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

Update by the EMA

The seventh EMA newsletter on the implementation of the EMA IT systems required by Regulation 2019/6 was published on 1 October 2021.

The EMA has made the following webinars available for industry:

Additional webinars are planned by the EMA during November 2021 on the following topics:

  • UPD interface – other product authorisation data;

  • Usage of the MAH’s UPD user interface;

  • User guidance to the registration process.

Additionally, an EMA Veterinary Information day is planned for 30 November.

The EMA has recently published a draft ‘Chapter 7’ of the Veterinary EU Implementation guide, which contains information for industry on the submission of volume of sales of veterinary medicines. It is available to download from the EMA's UPD webpage. Queries related to the UPD may be sent to vetchange.programme@ema.europa.eu.

Update by the Committee for Medicinal Products for Veterinary Use (CVMP)

The CVMP adopted a concept paper on scientific guidelines for limited market products deemed not eligible for authorisation under Article 23 of Regulation (EU) 2019/6 (EMA/CVMP/435071/2021) for a two-month period of public consultation.

Update by the Coordination Group for Mutual Recognition and Decentralised Procedures - Veterinary (CMDv)

The EMA and CMDv have published a document offering procedural advice for requests for the classification of variations not listed in either the Commission Implementing Regulation or the joint EMA/CMDv guidance on variations requiring assessment. It is available to download from the CMDv section of the HMA website. This document is accompanied by a request form which is to be used for specific requests for recommendations on the classification of a variation not already listed.

Three Best Practice Guides (BPGs) have recently been released for public consultation and are available on the CMDv webpage. These include the BPG for variations requiring assessment, variations not requiring assessment and worksharing applications. The deadline for comments is 11 November 2021.

The CMDv has also prepared a Q&A document to assist marketing authorisation holders and national competent authorities to manage the transition between the requirements of Directive 2001/82/EC and Regulation 2019/6.

Update by the European Commission

Further to the vote in the European Parliament on the criteria to be used for antimicrobials that are to be reserved for human use, the European Commission has published the criteria in draft form.

Update by the HPRA

The recordings of the HPRA information day on the implementation of the new veterinary regulation, which was held on 28 October 2021, will be uploaded to the HPRA website by 16 November.

The HPRA has cleaned and enriched the legacy data for the Reference Member State products which must be uploaded to the UPD. The data upload is expected to take place shortly.

The HPRA is continuing to prepare our internal systems to meet the changes required under Regulation 2019/6.