# The Veterinary Medicines Regulations 2007, Paragraph 9: Duties on the holder of a manufacturing authorisation


(1) A holder of a manufacturing authorisation must ensure that the veterinary medicinal product is manufactured in accordance with the marketing authorisation.
(2) He must have permanently at his disposal the services of at least one qualified person (manufacture) who is on the register of qualified persons (manufacture) maintained by the Secretary of State.
(3) He must hold a current Certificate of Good Manufacturing Practice.
(4) He must have in place a system of Quality Assurance and Quality Control.
(5) He must give to the Secretary of State on request proof of all control tests carried out on the veterinary medicinal product or the constituents and intermediate products of the manufacturing process in accordance with the data submitted in support of the application for the marketing authorisation.
(6) If he makes up a bulk package of veterinary medicinal products he must ensure that the package is labelled, in a way that the label is clearly visible and legible, with—
(a) the name of the veterinary medicinal product, its strength as shown in the summary of product characteristics and its pharmaceutical form;
(b) the batch number;
(c) the expiry date;
(d) any storage requirements; and
(e) any other warning necessary for the safe handling of the package.
(7) He must keep an adequate number of representative samples of each batch of a veterinary medicinal product in stock at least until the expiry date of the batch, and must submit any such sample to the Secretary of State if he requires it in writing.

---
Source: https://www.legislation.gov.uk/uksi/2007/2539/schedule/2/paragraph/9 (the official version)
Page: https://openlegislation.uk/veterinary-medicines-regulations-2007/schedule-2/paragraph-9
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.