S.L. 437.115 Art. 23Application for a wholesale distribution authorisation.

(1) An application for the grant of a wholesale distribution authorisation provided for in Article 99(1) of Regulation

(EU) 2019/6 shall be made in the manner provided by the Director, and shall include such information, documents and other material as provided for by these regulations and Regulation (EU) 2019/6.

(2) An application for the grant of a wholesale distribution authorisation shall include the following:

(a) the name and address of the applicant;

(b) the name of the responsible person provided for in Article 100(2)(a) of Regulation 2019/6;

(c) the address of the premises that is to be used for the purpose of wholesale distribution;

(d) other relevant permits for the premises that is to be used for the purpose of wholesale distribution from other Maltese regulatory entities;

(e) a licence, permit or equivalent document from the financial services or an equivalent authority if the applicant is a limited liability company;

(f) the equipment and control facilities as may be required in these regulations;

(g) information, documentation or evidence to prove that the premises is suitable and adequate, and that there are suitable facilities, installations and equipment so as to ensure proper conservation and distribution of veterinary medicinal products as determined by the Director;

(h) the pharmaceutical forms of the products to be distributed, in particular any sterile product and product requiring storage below eight Centigrade (8º), if applicable;

(i) the details of narcotic or psychotropic drugs, blood, or veterinary immunological medicinal products;

(j) the approval from the authority in the territory of Malta responsible for planning and building permits, if applicable; and

(k) the activities related with the wholesale distribution of veterinary medicinal products intended to be carried out by the applicant:

Provided that the Director may request from the applicant any other relevant information or additional document, which is deemed necessary for the purpose of these regulations at any time.

(3) The premises used for the wholesale distribution of veterinary medicinal products shall not be interconnected with other premises which are used for other commercial activities or for habitation:

Provided that, interconnection with any other premises which is used for other commercial activities or for habitation may be allowed when the scale of activities and the commercial turnover of veterinary medicinal products may be reasonably expected to be below a certain threshold established by the Director by means of a notice in the Gazette. In such cases, the physical connection between the premises shall be kept to a minimum whilst the different areas shall be clearly demarcated and properly marked so that a visible distinction can be made clearly and unequivocally:

Provided further that, the provisions of this sub-regulation shall not apply in respect of existing premises before the coming into force of these regulations and which cannot be structurally altered as to comply with the said provisions.

(4) The Director may revoke a wholesale distributor authorisation granted through such an exemption at any time.