Division 1 The anti-rabies vaccine must:

be a vaccine other than a live modified vaccine and fall within one of the following categories:

1. (i)

   an inactivated vaccine of at least one antigenic unit per dose (recommendation from the World Health Organisation); or

2. (ii)

   a recombinant vaccine expressing the immunising glycoprotein of the rabies virus in a live virus vector;

where it is administered in a F1member State or Northern Ireland, it must have been granted a marketing authorisation in accordance with:

1. (i)

   Article 5 of Directive 2001/82/EC F2, as it has effect in European Union Law, as amended from time to time; or

2. (ii)

   Article 3 of Regulation (EC) No 726/2004 F3, as it has effect in European Union law, as amended from time to time;

where it is administered in F4a third country which is not a member State, have been granted an approval or a licence by the competent authority and meet at least the requirements laid down in the relevant part of the Chapter concerning rabies in the Manual of Diagnostic Tests and Vaccines for Terrestrial Animals of the World Organisation for Animal Health;

F5where it is administered in Great Britain, have been granted a marketing authorisation in accordance with regulation 4 of the Veterinary Medicines Regulations 2013.