S.L. 458.37 Art. 8Granting of licence.

(1) A wholesale distribution licence shall only be granted if the Authority is satisfied that the applicant has at least -

(a) suitable and adequate premises, installations and equipment, so as to ensure proper conservation and distribution of the medicinal products;

(b) adequate staff, and in particular, a responsible person.

(2) A licence shall not be granted or renewed unless the applicant:

(a) makes the premises, installations and equipment accessible at all times for inspection;

(b) obtains the supplies of medicinal products from persons who are themselves in possession of a distribution licence, or who are exempt from obtaining such authorisation under the terms of regulation 3(4) of the Manufacture and Importation of Medicinal Products for Human Use Regulations, and verifies that the medicinal products received are not falsified by checking the safety features on the outer packaging, in accordance with the requirements as may be adopted by the Commission: Provided that the requirements of this paragraph shall not apply where a medicinal product is directly received from a third country but not imported, that is to say, not to be placed on any Member State market. However, in that case wholesale distributors shall ensure that the medicinal products are obtained only from persons who are authorised or entitled to supply medicinal products in accordance with the applicable legal and administrative provisions of the third country concerned. The wholesale distributor should also exercise all necessary caution and precautions in order to ensure that these medicinal products not intended to be imported, remain in quarantine and do not in any way end up on any Member State market: Provided further that the requirements of the above proviso shall not apply to the import of a medicinal product meeting the conditions laid down in regulation 11B of the Manufacture and Importation of Medicinal Products for Human Use Regulations;

(c) supplies medicinal products to persons who are themselves in possession of a wholesale distribution licence or who are otherwise authorised or entitled to supply medicinal products to the public: Provided that in the case of distribution of medicinal products to third countries this shall not apply. However, when wholesale distributors supply medicinal products to persons in third countries, they shall ensure that such supplies are only made to persons who are authorised or entitled to receive medicinal products for wholesale distribution or supply to the public in accordance with the applicable legal and administrative provisions of the third country concerned;

(d) has an emergency plan which ensures effective implementation of any recall of medicinal products from the market as ordered by the Authority or carried out in co-operation with the manufacturer or marketing authorization holder for the medicinal product concerned;

(e) keeps records, either in the form of purchase/sales invoices, or on computer, or in any other form, available for inspection by the Authority, for a period of five years of any transaction in medicinal products received, dispatched or brokered, containing at least the following information:

(i) date;

(ii) name and pharmaceutical form of the medicinal product;

(iii) quantity received, supplied or brokered;

(iv) name and address of the supplier or consignee, as appropriate;

(v) batch number of the medicinal product;

(f) complies with the principles and guidelines of good distribution practice for medicinal products as published by the Commission;

(g) maintains a quality system setting out responsibilities, processes and risk management measures in relation to their activities;

(h) immediately informs the Authority and, where applicable, the marketing authorisation holder, of medicinal products he receives or are offered which he identifies as falsified or suspect to be falsified.

(3) For the purposes of sub-regulation (2)(e), where the medicinal product is obtained from another wholesale distributor, the wholesale distribution authorisation holder must verify compliance with the principles and guidelines of good distribution practices by the supplying wholesale distributor. This includes verifying whether the supplying wholesale distributor holds a wholesale distribution authorisation. Where the medicinal product is obtained from the manufacturer or importer, wholesale distribution authorisation holders shall verify that the manufacturer or importer holds a manufacturing authorisation. Where the medicinal product is obtained through brokering, the wholesale distribution authorisation holder shall verify that the broker involved fulfils the requirements set out in these regulations and in the Act.

(4) The requirements set out in paragraphs (a) and (d) to (h) of sub-regulation (2) shall apply to the brokering of mutatis mutandis medicinal products.

(5) The Authority shall enter the information relating to the licence referred to in sub-regulation (1) in the European Union database as may be established by the Commission. At the request of the Commission or any Member State, the Authority shall provide all appropriate information concerning the individual licences which were granted under sub-regulation (1).