European Union: Reform Of The Veterinary Medicines Regulations 2013 Takes Shape For GB

Modernisation of the regulatory framework aims to reduce the administrative burden for businesses in Great Britain

The Veterinary Medicines Directorate (VMD) held a consultation last year on the review of the Veterinary Medicines Regulations 2013 with input from businesses involved in the manufacture, distribution and dispensation of veterinary medicinal products.

The VMD has now announced in its response that it will implement the majority of the proposed changes, while also making necessary amendments to proposals. This will bring about a much-needed transformation in the regulatory framework for veterinary medicines.

The changes that are being introduced will only relate to the regulation of veterinary medicines in England, Scotland and Wales and does not include Northern Ireland (NI). (The VMD has published a full summary table of consultation responses to each proposal of the review.)

Single dossier and labels for European regions

The VMD has amended its proposal on the information required for a marketing authorisation for veterinary medicines so that it aligns with the EU rules. This means that the government will allow companies to submit a single dossier for the European regions, aiming to reduce the administrative burden and help facilitate the continued availability of veterinary medicines in Great Britain (GB).

Similarly for labelling, the VMD has decided to amend its proposal, in order to align fully with the regulatory requirements for veterinary medicines in NI and the EU. This will facilitate the option to use joint labelling across GB, NI and the EU.

Sustainable labelling and package leaflets

The VMD has retained the option to introduce more innovative methods for labelling products, such as QR codes and electronic package information leaflets as alternatives to physical package leaflets. This will likely save significant printing costs, as well as allowing for easier labelling for products destined for different jurisdictions and fewer physical resources needed to package the product.

The response acknowledges concerns from respondents regarding a lack of technology literacy and access to the technological infrastructure, as well as broader security risks. The VMD's response provides some reassurance, with a comment that guidance will be given in due course to address these concerns and clarify questions raised around these changes.

UK availability of veterinary medicines

The VMD will introduce a requirement for companies with marketing authorisations for veterinary medicines to report any current or upcoming shortages (that is, when supply does not meet the demand at a national UK level), where known.

In addition, to ensure that the availability of veterinary medicines in the UK is not affected, the VMD has confirmed that marketing authorisation holders will continue to be allowed to be based in countries with equivalent regulatory standards to the UK. Additionally, the role of a UK-based local representative will be introduced on a voluntary basis, with more information on this (and the benefits of this role) to come at a later date.

Data protection periods for generics market

The VMD will be proceeding with its proposed extension of some data protection periods awarded to veterinary medicines with the goal to support and encourage a thriving generics market in the UK. Currently, applications for generic products can be submitted after eight years of authorisation but cannot be marketed until the 10-year data protection period has expired, with limited cases where there is an extension to 13 years.

The extension will be implemented, despite several responses highlighting concerns around the potential risk of risk of increased veterinary medicine prices, supply issues and negative implications for availability of medicines for minor species as well as a lack of full harmonisation with the EU data protection periods.

Collection and disposal proposal scrapped

The VMD will not be implementing its proposal for a collection and disposal system. This is due to various reasons such as biosecurity concerns around the return of medicated feed to feed business operator sites. There was also wider concern that the change would potentially place significant strain on the industry and result in a reduced production and sale of medicated feed, as well as placing animal welfare at risk. However, VMD is committed to reviewing whether a collection and disposal system should be in place and what a potential system should look like and how it could be introduced.

Clarification on advertising

The initial consultation proposed a restriction on the advertising of veterinary prescription medicines; that is, POM-V (prescription-only medicine-veterinarian) and POM-VPS (prescription-only medicine-veterinarian, pharmacist, suitably qualified person) targeted at professional keepers of animals. However, the government has decided not to implement this restriction.

Instead, the revised proposal requires the inclusion of a statement on the advertisement that it is the prescriber who decides on the product. One of the main reasons cited for this was the impact this would have on a potential lack of education and professional development for famers, which is mostly sponsored through advertising in the UK.

The regulations will also explicitly clarify that the advertisement should only include factual statements in line with the summary of product characteristics of the veterinary medicine, as is the case with over-the-counter human medicines.

Osborne Clarke comment

The consultation response will be welcomed by many businesses for its role in aligning requirements in the veterinary industry (such as dossier and labelling requirements) across GB, NI and the EU. This will undoubtedly facilitate trade and reduce regulatory divergence, as well as encourage further innovation within the industry in areas such as new information formats through QR codes and electronic packaging information leaflets.

However, it is notable that there are still various divergences between the position in the UK and the EU, such as the approach to the length and classifications of regulatory data protection periods for generic veterinary medicines. This means that businesses will need to be remain vigilant and identify the relevant differences to take advantage of the varying timelines and rules to suit their businesses.

Veterinary practices and manufacturers of veterinary medicines will be keeping a close eye on the new rules, accompanying guidance and its implementation; particularly, to assess whether the changes will encourage the development and marketing of new and innovative products for the GB market.