Return from the summer break sees updated Notice to Applicants and first EMA advice on implementation of the new veterinary medicines regulation

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.

Eudralex Notice to Applicants guidance for VMPs updated

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:

• Volume 6A Procedures for marketing authorisation; CHAPTER 1 Marketing authorisation (Link).
• Volume 6C Regulatory Guidelines; Guideline on the categorisation of extension applications (EU) versus variations applications (Link).
• Volume 6C Regulatory Guidelines; Guideline on the packaging information of veterinary medicinal products authorised by the union (Link).

New Veterinary Medicines Regulation (EU) 2019/6

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:

Delegated Acts

• Requirements for the collection of data on antimicrobial medicinal products used in animals (Link)
• Amendments to Annex II, detailing the technical requirements for a full dossier for a marketing authorisation and the specific requirements for particular types of products (Link)

Implementing Acts

• Necessary measures and practical arrangements for the Union database on veterinary medicinal products (Link)
• List of variations not requiring assessment (Link)

Committee for Medicinal Products for Veterinary Use (CVMP) meeting of September 2019

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.

eSubmissions and PDF/A use for VNeeS

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).

Small and Medium-sized Enterprises (SMEs)

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).

Monthly report

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:

Quality

• Use of peptone in the manufacture of active substance

Novel therapies

• Revised Questions and Answers on allogeneic stem cell-based products for veterinary use: Specific questions on extraneous agents
• Revised Questions and Answers on allogeneic stem cell-based products for veterinary use: specific questions on sterility

Residues and consumer safety

• VICH GL57: Studies to evaluate the metabolism and residue kinetics of veterinary drugs in food-producing species: marker residue depletion studies to establish product withdrawal periods in aquatic species
• VICH GL36(R2) Studies to evaluate the safety of residues of veterinary drugs in human food: general approach to establish a microbiological ADI

Antimicrobial resistance (AMR)

• Answer to the request from the European Commission for updating the scientific advice on the impact on public health and animal health of the use of antibiotics in animals - Preliminary risk profiling for new antimicrobial veterinary medicinal products

Regulatory procedures

• Update of the veterinary postauthorisation guidance on the EMA public website