News about Licensing and supervision
Guidance on the implementation of decentralised elements in clinical trials with medicinal products is now available
| 04 May 2021 |
Decentralised clinical trials with medicinal products meet the patients, wherever they are, in a faster and more efficient process benefitting both patient, healthcare professionals and industry. It is therefore gratifying to be able to announce that another important milestone has been reached in the Danish Medicines Agency's project to ensure an up-to-date and robust regulatory framework for decentralisation of clinical trials.
Announcement of altered dispensing status for gadolinium-containing contrast agents (ATC code: V08CA)
| 22 February 2021 |
The Danish Medicines Agency hereby informs you that the dispensing status for all gadolinium-containing contrast agents, regardless of strength, pack size and indication is changed to ‘BEGR’ (only to be dispensed to hospitals) as of 5 October 2020.
| 20 January 2021 |
In many cases, participating in a clinical trial is a considerable burden for the trial subjects. Clinical trials often involve many hospital appointments with a lot of travel and waiting time. The people who are affected the most live far away from the hospital departments concerned, with resulting unequal access to clinical research in Denmark.
| 20 January 2021 |
Participate in a clinical trial from the comfort of your own home. It may sound a little crazy, but it is actually possible in many respects. The Danish Medicines Agency has started a project to enable researchers and pharmaceutical companies to conduct so-called decentralised clinical trials which by means of new technologies make it easier for people to participate in clinical trials. It makes it more convenient for the participants and increases efficiency, while ultimately getting medicines to market faster for the benefit of patients.
| 23 November 2020 |
Please be informed that the gateway for SUSAR submission is now available again. If You after 48 hours have submissions that are pending acknowledgements, please contact the Danish Medicines Agency.
The Danish Medicines Agency cannot receive electronic adverse drug reactions via E2B in the period November 19th from 10:00 CET to November 24th
| 11 November 2020 |
Due to implementation of a new IT-system is it not possible for the Danish Medicines Agency to receive electronic adverse drug reactions (SUSARs) via E2B (DKMAEUDRA) in the period November 19th (10:00 CET) to November 24th 2020. Submissions to EVCTMPROD are not affected.
| 09 October 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.
| 06 October 2020 |
A fine or imprisonment of up to four months is the ultimate punishment if the results from clinical trials of medicines are not published. The Danish Medicines Agency will be taking a tougher line on investigators – the so-called sponsors of clinical trials of medicines – if they do not publish the results of the trials they carry out.
| 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.
| 04 June 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. (updated)
| 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).
| 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.
| 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.
| 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.
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.
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.