PART 2U.K.Authorised veterinary medicinal products

ExemptionsE+W+S

15.—(1) These Regulations do not apply to an inactivated autogenous vaccine that is manufactured, on the instructions of a veterinary surgeon, from pathogens or antigens obtained from an animal and used for the treatment of that animal.

(2) Schedule 1 and Part 1 of Schedule 2 do not apply in relation to an inactivated autogenous vaccine that is—

(a)manufactured by a person and in premises authorised in accordance with Part 2 of Schedule 2, on the instructions of a veterinary surgeon, from pathogens or antigens obtained from an animal; and

(b)used for the treatment of—

(i)other animals on the same site;

(ii)animals intended to be sent to those premises; or

(iii)animals on a site that receives animals from those premises.

(3) Schedule 1 and Part 1 of Schedule 2 do not apply in relation to—

(a)blood or blood constituents from a blood bank authorised in accordance with [F1Part 2] of Schedule 2;

(b)a product manufactured for administration under the cascade by a person and in premises authorised in accordance with [F2Part 2] of Schedule 2; or

(c)F3... stem cell products for use as an autologous treatment for [F4non-food producing animals] from an F3... collection centre authorised in accordance with [F5Part 2] of Schedule 2.

(4) Schedule 6 (exemptions for small pet animals) has effect.

Extent Information

E1This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

ExemptionsN.I.

15.—(1) These Regulations do not apply to an inactivated autogenous vaccine that is manufactured, on the instructions of a veterinary surgeon, from pathogens or antigens obtained from an animal and used for the treatment of that animal.

(2) Schedule 1 and Part 1 of Schedule 2 do not apply in relation to an inactivated autogenous vaccine that is—

(a)manufactured by a person and in premises authorised in accordance with Part 2 of Schedule 2, on the instructions of a veterinary surgeon, from pathogens or antigens obtained from an animal; and

(b)used for the treatment of—

(i)other animals on the same site;

(ii)animals intended to be sent to those premises; or

(iii)animals on a site that receives animals from those premises.

(3) Schedule 1 and Part 1 of Schedule 2 do not apply in relation to—

(a)blood or blood constituents from a blood bank authorised in accordance with Part 3 of Schedule 2;

(b)a product manufactured for administration under the cascade by a person and in premises authorised in accordance with Part 4 of Schedule 2; or

(c)equine stem cell products for use as an autologous treatment for horses from an equine collection centre authorised in accordance with Part 5 of Schedule 2.

(4) Schedule 6 (exemptions for small pet animals) has effect.

Extent Information

E2This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only