News
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New comprehensive list of euphoriant substances regulated in Denmark
| 26. februar 2016 |
You can now find a comprehensive list of euphoriant substances that are subject to control in Denmark via the executive order on euphoriant substances.
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Form for notification of invoice details concerning clinical trials discontinued
| 23. februar 2016 |
The Danish Medicines Agency has decided to discontinue the form for notification of invoice details concerning clinical trials. Instead, the cover letter should provide details of who we should send the invoice to and any comments you want us to state on the invoice.
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Twelve new substances on the list of euphoriant substances
| 17. februar 2016 |
As of 18 February 2016, 12 new substances are included in the Danish executive order no. 557 of 31 May 2011 on euphoriant substances issued by the Danish Ministry of Health. The information is primarily relevant to companies authorised to deal with euphoriant substances.
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Danish Pharmacovigilance Update, January 2016
| 10. februar 2016 |
The January issue of Danish Pharmacovigilance Update with news from the EU, the DKMA and short news.
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EMA: No changes to the safety profile of Gardasil
| 9. februar 2016 |
The European Medicines Agency (EMA) has recently completed its annual routine safety assessment of the HPV vaccine Gardasil®. The conclusion is that there are no changes to the safety profile.
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Updated list of biological medicinal products
| 4. februar 2016 |
The Danish Medicines Agency has added five new medicinal products to the list of biological and biosimilar medicinal products.