News
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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.
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Safer prescription of blood thinning agents
| 04 September 2018 |
A collaboration between pharmaceutical companies, pharmacies and authorities has eliminated a common cause of dosing errors involving blood thinning agents.
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Danish Medicines Agency launches new concept for National Scientific Advice
| 31 August 2018 |
Today, 31 August 2018, the Danish Medicines Agency is launching a new concept for National Scientific Advice for companies, hospitals and others who request advice on the requirements applicable to clinical investigation and marketing authorisations.
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New recommendations for use of Xofigo for treatment of prostate cancer which has spread to the bones
| 28 August 2018 |
The EU's Pharmacovigilance Risk Assessment Committee (PRAC) has adopted new recommendations for use of Xofigo for treatment of prostate cancer which has spread to the bones (bone metastases). Xofigo should only be used in symptomatic patients who have had two previous treatments for prostate cancer and who cannot be treated with other medicines.
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Companies can now apply for authorisation to produce cannabis bulk and cannabis primary products
| 21 August 2018 |
On 1 July 2018, a new executive order entered into force which gives companies the possibility of cultivating medicinal cannabis and producing cannabis bulk and cannabis primary products from Danish-grown cannabis.
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Danish Medicines Agency lands new European chairmanship
| 20 August 2018 |
Nikolai Brun, Director of Medical Evaluation & Biostatistics, has been elected chair of the Task Force on Big Data in the pharmaceutical area. The task force is a collaboration between the European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) which is to identify advantages and challenges of using big data for the development of medicine.
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Recall of valsartan blood pressure medicine
| 10 August 2018 |
Impurities that could potentially be harmful to health have been found in variants of medicines containing the active substance valsartan. The medicine is used to treat hypertension and heart failure. Patients treated with these medicines are therefore advised to contact their doctor as soon as possible in order to to be switched to another type of medicine.
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Heat wave: Retailers may refrain from selling non-prescription drugs
| 31 July 2018 |
Due to the summer heat, the Danish Medicines Agency has given Danish retailers dispensation from the requirement to stock a basic selection of medicines if they are having trouble keeping the temperature in their store cool enough for proper storage of the drugs. This dispensation applies until 1 September.
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Phase I clinical trials and non-commercial clinical trials now exempt from fees
| 11 July 2018 |
Fees are no longer charged for Phase I clinical trials and non-commercial clinical trials of medicines. This is the result of the Growth Plan for Life Science and the Budget for 2018. The new rules entered into force on 1 July 2018.
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DKMA Update June 2018
| 03 July 2018 |
In this issue of DKMA Update you can read about new rules on private individuals' import of medicines, Danish Medicines Agency being key driver in European solution for complex clinical trials and much more.