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

Update by the EMA

The EMA has published the Guideline of Veterinary Good Vigilance Practices (VGVP). This brings together guidance for marketing authorisation holders, national competent authorities and the EMA on the requirements, roles, activities and procedures related to collection and recording of suspected adverse events for veterinary medicinal products occurring within the EU/EEA or in third countries.

Update by the CMDv

Three Best Practice Guides (BPGs) have recently been released for public consultation and are available on the CMDv webpage. These include the BPG for validation of applications, changing the reference member state and for handling marketing authorisations for veterinary medicinal products intended for limited markets (national, mutual recognition and decentralised procedures). The deadline for comments is the 15 December 2021.

CMDv have started revising its website to meet the requirements of the Regulation 2019/6 with a new subpage dedicated to re-examination after DCP/VRA which can be found under the ‘Procedural Guidance’ section. A new SPC harmonisation webpage is also available and includes the three recently adopted BPGs for the SPC harmonisation procedure. The website will be updated on an ongoing basis and will coincide with the publication of many of the revised or new BPGs and Guidance documents.

Update by the European Commission

On 6 October 2021, the European Commission published the criteria for the designation of antimicrobials to be reserved for the treatment of certain infections in humans, called Commission Delegated Regulation EU 2021/1760. On 29 October, the Commission published the design of a common logo for the retail of veterinary medicinal products at a distance.

Update by the HPRA

The HPRA has uploaded information on the information day on the implementation of Regulation 2019/6 in Ireland, which was held on 28 October 2021. Information on questions and answers that were not addressed during the event are available on the information day webpage.

In order to facilitate the transition from the current to the new variation classifications and procedures, the HPRA requests that, as far as possible, non-urgent variations are not submitted under Commission Regulation (EC) 1234/2008 after 15 December 2021. Urgent variations under Regulation (EC) 1234/2008 will be accepted but MAHs are requested to minimise the number of variations submitted between 15 December 2021 and 28 January 2022.