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Danish Pharmacovigilance Update, February 2016
| 09 March 2016 |
The February issue of Danish Pharmacovigilance Update with news from the EU, the DKMA and short news.
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New comprehensive list of euphoriant substances regulated in Denmark
| 26 February 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 February 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 February 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 February 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
| 09 February 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
| 04 February 2016 |
The Danish Medicines Agency has added five new medicinal products to the list of biological and biosimilar medicinal products.
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Access to results in EudraCT from 13 January
| 13 January 2016 |
When a clinical trial of medicinal products has ended, the trial results must be entered in the EudraCT database. The system has been unavailable for a period of time during which data could not be entered in the EudraCT database. The EMA now re-opens the database and results can be entered in EudraCT again.
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New clinical trial regulation under way
| 12 January 2016 |
New EU Clinical Trial Regulation has been postponed until 2018
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New Director General of the Danish Medicines Agency
| 11 January 2016 |
The Danish Ministry of Health has appointed Thomas Senderovitz as Director General of the newly established Danish Medicines Agency.
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Danish Pharmacovigilance Update, December 2015
| 08 January 2016 |
The December issue of Danish Pharmacovigilance Update with news from the EU, the Danish Medicines Agency and short news.
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Updating of summaries of product characteristics due to changed ATC codes for 2016
| 07 January 2016 |
Marketing authorisation holders of medicinal products authorised under the national procedure, the decentralised procedure as well as the mutual recognition procedure should be aware that some ATC codes have been changed for 2016.
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The Danish Medicines Agency has a new website
| 04 January 2016 |
Today, the Danish Medicines Agency launched its new website – laegemiddelstyrelsen.dk/en – where you can read about and subscribe to news about licensing and supervision of medicines, side effects, reimbursement, pharmacies and medical devices.
