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The Veterinary Medicines Regulations 2013
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Rhagor o Adnoddau
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Changes to legislation:
There are currently no known outstanding effects for the The Veterinary Medicines Regulations 2013, Paragraph 8.
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Duties on the holder of a manufacturing authorisationE+W+S
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Memorandwm Esboniadol
8.—(1) A holder of a manufacturing authorisation must ensure that the veterinary medicinal product is manufactured in accordance with the marketing authorisation.
[F1(2) The holder must have permanently at the holder’s disposal the services of—
(a)staff complying with any legal requirements in relation to manufacture of veterinary medicinal products; and
(b)at least one qualified person (manufacture).
(2A) The holder must place at the disposal of any qualified person (manufacture) all necessary documents, premises and technical and other facilities in order to enable that person to discharge their duties as the qualified person.
(2B) Where any qualified person (manufacture) ceases to be available to provide services to the holder, the holder must give notice of the fact to the Secretary of State—
(a)at least 30 days in advance of the person’s ceasing to be so available; or
(b)where such notice is not possible, at the earliest opportunity.]
[F2(3) The holder must—
(a)comply with good manufacturing practice and have a valid certificate of good manufacturing practice;
(b)use as starting materials only active substances which have been manufactured in accordance with good manufacturing practice and distributed in accordance with good distribution practice for active substances;
(c)verify that each manufacturer, distributor or importer from whom the holder obtains active substances and to which paragraph 26 applies is registered with the Secretary of State under that paragraph;
(d)carry out audits based on a risk assessment in relation to the manufacturers, distributors and importers from which the holder obtains active substances;
(e)have in place a system of quality assurance and quality control; and
(f)give to the Secretary of State, on request, proof of any control test specified by the Secretary of State which has been 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.
(3A) The holder of a manufacturing authorisation must inform the Secretary of State and the holder of any relevant marketing authorisation where the holder obtains information that veterinary medicinal products which fall within the scope of its manufacturing authorisation are falsified, or are suspected of being falsified, irrespective of whether those products were distributed within the legal supply chain or by illegal means.]
(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.
[F3(6) A holder must keep detailed records of all veterinary medicinal products which the holder supplies.]
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
F1Sch. 2 para. 8(2)-(2B) substituted for Sch. 2 para. 8(2) (E.W.S.) (17.5.2024) by The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 87(a)
F2Sch. 2 para. 8(3)(3A) substituted for Sch. 2 para. 8(3) (E.W.S.) (17.5.2024) by The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 87(b)
F3Sch. 2 para. 8(6) inserted (E.W.S.) (17.5.2024) by The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 87(c)
Duties on the holder of a manufacturing authorisationN.I.
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.
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
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