New changes to the Danish Wholesale Distribution Authorisation application form effective from November 2024
The update introduces modifications to Annex 1 and Annex 2 of the application form, including new activities, while others have been removed. Some key changes are:
- Renaming sections 2.1 and 2.3 to "2.1 Purchase" and "2.3 Sale", so the activities no longer cover physical handling of medicines.
- The section on low-temperature storage is now entitled "3.2 Products requiring low-temperature storage", and it must specify whether refrigeration (2-8 °C) or lower temperatures are required.
- The "3.3 Other products" section now includes set categories: "Medicinal products for clinical trials", "Homeopathic medicines", and "Medical gases".
- Certain activities, including "3.1.2 Medicines made from blood", "3.1.3 Immunological medicines", and "3.1.4 Radioactive medicines", have been removed.
Going forward, an application for a WDA amendment must include a completed Annex 1 for all sites and Annex 2 for all contractors, regardless of the nature of the amendment.
While all new applications and applications for amendments are subject to the changes, already issued WDAs will remain valid after 1 November 2024.
The update of the application form follows a revision of the EU-wide format for WDAs, along with the associated interpretation document, as a result of the entry into application of Regulation (EU) 2019/6 on veterinary medicinal products and repealing Directive 2001/82/EC.
Read the news on the Danish Medicines Agency's website (in Danish)
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