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EMA recommends conditional authorisation of the COVID-19 vaccine from Moderna
The European Medicines Agency, EMA, has recommended the European Commission to grant a conditional authorisation for the COVID-19 vaccine for use throughout the European Union, including Denmark.
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European Commission authorises one more COVID-19 vaccine
On 6 January 2021, the European Commission granted a conditional marketing authorisation for the COVID-19 vaccine from Moderna. The vaccine has demonstrated a 94 per cent efficacy in trials. The authorisation is valid throughout the European Union including Denmark.
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Thomas Senderovitz leaves the Danish Medicines Agency
Thomas Senderovitz has announced that he is leaving his role as Director General of the Danish Medicines Agency to pursue fresh opportunities.
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Publication of educational materials for centrally authorised medicinal products
From January 1st 2023 and forward – and not retroactively – the Danish Medicines Agency now publishes educational material for medicinal products approved via the centralised procedure.
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Registration of approved pack sizes in the Union Product Database
In accordance with Commission Implementing Regulation (EU) 2021/16 of 8 January 2021, approved pack sizes for veterinary medicinal products must be registered in the Union Product Database (UPD). In connection with the registration of data in UPD, the Danish Medicines Agency has found that information on approved pack sizes in the summary of prouct characteristics (SPC) for veterinary medicinal products is not always complete. Therefore there may be missing information on approved pack sizes in the UPD for some products. Consequently, marketing authorisation holders (MAH) for veterinary medicinal products are encouraged to check the information in the UPD.
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Union Product Database: Deadlines for the Submission of Annual Volume of Sales data for veterinary medicinal products
According to Article 58(12) of Regulation (EU) 2019/6 , all Marketing Authorisation Holders must submit the annual Volume of Sales for each veterinary medicinal product to the Union Product Datab
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New EU rules on falsified medicines
When new EU rules enter into force on 9 February 2019, it will be harder for falsified medicines to reach patients in the EU. The new rules, which introduce new safety features on the packaging of medicines and other measures, are to prevent falsified medicines from entering the legal supply chain of medicines – for example in pharmacies and hospitals.
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New report: Evaluation of the relationship reform
The framework for collaboration between healthcare professionals and companies has just been evaluated. The evaluation concluded that the rules and administration work well, but compliance with the rules lags behind. There is a need for more information to healthcare professionals about the rules.
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Danish Medicines Agency to send safety information directly to healthcare professionals
When side effects or the like is discovered for medicines, the medicine’s product information sometimes needs to be changed to the point that healthcare professionals must be informed directly. Up to
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Updating of summaries of product characteristics due to changed ATC codes for 2022
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 2022.
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About the EU database of veterinary medicinal products (the Union Product Database)
The Union Product Database (UPD) was launched on 28 January 2022. The database will contain all authorised veterinary medicines in the EU. The Danish Medicines Agency and the other countries’ drug reg
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Proposal for SPC harmonisation of a veterinary medicinal product
According to Article 69-72 of Regulation (EU) 2019/6, National Competent Authorities (NCAs) as well as Marketing Authorisation Holders (MAHs) may propose harmonisation of the SPCs of Reference Veterin
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Combined studies with a clinical trial and a performance study: Sponsors now have the opportunity to apply for approval through a national coordinated application process
The Danish Medicines Agency, in collaboration with Danish Medical Research Ethics Committees, has developed a new guideline on a national coordinated application process for combined studies with a cl
