GovWire

Good Manufacturing Practice (GMP)

The Trade and Cooperation Agreement (TCA) between EU member states (not EEA members) and the UK ensures the mutual recognition of Good Manufacturing Practice (GMP) certificates issued by the National Competent Authority (NCA) for the territory where the manufacturing site is located, or by an EU NCA in another member State.

There are exceptional circumstances whereby an NCA can decide not to accept a GMP certificate issued by the NCA of the manufacturing territory, such as where there are material inconsistencies or inadequacies in an inspection report, quality defects identified in post-authorisation surveillance or other evidence of serious quality or safety concern.

The VMD will continue to inspect veterinary-only manufacturing sites in the UK; the MHRA will continue to inspect those UK sites that manufacture both human and veterinary medicines.

The TCA also states that the EU or UK NCA may recognise a GMP inspection conducted by the other party outside its respective territory. We will consider recognising an EU NCAs GMP certificate issued to a manufacturer outside the EU on a case-by-case basis. If there is no EU NCA GMP certificate or we are unable to recognise it for any reason we or the MHRA will inspect the site.

Manufacturing activities, batch (Quality Control) testing, batch certification and release and Qualified Persons (QPs)

On 19 December 2022, the EU announced that current grace period for veterinary medicines would be extended until 31 December 2025.

This means that batch (QC) testing andQPcertification and release can continue to occur in GB for the whole UK market, including Northern Ireland. It also means that goods moving through GB do not need to be retested, certified, and released when entering NI if they do not meet the Common Transit Convention (CTC) requirements.

The Government will ensure that reasonable notice is provided to enable businesses to make appropriate preparations if needed. The length of the notice period will depend on the outcome of discussions.

Wholesalers and retailers of veterinary medicines, including veterinary surgeons and feed business operators

Because of the EU announcement explained above, the wholesale and retail of veterinary medicines to NI, including premixes and medicated feed, can continue as they do now. The Government will ensure that reasonable notice is provided to enable businesses to make appropriate preparations if needed. The length of the notice period will depend on the outcome of discussions.

Exporting premixes and medicated feed from GB to the EU

The UK Veterinary Medicines Regulations allows approved GB commercial feed mills to incorporate non-UK authorised premixes into feed provided that the final medicated feed is for export to a country where that premix is authorised. Feed mills must notify the VMD of the products they export as outlined in the guidance Manufacturing and supplying veterinary medicines for animal feed export of unauthorised substances or feed containing them.

It is the responsibility of the feed mill to ensure compliance with the importation requirements of the country of use, noting the information provided above around the extension to standstill requirements when moving medicines to NI.

UKs continued recognition of manufacturing sites, locations of product batch (QC) testing and sites of QP certification/release in the EU

We will continue to recognise manufacturing sites, locations of product batch (QC) testing and sites of QP certification/release in the EU for batches placed on to the GB market until the new Veterinary Medicines Regulations are in effect.

Any proposed changes to the Veterinary Medicines Regulations will be subject to public consultation when you will have an opportunity to comment on proposals. We recommend waiting for this consultation as it may not be necessary to make changes to meet GB requirements.

We will also continue to recognise a manufacturing site located in a country with which the UK has a mutual recognition agreement (MRA) that covers the manufacture of veterinary medicines. Products manufactured in those sites must still be imported into the UK via a ManA site and be batch (QC) tested and QP certified/released. The QP can accept batch testing carried out in Israel, Switzerland, Australia, New Zealand, USA, and Canada as we have an MRA that includes that provision.

Customs: Rules of origin for veterinary medicines or Active Pharmaceutical Ingredients being traded between the UK and the EU

The Trade and Cooperation Agreement (TCA) between the UK and the EU means that there are no tariffs on goods moving between these markets providing the goods meet the applicable rules of origin.

Most finished products and common Active Pharmaceutical Ingredients are tariff-free upon entry into the UK or the EU regardless of the origin of the goods. To determine whether your goods meet these rules of origin you should:

1. Use the Trade Tariff tool to determine the tariff classification and the tariff of your goods
2. Check whether your goods meet the rules of origin in the UK-EU TCA and which rules apply to your specific product
3. Check whether the importing party charges an import tariff on these goods when moving them from the UK

For help with importing and exporting contact the HMRC.

UK returned products

In the unlikely event, a veterinary medicine or component part is refused EU entry or inter GB/NI movement and you wish to place that batch of product or use that component on the UK market, you should liaise with us in the first instance at niprotocol@vmd.gov.uk.

Product Information Database and product authorisation numbers

The VMDs Product Information Database includes the territory for which a veterinary medicine is authorised Great Britain, Northern Ireland or UK wide.

An authorised product in the UK will have an authorisation number preceded by the symbol Vm on its product literature and labels. The first 5 numbers are the MAHs company number followed by a sequential product number. The first number of the product number element will be used as a territory identification number. These are:

• 4000 numbers UK wide Pre 2021 authorisations retaining a UK wide authorisation and these product numbers start with the number 4
• 3000 numbers NI MA For products authorised in NI only
• 5000 numbers GB MA For products authorised in GB only

Central authorisations issued by the European Commission (EC) are valid in all EU member states, includin

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