Two experienced managers from the European Medicines Agency (EMA), Kristina Paterson and Jana Schalansky, shared the Agency’s view on consultants and their many beneficial roles in Agency procedures at the general assembly of the AVC (Association of Veterinary Consultants). The meeting was held at the historic buildings of the veterinary faculty in Utrecht, The Netherlands in October 2024. The AVC is a recognised EMA stakeholder and members participate in events, meetings, and public consultations. AVC members are independent veterinarians with experience and expertise in managing application dossiers and essential procedures intended for the EMA, EFSA (European Food Safety Authority), UK FSA (Food Standards Agency), US FDA (Food and Drug Administration), and other international regulatory bodies.
The keynote guest speakers made a joint presentation on the “Role of Consultants in the operation of Regulation (EU) 2019/6”, which is the (still) new veterinary medicines legislation. Kristina Paterson, Head of Veterinary Regulatory Affairs and Referrals, started with acknowledging that consultants can form an important link between the applicant and the competent authority, especially for small companies. For Innovation Task Force meetings and scientific advice on product developments, maximum residue limits and other procedural steps, the consultant can give applicants a shortcut to the many and complex issues in the regulatory route to market. The interactions that EMA has with applicants and their consultants are intended to assist innovation for veterinary medicinal products and increase their availability.
Jana Schalansky, Head of Veterinary Strategic Support, also informed about the Task Force on Availability of Authorised Medicines for human and veterinary use (TF-AAM), which works on solutions to tackle disruptions in supply and availability across all member states. At national level, shortages are an increasing problem, and on the veterinary side there is no structured industry reporting channels. EMA coordinates scientific expertise on medical alternatives and an availability team works on shortage case management. Currently, the extent of shortages of VMPs (Veterinary Medicinal Products) is relatively unknown, and reporting and regulatory flexibility should be improved.
The presenters opened a discussion questioning if EMA provides the right platforms for interaction, and requested direct feedback on procedures for consultations and focus group meetings. AVC members debated with insight and honesty their experiences on EMA interactions, which are overall very positive, constructive and well-informed. Several procedures could benefit from a better understanding of the conditions for small and medium-sized companies, where the scientific innovation capacity is huge, but regulatory, legal and IT (Information Technology) skills are under-prioritised. This requires very thorough and basic guidance and interactions, which the EMA secretariat is striving to provide in this complex environment. The meeting was very productive and AVC members thanked EMA for recognizing of the important role that consultants provide for EMA dossiers and procedures.
