News about licensing of medicines
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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.
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Updating of summaries of product characteristics due to changed ATC codes for 2015
| 16 January 2015 |
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 in 2015.
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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”.
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New application forms mandatory from 1 January
| 14 December 2015 |
From 1 January 2016, it will be mandatory to use the eAF to apply for marketing authorisations, renewals and variations. This applies to both human and veterinary medicinal products, and it applies to all procedure types.
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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.
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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.
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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.
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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.
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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.
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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)
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Send Danish package leaflet when applying for changes to product information
| 11 February 2015 |
When applying for changes to the product information, marketing authorisation holders must always send a Danish version of the package leaflet to the Danish Health and Medicines Authority, whether the medicinal product is marketed in Denmark or not (unless the medicinal product is subject to section 11 about omission of the package leaflet, cf. Executive order no. 869 of 21 July 2011, as amended, on the labelling etc. of medicinal products).
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New format requirements for applications for authorisation of medicinal products
| 13 July 2015 |
On 1 July 2015, the rules governing applications for marketing authorisations for medicinal products were amended in three areas as a result of new requirements from the European Medicines Agency (EMA).
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Time slots for DCP procedures with Denmark as Reference Member State (RMS)
| 28 January 2014 |
The Danish Health and Medicines Authority wishes to inform future applicants of the possibility to request for a time slot to applications for marketing authorisations through the decentralised procedure (DCP) where Denmark is acting as reference member state (RMS).
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Available time slots in Q1 2015 for DCP applications with Denmark as reference member state
| 14 November 2014 |
Companies wishing to apply for a marketing authorisation for a medicinal product can request a specified submission date (time slot). Time slots are available in the first quarter of 2015.
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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.
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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.
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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.
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New format requirements for marketing authorisation applications
| 15 June 2017 |
The Danish Medicines Agency is postponing the phasing-out of NeeS and tightens the format requirements for updating the assessment report prior to MRP/RUP.
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New format requirements for marketing authorisation applications from 1 January 2018
| 10 November 2017 |
The NeeS submission format will be discontinued for applications submitted under the mutual recognition procedure (MRP). This change is related to medicinal products for human use. Parallel import and parallel distribution are not affected by this change.
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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.