Business and trade

EU and UK relationship

The UK left the EU on 31 January 2020, with the transition period ending on 31 December 2021. The EU-UK trade and co-operation agreement (TCA) has been published, with a specific Annex (TBT-2) dedicated to medicinal products, both human and veterinary.

Information for Marketing authorisation holders

Veterinary Medicines Directorate (VMD) Information Hub – for VMD communications following the end of the transition period for veterinary medicines in the UK.

VMD information Hub restructure and renewed product movement explainer

The VMD have reviewed the structure of the hub now that the end of the Transition period has passed. Much of the content within the Information Hub is now part of ‘Business as usual’ guidance on gov.uk

So, the VMD Information Hub is now one gov.uk page (no graphic) which contains links to 3 new explainer pages and general information covering: legal controls, future Regulations, the EU and UK Trade and Cooperation Agreement, and the Northern Ireland Protocol.

New explainer pages

The old hub content that has been published in normal guidance has been removed and the remaining relevant information combined into 1 of 3 explainers. Below describes the content you can expect to find, and where.

Explainer subject Summary Current contents
Application and authorisation

 

Explainer for the pharmaceutical industry on the implementation of the Veterinary Medicines Regulations relating to applications and authorisations for veterinary medicines.

 

CAP conversion

MAH location

Named distributor

MAs grated prior to 31 December 2020

Labelling and packaging

Maximum Residue Limits

Manufacturing and distribution

 

Explainer for Marketing Authorisation holders, wholesale dealers, retailers (including veterinary surgeons) and feed business operators on the manufacture and movement of veterinary medicines.

 

GMP

Manufacturing activities (including product movement)

Wholesalers and retailers

UK returned products

PID and Vm numbers

Definition of placed on the market

Pharmacovigilance

 

Explainer for the pharmaceutical industry on the implementation of the Veterinary Medicines Regulations relating to Pharmacovigilance.

 

National competent authority

Adverse event reporting

PSURs

QPPV location

Pharmacovigilance inspections

DDPS


New Product Movement explainer
(linked to from Manufacturing and distribution)

The VMD has also reviewed the Product movement explainer which now combines the import/export activity to one movement, and updated the customs resource content for GB-NI, NI-GB and EU to/from NI.

Please provide any feedback or questions to vetmedtrade@vmd.gov.uk.

Information updated 09/02/21 (right click within the pdf and select ‘reload’ to refresh your browser).

Further advice and information  (including Government links)

Rules of Origin under UK -EU Trade and Cooperation AgreementNOAH has developed a briefing for members – please note this should not be taken as legal clarification. (22/01/2021)

Further information on Rules of Origin can be found using the links below:
Exporting Under Preference on Gov.UK
https://www.gov.uk/guidance/claiming-preferential-rates-of-duty-between-the-uk-and-eu
Download Business Guidance for Rules of Origin
The Rules of Origin Chapter of the TCA is on page 27, and the Product Specific Rules are on page 423.

Border operating model: GB-EU (Cabinet Office) updated 31/12/2020 with updates from the UK-EU agreement including the provisions on proving originating status for preferential access for GB-UK and UK-GB trade (for VMD correction to veterinary medicines import process map: see https://www.gov.uk/guidance/vmd-information-hub)

UK/ EU Free Trade Agreement (published 24/12/2020)

Customs, VAT and excise legislation from 1 January 2021

The Government has put together a collection of Customs, VAT and Excise EU legislation and Customs notices that have the force of law applicable to the UK. (17/12/2020)

UK Tariff SI published

From 1 January 2021 the UK will apply a UK-specific tariff to imported goods. This UK Global Tariff (UKGT) will replace the EU’s Common External Tariff which applies until 31 December 2021. Click here for the SI and here for the main Government page on tariffs. (17/12/2020)

Transporting goods

Government guidance has been published that includes information on inland border facilities and Kent traffic management:

Use this service to:

