Notifications for the pharmaceutical industry about licensing, supervision and monitoring of medicines

The Danish Medicines Agency can again receive electronic adverse reaction reports via E2B

| 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 is replacing its register of medicines

| 13 November 2020 |

The Danish Medicines Agency´s current register of medicines – called KAT – is being replaced with a new and improved register. The new register is built on a Microsoft Dynamic CRM-platform and has been named “LEOPARD”, which is an abbreviation for “The Danish Medicines Agency´s Electronic Information- Packaging and Address-register for Denmark”. LEOPARD is scheduled to be implemented on November 23, 2020.

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.

Opioid use in Denmark is decreasing

| 04 November 2020 |

Total sales of opioids have decreased by more than 20 per cent in the past four years, and there are now fewer Danes who use the most common type of opioid, tramadol. So reveals two new studies from the Danish Health Data Authority and the Danish Medicines Agency.

Extraordinary measures for clinical trials due to COVID-19

| 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.

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.

COVID-19: Regulatory guidance in connection with COVID-19 and possible impact on assessment times

| 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)

The Danish Medicines Agency will be closed on 22 May 2020

| 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).

Compassionate use permit for Remdesivir

| 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.

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.

EMA clarifies use of chloroquine and hydroxychloroquine for COVID-19

| 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.

Clarification on companies’ notification of supply problems to the Danish Medicines Agency

| 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.

Inquiries to the Danish Medicines Agency about medicines

| 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.

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.

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.