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The European Commission's decision concerning veterinary medicinal products containing zinc oxide
| 06 July 2017 |
On 26 June 2017, the European Commission adopted a decision to withdraw all marketing authorisations for veterinary medicinal products containing zinc oxide administered orally to food producing species. The medicinal products affected by the decision appear from Annex I to the decision.
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New fees for medicinal products, pharmaceutical companies and clinical trials from 1 July 2017
| 03 July 2017 |
On 1 July 2017, a new executive order on fees payable for medicinal products, pharmaceutical companies and clinical trials became effective. The new fees involve changes in a number of areas.
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Adverse event reports for centrally authorised veterinary medicinal products should not be sent to the DKMA
| 03 July 2017 |
The Danish Medicines Agency no longer requests the direct transfer of serious and unexpected third-country adverse event reports for centrally authorised veterinary medicinal products.
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Substantial progress in cooperation with CFDA only six weeks after state visit
| 23 June 2017 |
During the official state visit at the beginning of May, the Chinese and Danish Ministers for Health and Food signed a Memorandum of Understanding about the establishment of the China-Denmark Food and Drug Regulatory Cooperation Centre. Only six weeks after the state visit, the China Food and Drug Administration (CFDA) and the Danish Medicines Agency held a successful seminar on 20 and 21 June in Beijing on the licensing of medicines and the drafting of a work programme with common activities up to and including 2020.
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Evaluation of a Danish meta-analysis of antidepressants
| 21 June 2017 |
The Danish Medicines Agency has evaluated a Danish meta-analysis made by the Copenhagen Trial Unit on the effects of antidepressants (SSRIs). The analysis attracted extensive media coverage.
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Eleven new substances on the list of euphoriant substances
| 16 June 2017 |
On 15 June 2017, 11 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. The information is primarily relevant to companies authorised to deal with euphoriant substances.
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New format requirements for marketing authorisation applications
| 15 June 2017 |
The Danish Medicines Agency is postponing the phasing-out of NeeS and tightens the format requirements for updating the assessment report prior to MRP/RUP.
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Annual report 2016 - Clinical trials of medicines
| 13 June 2017 |
LLast year, the Danish Medicines Agency received 286 clinical trial applications. This is a small decline compared to 2015. However, the number of clinical trial applications has remained stable at around 300 applications per year since 2013.
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Tramadol: It is important that we are informed of side effects
| 13 June 2017 |
Doctors should contact the Danish Medicines Agency if clinical experience shows that the side-effect profile of a medicinal product is not consistent with the summary of product characteristics.
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Extensive modernisation of our IT from 8 June to 13 June
| 08 June 2017 |
The Danish Medicines Agency will launch an extensive modernisation of our IT systems from Thursday 8 June 2017 at 6pm to Tuesday 13 June 2017 at 8am. During this period, you may experience longer response times and some of our IT systems and forms will not be available.
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Danish Pharmacovigilance Update, May 2017
| 08 June 2017 |
The May issue of Danish Pharmacovigilance Update.
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Danish Pharmacovigilance Update, April 2017
| 22 May 2017 |
The April issue of Danish Pharmacovigilance Update.
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Agreement on Chinese-Danish cooperation signed
| 03 May 2017 |
The Danish Medicines Agency and the China Food and Drug Administration have taken an important step towards closer cooperation.
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Danish Pharmacovigilance Update, March 2017
| 18 April 2017 |
The March issue of Danish Pharmacovigilance Update.
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More batches of EpiPen® are withdrawn
| 06 April 2017 |
MEDA has decided to withdraw four more batches of EpiPen®. The withdrawal concerns two batches of EpiPen® 300 micrograms/dose and two batches of EpiPen® Jr 150 micrograms/dose. The latter is used for acute hypersensitivity reactions in children. The reason for the withdrawal is that there is a risk that the auto-injector does not work.
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Think twice when you buy and use self-tests
| 06 April 2017 |
The Danish Medicines Agency has launched a new video as part of its health app campaign. The campaign encourages consumers to be critical when they use self-tests bought on the internet.
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Illegally imported medicines bought from Biovea.com
| 03 April 2017 |
In recent days, a number of people have contacted the Danish Medicines Agency because medicines they bought online from Biovea have been seized. The seized medicines were dispatched from the USA, and import of medicine from the USA is illegal for Danish citizens. More information and good advice.
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New campaign: Be critical when using health apps
| 22 March 2017 |
The Danish Medicines Agency has launched a new campaign on its website and Facebook to encourage consumers to be critical when they use health apps they have downloaded or bought on the internet.
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New recommendation for phasing out zinc oxide for young pigs
| 21 March 2017 |
The European Medicines Agency's Committee for Medicinal Products for Veterinary Use (CVMP) has confirmed a previous decision to phase out zinc oxide. Consequently, the CVMP has once more recommended to the European Commission that medicinal products containing zinc oxide for the prevention of diarrhoea in young pigs should be withdrawn from the market.
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Withdrawal of a batch of EpiPen® 300 micrograms
| 17 March 2017 |
MEDA recalls a batch of the adrenaline product EpiPen® 300 micrograms/dose, which is used for sudden allergic reactions. There is a risk that the auto-injector does not work. The withdrawal concerns product number 578818 with batch number: 5FA665B and expiry date 03/2017.
