2023
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Recall of the antibiotic Dicillin from Sandoz
| 07 February 2023 |
Patients who are treated with Dicillin Sandoz 500 mg capsules are instructed to return the medicine to a pharmacy and have it replaced. It is important not to stop treatment but to have the medicine replaced with another antibiotic. The pharmacies have been informed to dispense an alternative medicine.
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Order books and Procedure Start Table
| 12 January 2023 |
In order to improve the companies' possibility to follow the status of their submitted variations, the Danish Medicines Agency is expanding its order book for variations to include all national type I
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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.
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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