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Public consultation on electronic package leaflets and summaries of product characteristics across the EU
| 12 March 2019 |
What should the package leaflets and labels of medicines for citizens and the summaries of product characteristics for healthcare professionals look like in the future? A public consultation on key principles about this has been launched throughout the EU, with comments to be submitted by 31 July.
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Vaginal mesh from Bard removed from the EU markets
| 12 March 2019 |
The company Bard has decided to stop the sale of vaginal mesh implants on the markets in the EU. The decision is based on commercial reasons according to Bard.
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Common European recommendations establish a framework for testing medicines of the future
| 08 March 2019 |
The common European subgroup for complex clinical trials with trial subjects, which is headed by Denmark, has just published a set of recommendations for the development of personalised medicine.
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New EU report on big data paves the way for action
| 01 March 2019 |
A taskforce on big data in the pharmaceutical area, the HMA-EMA Joint Big Data Taskforce, has just published its first report. The report offers a definition of big data and several recommendations for European authorities that regulate medicines and medical devices.
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New data analysis centre to open at the Danish Medicines Agency
| 08 February 2019 |
The Danish government today announced its decision to support the establishment of a new data analysis centre in the Danish Medicines Agency. The centre is to handle the analysis of large data quantities in the pharmaceutical and medical devices areas and will set new standards for the monitoring of the safety and efficacy of medicines and medical devices after their marketing.
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DKMA Update December 2018
| 23 January 2019 |
In this issue of DKMA Update you can read about safety for medical devices; new biosimilar medicines for Humira; better conditions for clinical trials in Denmark; new front page for our website and much more
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Updating of summaries of product characteristics due to changed ATC codes for 2019
| 18 January 2019 |
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 2019.
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Reimbursement of medicinal cannabis of the pilot programme effective as of 1 January 2019
| 16 January 2019 |
On 1 January 2019, a special reimbursement scheme for medicinal cannabis in the four-year pilot programme entered into force. Reimbursement is retroactive for purchases made in 2018.
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New report on adverse reactions reported with tramadol for pain relief
| 20 December 2018 |
The Danish Medicines Agency has received 830 reports of suspected adverse reactions with tramadol since the medicine was marketed in March 1993. 155 of them describe symptoms of dependence. This follows from a report that has just been published. In 2017, about 265,000 individuals received treatment with tramadol in Denmark.
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New format requirements for Marketing Authorization submissions from 1 January 2019
| 17 December 2018 |
The NeeS submission format will be discontinued for all applications submitted under the national procedure (NP), i.e. applications for variations, renewals etc. This change is related to medicinal products for human use. Parallel import and parallel distribution are not affected by this change.
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Til lægemiddelvirksomheder: Indsend variationer inden Brexit
| 19 November 2018 |
Storbritannien betragtes som udgangspunkt som et 3. land (udenfor EU/EEA) efter Brexit den 29. marts 2019. Lægemiddelstyrelsen opfordrer derfor lægemiddelvirksomheder til at indsende variationer snarest muligt.
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Theme event on big data and medicine
| 08 November 2018 |
The U.S. Food and Drug Administration, FDA, The European Medicines Agency, EMA, and Novo Nordisk are among the speakers when The Danish Medicines Agency on 20 November 2018 puts focus on big data and medicine under the event heading “From Big Data to Real World Evidence”.
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Three research projects to increase our knowledge of medicinal cannabis
| 01 November 2018 |
Three projects have just been granted funds to give us more knowledge about the efficacy of medicinal cannabis. A total of DKK 5 million have been distributed of the funds that were appropriated by the negotiating parliamentary parties under the special funds agreement 2018-2021 to accumulate scientific knowledge of medicinal cannabis.
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Small increased risk of certain types of skin cancer associated with the use of hydrochlorothiazide
| 30 October 2018 |
There is a small increased risk of developing basal cell carcinoma and squamous cell carcinoma in long-term use of blood pressure medicine containing hydrochlorothiazide. This follows from a review of new studies and available data undertaken by the European Medicines Agency, EMA.
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Brexit: Two-year implementation period for name and address changes
| 17 October 2018 |
During an implementation period of maximum two years, it will be permitted to sell released packs on which a UK marketing authorisation holder or a representative is indicted as well as packs on which an EEA marketing authorisation holder or a representative is indicated for the concerned D.Sp.No. (Danish speciality number).
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Debate on research dissemination at the Danish Medicines Agency
| 28 September 2018 |
On 1 October, the Danish Medicines Agency and the Danish Society for Pharmacoepidemiology have invited a number of researchers, doctors and communication officers from research institutions throughout Denmark to a debate on how the findings of new health research can be disseminated most responsibly. The debate meeting can be followed live on the Danish Medicines Agency’s Facebook profile.
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Drug agency from China visits Denmark
| 28 September 2018 |
A delegation from the Centre for Drug Evaluation under the China National Medical Products Administration visited the Danish Medicines Agency this week to discuss clinical trials and drug monitoring, among other things. The meeting at the Danish Medicines Agency is part of a Danish-Chinese collaboration under the auspices of the China-Denmark Food and Drug Regulatory Cooperation Centre, which was established with the signing of a collaboration agreement in May of last year, and which aims to strengthen regulatory efforts in the two countries.
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Medicines of the future in focus at World Economic Forum
| 20 September 2018 |
Medicines of the future is one of the topics being debated at the meeting of the World Economic Forum, which is currently place right now in Tianjin in China. The Danish Medicines Agency is attending.
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Danish Medicines Agency aces European benchmark survey
| 19 September 2018 |
The Danish Medicines Agency has just scored 4.5 of a possible 5 in the common-European survey known as the Benchmarking of European Medicines Agencies (BEMA). ”It's a really good result that will benefit all of us and may help raise the standard throughout Europe,” said the Danish health minister.
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Contaminated valsartan has so far not caused an increased incidence of cancer cases in Denmark
| 13 September 2018 |
A Danish registry study has examined if the cancer incidence rate is higher among people treated with the blood pressure lowering medicine Valsartan, which due to the risk of contamination was recalled from the market in July 2018. The study concludes that no increased cancer incidence can be seen at present.
