Monthly update on implementation of the New Veterinary Regulation — January 2021
The European Commission has recently advised that the current state of play on the elaboration of the implementing and delegated acts is that overall, the work is progressing on time. However, due to COVID-19, the progress for the elaboration of certain acts has been slightly delayed. Two implementing acts have already been adopted, and were published in the Official Journal on 11 January:
The Commission has reaffirmed its ‘ambition for timely implementation’ during the course of this year.
During January, the European Medicines Agency (EMA) has published:
The EMA is working on the basis that the UPD will be available to Member States to begin the process of uploading national product data from July 2021.
The Coordination Group for Mutual Recognition and Decentralised Procedures – Veterinary (CMDv) continues to reflect on the envisaged changes to various regulatory processes and their impact. A number of best practice guides (BPGs) are being drafted at present, including:
BPG for product selection for SPC harmonisation
BPG for SPC harmonisation of reference products
BPG for SPC harmonisation of generic and hybrid products
Revision of the QRD template is also being undertaken to meet the new requirements. Discussions on the transition measures in relation to the renewal of marketing authorisations that expire post January 2022 are continuing with the EU Commission. Further to the finalisation of the list of variations not requiring assessment, a guidance document for the classification of variations is planned.