In our first post for 2021, looking at the updates from the 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.
The first of the implementing acts for Reg. 2019/6 have now been published in the official journal of the EU:
Also in relation to the Union product database, a draft implementation guide, in five chapters and an overview, is now available for public consultation (Link).
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 (Link). Similarly, the 2021 workplan for the Pharmacovigilance Working Party (PhVWP-V) has also been published (Link), with work scheduled to continue on the guidelines on veterinary good pharmacovigilance practice (VGVP).
Highlights from the CVMP meeting of 19 – 20 January have now been published (Link), 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:
These documents will be published on the EMA website in the coming weeks.
Applicants have been reminded that it is now mandatory to use v184.108.40.206 of all electronic application forms, but that the version of the form should not be changed during an ongoing procedure (Link).
The EMA has published its updated recommended submission dates, extending to July 2022, with notes regarding the coming into effect of Reg. 2019/6 (Link).
Two VICH guidelines have progressed to the next stage of adoption, with one now in effect in the EU:
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 (Link).
Three routine reports have been published by the EMA in December and January:
The second revision of the EudraVigilance access policy for VMPs has been released for a 2-month public consultation (Link).