Reg 2019/6 - Update on Preparations from the EU Regulatory Network
The new veterinary medicines regulation (EU) 2019/6 becomes applicable on 28th January 2022. As the deadline approaches, implementation activities are accelerating and the entire regulatory network of Europe is preparing for the coming changes. The EMA / HMA, national regulators and industry organisations are all providing regular updates on the progress. Below is a summary of the most recently published information.
Variations requiring assessment
A joint EMA/CMDv guidance on the details of the classification of variations requiring assessment according to Article 62 of the Regulation has been adopted by CVMP at the May plenary meeting; this has been sent to HMA for endorsement and will be published in due course.
union product database (UPD)
The EU Implementation Guide for the UPD has been updated, including the explanatory note and Chapters 1 – 5:
- Registration and data access requirements for the User Interface
- Format for the electronic submission of VMP information
- Process for the initial submission and maintenance of VMP information
- Process and format for the submission of legacy data on VMPs
- Technical specifications
Critically Important Antimicrobials
EMA / Federation of Veterinarians of Europe (FVE) will host their 2nd webinar on the new Veterinary Medicines Regulation, on 23 June. This will focus on changes to the classification of critically important antimicrobials.
The USKVBL has updated its summary webpage on Reg 2019/6, providing a brief overview of the current implementation status, including a clarification on transition measures for VMPs subject to renewal after the date of coming into effect of Reg 2019/6.
The HPRA has issued its April summary update of significant developments with Reg 2019/6, from the EMA, CMDv, EC and the HPRA. The April updates include news on IT preparations and the QRD templates.
Also in relation to Reg 2019/6, the HPRA has issued a reminder that antiparasitic VMPs for food-producing species will become prescription only medicines from 28 January 2022.
CBG-MEB has also issued the first of its Reg 2019/6 update webpages, summarising the current status of implementation and the main changes being introduced.