News about licensing of medicines

Medicines of the future in focus at World Economic Forum

| 20 September 2018 |

Medicines of the future is one of the topics being debated at the meeting of the World Economic Forum, which is currently place right now in Tianjin in China. The Danish Medicines Agency is attending.

Brexit, change of Reference Member State from UK to DK

| 01 February 2018 |

The Danish Medicines Agency would like to inform marketing authorisation holders that we welcome being the Reference Member State (RMS) for MRP/DCP authorised medicines, should you request Denmark as the future RMS when the UK is leaving the EU.

Theme event on big data and medicine

| 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”.

Available time slots for DCP applications with Denmark as reference member state

| 28 October 2016 |

Companies wishing to apply for a marketing authorisation for a medicinal product can request a specified submission date (time slot). Time slots are available.

Danish Medicines Agency launches new concept for National Scientific Advice

| 31 August 2018 |

Today, 31 August 2018, the Danish Medicines Agency is launching a new concept for National Scientific Advice for companies, hospitals and others who request advice on the requirements applicable to clinical investigation and marketing authorisations.

New format requirements for Marketing Authorization submissions from 1 January 2019

| 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.

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.

Clarification of labelling practice for warning statements on human medicines

| 05 January 2022 |

During our review of applications for marketing authorisations for human medicines and variations to marketing authorisations, we have noted uncertainty about the labelling practice regarding the warning statements of schedule 2 of the Danish executive order on labelling. The question is whether these warnings are required on the packaging and in the package leaflet if the warning statements are not supported by the summary of product characteristics (SPC) of the medicinal product concerned. We therefore find it necessary to clarify the labelling practice for warning statements on human medicines.

Assessment of new names of authorised veterinary medicines under the new veterinary regulation

| 22 February 2022 |

The assessment of names for already authorised veterinary medicines must be approved by the Danish Medicines Agency before the submission of a variation application.

2022 deadline for submitting applications concerning marketing authorisations and clinical trials

| 19 October 2022 |

The deadline for submitting applications concerning marketing authorisations and clinical trials is 20 December 2022. The Danish Medicines Agency is closed for the Holiday Season, from 24 December, 2022, until 1 January, 2023, both days included. Applications concerning marketing authorisations and clinical trials need to be submitted before 20 December, 2022. We will consider applications submitted after 20 December, 2022, as if they have been received 2 January 2023.

2023 deadline for submitting applications concerning marketing authorisations and clinical trials

| 13 November 2023 |

The deadline for submitting applications concerning marketing authorisations and clinical trials is December 20, 2023. The Danish Medicines Agency is closed for the Holiday Season, from December 23, 2023, until January 1, 2024, both days included. Applications concerning marketing authorisations and amendments to clinical trials need to be submitted before December 20, 2023. We will consider applications submitted after December 20, 2023, as they have been received January 2, 2024.

Updating of summaries of product characteristics due to changed ATC codes for 2023

| 02 January 2023 |

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 2023.

Updated status for completion of delayed cases in the licensing area

| 19 October 2023 |

Status for completion of delayed cases in the licensing area as of 1 October 2023 is now updated on the Danish Medicines Agency's website. The Danish Medicines Agency publishes updates on the status

Updating of summaries of product characteristics due to changed ATC codes for 2016

| 07 January 2016 |

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 2016.

Phasing-out of the NeeS format for applications for marketing authorisations of medicinal products

| 12 December 2016 |

Due to an increasing number of requests, we would like to point out the phasing-out plan for NeeS and the transition to eCTD/VNeeS as outlined in the eSubmission Roadmap. The format requirements apply to applications for marketing authorisations for medicinal products as well as maintenance of these (variations, renewals etc.). The changes do not apply to parallel import and parallel distribution.

Updating of summaries of product characteristics due to changed ATC codes for 2018

| 18 January 2018 |

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 2018.

All marketing authorisation letters are now sent electronically to Danish companies

| 01 March 2018 |

On 20 February 2018, the Danish Medicines Agency extended its use of digital post and now sends all letters, and not just decisions, about marketing authorisations electronically to Danish companies.

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)

Notification of medicine price and assortment changes between Christmas and New Year

| 15 December 2021 |

The Danish Medicines Agency is closed between Christmas and New Year, from Friday 24 December 2021 to Sunday 2 January 2022 - both days inclusive. However, the Danish Medicines Agency provides suppo

Updating of summaries of product characteristics due to changed ATC codes for 2017

| 20 January 2017 |

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 2017.