Notifications for the pharmaceutical industry about licensing, supervision and monitoring of medicines
| 18 May 2020 |
The Danish Medicines Agency will be closed on 22 May 2020, the day after Ascension Day. However, we process urgent applications for compassionate use permits (applications for dispensing of non-marketed medicines manufactured by pharmaceutical companies).
| 14 May 2020 |
The European Commission, the European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) – a network for the national drug regulatory authorities in the EU/EEA – have prepared common regulatory guidance for marketing authorisation holders. The guidance can be used during the COVID-19 pandemic and describes situations in which the authorities will apply flexibilities during the pandemic.
| 05 May 2020 |
The Danish Medicines Agency would like to inform you that it is possible to apply for a general compassionate use permit for Remdesivir for the treatment of COVID-19 patients who cannot be included in one of the protocol-based clinical trials that are currently being conducted in Denmark.
| 24 April 2020 |
UPDATED. We are aware that COVID-19 has consequences with regards to the conduct of clinical trials in Denmark. Multiple factors play a role such as trial participants in quarantine, limited access to public places (including hospitals) due to the risk of spreading infections etc.
Danish Medicines Agency has assessed and sent out replies for an exceptionally high number of clinical trial applications in March
| 06 April 2020 |
The Danish Medicines Agency has been extremely busy lately with the assessment of applications for clinical trials – not only COVID-19-related applications, but also applications for clinical trials of other medicines. All applications have been assessed, and all applicants have received a timely reply.
| 02 April 2020 |
Chloroquine and hydroxychloroquine must only be used for COVID-19 in clinical trials or national emergency use programmes in COVID-19 patients whose condition is critical, says the European Medicines Agency, EMA.
| 01 April 2020 |
The Danish Medicines Agency would like to clarify when and how companies must notify the Danish Medicines Agency of any supply problems they might experience.
| 27 March 2020 |
It is important to us that companies and industry associations feel they receive a prompt reply when they contact the Danish Medicines Agency.
COVID-19 and production of protective equipment: Collaboration between Danish Medicines Agency and Danish companies
| 24 March 2020 |
The Medicoindustrien, the Confederation of Danish Industry and the Danish Medicines Agency have formed a new collaboration to switch the production to gloves, lab coats, mouth shields, isolation gowns, masks and hand sanitizer.
| 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.
| 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.
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.
| 08 March 2019 |
The common European subgroup for complex clinical trials with trial subjects, which is headed by Denmark, has just published a set of recommendations for the development of personalised medicine.
| 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.
| 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
| 18 January 2019 |
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 2019.
| 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.
| 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.
| 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.
| 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”.