S.L. 437.115 Art. 25Obligations of the wholesale distributor of veterinary medicinal products.

(1) The wholesale distributor of veterinary medicinal products shall:

(a) comply with the requirements as stipulated by

Article 101 of Regulation (EU) 2019/6;

(b) immediately inform the Director of any change in the details given in the original application within one (1) working day of the said change;

(c) provide the Director access to his premises at any reasonable time to carry out inspections as necessary;

(d) provide any sample of the veterinary medicinal products which are distributed or were distributed or intended to be distributed or found in the authorized premises at the request of the Director;

(e) provide any information and document about veterinary medicinal products, including data on sales, distribution and use of veterinary medicinal products as requested by the Director;

(f) inform the Director of any intention to relocate the premises authorised for the wholesale distribution of veterinary medicinal products three (3) months prior relocation and shall apply for a new authorisation in accordance with regulation 23; and

(g) carry out any other responsibility as may be established from time to time by the Director.

(2) When the veterinary medicinal product is obtained from the manufacturer or importer, the wholesale distributor shall verify that the manufacturer or importer holds a valid manufacturing authorisation.

(3) When the veterinary medicinal product is obtained through brokering, the wholesale distributor shall verify that the broker satisfies the requirements set out in these regulations and that he has a valid registration for the activity of brokering.

(4) When the veterinary medicinal product is obtained from another wholesale distributor of veterinary medicinal products, the wholesale distributor shall verify that the other wholesale distributor of veterinary medicinal products holds a valid wholesale distribution authorisation.

(5) When distributing veterinary medicinal product to persons entitled to retail veterinary medicinal products in the territory of Malta the wholesale distributor shall keep record of at least the name of veterinary medicinal product, name of recipient, pharmaceutical form, batch number, expiry date and quantities supplied in respect of each transaction.

(6) A wholesale distributor shall exercise all necessary precautions when veterinary medicinal products are received from a third country but not imported for the sole purpose of export, in order to ensure that these veterinary medicinal products do not in any way end up on any Member State market.

(7) The Director may request the wholesale distributor to provide a letter of access issued by the marketing authorisation holder granting the wholesale distribution authorisation holder the use of such marketing authorisation in respect of each veterinary medicinal product he distributes and which is obtained directly from the marketing authorisation holder or his legal representative.