S.L. 458.51 · Medicines Products (Injunction To (S.L. 458.51)
S.L. 458.51 Art. 5Application for compliance orders by qualified entities.
(1) Where a qualified entity wishes to seek a compliance order, it shall submit its written application to the Authority. In its application, it shall satisfy the Authority that it has tried to achieve the cessation of the infringement in consultation with either the defendant or both the defendant and another qualified entity of the Member State or EEA State in which the injunction is sought. The Authority shall only entertain a written application if the qualified entity shows to its satisfaction that the cessation of the infringement was not achieved within two weeks after the request for consultation was received.
(2) Where the qualified entity is from another Member State or EEA State, the Authority shall treat the list of qualified entities published by the Commission as conclusive proof of the legal capacity of the legal entity to present such written application in Malta.
(3) The Authority shall, at the request of a qualified entity from Malta, communicate to the Commission the name and objects of such entities and that such qualified entity should be added to the list of qualified entities so as to facilitate the redress of inter-community infringements.
(4) Before proceeding for the issue of a compliance order under regulation 6, the Authority shall, if it considers it to be possible and reasonable to do so, seek first to achieve voluntary compliance by a person licensed under the Act and other persons involved, in accordance with these regulations, the Act or any other law dealing with consumer rights and protection.
(5) For the purposes of these regulations, an infringement occurs when any act is committed contrary to Directive 92/28/EEC as transposed by the 2005 Regulations.