The Veterinary Medicines Regulations 2007

PART 2 Requirements for a wholesale dealer’s authorisation

Application

16.  An application for a wholesale dealer’s authorisation must be made to the Secretary of State.

Time limits

17.  The Secretary of State must process an application for a wholesale dealer’s authorisation within 90 days of receiving it.

Granting the authorisation

18.—(1) The Secretary of State must grant a wholesale dealer’s authorisation if he is satisfied that this paragraph is complied with.

(2) The authorised site must be—

(a) weatherproof;

(b) secure and lockable;

(c) clean; and

(d) free from contaminants.

(3) If the veterinary medicinal products covered by the authorisation are subject to specific storage conditions, the site must be capable of fulfilling those requirements.

(4) The authorisation holder must—

(a) have at his disposal the services of technically competent staff; and

(b) have an effective emergency recall plan.

The authorisation

19.—(1) The wholesale dealer’s authorisation must specify—

(a) the types of veterinary medicinal products and pharmaceutical forms that may be dealt in;

(b) the place where they are to be stored;

(c) the name and address of the person holding the authorisation;

(d) the address of the premises to which it relates;

(e) the name of the qualified person nominated to act under the Guidelines on Good Distribution Practice under paragraph 22.

(2) It may cover more than one site.

(3) It lapses if the holder does not deal in veterinary medicinal products for five years.

Suspension or revocation of the authorisation

20.  The Secretary of State may suspend or revoke a wholesale dealer’s authorisation if the holder—

(a) has not complied with these Regulations; or

(b) no longer has suitable premises or equipment.

Appeals

21.—(1) A person may appeal against a refusal, suspension or revocation of a wholesale dealer’s authorisation to a person appointed for the purpose by the Secretary of State.

(2) The appointed person must consider the appeal and report in writing to the Secretary of State.

(3) The Secretary of State must give written notification of his final determination and the reasons for it.

Duties on the holder of a wholesale dealer’s authorisation

22.—(1) The holder of a wholesale dealer’s authorisation must store veterinary medicinal products in accordance with the terms of the marketing authorisation for each product.

(2) He must comply with the Guidelines on Good Distribution Practice of Medicinal Products for Human Use(1) as if the veterinary medicinal products were authorised human medicinal products.

(3) He must carry out a detailed stock audit at least once a year.

(4) He must supply information and samples to the Secretary of State on demand.

(5) He must notify the Secretary of State if there are any changes to the information held by him.

(6) It is an offence to fail to comply with this paragraph.

(1)

OJ No. C 63, 1.3.94, p. 4.