Implementation of Veterinary Medicines Regulation set to dominate EMA agenda for 2021
In our first post for 2021, looking at the updates from the European Medicines Agency (EMA), it is not surprising that the news is dominated by the implementation of the Veterinary Medicines Regulation, which comes into force from 28 January 2022. There is a huge amount of work still to do on the implementing and delegated acts, not to mention the soft-law, such as guidelines, which will provide all the detail so badly needed by both industry and the regulators.
Implementation of Veterinary Medicines Regulation (EU) 2019/6
The first of the implementing acts for Reg. 2019/6 have now been published in the official journal of the EU:
- Commission Implementing Regulation (EU) 2021/17 of 8 January 2021 establishing a list of variations not requiring assessment
- Commission Implementing Regulation (EU) 2021/16 of 8 January 2021 laying down the necessary measures and practical arrangements for the Union database on veterinary medicinal products (Union product database)
Also in relation to the Union product database, a draft implementation guide, in five chapters and an overview, is now available for public consultation.
Meanwhile, the CVMP workplan for 2021 has also been published, highlighting the ongoing activities of the CVMP with respect to implementation of Reg. 2019/6. Similarly, the 2021 workplan for the Pharmacovigilance Working Party (PhVWP-V) has also been published, with work scheduled to continue on the guidelines on veterinary good pharmacovigilance practice (VGVP).
CVMP plenary January 2021
Highlights from the CVMP meeting of 19 – 20 January have now been published, with the following general regulatory and scientific developments. The CVMP adopted its strategy on antimicrobials for 2021-2025 and also adopted a series of concept papers for consultation, regarding immunological products:
- Concept paper for a guideline on vaccine antigen master files
- Concept paper for a guideline on vaccine platform technology master files
- Concept paper for revision of the guideline on multi-strain dossiers for inactivated vaccines against avian influenza, bluetongue and foot and mouth disease
- Concept paper for revision of the “Note of guidance on veterinary field trials” and the position paper on indications for veterinary vaccines
These documents will be published on the EMA website in the coming weeks.
Applicants have been reminded that it is now mandatory to use v18.104.22.168 of all electronic application forms, but that the version of the form should not be changed during an ongoing procedure.
The EMA has published its updated recommended submission dates, extending to July 2022, with notes regarding the coming into effect of Reg. 2019/6.
Scientific guidelines: VICH and antibiotics dosing
Two VICH guidelines have progressed to the next stage of adoption, with one now in effect in the EU:
- VICH GL58 is now in effect, following adoption by CVMP in December 2019: “Stability Testing of New Veterinary Drug Substances and Medicinal Products in Climatic Zones III and IV”.
- VICH GL59 has been formally adopted by the CVMP, due to come into effect in November 2021: “Harmonisation of criteria to waive laboratory animal batch safety testing for vaccines for veterinary use".
The first version of a “Reflection paper on dose review and adjustment of established veterinary antibiotics in the context of SPC Harmonisation” has now been published, following the close of consultation.
EMA update reports
Three routine reports have been published by the EMA in December and January:
- Monthly report on application procedures, guidelines and related documents for veterinary medicines November 2020
- News bulletin for small and medium-sized enterprises - Issue 51
- Veterinary medicines: highlights of 2020
The second revision of the EudraVigilance access policy for VMPs has been released for a 2-month public consultation.