News
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Danish Pharmacovigilance Update, May 2016
| 03 June 2016 |
The May issue of Danish Pharmacovigilance Update with news from the EU.
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New common EU rules on medical devices under way
| 03 June 2016 |
The Netherlands presidency of the Council and representatives of the European Parliament have reached political agreement on new EU rules on medical devices. The rules will strengthen patient safety and allow patients to benefit from new innovative devices.
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New Danish act on clinical trials
| 25 May 2016 |
The Danish Parliament has adopted a new act on clinical trials of medicinal products, which means that new research ethics committees will be established. However, the act does not come into force until 2018.
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Nine applications for funds earmarked for research in HPV adverse reactions
| 12 May 2016 |
The Danish Parliament has earmarked an amount of DKK 7 million for research into possible adverse reactions from the HPV vaccines. The deadline for applications has expired and the applications will now be reviewed by Innovation Fund Denmark.
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Danish Pharmacovigilance Update, April 2016
| 10 May 2016 |
The April issue of Danish Pharmacovigilance Update with news from the EU, the DKMA and short news.
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New video graphics about the HPV vaccine
| 03 May 2016 |
The Danish Medicines Agency has made a video which explains how the authorities monitor the safety of the HPV vaccine.
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Two new directors to join the Danish Medicines Agency
| 29 April 2016 |
The Danish Medicines Agency has appointed Janne Lehmann Knudsen as Director of Pharmacovigilance & Medical Devices and Iben Vitved as Director of Finance.
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Danish Pharmacovigilance Update, March 2016
| 25 April 2016 |
The March issue of Danish Pharmacovigilance Update with news from the EU, the DKMA and short news.
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Promising prospects for cooperation with Mexico
| 15 April 2016 |
Thursday, the Danish Medicines Agency's new Director General Thomas Senderovitz signed a cooperation agreement between the Mexican drug regulatory authority and the Danish Medicines Agency.
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Strong ambitions for the newly established Danish Medicines Agency
| 18 March 2016 |
The Danish Medicines Agency must stand out both nationally and internationally. This was the clear message of Danish Minister for Health Sophie Løhde, who paid a visit to the agency yesterday.
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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.