S.L. 458.37 Art. 9Duty of wholesale dealer.

(1) It shall be the duty of the wholesale dealer, when supplying medicinal products to a person authorised or entitled to supply them to the public, to enclose a document thereby making it possible to ascertain the date, name and pharmaceutical form of the medicinal product, quantity supplied, batch number of the medicinal products and the name and address of the supplier or consignee: Provided that the requirements of this sub-regulation shall also apply to the supply of medicinal products to persons in third countries authorised or entitled to supply medicinal products to the public.

(2) In addition, the wholesale dealer shall, in respect of each product he is distributing in Malta, furnish to the Authority an authenticated copy of the marketing authorization together with a letter of access issued by the marketing authorization holder granting the wholesale dealer the use of such marketing authorisation:

Provided that a wholesale dealer may only engage in the wholesale distribution of medicinal products in Malta in respect of which no such authenticated copy of a valid marketing authorization and letter of access has been forwarded to the Authority, if he is in possession of a parallel import licence issued in terms of the law.

(3) Every wholesale dealer shall, within the limits of his responsibilities, ensure that an appropriate and continuous supply of medicinal products is furnished to pharmacies and persons authorized to supply medicinal products in order to satisfy the needs of patients.

(4) It shall be the duty of wholesale distributors of active substances, including active substances that are intended for export, to comply with the current European Union good distribution practice for active substances.