Paragraph 20 Authorisation in relation to products for administration under the cascadeF1E1
England, Wales and Scotland
Subject to sub-paragraph (2), no person may manufacture a product for administration under the cascade that is the pharmaceutical equivalent of an authorised veterinary medicinal product.
The Secretary of State may authorise the manufacture of a product notwithstanding sub-paragraph (1) where there is difficulty in relation to the supply of the authorised veterinary medicinal product.
The holder of an authorisation under paragraph 14(1)(a)(ii) may not supply a product manufactured in accordance with that sub-paragraph other than to a veterinary surgeon who has prescribed the product under the cascade.
The holder of an authorisation under paragraph 14(1)(a)(ii) must—
provide a list of products manufactured in accordance with that sub-paragraph to the Secretary of State annually or at the request of the Secretary of State;
provide sales data for products supplied under sub-paragraph (3) at the request of the Secretary of State.
For the purposes of this paragraph, a product is the pharmaceutical equivalent of an authorised veterinary medicinal product if—
it has the same qualitative and quantitative composition in active substances; and
it has the same pharmaceutical form.
Annotations
Textual amendments
- F1
Sch. 2 Pt. 2 (paras. 14-25 entitled "Authorisation of autogenous vaccines, blood-banks, stem cell centres and products manufactured under the cascade") substituted for Sch. 2 Pt. 2 (paras. 14-19 entitled "Authorisation of manufacturers of autogenous vaccines"), Pt. 3 (paras. 20-24 entitled "Authorisation of blood banks"), Pt. 4 (paras. 25-29 entitled "Authorisation of manufacturers of products for administration under the cascade") and Pt. 5 (paras. 30-35 entitled "Authorisation of equine stem cell centres") (E.W.S.) (17.5.2024) by The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 92
Extent
- E1
This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only