1. 1 PHARMACOVIGILANCE & THE NATIONAL ADVERSE DRUG REACTION (ADR) REPORTING SYSTEM Sarah Spiteri Post-Licensing Directorate Medicines Authority

2. 2 Legal Framework for Pharmacovigilance (PhV) “The Authority shall set up a pharmacovigilance system which shall be used to collect information which is useful in the surveillance of medicinal products, with particular reference to adverse reactions in human beings, to evaluate scientifically such information and to take into account any available information on the misuse and the abuse of medicinal products which may have an impact on the evaluation of their benefits and risks.” (Article 4(a) of L.N. 22 of 2004)

3. 3 Legal Framework for PhV “The Authority shall ensure that reports of suspected serious adverse reactions that have taken place on its territory are immediately made available to the marketing authorisation holder, the Commission, the Agency and Member States within 15 calendar days of their notification.” (Article 7 of L.N. 22 of 2004)

4. 4 Legal Framework for PhV “The Authority shall suspend, withdraw or vary a marketing authorisation whenever such action results necessary following an evaluation of pharmacovigilance data. Such decision shall be communicated to the Agency, to the Member States and to the marketing authorisation holder. In any case of urgency, the Authority may suspend the marketing authorisation of a medicinal product, provided that the Agency, the Commission and the Member States are informed thereof at the latest on the following working day.” (Article 8 of L.N. 22 of 2004)

5. 5 Role of the Medicines Authority Collection of information on ADRs from Healthcare Professionals (HCPs) and the pharmaceutical industry; Scientific evaluation of the information collected; Expedited reporting of suspected serious ADRs to relevant Marketing Authorisation Holders (MAHs); Regulatory action if so required following evaluation of data; Communication of the outcome of data evaluation.

6. 6 Role of the Medicines Authority Sharing information with HCPs and pharmaceutical companies; Sharing of information with regulatory authorities in other Member States; Operation within a wider international framework, including the EU and the WHO International Drug Monitoring Programme; Provision of Guidance Notes for Stakeholders.

7. 7 Development of the PhV System Development of an ADR reporting form ADR database Consistent with EU legislation and guidance Developed with advice of experts from other MS (Ireland) Regular attendance at Pharmacovigilance Working Party (PhVWP) Associate Members in WHO (leading to eventual Full Membership)

8. 8 Evaluation of Safety Data and Regulatory Action Scientific evaluation of: Individual reports Cumulative information - Literature Reports - Study Reports - Global Safety Data Regulatory action Dear HCP letters Regular “Drug Safety Bulletin”

9. 9 Collaboration with Stakeholders Co-operation among all partners in sharing safety information is essential for the Medicines Authority to carry out its functions wrt: Collation and evaluation of new safety information; Detection and prevention of potential safety hazards; Provision of an information service to HCPs and MAHs Safeguarding public health.

10. 10 Thank you for your attention You can visit our website at: http://www.health.gov.mt/mru Email: postlicensing.mru@gov.mtpostlicensing.mru@gov.mt Tel. No.: +356-23439135