Veterinary medicines unfettered access from Northern Ireland
Guidance to the veterinary pharmaceutical industry on moving goods from NI to GB under unfettered access arrangements and placing qualifying NI goods on the GB market.
Unfettered access from Northern Ireland to the rest of the UK
Marketing Authorisation Holders (MAHs) and authorised suppliers of qualifying veterinary medicines based in Northern Ireland will be able to move their products from Northern Ireland to the rest of the UK and place them on the market in Great Britain.
You’ll still be able to do this even if there are changes between the EU rules that apply in Northern Ireland under the terms of the Northern Ireland Protocol, and the rules in Great Britain. This is part of the Government’s commitment for Northern Ireland businesses to have unfettered access to the rest of the UK market.
Only qualifying Northern Ireland goods will be able to benefit from this arrangement. You can find more information about Qualifying Northern Ireland goods on GOV.UK.
Qualifying veterinary medicines
Selling veterinary medicines which are not authorised for use in Great Britain is an offence. The Northern Ireland based MAHs and the veterinary medicine must meet the following criteria in order to place veterinary medicines on the market in Great Britain:
- the MAH is based in Northern Ireland and has access to the Qualified Person for Pharmacovigilance (QPPV)
- has a valid Marketing Authorisation in Northern Ireland
- it is not a product in respect of which there is a Marketing Authorisation which is valid in Great Britain (including any marketing authorisation which has effect under paragraph 3 of Schedule 1A)
- it is not a product in respect of which an unfettered access certificate has already been issued. An unfettered access certificate is one that has been issued for a veterinary medicine when the transparency arrangements and other conditions of unfettered access have been met
- it is not a product to which Article 41(1) of the EU Withdrawal Agreement applies
- have met the ‘transparency arrangements’ set out below
Transparency arrangements
Veterinary medicines, which are a highly regulated goods, must meet the required UK safety and quality standards. Therefore, before they can be placed on the market in Great Britain, Northern Ireland based MAHs supplying veterinary medicines under unfettered access must provide the VMD with the same information they provided and continue to provide to the EU regulator.
These arrangements fulfil the need for UK authorities to have access to relevant information which provides the necessary assurance of safety and efficacy. Once all the information is provided, these products can automatically be placed on the market in Great Britain. We will not use this information to undertake any additional assessment.
If the qualifying veterinary medicines criteria are met, then as the MAH you will need to provide any information submitted to the EU in support of that product. You should contact us before you plan to submit any information to discuss the data requirements, but usually this will constitute:
- the original dossier including any Maximum Residue Limit dossier/data if applicable
- supporting data for completed and ongoing variations and renewals
- any conditional data that may be required to be submitted at a later date to enable the authorisation of the product
We will send you a certificate to indicate these transparency arrangements have been met within 30 days.
On an ongoing basis, you will need to provide any information submitted to the EU, simultaneously to the VMD. This may include:
- supporting data for variations and renewals
- Periodic Safety Update Reports, DDPS or other Pharmacovigilance information
- adverse event reports
- batch defect notifications
- batch recall notifications
- rapid alerts
- any information provided to the EU regulator regarding that product, such as Corrective Action and Prevention Action data
You can submit your completed application form and data securely through your Veterinary Medicines Digital Service account.
If, during the assessment process for a marketing authorisation to be valid in Northern Ireland or through ongoing safety surveillance, we determine that risks to animal health, human health or to the environment outweighs the product benefit, we will take action to prevent the product being placed on the market in Great Britain or to remove the product from the market (both in Great Britain and Northern Ireland) until concerns are addressed.
Last updated 22 September 2021 + show all updates
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Application form added
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First published.