The Danish Medicines Agency will be closed over Christmas and New Year, from Saturday 23 December 2023 to Monday 1 January 2024, both days included. Read which deadlines apply to applications within the Danish Medicines Agency's area in 2023 ..read more

The Danish Medicines Agency is closed between Christmas and New Year, up to and including 1 January 2024. During this period, we will, however, handle urgent applications for compassionate use permits (applications for dispensing of non-marketed medicines ..read more

Applications for import/export certificates received via NDS Web must reach us by 15 December 2023 to be reviewed before Christmas. Applications submitted in any other way must reach us by 8 Decembe ..read more

The last day for submitting an application for a certificate of free sale to export a medical device  will be Wednesday 13 December 2023. Any application received after that will be considered re ..read more

Your application for a company authorisation must reach us by 15 December 2023 for the review to start before Christmas. Any application received after that will be considered received on 2 January ..read more

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 ..read more

Applications for export certificates for medicinal products must reach us by 13 December 2023 to be reviewed and issued before Christmas.  Any applications submitted after 21 December will be consid ..read more

Four EU countries – including Denmark – have published the first versions of digital product information for selected medicines. A pilot initiative is right now testing the use of digital product information for medicines used by citizens and healthcare professionals throughout the EU ..read more

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 ..read more

As a precautionary measure, the Danish Medicines Agency has decided to quarantine a specific batch of COVID-19 vaccines from Pfizer/BioNTech in response to vaccine centres having observed a possible error when using a specific vaccine batch. Over the next days, some people will therefore experience having their vaccination appointment cancelled. At present, there are no signs of any impact on the efficacy and safety of the batch in question ..read more