The Veterinary Medicines (Amendment etc.) Regulations 2024

Amendment to paragraph 8

87.  In paragraph 8 (duties on holder of manufacturing authorisation)—

(a)for sub-paragraph (2) substitute—

“(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.”;

(b)for sub-paragraph (3) substitute—

“(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.”;

(c)after sub-paragraph (5) insert—

“(6) A holder must keep detailed records of all veterinary medicinal products which the holder supplies.”.