Registration of QPPV and PSMF number for veterinary medicinal products

Under Commission Implementing Regulation EU 202116 of 8 January 2021, all Marketing Authorisation Holders of Veterinary Medicinal products in the EU, must register information on Qualified Persons for Pharmacovigilance QPPV and Pharmacovigilance System Master File PSMF in the Union Product Database UPD.

Initial registration of information about QPPV and PSMF 

The initial registration of information about QPPV and PSMF number, must be done by submitting the relevant variation, that does not require assessment (VNRA). The Danish Medicines Agency can inform that, no fee will be charged, for initial registration of this information, if the registration is made no later than 31. December 2023. At the initial registration of the information in UPD, “one-off registration of QPPV” or “one-off registration of PSMF number”, must be entered in the Submission comment field. 

Subsequent changes to the information about QPPV and PSMF

Subsequent changes to the information about QPPV or PSMF must be submitted via the relevant VNRA. The Danish Medicines Agency can inform that, in accordance with the Executive Order on fees for Medicinal Products and Pharmaceutical Companies etc., these changes will be charged. 

 

Theme page about the new veterinary medicinal products regulation (bullet 3)