Records by a holder of a manufacturing authorisationE+W+S
21.—[F1(1) The holder of a manufacturing authorisation must record the following information in respect of any veterinary medicinal product supplied by the holder—
(a)the name of the veterinary medicinal product and marketing authorisation number if applicable;
(b)the pharmaceutical form and strength of the product;
(c)the quantity of product supplied;
(d)the batch number and expiry date;
(e)the date of the transaction under which the product was supplied;
(f)the company name and the permanent address or registered place of business of the recipient of the supply.]
(2) The holder must keep with the record all certification provided by the qualified person (manufacture) in relation to that batch.
(3) The holder must keep all records and certificates for at least five years from the date the veterinary medicinal product is placed on the market [F2or for one year after the date of expiry of the batch, whichever is the longer.].
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
F1Reg. 21(1) substituted (E.W.S.) (17.5.2024) by The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 12(a)
F2Words in reg. 21(3) inserted (E.W.S.) (17.5.2024) by The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 12(b)
Records by a holder of a manufacturing authorisationN.I.
21.—(1) A holder of a manufacturing authorisation must, as soon as is reasonably practicable, make a record of each batch of veterinary medicinal product manufactured, assembled or supplied, which must include—
(a)the name of the product;
(b)the quantity manufactured, assembled or supplied;
(c)the date of manufacture, assembly or supply;
(d)the batch number and expiry date; and
(e)in the case of supply, the name and address of the recipient.
(2) The holder must keep with the record all certification provided by the qualified person (manufacture) in relation to that batch.
(3) The holder must keep all records and certificates for at least five years from the date the veterinary medicinal product is placed on the market.
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