News items 2015
New application forms mandatory from 1 January
| 14 December 2015 |
From 1 January 2016, it will be mandatory to use the eAF to apply for marketing authorisations, renewals and variations. This applies to both human and veterinary medicinal products, and it applies to all procedure types.
Danish Pharmacovigilance Update, November 2015
| 08 December 2015 |
The November issue of Danish Pharmacovigilance Update with news from the EU, the Danish Medicines Agency and short news.
Danish Pharmacovigilance Update, October 2015
| 12 November 2015 |
The October issue of Danish Pharmacovigilance Update with news from the EU, the Danish Medicines Agency and short news.
The Danish Ministry of Health has appointed three new Directors General
| 08 October 2015 |
The Danish Ministry of Health has now filled three vacant Director General positions that were advertised in August.
Danish Pharmacovigilance Update, September 2015
| 07 October 2015 |
The September issue of Danish Pharmacovigilance Update with news from the EU, the DHMA and short news.
New practice for MIAs
| 01 October 2015 |
As of 1 October 2015, the Danish Health and Medicines Authority will change the practice for issuing Manufacturing and Importation Authorisations (MIAs) to pharmaceutical companies. This means that all manufacturing activities will be listed on the authorisation.
2nd generation contraceptive pills associated with the lowest risk of blood clots
| 16 September 2015 |
The Danish Health and Medicines Authority still encourages women to use 2nd generation contraceptive pills instead of 3rd and 4th generation contraceptive pills.
Danish Pharmacovigilance Update, August 2015
| 15 September 2015 |
The August issue of Danish Pharmacovigilance Update with news from the EU, the DHMA and short news.
Christian Schneider appointed new NIBSC director
| 10 September 2015 |
Christian Schneider, Medical Head of Division, has been appointed new director of the National Institute for Biological Standards and Control (NIBSC), which is located north of London, England.
Executive order on euphoriant substances – nine new substances
| 31 August 2015 |
On 25 August 2015, new substances were included in annex 1 of executive order no. 557 of 31 May 2011 on euphoriant substances issued by the Danish Ministry of Health.
New organisation structure of DHMA
| 11 August 2015 |
The Danish Medicines Agency to be re-established as an independent agency.
Asthma inhaler recalled
| 05 August 2015 |
Pharmaceutical company AstraZeneca recalls a batch of Bricanyl Turbuhaler. One inhaler of this batch is empty and contains no medicine.
Increase in clinical trial applications
| 03 August 2015 |
An increasing number of clinical trial applications, improved production and assessment performance, but also longer assessment times.
Danish Pharmacovigilance Update, June 2015
| 14 July 2015 |
The June issue of Danish Pharmacovigilance Update with news from the EU, the DHMA and short news.
New format requirements for applications for authorisation of medicinal products
| 13 July 2015 |
On 1 July 2015, the rules governing applications for marketing authorisations for medicinal products were amended in three areas as a result of new requirements from the European Medicines Agency (EMA).
Clinical trial authorisation applications
| 06 July 2015 |
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 applied for 162 trials and researchers for 122.
Guide to individual case safety reporting
| 26 June 2015 |
We have prepared a guide to companies on the electronic reporting of adverse drug reactions (ADR) to the Danish Health and Medicines Authority.
Global operation against illicit medicines completed
| 19 June 2015 |
A global medicine operation results in 156 arrests and shutdown of more than 2,400 websites.
CUG certificates for login to DKMAnet must be replaced
| 12 June 2015 |
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. primarily users employed in companies without a Danish CVR registration number. If you are currently using a CUG certificate of the old type to log in to DKMAnet, you must obtain a new certificate before 1 September 2015.
Danish Pharmacovigilance Update, May 2015
| 09 June 2015 |
The May issue of Danish Pharmacovigilance Update with news from the EU, the DHMA and short news.