The EU Veterinary Medicines Regulation (2019/6) came into law on 27 January 2019, bringing with it many changes, some highly significant. With a three-year transition period for all parties to make the necessary changes and put everything in place to implement the new laws in each of the member states, the new rules finally became applicable on 28 January 2022. Our Technical Director Rick Clayton reflects on where we are now.

The implementation of the new rules required four substantial areas of work. Firstly, it required an unprecedented number of implementing acts and delegated acts to be drafted, to navigate the infamous ‘comitology procedure’, and to be adopted and published. And 12 of the 26 acts required had to be adopted before the end of the three-year transition period. Secondly, the rules required the development, validation and launch of a substantial new IT system, comprising three large and inter-connected databases with sophisticated functionalities. The idea was to ensure workflow efficiencies and more modern information management capabilities. Thirdly, many procedural and scientific guidelines had to be revised or, in some cases, new guidelines developed. And lastly, the labelling and packaging of all existing products needs to be updated to comply with the new rules, within a 5-year deadline ending on 29 January 2027.

Implementing acts and delegated acts

The European Commission is on schedule with the implementing measures, with 16 acts published, although there were significant delays to one relating to detailed rules on exports from third countries – Article 118 for those in the know. Remaining obligatory acts have deadlines in 2025 and 2027.

The databases

The second substantial area of work is the development of 3 databases: a Union Product Database (UPD), to house data on every veterinary medicine authorised in the EU; a pharmacovigilance database to collate every adverse event reported; and a database on every licenced wholesale/distributor and every good manufacturing certified premises.

Work on these databases is not on track as the amount of time and resources needed for the work was totally underestimated. And delays in the European Medicines Agency (EMA) securing the necessary funding from the Commission have not helped. It’s fair to say that the EMA moved mountains to deliver a ‘minimum viable product’ for the UPD by the 3-year transition deadline but was hampered by IT bugs and the challenge of shepherding 26 resource-stretched members states to upload all their legacy product data.

Unfortunately, the various bugs and incorrect or missing product data has meant the system is currently not viable. To top that, many of the regulatory processes or requirements depend upon the functioning of these IT systems. This has created a massive increase in regulatory administrative burden to navigate the obstacles, the opposite of one of the main objectives of the new regulation.

To truly deliver increased efficiencies in regulatory processes and data management, it’s clear that functionalities beyond the bare minimum are needed. And although development of the IT systems continues, progress is slow, and business cases for regulators are prioritised over those for industry. Furthermore, the budget for this work will end after 2025.

Updating regulatory processes and guidelines

The changes in regulatory procedures have required many procedural guidelines to be updated, for example CMDv best practice guides, particularly for product life cycle management. There is also guidance for the new SmPC
harmonisation process and the new provisions for the protection of technical documentation.

In addition, the new rules introduced some new concepts and definitions requiring new or revised scientific guidelines, such as: limited markets and exceptional circumstances, novel therapies (e.g. cell-based therapy or use of bacteriophages), vaccine antigen master file, vaccine platform technology master files, and for multi-strain dossiers. Of particular interest has been the revision of the CVMP Recommendation on the evaluation of the benefit-risk balance of veterinary medicines to reflect new wording in the regulation and the implementation of provisions to reduce the risk of antimicrobial resistance (AMR).

Pharmacovigilance – reporting of adverse effects of medicines – has undergone significant revisions under the new rules, requiring substantial (re)development of both company and regulatory agency systems. Workload burden to implement the changes has been compounded by the new systems not being ready or not functioning correctly, and the necessary guidance not being in place. This is further hampered by the need to ‘learn as you do’, particularly in the transition from periodic adverse event reporting to more frequent signal detection and management.

Updating labelling and packaging of all existing products

One major activity, which is currently stretching the resources of both companies and regulatory agencies, is the requirement to update the labelling and packaging of all existing products by 29 January 2027. For each product a licence update dossier must be prepared, submitted and potentially assessed. Considering that there are an estimated 40,000 plus products in the EU, this is a monumental task, and perhaps even ‘mission impossible’ within the 5-year deadline. We would question why there is such a strict deadline, given this is purely administrative and not in response to any safety concerns.

So where are we?

Does the new regulation meet its objectives?

The answer for each of the objectives is ‘it is too soon’, particularly as the full implementation is not yet complete. Furthermore, the full benefits of the IT systems will only be delivered when all the necessary functionalities are put in place – and all bugs eliminated! With doubts around the future funding of this work, there are questions whether the full potential to reduce administrative burden will ever be attained.

So at the moment, the new rules have actually largely increased administrative burden with the development and implementation of new systems and the one-off but massive exercise of updating packaging. And this burden will continue for at least another three years.

Looking to the future

Despite the current situation, we must look to the future with positivity. The AnimalhealthEurope regulatory and technical working parties have been heavily engaged in the consultation process for every element of the development and implementation of these new rules on veterinary medicines.

When implementation is complete both the regulatory authorities and industry can focus on refining the systems to reduce administrative burden wherever possible, for the benefit of everyone involved. We must also remember that the new rules bring new opportunities, for example opening the door to novel therapies and new approaches for the registration of vaccines.

Acknowledgements

I would like to thank all the experts in AnimalhealthEurope working parties for their dedication and accomplishments during this unprecedented period of intense work. In particular, my thanks go to the subject matter experts representing AnimalhealthEurope on the EMA stakeholder groups for IT and Pharmacovigilance. Finally, I wish to acknowledge the hard work of my colleagues, Dave and Jaume, managing and coordinating the workload.

Rick Clayton,
Technical Director