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.
Registration of missing pack sizes in UPD for products approved nationally and via MRP or DCP with Denmark as the Reference Member State (RMS)
In case of missing pack sizes in UPD, The MAH is kindly requested to complete the pack size request form and send it to the email. In the email, the MAH should confirm that they are requesting registration of approved pack sizes only.
The update of the UPD with the missing pack sizes will occur from mid-April. Once the pack sizes have been registered in the UPD, the MAH is kindly requested to update the information on availability. As per previous correspondence from the EMA to MAH, the information must be registered in the UPD no later than the end of June 2023.
The MAH is also kindly requested to add information about the pack size(s) in the SPC as part of the next variation to change the SPC.
Registration of missing pack sizes in UPD for products approved via MRP or DCP with Denmark as the Concerned Member State (CMS) or via the Centralised Procedure
For products approved via MRP or DCP with Denmark as the CMS, MAH should contact the RMS.
For products approved via the Centralised Procedure, MAH should contact the EMA.
Approval of new pack sizesApproval of new pack sizes must be applied for by submitting the relevant variation requiring assessment (VRA) or variation not requiring assessment (VNRA).