Monthly update on implementation of the New Veterinary Regulation — June 2021

Update of note by the EMA

The Committee for Medicinal Products for Veterinary Use (CVMP) adopted for a two-month public consultation a number of draft guidelines relating to the implementation of pharmacovigilance requirements for the new veterinary regulation at its meeting on 15-17 June:

  • veterinary good pharmacovigilance practice (VGVP) modules on collection, reporting and recording of suspected adverse events for veterinary medicinal products (EMA/CVMP/PhVWP/635856/2020);

  • VGVP Draft Annex Glossary (EMA/CVMP/PhVWP/118227/2021);

  • signal management (EMA/307620/2021);

  • veterinary pharmacovigilance communication (EMA/CVMP/PhVWP/63454/2021);

  • pharmacovigilance inspections (EMA/264458/2021) and

  • PhV Systems and their PSMF and QMS (EMA/INS/PhV/257136/2021).

Update of note by the CMDv

The CMDv is continuing its preparations for 2022 and is in discussion with the European Commission on the transitional measures to be implemented in relation to the handling of ongoing procedures. Further information will be published when available.

Update of note by the European Commission

The European Commission has stated that work is continuing on the Delegated Act on the criteria for the designation of antimicrobials to be reserved for humans. A favourable outcome to discuss in the European Parliament is required before the legislation can be finalised. This is not now expected before the summer break, and may not be available until October.

Update of note by the HPRA

The HPRA has accelerated work to prepare for the export of national product data to the Union Product Database (UPD). The HPRA expects to commence exporting the data in September. The HPRA is making a significant capital investment in its IT systems in order to be able to export data to the UPD on an ongoing basis post ‘go-live’ of the UPD in January 2022.

The HPRA is making excellent progress in changing the method of supply of antiparasitic veterinary medicinal products for use in food-producing animals. At this time, the HPRA expects that all products will be approved by the deadline of 28 July, facilitating the clean up of data before export to the UPD.