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After what appeared to be a quiet summer period at the EMA and the European Commission (EC), several significant publications demonstrate that there has been a lot of activity going on in the background. Apart from more routine activities, we have seen the release of an updated Eudralex Volume 6 (Notice to Applicants) and also the first of the EMA advice to the EC regarding the implementation of the new veterinary medicines regulation.
After many years of waiting, the Notice to Aplicants has been updated, bringing the guidance in line with the latest experience. Specifically, the following sections of the NTA have been updated:
The EMA has now provided the first of its advice to the EC regarding the implementation of Regulation (EU) 2019/6. Specifically, advice has now been given by the EMA on the following implementing and delegated acts:
The EMA has posted the press release with details of the CVMP's meeting of 10 – 12 September 2019 (Link). There were no significant updates regarding general regulatory affairs and no new guidance documents have been adopted, with business focused on product-specific discussions.
Mandatory use of the PDF/A format in VNeeS (Link) will be live from early 2022. However, it is strongly recommended to create any new documents as PDF/A as soon as possible, to avoid the need for conversion of legacy files required for future submissions (see PDF/A Q & A – Link).
The latest news bulletin for SMEs has now been published, summarising all the relevant publications from the EMA which SMEs need to be aware of (Link).
The July monthly report on application procedures, guidelines and related documents for VMPs has been published (Link). Amongst other things, this document summarises the guidance adopted by the CVMP so far in 2019, which cover the following subjects: