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Detailed guide: From 1 January 2021 Import and export of veterinary medicines explainer

Veterinary Medicines Directorate

October 28
13:36 2020

Moving finished products from the EU to GB

The Border Operating Model outlines the processes for moving goods between the EU and GB from 1 January 2021. The Model explains general changes that will affect all goods, but also sets out the specific requirements for certain highly regulated goods such as veterinary medicines.

Note: The guidance contains a process map on importing veterinary medicines which erroneously infers that all medicines will be required to be held on a manufacturing authorisation/importation (ManA) Site and will require retesting and batch release. This is not the case - a corrected version will be published in September.

In GB, we will continue to recognise until January 2023:

  • Marketing Authorisation Holder (MAH) location: this means we will continue to accept MAHs located in an EU member state for existing and new marketing authorisations for this time period
  • Manufacturing: for the same period, we will continue to accept EU member state locations for: Qualified Persons (QPs); sites of product batch (QC) testing, and sites of QP certification/release

Moving finished products from GB to the EU (Updated 28/10/20)

The EU considers the movement of veterinary medicines manufactured in GB directly to the EU to be an import and subject to EU importation requirements, which include batch (QC) testing and QP certification/release within the EU.

This is also an export and will be subject to UK export requirements.

A veterinary medicine placed on the market before the end of the transition period may continue to be sold and supplied in accordance with its MA, from 1 January 2021 without the need for repeating batch (QC) testing and QP certification /release. See Veterinary medicinal products placed on the EU and NI markets before 1 January 2021 for more information.

Moving finished products from GB to NI (Updated 28/10/20)

Under the Northern Ireland Protocol (the Protocol), the EU considers the movement of veterinary medicines manufactured in GB directly to NI to be subject to the same EU rules as movement from GB to the EU as set out in the section above. The applicable regime will need to take account of the outcome of discussions between the UK and the EU in the Joint Committee established under the Withdrawal Agreement. Further guidance will be provided in due course.

We do not consider movement from GB to NI to be an export, as this movement remains within the UK.

A veterinary medicine placed on the market before the end of the transition period may continue to be sold and supplied in accordance with its MA, from 1 January 2021 without the need for repeating batch (QC) testing and QP certification /release. See Veterinary medicinal products placed on the EU and NI markets before 1 January 2021 for more information.

Moving finished products from NI to GB

Moving products with a valid GB marketing authorisation from NI to GB should take place as it does now. Further guidance on Unfettered Market Access for Northern Ireland businesses will be available in due course.

Moving finished products from NI to Ireland

To avoid a hard border on the island of Ireland, there will be no change for the movement of goods covered by the Protocol between NI and Ireland (and other EU member states).

Moving finished products to/from the EU to/from the Island of Ireland, through GB

Finished products manufactured/QP released in the EU moving through GB to the island of Ireland are not considered an import or export by either the UK or EU if conforming to the Common Transit Convention.

Moving finished products from outside of the EU to GB

Finished products imported from outside the EU must enter GB via an authorised manufacturing authorisation/importation (ManA) site and undergo batch (QC) testing before QP certification/release.

For GB-only MAs, the QP may choose to accept the batch (QC) testing carried out in a country with which the UK has a mutual recognition agreement (MRA) that includes such a provision.

Moving finished products from GB to outside of the UK

Finished products moving from GB to outside of the UK is an export and will be subject to UK export requirements.

UK returned products

In the unlikely event, a veterinary medicine or component part is refused EU entry or inter NI/GB 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, via email to vetmedtrade@vmd.gov.uk.

Good Manufacturing Practice Certificates

The EU will continue to recognise Good Manufacturing Practice (GMP) certificates issued by the VMD for inspections carried out in NI but not for those carried out in GB.

We will take a risk-based approach to inspecting manufacturing sites located in EU member states, which will include accepting valid GMP certificates issued by their National Competent Authorities until January 2023.

Contact

If you have any questions please email vetmedtrade@vmd.gov.uk

Published 16 September 2020
Last updated 28 October 2020 +show all updates
  1. Updated sections for; Moving finished products from GB to the EU; and Moving finished products from GB to NI

  2. UK returned products section added

  3. First published.

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