News items 2015
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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.
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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).
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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.