Statutory guidance

Import of intermediate products - Import Information Note (IIN) ABP/20

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 intermediate products for use in the manufacture of medicinal products, veterinary medical products, medical devices for medical and veterinary purposes, active implantable medical devices, in vitro diagnostic medical devices for medical and veterinary purposes, laboratory reagents or cosmetic products. 

An intermediate product is defined in Annex I point 35 of Regulation (EU) 142/2011 as a derived product:  

a) which is intended for uses within the manufacturing of medicinal products, veterinary medicinal products, medical devices for medical and veterinary purposes, active implantable medical devices, in vitro diagnostic medical devices for medical and veterinary purposes, laboratory reagents or cosmetic products as follows, either:  

      i) as material in a manufacturing process or in the final production of a finished product

      ii) in validation or verification during a manufacturing process

      iii) in quality control of a finished product

b) whose design, transformation and manufacturing stages have been sufficiently completed in order to be regarded as a derived product and to qualify the material directly or as a component of a product for the purposes referred to in point (a)

c) which however requires some further manufacturing or transformation, such as mixing, coating, assembling or packaging to make it suitable for placing on the market or putting into service, as applicable, a medicinal product, veterinary medicinal product, medical device for medical and veterinary purposes, active implantable medical device, in vitro diagnostic medical devices for medical and veterinary purposes, laboratory reagent or cosmetic products

If a product cannot meet the above criteria (in that the product to be imported is not intended for use as per (a), (b) and (c) above) or the product to be imported requires further processing to extract a product which will then be used as above then the importer should contact the Animal and Plant Health Agency (APHA) imports team (see section 10) to determine the requirements for import.

Intermediate products must be derived from the following materials: 

a) in the case of intermediate products to be used in the manufacture of products referred to in 1(a) above from:

      i) category 3 materials referred to in Article 10 of Regulation (EC) 1069/2009 other than 10(c), 10(n), 10(o) or 10(p)

      ii) products generated by the animals referred to in Article 10(i), 10(l) and 10(m) of Regulation (EC) 1069/2009

      iii) mixtures of the materials referred to in points a.i and a.ii above

b) in the case of intermediate products destined for medical and veterinary devices, in vitro diagnostic medical and veterinary devices and laboratory reagents only from:

      i) materials that fulfil the criteria referred to in paragraph a.i. above except that they may have originated from animals which have been submitted to illegal treatments as defined in Article 1(2)(d) of Directive 96/22

      ii) category 2 materials referred to in Article 9(f) and 9(h) of Regulation (EC) 1069/2009

      iii) mixtures of the materials referred to in points b.i. and b.ii above

      iv) the importer must also demonstrate to the competent authority that the materials do not carry any risk of transmission of a disease communicable to humans or animals or are transported under conditions which prevent the transmission of any diseases communicable to humans or animals

c) if an importer wishes to import intermediate products destined for the manufacture of active implantable medical devices, medicinal products and veterinary medicinal products which are derived from materials mentioned in b) above they should contact the APHA imports team as imports will only be permitted where the competent authority considers the use of such material justified for the protection of public or animal health

3. Production standards 

Intermediate products must have been produced and stored in accordance with the requirements of Annex XII of Regulation (EU) 142/2011. 

4. Country of origin  

Imports are permitted from trading partners that are listed as a member of the World Organisation for Animal Health (WOAH). 

5. Approved establishments 

Products must be produced in an establishment approved to export to Great Britain (GB). Importers should check prior to importation that the premises are listed on the correct list.  

Find consolidated lists of approved plants (excluding the EU)

Find approved EU food establishments

If the establishment or plant is not listed, importers are urged to contact the company concerned, who should contact their competent authority immediately. If the plant is not included on the appropriate list when veterinary checks are carried out the consignment is likely to be held and could be rejected and re-exported or destroyed. 

6. Border Target Operating Model (BTOM) risk categorisation 

Imports of highly processed intermediate products from the EU and permitted non-EU countries are categorised as low risk under the Border Target Operating Model (BTOM).  Intermediate products which are not considered to be highly processed are categorised as medium risk.

Find more information about risk categories from:

• the EU to GB
• non-EU countries to GB

Highly processed intermediate products 

To be considered ‘highly processed’ the intermediate product must have undergone processing which ensures it both:

• does not carry any risk of transmission of a disease communicable to humans or animals
• cannot be returned to its original structure or composition

An importer should, if requested by the competent authority, be able to provide evidence to demonstrate that the product meets these criteria. 

Whilst it may not be possible to confirm that a product is free from human and animal pathogens, the importer should have sufficient knowledge of the product to be able to demonstrate that it has been sourced and processed in such a way to mitigate the risk of the product being capable of transmitting a disease communicable to humans and animals.

To do this, the following are examples of the types of assurances that may be provided as evidence. 

Safe sourcing of products 

Intermediate products may be imported from any third country listed as a member of the World Organisation for Animal Health (OIE) in the OIE bulletin and must comply with import conditions laid down in Annex XII of Assimilated Regulation (EU) 142/2011.

By providing additional assurances of safe sourcing, this can help demonstrate the appropriateness of the subsequent processing method applied to the product, in order to mitigate any risks of disease transmission. For example, by sourcing ABP from specific pathogen-free animals.

Processing 

Assurances should be provided about on or more of the following:

• the suitability of the processing method, for example by demonstrating the application of appropriately validated scientific methodology or by using recognised production standards, such as International Organisation for Standardization (ISO) or Good Manufacturing Practice (GMP) 
  
  
• the effectiveness of the processing method, for example by using suitable laboratory analysis to quantitatively or qualitatively demonstrate that, within analytical limits of detection, negligible levels of an indicator pathogen is present after processing

An indicator pathogen is an organism representative of one which is consistently present in the product before processing. It should not be less resistant to the lethal aspects of the processing method than other endogenous pathogens in the product and should be relatively easy to quantify, identify and confirm. 

7. Documentation 

Imports to GB must be accompanied by an importers’ declaration that conforms to the model found on GOV.UK, and which is signed by the importer. 

Imports of intermediate products from EU and European Free Trade Association (EFTA) countries do not currently need to be accompanied by an importer declaration. However, the consignment must be accompanied by a commercial document.

Model health certificates for other animal by-products

8. Labelling requirements 

The outer packaging must be labelled applicable for the products usage in line with the following wording: 

“FOR MEDICINAL PRODUCTS/ VETERINARY MEDICINAL PRODUCTS/ MEDICAL DEVICES FOR MEDICAL AND VETERINARY PURPOSES/ ACTIVE IMPLANTABLE MEDICAL DEVICES/ IN VITRO DIAGNOSTIC MEDICAL DEVICES FOR MEDICAL AND VETERINARY PURPOSES/ LABORATORY REAGENTS/ COSMETIC PRODUCTS ONLY – ABC CATEGORY X”. 

9. Transport requirements 

Once checked at the BCP the intermediate products must be transported directly from the BCP either to: 

a) a registered establishment or plant for the production of laboratory reagents, medical devices and in vitro diagnostic medical devices for veterinary purposes or the derived products referred to in Article 33 of Regulation (EC) 1069/2009, where the intermediate products must be further mixed, used for coating, assembled or packaged before they are placed on the market or put into services in accordance with UK legislation applicable to the derived product

b) an establishment or plant which has been approved for the storage of ABPs in accordance with Article 24(1)(i) of Regulation (EC) 1069/2009, from where they must be dispatched to an establishment or plant referred to at (a) above for the uses referred to at (a) above.  

10. 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