S.L. 437.47 Art. 58Wholesale distribution of veterinary medicinal product.

(1) In the Director, the wholesale distribution of veterinary medicinal products is subject to the holding of an authorisation. The Veterinary Services shall take all appropriate measures to ensure that the time taken for the procedure for granting this authorisation does not exceed ninety days from the date on which it receives the application.

When the market situation in Malta is such that it gives rise to a temporary supply issues for an authorised veterinary medicinal product, the procurement of small quantities of the same authorised veterinary medicinal product, or an essentially similar veterinary medicinal product, by a veterinary surgeon is permitted and is excluded from the scope of the definition of wholesale distribution:

Provided that when a veterinary surgeon has recourse to this regulation he has the appropriate means to be kept informed by this supplier of any batch or product recall and adverse drug reactions. Supplies of small quantities of veterinary medicinal products from one retailer to another may be excluded from the scope of the definition of wholesale distribution under a decision to be laid down by the Veterinary Services.

(2) In order to obtain the authorisation for distribution, the applicant shall have at his disposal technically competent staff and suitable and sufficient premises complying with the requirements laid down in the Director as regards the storage and handling of veterinary medicinal products:

Provided that for the purposes of this sub-regulation "technically competent staff" means responsible or qualified persons who shall be professionally responsible for the activity in question. Such person(s) must be in possession of qualifications as required by the Veterinary Services: Provided further that, where more than one responsible or qualified person is nominated, the application will clearly specify the responsibilities of each respective person.

(3) The holder of the authorisation for distribution shall be required to keep detailed records. The following minimum information shall be recorded in respect of each incoming or outgoing transaction:

(a) date;

(b) precise identity of the veterinary medicinal product;

(c) manufacturer’s batch number, expiry date;

(d) quantity received or supplied;

(e) name and address of the supplier or recipient. At least once a year a detailed audit shall be carried out to compare incoming and outgoing medicinal supplies with supplies currently held in stock, any discrepancies being recorded.

These records shall be available for inspection by the Veterinary Services for a period of at least three years.

(3A) The holder of a distribution authorisation shall have an emergency plan guaranteeing the effective implementation of any recall operation ordered by the competent authorities or undertaken in cooperation with the manufacturer of the medicinal product in question or the holder of the marketing authorisation.

(4) The Veterinary Services shall take all appropriate measures to ensure that wholesalers supply veterinary medicinal products only to persons permitted to carry out retail activities in accordance with regulation 59, or to other persons who are lawfully permitted to receive veterinary medicinal products from wholesalers.

(5) Any distributor, not being the marketing authorization holder, who imports a product from another Member State shall notify the marketing authorization holder and the Veterinary Services to which the product will be imported of his intention to import it. In the case of products which have not been granted an authorisation pursuant to European Regulation (EC) No 726/2004, the notification to the Veterinary Services shall be without prejudice to additional procedures provided for in the legislation of Malta.