News
-
Restriction on sale of medicines in pharmacies (clarification)
| 19 March 2020 |
The Minister of Health has activated parts of the drug preparedness. This means that you cannot buy more prescription medicines at the pharmacy than what you normally use, and that the amount of OTC medicines being dispensed has been limited. The decision has been taken to avoid hoarding.
-
Fast-track Approval of Clinical Trials investigating COVID-19
| 17 March 2020 |
Clinical trials investigating treatments for COVID-19 will be processed within 3 days. The processing time is extended if major objections is raised but we prioritise to have these solved immediately.
-
All efforts taken to minimise supply disruption of medicines and medical devices
| 10 March 2020 |
Authorities and companies in Denmark and abroad are collaborating intensively to minimise potential disruptions in the supply chain of medicines and medical devices caused by the COVID-19 outbreak.
-
New enhanced reporting requirement is to strengthen the surveillance of medical devices
| 05 March 2020 |
A new rule imposing an enhanced reporting requirement on medical devices has just entered into force. The rule is to ensure that the surveillance of medical devices is strengthened and becomes more focused for the benefit of patients.
-
New head of the Danish Medicines Agency’s Data Analytics Centre
| 05 March 2020 |
The Danish Medicines Agency has hired Jesper Kjær as head of the Agency’s Data Analytics Centre as of 1 April. The Data Analytics Centre will officially open later this year.
-
The authorities are getting ready for fast-track approval of vaccines for coronavirus
| 17 February 2020 |
Drug regulatory authorities around the world are supporting researchers and companies in the fast development of a vaccine for coronavirus (2019-nCoV) and are getting ready to facilitate an approval as fast as possible without compromising safety.
-
Danish Medicines Agency's top priorities in 2020
| 08 January 2020 |
A data-driven medicines agency, the continued supply of medicines, a great place to work and productivity and quality are the top priorities for the Danish Medicines Agency in 2020.
-
Updating of summaries of product characteristics due to changed ATC codes for 2020
| 08 January 2020 |
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 2020.
-
Stenocare no longer sells cannabis oil in Denmark
| 07 November 2019 |
Stenocare has informed the Danish Medicines Agency that they no longer sell cannabis oils in Denmark.
-
Suspension of Scanpharm A/S's authorisation to manufacture medicines
| 07 November 2019 |
The Danish Medicines Agency has suspended parts of Scanpharm A/S’s authorisation to analyse medicines before these are made available to patients.
-
More resources to improve the patient safety of medical devices
| 29 October 2019 |
Patient safety is to be improved by a threefold increase in staff and a restructuring of the agency’s Medical Devices Unit into four specialised teams.
-
New concept for regulatory advice on medical devices
| 28 August 2019 |
The Danish Medicines Agency has launched a pilot project to offer targeted advice on rules and regulations in the area of medical advices to startups and small and medium-sized medical device manufacturers as well as educational and research units. New rules are under way throughout the EU from 2020.
-
Supply of medicines in Denmark
| 22 July 2019 |
The Danish Medicines Agency is receiving an increasing number of enquiries regarding problems with the supply of certain medicines in Denmark. The supply shortage is not critical but it is challenging and an inconvenience for the general public, medical professionals and pharmacies alike. The Danish Medicines Agency is monitoring developments and working with other authorities and stakeholders both in Denmark and abroad to remedy the issues.
-
Supply of cannabis oil from Stenocare affected in Denmark
| 12 July 2019 |
Several consignments of cannabis oil from the Danish firm Stenocare have been placed in quarantine and taken off the market because the cannabis used in the oil was cultivated in non-approved facilities. The supply of cannabis oil in Denmark will therefore be affected.
-
Danish Medicines Agency strengthens its policy on conflicts of interest
| 05 July 2019 |
New staff members of the Danish Medicines Agency are not permitted to own shares in pharmaceutical or medical device companies. Currently employed staff will be asked to divest any shares within two years. This appears from the agency’s internal policy on conflicts of interest, which enters into force on 4 July 2019.
-
Good progress in Denmark-China collaboration
| 01 July 2019 |
The Danish Medicines Agency’s collaboration with the Chinese drug regulatory authorities has entered a new phase, reaching agreement on specific collaboration projects among which a project on quality control of radiopharmaceuticals.
-
Withdrawal of vaginal mesh
| 03 May 2019 |
Three types of vaginal mesh for surgical treatment of pelvic organ prolapse have been withdrawn in the USA after the FDA has assessed that the evidence of the products' efficacy and safety is insufficient. As a result, the products will no longer be available in Denmark.
-
Report on suspected side effects reported for medicinal cannabis
| 10 April 2019 |
Dizziness, nausea and concentration problems are some of the suspected side effects that have been reported to the Danish Medicines Agency in the first year of the medicinal cannabis pilot programme.
-
End of day meeting on new EU recommendations on complex clinical trials at the Danish Medicines Agency
| 29 March 2019 |
The Danish Medicines Agency invites pharmaceutical companies, researchers and other interested parties to an end of day meeting on the new European recommendations on complex clinical trials which aim to support the development of personalised medicine.
-
Danish Medicines Agency to help build better drug regulatory authorities in low- and middle-income countries
| 14 March 2019 |
Today, the Danish Medicines Agency signed an agreement with WHO to help build up drug regulatory authorities in low- and middle-income countries, including Africa.