SCHEDULE 3 Classification and supply, wholesale dealers and sheep dip

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 on being 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 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 for Human Use(1).

(2) It may cover more than one site.

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

(4) The holder of a wholesale dealer’s authorisation must notify the Secretary of State, and if necessary apply for a variation of the authorisation, before making a material alteration to the premises or facilities used under the authorisation, or in the operations for which they are used, and failure to do so is an offence.

Suspension, variation or revocation of the authorisation

20.  The Secretary of State may suspend, vary 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.

Duties on the holder of a wholesale dealer’s authorisation

21.—(1) The holder of a wholesale dealer’s authorisation must—

(a) store veterinary medicinal products in accordance with the terms of the marketing authorisation for each product;

(b) comply with the Guidelines on Good Distribution Practice of Medicinal Products for Human Use as if the veterinary medicinal products were authorised human medicinal products;

(c) carry out a detailed stock audit at least once a year; and

(d) supply information and samples to the Secretary of State on demand.

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

(1)

OJ No C 63, 1.3.94, p. 4.