: Cardiovascular monitoring when initiating and re-initiating treatment with fingolimod (Gilenya®).

Updating of summary of product characteristics prompted by changed ATC codes for 2013

We advise marketing authorisation holders of veterinary medicinal products authorised under the decentralised procedure and the mutual recognition procedure that some ATC codes have changed in 2013.

Text on reporting of adverse reactions in SPC and PL

In connection with the pharmacovigilance legislation from 2011, which entered into force in the summer 2012, a requirement was introduced for the summary of product characteristics and the package leaflet of human medicinal products to include a text encouraging the reporting of suspected adverse reactions in compliance with the applicable national reporting system. In regard to the text in the package leaflet, the Danish Health and Medicines Authority is planning an amendment of the Danish executive order on labelling to extend the deadline for implementation of the executive order's section 35(3) for medicinal products authorised on or before 20 July 2012.

Preliminary data on Medicine Prices available to all subscribers of Medicine Prices for Companies

As of 1 March 2013, anyone who subscribes to Medicine Prices for companies has access to preliminary data on Medicine Prices. Preliminary data will be made available 11 and 10 days prior to the effective date of a new medicine price period. This follows from an amendment to the Danish executive order no. 59 of 29 January 2009 on medicine prices and supply conditions.

Amendment of Danish executive order on euphoriant substances 6 March 2013

As of 6 March 2013, the substances below are included in annex 1 of executive order no. 557 of 31 May 2011 on euphoriant substances issued by the Danish Ministry of Health.

Direct Healthcare Professional Communication is published on the website

The Danish Health and Medicines Authority will in future place the Direct Healthcare Professional Communications (DHPCs) that are sent out in Denmark to doctors and others here on the website.