News from the Danish Medicines Agency
COVID-19 drug preparedness rules extended for the rest of the year
| 02 September 2020 |
The Minister of Health has decided to extend the applicability of the executive order that lays down special rules for the drug preparedness in connection with the handling of COVID-19 to 31 December 2020.
Relaxation: Information on face masks permitted to be in Swedish, Norwegian or English besides Danish
| 19 August 2020 |
The Danish Medicines Agency temporarily eases the requirement that the instructions for use and labelling of surgical face masks must be in Danish. This permits the sale of face masks with labelling and instructions for use in Swedish, Norwegian or English until 1 December.
European strategy for regulation of medicines open for public consultation
| 14 August 2020 |
Availability and the supply of medicines, digital transformation and efforts against antimicrobial resistance are but some of the priority areas in the draft network strategy to 2025 that has been submitted for public consultation by the medicines agencies in Europe and the European Medicines Agency, EMA. The strategy is open for public consultation until 4 September 2020.
Paracetamol for children may again be sold by retail outlets
| 13 July 2020 |
Paracetamol painkillers for children may again be sold by supermarkets, kiosks and other shops with permission to sell over-the-counter medicines. From March to today, the medicine was only available from pharmacies.
EU countries join forces to ensure people have access to a COVID-19 vaccine
| 02 July 2020 |
Last week, the EU countries and the European Commission published a European strategy to ensure citizens have swift access to a safe and effective COVID-19 vaccine. The Danish Medicines Agency participates as representative of Denmark in a European steering board that will be coordinating the joint procurement of vaccines.
EMA recommends approval of remdesivir for COVID-19 in the EU
| 26 June 2020 |
The European Medicines Agency has recommended granting a conditional marketing authorisation to Veklury, a remdesivir-containing product, for the treatment of COVID-19 in adults and adolescents from 12 years of age with pneumonia who require supplemental oxygen. This will make Veklury the first medicine for COVID-19 that is authorised in the EU.
Danish Medicines Agency increases communication on medicine supply
| 24 June 2020 |
The Danish Medicines Agency reinforces the communication about the supply of medicines in Denmark through announcements that will be sent out when supply problems are expected to have therapeutic consequences for the patients.
Suspension paracetamol for children no longer prescription-only
| 15 June 2020 |
The Danish Medicines Agency has now lifted part of its restriction on the sale of suspension paracetamol for children, implying that the medicine can once again be bought over the counter from a pharmacy.
Becoming part of Europe’s best in class
| 03 June 2020 |
The foundation of the Data Analytics Center was established, our European position was strengthened, yet not all objectives were achieved. This is the conclusion in the Danish Medicines Agency’s annual report for 2019.
Clinical trials of hydroxychloroquine are stopped temporarily
| 27 May 2020 |
Five clinical trials in Denmark testing the efficacy of hydroxychloroquine on COVID-19 are discontinued until further notice. This takes place after a major international study has indicated that there is no beneficial effect of using the product; in contrast, there could be serious adverse reactions.
Several actions taken to ensure the supply of medicine during COVID-19
| 27 May 2020 |
Several actions have been taken nationally to counter supply problems affecting vital medicines during the COVID-19 pandemic. Work is also done at the EU level to ensure the supply of medicines.
COVID-19: Facts about chloroquine and hydroxychloroquine
| 07 April 2020 |
There are many rumours that hydroxychloroquine or chloroquine has a documented effect on COVID-19 and that other countries have approved it for COVID-19.
COVID-19: See the list of approved Danish clinical trials of medicines for COVID-19
| 07 April 2020 |
The Danish Medicines Agency has approved the first applications for clinical trials of medicines for COVID-19. A list on the Danish Medicines Agency’s website keeps you updated on approved applications.
Follow worldwide studies and research on medicines for COVID-19
| 03 April 2020 |
The Danish Medicines Agency has formed a COVID-19 group that will continuously update a public list of worldwide studies and research on medicines for COVID-19.
No evidence confirms reports that blood pressure medicines could worsen COVID-19
| 30 March 2020 |
After several specialist media and patient organisations in Denmark have disproved reports that ACE inhibitors and angiotensin receptor blockers could worsen the condition of COVID-19 patients, the European Medicines Agency now sends the same message.
Danish Medicines Agency initiates COVID-19 data analyses
| 27 March 2020 |
What is the drug consumption and medical history of Danish COVID-19 patients? And does the use of certain painkillers, including ibuprofen, affect the disease course of COVID-19?
More than 1,000 have responded to the Denmark helps Denmark campaign
| 27 March 2020 |
This weekend the Danish Medicines Agency launched the Denmark helps Denmark campaign wherein companies and manufacturers can make contributions to increase the supply of protective equipment like facemasks, gloves and shields for frontline staff. Thursday the number of responses exceeded 1,000.
COVID-19: Danish Medicines Agency puts inspection and control tasks on hold
| 26 March 2020 |
Due to the COVID-19 pandemic, the Danish Medicines Agency is putting all on-site inspections and laboratory controls on hold until further notice. The Danish Medicines Agency will, however, continue with office-based assessments and controls, and, if needed, also on-site inspections.
COVID-19: Watch out for illegal online sale
| 26 March 2020 |
Unauthorised retailers are illegally selling medicines and self-test kits online by exploiting fears and concerns amid the COVID-19 pandemic. “Extremely unsympathetic and dangerous to people’s lives and well-being,” says the Danish Medicines Agency’s Director General.
Paracetamol for children now only available from pharmacies
| 25 March 2020 |
Due to problems of supplying paracetamol for children, the Danish Medicines Agency is now taking action to ensure that there is enough for the children who need it the most. Director General of the Danish Medicines Agency: ”Buy only what you need”.