The Veterinary Medicines (Amendment etc.) Regulations 2024

New paragraphs 21A, 21B, 21C, 21D, 21E and 21F

116.  After paragraph 21 (and immediately before the heading for Part 3) insert—

“Register of authorised wholesale dealers

21A.   The Secretary of State must establish, maintain and publish on a website a register of authorised wholesale dealers and their sites.

Documentation accompanying veterinary medicinal products supplied wholesale

21B.— (1) This paragraph applies in relation to wholesale supply of veterinary medicinal products.

(2) The holder of a wholesale dealer’s authorisation must ensure that a document accompanies each consignment of veterinary medicinal products specifying—

(a) the name of the veterinary medicinal product;

(b) the strength and pharmaceutical form;

(c) the date on which the veterinary medicinal product was supplied;

(d) the quantity of product supplied;

(e) the batch number;

(f) the expiry date;

(g) the name and address of the wholesale dealer supplying the product;

(h) the means by which the product was transported and the required conditions of storage;

(i) the name of the person to whom the product was supplied and the address to which it is to be delivered.

(3) The holder of a wholesale dealer’s authorisation must make a record of the information mentioned in sub-paragraph (2) and must keep it for at least five years.

Recalled, counterfeit or returned products

21C.— (1) The holder of a wholesale dealer’s authorisation must comply with any requirement by the Secretary of State to recall a veterinary medicinal product and must record the details of the recall operation.

(2) The holder of a wholesale dealer’s authorisation must record any veterinary medicinal product which is—

(a) recalled (whether or not the holder physically receives the recalled product);

(b) discovered to be counterfeit; or

(c) returned.

(3) Where any veterinary medicinal product is recalled or returned and physically received, the wholesale qualified person must assess the product received in order to determine whether the product has been stored (including during transport) in accordance with the summary of product characteristics.

(4) Where a recalled or returned veterinary medicinal product has not been stored (including during transport) in accordance with the summary of product characteristics or where it is not possible for the wholesale qualified person to determine whether the product has been stored in accordance with the summary of product characteristics, the product may not be re-sold.

(5) Any veterinary medicinal products which may not be re-sold must be identified, held separately and destroyed and the holder of a wholesale dealer’s authorisation must develop a suitable procedure to set out the steps to be taken in accordance with this sub-paragraph.

(6) The holder of a wholesale dealer’s authorisation must keep any information recorded under this paragraph for five years.

Audit

21D.— (1) At least once a year, the holder of a wholesale dealer’s authorisation must carry out a detailed audit of stock and compare the incoming and outgoing veterinary medicinal products recorded with products currently held and record the results of the audit in written form.

(2) Where, as a result of the audit mentioned in sub-paragraph (1), the holder identifies a discrepancy the holder must—

(a) make a record of that fact,

(b) conduct an investigation for the purpose of discovering the cause of the discrepancy, and

(c) maintain records of that investigation.

(3) The holder must keep the records mentioned in sub-paragraphs (1) and (2) for a period of five years from the date of the audit and the Secretary of State may require the holder to provide a copy of them at any time within that period.

Contractual arrangements between holders of wholesale dealer’s authorisations

21E.   Where the holder of a wholesale dealer’s authorisation contracts out any wholesale dealing activities to another such holder, the arrangement must record in writing the responsibilities of each party in relation to their respective roles in the supply process and, in particular, in connection with the recall of a veterinary medicinal product under paragraph 21C.

Self-inspection programme

21F.— (1) The holder of a wholesale dealer’s authorisation must have in place a self-inspection programme which ensures that every aspect of its business is inspected at least once a year in order to ensure that it is complying with good distribution practice.

(2) Where, as a result of the self-inspection mentioned in sub-paragraph (1), the holder identifies any non-compliance the holder must—

(a) make a record of that fact,

(b) conduct an investigation for the purpose of discovering the cause of the non-compliance, and

(c) maintain records of that investigation.

(3) The holder must keep the records mentioned in sub-paragraph (2) for a period of five years from the date of the audit and the Secretary of State may require the holder to provide a copy of them at any time within that period.”.