Statutory guidance

General licence to move germinal product from designated premises within a restricted zone to premises outside a restricted zone (EXD 658(GB))

Updated 8 October 2025

Applies to England, Scotland and Wales

This licence allows, subject to compliance with the conditions of the licence, the movement of germinal product from bluetongue susceptible animals from premises within a bluetongue restricted zone to a premises outside a restricted zone. 

Signed: Katherine Lumb, Veterinary Inspector 

Date: 29 September 2025 

Time: 4:30pm

Veterinary Inspector appointed by the Secretary of State. 

Legislation 

This licence is made under regulation 13 of the Bluetongue Regulations 2008 (as amended). 

Conditions of the licence

1. 1. The movement of germinal product shall be from a designated germinal product collection premises located within a bluetongue restricted zone to premises in Scotland or Wales.
2. 2. This licence authorises the movement of frozen restricted germinal product subject to post-collection testing of donor animals with either:
   1. a. Bluetongue RT-PCR, of samples taken at least 6 full days but no more than 34 days after the collection of the product or;
   2. b. Bluetongue serological test (ELISA), of samples taken at least 28 full days and no more than 60 days after the collection of the product.
3. 3. In any situation where post-collection testing cannot be conducted within the timeframes specified in condition 2, the germinal product is not authorised to move out of the restricted zone.
4. 4. Germinal product moved under this licence must be from donor animals which did not show any clinical sign of bluetongue on the day of collection.
5. 5. The germinal product must not be moved to a destination premises in Scotland or Wales until the test results of condition 2 above have been returned with negative results.
6. 6. Where germinal product is collected at a designated collection centre over an extended period or continuously, or pursuant to a regular sampling cycle, the post collection negative result must be from a sample from the animal which has provided the germinal product moving under this licence taken at least 6 days and no more than 34 days after the day of collection of that germinal product.
7. 7. If any of the tests in condition 2 return a positive result, then the licensee must ensure that the tested donor animal is isolated and the restricted germinal product collected from the tested donor animal is isolated and destroyed subject to advice from an APHA veterinary inspector.
8. 8. The germinal product intended to be moved under this licence should be quarantined and stored appropriately in a straw or another isolated, labelled, container (e.g. a Hexi goblet) separate from restricted product which does not meet the testing requirements in condition 2.
9. 9. The licensee must ensure that accurate and auditable records are kept for the duration of the germinal product storage. These records must be retained for a minimum of two years. Records should include: 
   1. • the animal identification number of the donor animal. 
   2. • the date the sample for testing was collected. 
   3. • the date, type and quantity of germinal product collected. 
   4. • the date the post-collection bluetongue PCR test was undertaken, and results received.  
   5. • if selected, the date the post-collection ELISA test was undertaken, and results received.
   6. • if relevant, the date that germinal product embryo from donor animals who subsequently returned bluetongue PCR and/or serology positive results were destroyed. 
10. 11. When moving anything under the authority of this licence, a person must carry a consignment note. The consignment note must include: 
    1. • the donor details (animal ID) of the germinal product being moved, 
    2. • the date of the collection and movement, 
    3. • the name of the consignor, 
    4. • the address of the premises from which the movement started, 
    5. • the name of the consignee, and 
    6. • the address of the premises of destination. 
11. 12. Fresh germinal product must not be moved out of the restricted zone under this licence.

Explanatory notes

1. 1. ‘The relevant authority’ means the Secretary of State in England and the Welsh Ministers in Wales.
2. 2. ‘The Regulations’ means the Bluetongue Regulations 2008 (as amended) and the Bluetongue (Wales) Regulations 2008.
3. 3. ‘Designated germinal product collection premises’ means any premises that collect, process, store or in any other way handle germinal product that has had designation granted under regulation 14A of the Regulations on behalf of the Secretary of State.
4. 4. ‘Germinal product’ means Embryo, Ova and Semen.
5. 5. ‘Embryo’ means fertilised eggs collected from a donor female from a bovine, ovine, caprine or other susceptible species.
6. 6. ‘Ova’ means unfertilised eggs collected from a donor female from a bovine, ovine, caprine or other susceptible species.
7. 7. ‘Semen’ means semen collected from a donor male from a bovine, ovine, caprine or susceptible species.
8. 8. “Restricted germinal product” means semen, ova or embryo produced from an animal in a bluetongue restricted zone where the donor animal has not tested negative for bluetongue, or semen, ova or embryo collected from an animal that was present in a bluetongue zone (except for transiting non-stop) at any time or within the 60 days before the zone was declared and where the donor animal has not tested negative for bluetongue.
9. 9. If a donor animal is showing clinical signs of bluetongue on the day of collection, germinal product from this animal collected on that day cannot be moved under this licence. The animal should be treated as a suspect case and notified to APHA for an investigation to be completed.
10. 10. Storing germinal products separately means processed in a separate area and stored in a separate liquid nitrogen container that does not allow the possibility of transfer of bluetongue virus from germinal products not conforming to the license conditions.
11. 11. A designated site may include any premises that collect, process, store or in any other way handle germinal product that has been authorised as a designated premises on behalf of the Secretary of State or the Welsh Ministers. There are no designated premises in Scotland.
12. 12. Freezing of germinal product within a bluetongue restricted zone is not permitted except under licence or at a designated premises. It is prohibited to move fresh germinal products collected from animals resident in a bluetongue restricted zone outside of the bluetongue restricted zone.
13. 13. All requirements of the Disease Control (England) Order 2003 (as amended) (SI No.1729), The Disease Control (Interim Measures) (Scotland) Order 2002, and the Disease Control (Wales) Order 2003 (as amended) (SI No.1966) and licences under those Orders must be met. 
14. 14. All requirements under current GB legislation for germplasm must be met.
15. 15. All movements are subject to the germinal product being properly identified and accompanied by the appropriate duly completed movement documentation.
16. 16. A person moving anything under the authority of this licence must, if asked to do so by an inspector, or other officer of the relevant authority, give their name and address, produce the consignment note and allow copies or an extract to be taken. 
17. 17. When completing the sampling required in condition 2:
    1. a. you must commission your own Private Veterinary surgeon (PVS) to collect and test samples at your cost. Guidance on collecting and submitting samples for testing can be found on Improve International and must be followed if using a PVS.
    2. b. you must clearly indicate RT-PCR and/or ELISA (antibody) testing for Bluetongue virus and specify ‘Germinal Product freezing’ in bold at the top of the form. ELISA testing is not suitable for vaccinated animals. For PCR testing, vaccinated animals may show transient positivity in the test, therefore sampling should be avoided within the 7 days after vaccinating.
18. 18. Record keeping systems must be in place to ensure that all movements can be traced from the source premises to the destination premises.  
19. 19. If you suspect notifiable disease, you must report this immediately to Defra Rural Services Helpline on 03000 200 301. If you suspect notifiable disease in Wales, you must report this immediately to the Animal and Plant Health Agency on 03003 038 268. If you suspect notifiable disease in Scotland you must report this immediately to the Local Animal and Plant Health Agency Field Services team.
20. 20. All other relevant legislation must be complied with.  
21. 21. Contact the APHA on the number provided above or your Local Authority (LA) for further advice on biosecurity measures and any other legislation that may apply. 

Failure to observe the measures required in this licence is an offence under the Bluetongue Regulations 2008 (as amended). The penalty on conviction of an offence under this section is a maximum of 3 months’ imprisonment or a fine not exceeding Level 5 on the standard scale or both.

Contact us

For further advice on biosecurity measures and any other legislation that may apply, contact the APHA on 03003 038 268 or your local authority.