Statutory guidance

Import of research and diagnostic samples - Import Information Note (IIN) ABP/30

Published 2 December 2024

1. General information 

This Import Information Note (IIN) must be read in conjunction with the IIN for general information for imports of animal by-products (ABPs), which provides information on pre-notifications, veterinary checks, risk categories and more.

References to European Union (EU) legislation within this document are references to direct EU legislation which has been assimilated in Great Britain (assimilated direct legislation), as defined in the Retained EU Law (Revocation and Reform) Act 2023 and can be viewed on the UK legislation website. 

2. Scope

Import conditions for research and diagnostic samples. 

Research and Diagnostic Samples are defined in Regulation (EU) 142/2011 as ‘animal by-products and derived products intended for examination in the context of diagnostic activities or analysis for the promotion of progress in science and technology, in the context of educational or research activities. They must: 

• be imported in accordance with the requirements laid down in Regulation (EU) 142/2011
• have been authorised by the competent authority of the country of destination

Any subsequent use of research and diagnostic samples for purposes other than those referred to above shall be prohibited. They cannot for example be used for commercial use. 

3. Production standards 

Research and diagnostic samples must have been produced and stored in accordance with the requirements of Annex VI, Chapter I, Section 1 of Regulation (EU) 142/2011. 

Users that handle research and diagnostic samples shall take all necessary measures to avoid the spreading of diseases communicable to humans or animals during the handling of the materials under their control, by way of the application of good laboratory practice. 

The consignment must be sent directly from the point of entry to the authorised user. 

4. Country of origin 

Research and diagnostic samples can be imported from any country, but note the information below about disposal.

5. Documentation 

Imports must be accompanied by a commercial document which must specify the: 

a) description of the material and the animal species of origin

b) category of the material as defined in Regulation (EC) 1069/2009

c) quantity of the material

d) place of origin and the place of dispatch of the material

e) name and the address of the consignor

f) name and the address of the consignee and/or user

6. Authorisation 

Prior to importation, authorisation must be obtained from the Animal and Plant Health Agency (APHA). 

From non-EU countries

General authorisations (GAs) are available for certain products, but if one isn’t available or your product cannot comply with the conditions of a GA, you will need a specific authorisation. To apply for an authorisation complete an import licence application form and send it to APHA Centre for International Trade (CIT). 

From EU and European Free Trade Association (EFTA) member states

There is currently no requirement for consignments of research and diagnostic samples from EU and EFTA member states to be accompanied by an import authorisation.

From 1 February 2025, consignments must be accompanied by a general import authorisation for research and diagnostic samples from EU and EFTA member states.

This general authorisation can be used for any product that meets the definition of ‘research and diagnostic sample’ in section 2 and can comply with the conditions for import as set out in this import information note. 

You do not need to apply for a specific import authorisation to import research and diagnostic samples from the EU and EFTA member states.

7. Approval or registration of destination premises 

Any operator, establishment or plant that generates, transports, handles, processes, stores, places on the market, distributes, uses or disposes of ABPs including research and diagnostic samples, trade samples or display items must be approved or registered by APHA under Animal By-Products Enforcement Regulations before commencing operations. 

This requirement is provided for in Articles 23 and 24 of Regulation (EC) 1069/2009. 

How to register a premises or site that handles or uses ABPs

8. Transporters or couriers 

Any independent hauliers (including couriers) of animal by-products including research and diagnostic samples, trade samples or display items should also be registered as described above. The registration process only needs to be done once for each haulier. 

9. Veterinary checks  

Research and diagnostic samples are not subject to veterinary checks. 

10. Disposal of research and diagnostic samples 

Unless they are kept for reference purposes, transferred or re-dispatched to the third country of origin, research and diagnostic material, products derived from their use and waste shall be disposed of appropriately, in accordance with either:

• Animal By-Product Regulations (Regulation (EC) 1069/2009 and Regulation (EU) 142/2011), either:
  • as waste by incineration
  • by pressure sterilisation and (see Processing Method 1 in Chapter III of Annex IV to Regulation (EU) 142/2011) subsequent disposal or use in accordance with Articles 12 to 14 of Regulation (EC) 1069/2009
  • in accordance with point 4(b) of Section 1, Chapter I of Annex VI to Regulation (EU) 142/2011 in cases of quantities not exceeding 2000 ml, provided the samples or derived products have been produced and dispatched from third countries or parts of third countries, from which  imports of fresh meat of domestic bovine animals are authorised
    
    
• The Waste (England and Wales) Regulations 2011 or The Waste (Scotland) Regulations 2012

Any transfer of material from the authorised user to any other user must be pre-authorised by APHA.

11. Contact for further information

For more information about import requirements, contact the Animal and Plant Health Agency (APHA) imports team:

Centre for International Trade - Carlisle
Eden Bridge House
Lowther Street
Carlisle
CA3 8DX

Email: [email protected] 

Telephone: 03000 200 301