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Northern Ireland Protocol
The Northern Ireland Protocol (NIP)
What is the Northern Ireland Protocol?
The Northern Ireland Protocol was agreed between the UK and EU so that there would be no new checks on goods crossing the border between NI and the Republic of Ireland (ROI).
The protocol aims to:
- avoid a hard border between NI and the Republic of Ireland
- make sure of the integrity of the EU’s single market for goods
- facilitate unfettered access for NI goods to the GB market, and the inclusion of NI goods in free trade agreements between the UK and third countries
Veterinary medicinal products are essential to animal health and welfare and make a major contribution to the UK’s food security and public health. The majority of animal health companies have operated historically in both Great Britain (GB) and Northern Ireland (NI) with the NI business being managed and supplied from GB.
How will it impact veterinary medicinal products (VMPs) and NI animal health and welfare?
- NOAH member companies are growing increasingly concerned about the implications of the Northern Ireland Protocol (NIP) for their ability to fulfil regulatory requirements to maintain product authorisations, the impact on supply chains and disruption to product supply.
- NI is a small market for products meaning that the introduction of any NI specific requirements, either from a regulatory or supply chain point of view, poses serious challenges to product supply.
- The NIP in its current form will lead to NI specific requirements putting many products at risk of being discontinued for the NI market.
- An ‘all island of Ireland’ Marketing Authorisation (product licence) approach is not the solution. Products authorised in the Republic of Ireland are not automatically legally authorised in NI. The UK regulatory agency for veterinary medicines, the Veterinary Medicines Directorate (VMD), remains the regulator for NI.
- Industry estimates that up to 50% of veterinary medicinal products would be at risk from discontinuation for the NI market, resulting in a negative impact on disease status and animal health and welfare.
What is the current situation?
The NIP has not yet been fully implemented in respect of VMPs: in September 2021 the Government announced standstill arrangements would continue. Therefore, EU Regulation 2019/6 and EU Regulation 2019/4 have not been implemented in Northern Ireland from 28 January 2022, except for areas previously agreed in relation to the operational aspects concerning applications for new marketing authorisations and associated life-cycle management (variations, renewals, QRD text and pharmacovigilance).
For more details see the VMD’s information hub: https://www.gov.uk/guidance/vmd-information-hub
What could be the solution for veterinary medicines?
Similar concerns existed over human medicines and adaptations to the NIP were agreed between the EU and UK government to address them. A similar approach is needed for veterinary medicines. The solutions that are sought are:
- Allowing regulatory functions to remain in the UK if they are currently located there. In particular, there is a need for the MA holder location for nationally authorised products on the NI market to be permitted to be located in either the UK or EU.
- For medicines moving from Great Britain (GB) to NI, batch testing and release should not need to be repeated if it has already been carried out in GB or the EU.
- No manufacturing authorisation or import licences should be required for medicines supplied from GB to NI.
- Authorisation by the UK regulator can allow companies located in GB to use a single pack and leaflet when supplying markets in both GB and NI, with no need for separate packaging for the NI market.
NOAH welcomes the announcement by the European Commission in December 2022 that the current transition arrangements that were previously agreed between the UK government and European Commission can continue until the end of 2025 to help ensure continuity of supplies of veterinary medicinal products to NI.
However, animal health industry concerns remain; there is no change in the current divergent positions of the European Commission and the UK with regards to the requirements for regulation of products and supply into NI. Consequently, there is an absence of consistent direction for industry to follow, which is an extremely challenging situation for our highly regulated sector and there remains a real risk to the future availability of veterinary medicinal products in NI.
NOAH’s has produced a briefing paper with more details: Regarding Northern Ireland Protocol (NIP), Veterinary Medicinal Product (VMP) availability and the impact on animal health and welfare in Northern Ireland (January 2023)
Introduction of the Northern Ireland Protocol Bill
A Northern Ireland Protocol Bill has been introduced to Parliament (13 June 2022) that the Government says intends to ‘restore the balance inherent in the objectives of the Protocol – avoiding a hard border, protecting the integrity of the UK and safeguarding the EU Single Market’. This will now go through the parliamentary consultation process.
The Bill covers veterinary medicines under the ‘manufactured goods, medicines and agri-foods’ references within the regulation of goods section (clauses 7-11). The VMD say the Bill will provide the powers to disapply elements of EU law under the Protocol, for example those relating to EU rules on veterinary medicines. The Bill also provides the power for Ministers to make new law in connection with the Protocol, which could be used to create a UK-wide veterinary regime. This, VMD say, would remove regulatory barriers and supply challenges that will arise should the grace period end at the end of this year.
The UK government would like to reach a negotiated arrangement with the EU on veterinary medicines. If they are able to do this, the Bill will provide implementation powers. Alternatively, the EU could adjust its own legislation, as they have done for human medicines. In either event, VMD explains, the Bill aims to provide a long-term fix to supply concerns.