Updates for MAH New

Urgent call for submission of QRD v.9 updates (June 2026) New

In accordance with Article 152 of Regulation (EU) 2019/6, all marketing authorisations for veterinary medicinal products (VMPs) granted under Directive 2001/82/EC, as amended, must be updated to align their product information with QRD template version 9. 

These updates must be completed at the latest by 29 January 2027, after which all products placed on the market must have product information compliant with QRD v9.

The current number of purely nationally authorised marketing authorisations updated through G.I.18 VRAs appears insufficient to ensure that all relevant VMPs will have their marketing authorisations updated by 29 January 2027. Only those products that are not currently on the market are exempt from this deadline; however, they must be updated before they are reintroduced to the market.

MAHs are kindly encouraged to provide information regarding all outstanding submissions to BASG and to submit the outstanding G.I.18 VRAs as soon as possible in order to facilitate the swift handling of the procedures. Please inform the BASG of the names and marketing authorisation numbers of the concerned VMPs, including those – marked - not currently marketed (using the email addresses: basg-heve@basg.gv.at and vet.regulatory@basg.gv.at).

For important information on submitting annual volume of sales data in the UPD for veterinary medicinal products, including registered veterinary medicinal products, see Heads of Medicines Agencies: Implementation of the VMP Regulation.

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