Paragraph 31 Placing on the marketE1

England, Wales and Scotland

(1)

A holder of a marketing authorisation must notify the Secretary of State when the veterinary medicinal product is first placed on the market in the United Kingdom, and the date on which it was placed on the market.

(2)

A holder of a marketing authorisation who removes the veterinary medicinal product from the market in the United Kingdom must notify the Secretary of State at least two months (or a shorter period in exceptional circumstances) before doing so.

F1(2A)

A holder of a marketing authorisation who identifies a shortage of the veterinary medicinal product must notify the Secretary of State as soon as is reasonably practicable.

(2B)

For the purposes of sub-paragraph (2A) a shortage of a veterinary medicinal product occurs when supply does not meet demand at a national level within the United Kingdom.

(3)

Upon request by the Secretary of State, the marketing authorisation holder must provide—

(a)

all data relating to the volume of sales of the veterinary medicinal product by the holder; and

(b)

any data in the holder’s possession relating to the number of prescriptions written for the product and the total volume supplied under those prescriptions.

Annotations

Textual amendments

F1: Sch. 1 para. 31(2A)(2B) inserted (E.W.S.) (17.5.2024) by The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 51

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

Notes on Schedule 1

Textual amendments

F1: Words in Sch. 1 heading inserted (E.W.S.) (31.12.2020) by The Veterinary Medicines and Residues (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1461), regs. 1(2)(b), 4(7)(a)
F2: Words in Sch. 1 heading inserted (N.I.) (31.12.2020) by The Animals (Health, Identification, Trade and Veterinary Medicines) (Amendment) (EU Exit) Regulations (Northern Ireland) 2020 (S.R. 2020/353), regs. 1(3), 10(13)(a)