ARCHIVE: International trade: Importer Information Notes - Intermediate products (ABP IIN 20)
Importer Information Note on conditions of import for Intermediate products to be used in the manufacture of medicinal products, veterinary medicinal products, medical devices, in vitro diagnostics and laboratory reagents
1. Definition of an intermediate products
An intermediate product is defined in Regulation (EU) No 142/2011 to mean a derived product:
- which is intended for the manufacture of medicinal products, veterinary medicinal products, medical devices, active implantable medical devices, in vitro diagnostic medical devices or laboratory reagents;
- 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 that purpose;
- which however requires some further handling or transformation, such as mixing, coating, assembling, packaging or labelling to make it suitable for placing the product on the market or putting it into service, as applicable, as a medicinal product, veterinary medicinal product, medical device, active implantable medical device, in vitro diagnostic medical device or laboratory reagent;
Therefore the intermediate product must be a derived product as stated in (b) above which only requires some further handling or transformation as stated in (c) above and is the derived product that is intended for the manufacture of the medicinal products, veterinary medicinal products, medical devices, active implantable medical devices, in vitro diagnostic medical devices or laboratory reagents.
If a product cannot meet the above criteria (i.e. the product to be imported is not for the manufacture of one of the products referred to above or the product to be imported requires further processing to extract a product which will be then be used to manufacture the above mentioned devices) then the importer should contact the Specialist Service Centre for Imports below to determine the requirements for import.
Intermediate products to be used in the manufacture of products referred to in 1(a) above:
- Must come from an approved/registered plant;
- Must come from an approved country;
- Must be accompanied by certificate model declaration.
Intermediate products must be derived from the following materials:
- In the case of intermediate products to be used in the manufacture products referred to in 1(a) above must be derived from:
- Category 3 materials referred to in Article 10 of Regulation (EC) 1069/2009 other than 10(c), 10(n), 10(o) or 10(p).
- Products generated by the animals referred to in Article 10(i), 10(j) and 10(m) of Regulation (EC) 1069/2009.
- Mixtures of the materials referred to in points 1.i and 1.ii above.
- In the case of intermediate products destined for medical devices, in vitro diagnostic medical devices and laboratory reagents must only be derived from:
- Materials that fulfil the criteria referred to in 1.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/EC or Article 2(b) of Directive 96/23/EC;
- Category 2 materials referred to in Article 9(f) and 9(h) of Regulation (EC) 1069/2009.
- Mixtures of the materials referred to in points 2.i. and 2.ii above; and
- 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.
- If an importer wishes to import an 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 Specialist Service Centre for Imports below 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/processing/storage requirements
Intermediate products must have been produced and stored in accordance with the requirements of Annex XII of Regulation (EU) No 142/2011.
4. Labelling requirements
The outer packaging must be labelled “FOR MEDICINAL PRODUCTS/ VETERINARY MEDICINAL PRODUCTS/ MEDICAL DEVICES/ ACTIVE IMPLANTABLE MEDICAL DEVICES/ IN VITRO DIAGNOSTIC MEDICAL DEVICES/ LABORATORY REAGENTS ONLY” and they are not intended to be diverted at any stage within the Union for any other use.
5. Country of origin
As stated in Annex XII (d) the intermediate products can only come from a third country listed as a Member of the World Organisation for Animal Health (OIE) in the OIE bulletin.
6. Approved establishments
Intermediate products must have been prepared and stored in an establishment or plant registered or approved and supervised by the competent authority in the third country in accordance with Annex XII point 2. of Regulation (EC) No 1069/2009.
Imports from third countries must be accompanied by a declaration, which conforms to the model laid down in Annex XV, Chapter 20 of Regulation (EU) No 142/2011, and which is signed by the importer.
The declaration must be at least in one of the official languages of the Member State in which the inspection at the border inspection post must be carried out and of the Member State of destination; these Member States may allow the use of other languages and request official translations for declarations in such other languages.
Please note the transitional arrangements permit the use of existing import rules/documentation provided for in Regulation (EC) No 1774/2002 until 31 January 2012 provided that the accompanying documentation has been signed before 30 November 2011.
The EU has International Agreements with Norway, Switzerland and Liechtenstein which means that they implement EU veterinary legislation in relation to the movement of animal products. Therefore animal products from Norway, Switzerland and Liechtenstein must comply with the same requirements applying to animal products from EU Member States.
9. Veterinary checks
Consignments may only be imported through an approved BIP. Following satisfactory checks at the BIP, consignments may then circulate freely within the EU. A list of BIPs is available on the Defra website. If the consignment does not meet the import requirements, the BIP may require that the consignment is re-exported or destroyed.
Consignments must be pre-notified in accordance with the Products of Animal Origin (Third Country Imports) (England) Regulations 2006 to the relevant BIP, before arrival in the country, by completion of Part I of the Common Veterinary Entry Document (CVED), or by electronic means as agreed with the BIPs competent authority.
For further guidance on products see the Defra website.
10. Movement to premises of destination
Once checked at the BIP the intermediate products must be transported directly from the BIP either to:
- A registered establishment or plant for the production of the derived products referred to in Article 33 of Regulation (EC) No 1069/2009, where the intermediate products must be further mixed, used for coating, assembled, packaged or labelled before they are placed on the market or put into the services in accordance with the Union legislation applicable to the derived product; or
- An establishment or plant which has been approved for the storage of animal by-products 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 above for the uses referred to above.
11. Safeguard measures
Situations where emergency safeguard action has been taken, at very short notice, to prohibit or restrict the importation of certain animals/products from certain countries following an outbreak of serious disease in those countries may not be covered. Importers are advised to contact Animal Health (see below) to check if any action has been taken in relation to the current status of any particular country. Details of safeguard measures can also be found in our Declarations and Customer Information Notes.
Alternatively you can keep up to date with amendments to legislation by checking the European Commission’s website.
12. European Union legislation
Consolidated texts, which integrate the basic instruments of Union legislation with their amendments and corrections in a single, non-official document, are available. Each consolidated text contains a list of all legal documents taken into account for its construction.
Texts provided in this section are intended for information only. Please note that these texts have no legal value. For legal purposes please refer to the texts published in the 'Official Journal of the European Union'.
For non-consolidated legislation, please use the simple search option on the European Commission’s website.
13. Contact for general information on import requirements
Specialist Service Centre for Imports
Essex CM1 2RU
Tel: 01245 454860
Fax: 01245 351 162
14. Contacts for other important advice and guidance
Importers should note that the information given relates only to animal health and public health conditions of import. It does not give guidance on other conditions that may need to be met.
The information sheet below gives details of other organisations you may also need to consult.
Page published: 4
Page last modified: 4 March, 2011