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Research and Diagnostic Samples

 

  1. ‘Research and diagnostic samples’ refer to 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, or in the context of educational or research activities.

  2. The importation of products of animal origin for research and diagnostic purposes from third countries is prohibited unless authorised in advance by a licence issued by the Department of Agriculture, Food and the Marine.

  3. Regulation (EC) No 1069/2009 lays down health rules as regards animal by-products and derived products not intended for human consumption and repealing Regulation (EC) No1774/2002 (Animal By-Products Regulation)

  4. Commission Regulation (EU) No 142/2011 implementing Regulation (EC) No 1069/2009 of the European Parliament and of the Council lays down health rules as regards animal by-products and derived products not intended for human consumption and implementing Council Directive 97/78/EC as regards certain samples and items exempt from veterinary checks at the border under that Directive European Union (Animal By-Products) Regulations 2014 (S.I. No. 187 of 2014)

*Important:

Products of animal origin that do not comply with import conditions and controls can be seized either for destruction or return to the country of origin at the importers expense.

The import licence referred to below is issued without prejudice to import controls that may be required other than for public or animal health reasons and does not exempt importers from any prohibition, regulation or restriction imposed by any other Agency or Department.

 

  1. ‘Animal by-products’ means entire bodies or parts of animals, products of animal origin or other products obtained from animals, which are not intended for human consumption, including oocytes, embryos and semen.

  2. ‘Derived products’ means products obtained from one or more treatments, transformations or steps of processing of animal by- products.

  3. ‘Operator’ means the natural or legal persons having an animal by- product or derived product under their actual control, including carriers, traders and users.

  4. ‘User’ means the natural or legal persons using animal by-products and derived products for special feeding purposes, for research or for other specific purposes.

  5. ‘Establishment’ or ‘Plant’ means any place where any operation involving the handling of animal by-products or derived products is carried out, other than a fishing vessel.

1. An establishment using animal by-products and/or derived products for research or diagnostic purposes must be registered by the Department of Agriculture, Food and the Marine.

2. Furthermore, the registration must be in date as detailed in Article 23 of Regulation (EC) No 1069/2009.

3. Application for registration of an establishment should be made to:

Milk and Meat Hygiene/ABP/TSE Division
Grattan House, Grattan Business Centre
Dublin Road
Portlaoise
Co Laois
 

Phone: 0761 06440
Email: animalbyproducts@agriculture.gov.ie

Further information on registration of establishments, including application forms and conditions, are available at: https://www.agriculture.gov.ie/agri-foodindustry/animalbyproducts/

A copy of the Certificate of Registration issued by the Animal By-Products section must accompany an application for a VET 15 Research and Diagnostic Sample licence application.

 

  1. Each consignment must be delivered directly to the establishment registered to use animal by-products and/or derived products for research or diagnostic purposes indicated on the application.

  2. The consignment must be imported through a designated point of entry - either Shannon Airport or Dublin Airport.

  3. Each consignment must be accompanied by:

    −    A copy of a VET 15 import licence issued by the Department of Agriculture, Food and the Marine, and
    −    An original signed commercial document in accordance with the model in Annex I

  4. A completed electronic copy of the commercial document in the format provided in Annex I must be transmitted by email to the relevant point of entry at least 24 hours prior to arrival at that point of entry.

  5. The consignment must bear a label with the following words visibly and legibly displayed “for research and diagnostic purposes”.

  6. The consignment, if requested, must be made available for examination by an officer of theDepartment of Agriculture, Food and the Marine at the authorised point of entry.

  7. The consignment must be transported in accordance with IATA and ADR Regulations as appropriate and travel directly from the authorised point of entry to the registered user referred to at point (1).

  8. When importing from a third country via another Member State, the consignment must be presented at an approved European Union Border Inspection Post in the Member State of entry, as listed in Annex 1 to Commission Decision 2009/821/EC in accordance with Art 27(2) of Regulation (ec) no. 142/2011.

  9. During transport and storage, the material or its packaging must not be allowed to come into contact with animals or products of a different animal or public health status.

  10. The material is for examination in the context of diagnostic activities or analysis for the promotion of progress in science and technology and/or in the context of educational or research activities at the registered establishment.

  11. The materials are not for human consumption, re-sale or supply to any other establishment and must not be removed from the registered establishment except as referred to at point (15) below.

  12. The materials may not be used in a manufacturing process or in the final production of a finished product; in validation or verification during a manufacturing process; or in quality control of a finished product. Use of research and diagnostic samples for purposes other than in the context of diagnostic, educational or research activity is prohibited.

  13. The category and type of material imported must be in accordance with the Certificate of Registration issued to the establishment and conditions set out for establishments registered to use animal by-products and/or derived products for diagnostic, educational or research purposes.

  14. Users at the registered establishment shall take all necessary measures to avoid the spreading of disease communicable to humans or animals during the handling of the materials under their control, in particular by way of good laboratory practice.

  15. If at any time the conditions of the licence cannot be met or a pathogen is discovered in the imported material, work must be suspended and the particulars reported to AnimalProductImports@agriculture.gov.ie immediately.

  16.  Unless kept for reference purposes or re-dispatched to the third country of origin, research and diagnostic samples and any products derived from the use of those samples must be destroyed in accordance with Section 1 of Chapter III of Annex XIV of Regulation (EC) No. 142/2011.

  17. The user at the registered establishment must keep a register of consignments of research and diagnostic samples received which shall include the information referred to in Section 1 of Chapter I of Annex VI of Regulation (EC) No. 142/2011. A template Annex II Register of Consignments of Research and Diagnostic Samples is available in the section entitled ‘Application Forms and Supporting Documentation’ below. 

  18. The register for the preceding licence period must be submitted to AnimalProductImports@agriculture.gov.ie prior to any licence renewal.



1. Application forms for an annual VET 15 licence must be completed by the operator indicated in the Certificate of Registration submitted in support of the application.

2. Application forms are available the section entitled ‘Application Forms and Supporting Documentation’ below.

3. The original completed signed application form, together with a copy of the Certificate of Registration, should be submitted as early as possible, and in any case, not less than 7 working days before the intended date of import to:

Animal Product Imports
Department of Agriculture, Food and the Marine
1 East Agriculture House
Kildare Street
Dublin2
DO2 WK12

Phone: 01 6072000
Email: AnimalProductImports@agriculture.gov.ie

4. Please note the application should be completed by the “operator” referred to in the Certificate of Registration.

5. To expedite the processing of  an application form for a VET 15 Research & Diagnostic sample licence,  the applicant may email a scanned copy of the signed application form and a copy of the Certificate of Registration to AnimalProductImports@agriculture.gov.ie

6. However, the licence will not be issued until the original signed copy of the application form has been received.

 

  1. There is no requirement for a VET 15 import licence in relation to the movement of research and diagnostic samples between EU Member States.

  2. Research and diagnostic samples from Andorra, Channel Islands, Isle of Man, Faeroe Islands, Iceland, Liechtenstein, Norway, San Marino and Switzerland may also be imported without a VET 15 import licence.

  3. Further queries regarding the movement of research and diagnostic samples between EU Member States should be directed to AnimalProductImports@agriculture.gov.ie

Animal By-Products Registration Documents:

 

VET 15 Application Documents: