Pathogens

1. The import of pathogens and pathogenic agents is only permitted under a licence issued under The Importation of Pathogenic Agents Order, 1997 (S.I. No. 373 of 1997).

2. S.I. No. 373 of 1997, defines "pathogenic agents" as: any collection or culture of organisms or any derivative, present either alone or in the form of a manipulated combination of such a collection or culture of organisms capable of causing disease in any living being (other than man) and any modified derivatives of these organisms, or any genetically engineered organism, which can carry or transmit an animal pathogen, or the tissue, cell culture, secretions or excreta by which or by means of which an animal pathogen can be carried or transmitted but excluding immunological animal remedies controlled by the Animal Remedies Regulations, 1996 (S.I. No. 179 of 1996).

Important: Pathogens 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. Consignments must be transported with appropriate UN approved packaging and compliant with TATA and ADR Regulations.

2. Each consignment must be accompanied by a copy of the VET 40 licence and documents providing the name and address of consignor and consignee, destination laboratory, type of product and quantity.

3. The exterior of each vial, bottle or tube must be disinfected prior to packaging for dispatch.

4. The container(s) must be clearly labelled with the type of product and quantity and contain the import licence number and the consignee and destination laboratory's name and address.

5. The importer is responsible for ensuring that the person(s) consigning and dispatching the material to Ireland is/are aware of and comply with the undertakings in the application for this licence and the conditions contained in this licence.

6. When importing a pathogen from a third country, the consignment must be presented for inspection to an EU approved Border Control Post (BCP) listed in Post (BCP) listed on the following Page

a. Dublin Airport, Shannon Airport, Rosslare Port and Dublin Port are approved BCP for such consignments.

7. The importer or agent of the importer must provide a minimum of 24 hours advance notification of arrival on EU territory to the approved BCP through which it is proposed to import the consignment by submitting Part 1 of the CHED (Common Health Entry Document) in TRACES.

8. From the point of entry into Ireland, the consignment must remain in its original packaging and be transported directly to the laboratory of use without coming into contact with any animals.

9. The product and any product derived from it are for use at the laboratory as indicated on the license and for the purposes stated in the application form. It must not be sold, supplied, or dispatched from that laboratory.

10. As a minimum the containment measures specified for containment level 2' must be implemented in the laboratory at all times.

11. Any potentially infectious liquid waste must be disinfected in excess sodium hypochlorite (or suitable alternative effective disinfectant) prior to disposal via the drain. The procedure must be defined in an SOP and volumes noted in a worksheet.

12. All potentially dirty drains will have p traps of suitable depth and will be flushed at regular intervals to prevent drying out. This must be defined in an SOP.

13. Any substantive variation from the information provided in the licence application should be notified to DAFM and a reapplication may be sought if appropriate.

14. Any inspection report by a state or international agency containing a negative finding shall be notified to DAFM without delay.

15. If potential animal health risks, other than those already identified in your application arise work should be suspended and DAFM notified immediately.

16. Disposal of all waste material must be as stated in the licence application.

17. This licence is granted under the Importation of Pathogenic Agents Order, 1997 and nothing in this licence gives exemption from any prohibition or restriction imposed by any other legislation.

18. Records relating to the product imported under this licence containing an inventory of stock and date acquired and forming a complete audit trail from the time of importation shall be maintained for at least three years and be made available for inspection by an officer of this Department on request.

19. The importer or his agent shall provide all necessary assistance to an officer to enable him/her to inspect the products and records.

20. An inventoried facility pathogen archive must be maintained by the laboratory and be made available upon request to an officer.

21. Where relevant, any licence required from the Environmental Protection Agency for genetically modified organisms must be in place before importation takes place.

1. The original, fully completed and hand-signed application form should be submitted as early as possible 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

Email: AnimalProductImports@agriculture.gov.ie

2. To expedite the processing of an application form for a VET 40 pathogen licence, the applicant may email a scanned copy of the signed application form to AnimalProductImports@agriculture.gov.ie

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

1. There is still a requirement for a VET 40 import licence in relation to the movement of pathogens between EU Member States, as well as Andorra, Channel Islands, Isle of Man, Faeroe Islands, Iceland, Liechtenstein, Norway, San Marino and Switzerland.

2. In the case of these countries, there is no requirement for the consignment to undergo checks at the Border Control Post. However, they must enter via a designated point of entry either Dublin Airport, Shannon Airport, Dublin Port or Rosslare Port.

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

Download the application form below:

For additional queries please contact