Dr. Patricia Vella Bonanno CEO

1. Dr. Patricia Vella Bonanno CEO Medicines Authority 203,Level 3, Rue D’Argens, Gzira,GZR 1368 Tel: (+356) 2343 9000 Fax: (+356) 2343 9161 Email: info.medicinesauthority@gov.mt Medicines Authority For the benefit of public health

2. Medicines Authority Objective of the Medicines Authority: To protect public health through the regulation: of medicinal products and pharmaceutical activities

3. Medicines Authority The Medicines Authority • Set up in 2003 through the Medicines Act, 2003 • Functions delegated by the Licensing Authority • Authorisation of medicinal products • and pharmaceutical activities • Protection of public health & Consumers Licensing of medicinal products Post-licensing -Pharmacovigilance -Advertising Inspectorate and Enforcement

4. Medicines Authority Licensing of medicinal products Evaluation Benefits Efficacy Use of medicines • Risks • Safety • Side effects • Adverse drug reactions • Contra-indications Quality of products Expiry dates Active Ingredients (API) Inactive ingredients Storage conditions • Classification (OTC/POM) • Labelling • Patient leaflet • Summary of Product Characterisitics (SPC)

6. Medicines Authority Package leaflet

7. Medicines Authority Monitoring of safety and quality post-authorisation Following marketing authorisation products are monitored for safety and quality- Marketing authorisation holders remain responsible for the products - Variations to marketing authorisations - Reporting of adverse drug reactions- Monitoring of the quality of products on the market - Marketing authorisations may be suspended or withdrawn

8. Medicines Authority Regulation of clinical trials Clinical trials have been regulated since 2005 Authorisation is based on evaluation of scientific information (protocol etc) as well as ethical approval (patient consent etc) Regulation is primarily aimed at protecting clinical trial subjects Clinical trials produce information required for the evaluation of marketing authorisations and changes to authorisations List of clinical trials authorised is published

9. Medicines Authority Regulation of the medicines supply chain • Inspections in line with EU standards • Authorisation of pharmaceutical activities • Pharmaceutical activities in Malta • Manufacture – 16 • Importation – 11 • Wholesale dealers - 69 • Pharmacies – 218 • - Issues are addressed in a disciplined way within stipulated timeframes

10. Medicines Authority Monitoring and enforcement • - Ensuring that standards are achieved and maintained • Ensuring that the medicines supply chain is secured to prevent falsified medicines from entering the regulated supply chain • Enforcement of the legislation as required • Investigation of complaints • Monitoring of advertising of medicinal products • Market surveillance and sampling

11. Medicines Authority European activity • The Medicines Authority forms part of the European • network of medicines agencies including EMA • Representation on EMA scientific committees for medicines such as the Committee for Human Medicinal Products, Committee for Paediatric Medicines, Committee for Orphan Medicinal Products, Committee for Herbal Medicinal Products • Participation on Committees of • The European Commission • -Collaboration – WHO, Uppsala Centre

12. Medicines Authority Information to consumers and health professionals • Publication of leaflets • -Publication of articles – papers, professional journals • Participation on media programmes • Response to questions and provision of • Information (patients, HCPs) • Helpline 23439111 (09:00 – 12:00) • info.medicinesauthority@gov.mt • knowyourmedicines.info@gov.mt • - www.facebook.com/medicinesmalta

13. Medicines Authority Leaflets

14. Medicines Authority www.knowyourmedicines.gov.mt

15. Medicines Authority www.maltamedicineslist.com

16. Thank you