News from the Danish Medicines Agency
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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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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