S.L. 458.35 Art. 3Setting up of pharmacovigilance system.

(1) The Authority shall set up and operate a pharmacovigilance system for the fulfilment of its pharmacovigilance tasks and its participation in Community pharmacovigilance activities. The pharmacovigilance system shall be used to collect information on the risks of medicinal products as regards patients’ or public health. That information shall in particular refer to adverse reactions in human beings, arising from use of the medicinal product within the terms of the marketing authorisation as well as from use outside the terms of the marketing authorisation, and to adverse reactions associated with occupational exposure.

(2) By means of the pharmacovigilance system referred to in sub-regulation (1), the Authority shall evaluate all information scientifically, consider options for risk minimisation and prevention and take regulatory action concerning the marketing authorisation as necessary. A regular audit of its pharmacovigilance system shall be carried out and the results reported to the Commission on the 21st September, 2013 at the latest and then every two years thereafter.

(3) The suitable information collected within this system shall be communicated by the Authority to the other Member States and the Agency. The information shall be recorded in the database referred to in point (l) of the second subparagraph of Article 57(1) of Regulation (EC) No 726/2004 and shall be permanently accessible to all Member States and without delay to the public.

(4) It shall be the duty of doctors and other healthcare professionals to immediately report to the Authority any suspected adverse reaction to a medicinal product in Malta.

(5) The Authority shall facilitate patient reporting through the provision of alternative reporting formats in addition to web-based formats as well as take all appropriate measures to obtain accurate and verifiable data for the scientific evaluation of suspected adverse reaction reports. The Authority shall also ensure that the public is given important information on pharmacovigilance concerns relating to the use of a medicinal product in a timely manner through publication on the web-portal and through other means of publicly available information as necessary.

(6) The Authority shall ensure through the methods for collecting information and where necessary through the follow-up of suspected adverse reaction reports, that all appropriate measures are taken to identify clearly any biological medicinal product prescribed, dispensed, or sold in their territory which is the subject of a suspected adverse reaction report, with due regard to the name of the medicinal product, and the batch number.

(7) The Authority shall also take the necessary measures to ensure that a marketing authorisation holder who fails to discharge the obligations laid down in these regulations is subject to effective, proportionate and dissuasive penalties.