  • apply for a Kent Access Permit
  • check you have the paperwork you need to cross the border between Great Britain and the EU via the Port of Dover or Eurotunnel
    (14/12/2020)

Moving goods into, out of, or through Northern Ireland from 1 January 2021

What UK business can do now to get ready for 2021. This page provides links to sector-specific guidelines published by government departments relating to the Northern Ireland Protocol agreement. (10/12/2020)

Temporary relaxation on EU drivers’ hours rules

In response to pressures on local and national supply chains, the Department for Transport has pursuant to Article 14(2) of Regulation (EC) No 561/2006, introduced a temporary and limited urgent relaxation of the enforcement of EU drivers’ hours rules in England, Scotland and Wales from 12.01am on 10 December 2020 to 11.59pm on 30 December 2020. The online notification has now been updated. Please see below for further details;https://www.gov.uk/government/publications/temporary-relaxation-of-the-enforcement-of-the-drivers-hours-rules-all-sectors-carriage-of-goods-by-road  (added 10/12/2020)

Wood packaging material for import and export 

If you use or supply wood packaging material (WPM) to move goods to or from the EU or the rest of the world, you must make sure it meets international standards. See guidance from the Forestry Commission. 

FSA and EU exit 

The Food Standards Agency (FSA) also are adding to their EU exit webpage. Those with products regulated by the FSA are encouraged to refer to this frequently.  

 

Pet travel from 1 January 2021

Great Britain (England, Scotland and Wales), including the Channel Islands and Isle of Man, became a Part 2 listed third country under the EU Pet Travel Scheme from 1 January 2021.

Visit the .Gov website for up-to-date information on travelling with your pet (updated 16/12/2020)

UK/EU trade deal and animal health – NOAH comment

NOAH has previously welcomed the free trade agreement between the UK and EU. Confirmation that there will be zero tariffs and zero quotas is a key priority for NOAH as this will help ensure the continued availability and supply of animal health products for UK vets, farmers and pet owners. However, there will be some changes at the point of import/export involving additional bureaucracy for business.

Vitally important for the viability of the UK livestock sector is that trade in the majority of food and plant products can continue.

The UK retains regulatory autonomy. For our sector, a complete revision of the UK Veterinary Medicines Regulation 2013 will be required and this will form a major focus of NOAH’s work in 2021. It will provide opportunities to develop the regulatory climate business needs to encourage and foster innovation in the UK. This will involve a comprehensive review to ensure that the veterinary medicines regulations are fit for purpose for many years to come.

On areas such as the fight against AMR and sustainability, NOAH welcomes the collaborative approach set out in the trade agreement. A joined-up One Health approach is an integral part of NOAH’s Vision for Animal Health and Welfare.

A specialised Working Group on Medicinal Products, including veterinary medicinal products, has been established under the Partnership Council set out in the agreement. This will assist the Specialised Committee on Technical Barriers to Trade, reviewing and ensuring proper functioning of the Annex referring to medicinal products. A mutual agreement on Good Manufacturing Practice (GMP) and on GMP inspections is included which is welcome.  Currently, important issues such as the mutual recognition of batch testing, certification and release; any collaboration with the EU regulatory network; mutual recognition of Maximum Residue Levels (MRLs) for veterinary medicines for food producing animals or UK collaboration with the EU on matters relating to pharmacovigilance are not included.

NOAH will continue to work with Government and others to help protect the nation’s animals, ensuring medicines are available, looking at the opportunities for UK agriculture in future trade agreements and ensuring the UK is an attractive market for new animal health product innovation.

(08/01/2021)

Other trade deals

Common statement UK/Canada 

Until a free trade agreement with Canada is in place, this exchange of letters outlines that an interim arrangement for continued cooperation on the application of the CETA Protocol on pharmaceuticals. Specifically, this means that Canada and the UK will continue to recognise Certificates of GMP Compliance issued by each country’s regulatory agencies and to accept batch testing certificates held by a manufacturer without re-control of that batch at import. 

Press Releases

See Also