News about licensing of medicines
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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 2019
| 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.
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Crisis in Ukraine may impact review times and the prioritisation of cases
| 07 March 2022 |
As a result of the crisis in Ukraine, the Danish Medicines Agency performs tasks relating to the supply of medicines to the Danish market.
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Notification of medicine price and assortment changes between Christmas and New Year
| 02 December 2022 |
The Danish Medicines Agency is closed between Christmas and New Year. This means that there is no support regarding notification of medicine price and assortment changes from Monday 26 December 2022 to and including 30 December 2022.
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Updating of summaries of product characteristics due to changed ATC codes for 2024
| 02 January 2024 |
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 2024.
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Deadline for pre-Christmas issue of export certificates for medicinal products: 12 December 2024
| 02 December 2024 |
Applications for export certificates for medicinal products must be received by 12 December 2024 to allow for review and issuance before Christmas.
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Notification of changes in medicine prices and product ranges between Christmas and New Year 2023
| 28 November 2023 |
The Danish Medicines Agency is closed over Christmas and New Year. We will therefore not be offering support in relation to the notification of medicine prices and product ranges from Monday 25 Dece
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Call for Applications for Marketing Authorizations for Critical Medicines
| 22 August 2024 |
The Danish Medicines Agency is making a call for companies to apply for marketing authorizations for selected critical medicines. This initiative aims to ensure the supply of essential medicines in De