Consultation opens on proposed revisions to the Veterinary Medicines Regulations in Great Britain
Published on 15th Mar 2023
Businesses involved in the manufacture, distribution and dispensation of veterinary medicinal products should take the opportunity to respond before the 31 March deadline
The Veterinary Medicines Directorate (VMD) has announced a consultation to amend and supplement the Veterinary Medicines Regulations 2013.
The VMD is an executive agency which is sponsored by the Department for Environment, Food & Rural Affairs. It has noted that only minor changes have been made to the regulations since they came into force in October 2013. Almost ten years later, the VMD proposes that they need to be updated to reflect the numerous changes and technical advances that have occurred in the veterinary medicines industry.
This consultation relates to the regulation of veterinary medicines in England, Scotland and Wales only and does not include Northern Ireland. It will close on 31 March 2023.
Manufacturers, feed business operators and professional keepers of animals may want to consider the following areas being consulted on, as well as keeping an eye on proposals to change the regulations.
The VMD proposes to allow for innovative techniques such as pictograms and QR codes on product labelling, as well as electronic packaging information leaflets instead of physical information leaflets where appropriate. This will likely save significant printing costs, as well as allowing for easier labelling for products destined for different jurisdictions and ultimately fewer physical resources needed to package the product.
Clarification on advertising
The proposals suggested in the consultation aim to provide further clarity on what is meant by "advertising", particularly in relation to when veterinary medicines may be specifically promoted to targeted professional groups. It will also be further emphasised that it is an offence to advertise any unauthorised veterinary medicines.
Reduction of regulatory burden
Noting the different regulatory systems across Great Britain, Northern Ireland and the European Union, the VMD proposes similar requirements to those in the EU, enabling companies to submit similar dossiers when applying for marketing authorisations in all three jurisdictions.
Supply chain notifications
The VMD proposes to introduce a new requirement where companies with marketing authorisations for veterinary medicines will need to report any current or upcoming shortages (that is, when supply does not meet the demand at a national UK level) where this is known by the relevant company.
The consultation also aims to improve traceability in the sector, with a proposal that manufacturers will be required to record more detail on the products that they manufacture.
While there is already a requirement for all records and certificates to be kept for at least five years from the date that the relevant veterinary medicinal product was placed on the market, there is now an additional suggestion that this could be extended to "for one year after the date of expiry of the batch, whichever is the longer". This could potentially mean that records for relevant products need to be kept safely for a longer period of time.
More direction on storage and disposal of medicated feed
The VMD proposes that feed business operators and professional keepers of animals will need to have a collection and disposal system in place for expired or unused medicated feed. This is to ensure that unused, expired and waste feed is disposed of correctly and responsibly, especially when any of the feed contains antimicrobials.
This also includes an explicit requirement that medicated feed must not be given to any animals after their expiry dates and that products should be labelled with the warning "inappropriate disposal of this product poses a serious threat to the environment".
Osborne Clarke comment
The consultation emphasises the VMD's ambition to reduce regulatory burden, increase clarity and update the regulatory system of veterinary medicinal products in Great Britain in line with the changes and other technical advances that have been seen in the veterinary medicines industry.
Businesses that are involved in the manufacture, distribution and dispensation of veterinary medicinal products should take the opportunity to respond to the consultation before the deadline, and keep any consultation results (such as amendment of the regulations) under close review.
Other industries (such as manufacturers of human medicinal products) should keep an eye on developments in this area as there may be some cross-over learning points. For example, whether the use of electronic information leaflets may also, in the future, become a requirement for human medicines to help meet the sustainability agenda.
Additionally, it will be interesting to note whether this will lead to any further divergence between the regulation of veterinary medicines in the UK and the EU.
If you would like to discuss any of the issues in this Insight, please speak to your usual Osborne Clarke contact, or our experts below
This article is the first in our "A Legal Paws for Thought" series of Insights on the world of pets and relevant laws