Duties on the holder of a manufacturing authorisation
8.—(1) A holder of a manufacturing authorisation must ensure that the veterinary medicinal product is manufactured in accordance with the marketing authorisation.
(2) The holder must have permanently at their 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 and must place all necessary facilities at the qualified person’s disposal.
(3) The holder must—
(a)have a current Certificate of Good Manufacturing Practice;
(b)have in place a system of Quality Assurance and Quality Control; and
(c)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.
(4) A holder who makes up a bulk package of veterinary medicinal products 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.
(5) A holder 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 required in writing to do so.