Notifications for the pharmaceutical industry about licensing, supervision and monitoring of medicines
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.
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.
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.
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”.
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.
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.
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.
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.
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.
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.
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.
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.
Better conditions for clinical trials in Denmark
| 03 May 2018 |
The Danish government, the Danish People's Party and the Danish Social-Liberal Party have agreed to exempt commercial sponsors from all fees for phase I clinical trials of medicines. The government has previously decided – in connection with the Budget Bill 2018 – to remove the Danish Medicines Agency’s fees for non-commercial (research-initiated) clinical trials of medicines.
DKMA Update March 2018
| 28 March 2018 |
In this issue of DKMA Update you can read about evidence; changes to Tramadol’s summary of product characteristics; inspections of the sale of OTC medicines outside pharmacies and much more
New concept for national scientific advice
| 22 March 2018 |
The Danish Medicines Agency will soon launch a new national scientific advice concept for companies, hospital researchers and others who require advice on requirements for marketing authorisations or clinical trials.
New funds for accumulation of knowledge about medicinal cannabis
| 20 March 2018 |
The parties negotiating the special funds have earmarked a further DKK 5 million to increase knowledge about the use and effect of medicinal cannabis. You can apply for the funds now.
Brexit, change of Reference Member State from UK to DK
| 01 February 2018 |
The Danish Medicines Agency would like to inform marketing authorisation holders that we welcome being the Reference Member State (RMS) for MRP/DCP authorised medicines, should you request Denmark as the future RMS when the UK is leaving the EU.