VMD: New EU Exit Information Hub
The VMD has published an EU Exit Information Hub for the animal health sector and other stakeholders.
VMD says: “Throughout the government’s negotiations to leave the EU on 29 March the Veterinary Medicines Directorate (VMD) has developed plans for all possible outcomes including no deal.
“We have therefore published on GOV.UK our EU Exit Information Hub which sets out what the veterinary pharmaceutical industry and our other stakeholders will need to do differently if the UK leaves the EU without a deal. It also sets out the areas of veterinary medicines regulation where there will be no change.
“For the pharmaceutical industry the areas you will need to do things differently, including through new digital services, are:
- The application and authorisation process
- Location of Marketing Authorisation Holders and named distributors
- Shared labelling and Summary of Product Characteristics for products (SPC)
- Description of Pharmacovigilance (PhV) Systems (DDPS) and a Qualified Person for PhV (QPPV)
- Reporting adverse events to medicines
- Immunological batch release
“Please visit the VMD’s EU Exit Information Hub for detailed advice and guidance on the above areas and all areas of veterinary medicines regulation that will and won’t be changing in the event that the UK leaves the EU without a deal.
“The VMD will continue to assure the safety, quality and effectiveness of all veterinary medicines authorised in the UK to protect animal health, human health and the environment.”