Members: CEO, Licensing Director, Post-Licensing Director, Inspectorate and Enforcement Director, Information Systems Manager, Finance and Administration Manager, Operations and Regulatory Affairs Manager, Quality Manager.
Summary: The Management of the Medicines Authority meets to discuss strategy, finance and management aspects during the management meeting.
Members: CEO (Chair), Licensing Director, Post-Licensing Director, Inspectorate and Enforcement Director, Operations and Regulatory Affairs Manager, Quality Manager.
Summary: Technical, Regulatory and communications aspects related to one or more directorate are discussed in this platform.
Members : Licensing Director (Chair), Assessors, Pharmacists, Medicines Inspector and Herbal Consultant. Any other experts may be invited to attend depending on the product being classified, should more specific information be required.
By invitation: Malta Competition and Consumer Affairs Authority (Foods, Cosmetics and Medical Devices), Port Health, Food Safety Commission.
Summary: The Borderline Committee (BCC) within the Medicines Authority is the official committee that determines whether a product submitted to it for classification (borderline product) is a medicinal product or not. If the Committee determines that a product is a medicinal product, the product is subject to the Medicines Act and all the legislation regulating medicinal products.
Members: Director Licensing (Chair), all technical staff within the Licensing and Post-Licensing Directorate. Medicines Inspector and Pharmacovigilance invited on a need basis.
Summary: The Medicines Review Committee within the Medicines Authority meets to discuss regulatory and technical issues relating to ongoing applications related to medicinal products, both national and European. These include applications for all pre- (e.g. scientific advice) and marketing authorisation applications and post-authorisation activities (e.g. variations, pharmacovigilance issues) as well as clinical trial applications. The main objective is to reach an integrated opinion and support decision making on positions to be taken by the Medicines Authority in all ongoing technical procedures, at different levels. Other items to be presented include feedback from technical and regulatory meetings attended by members of the Medicines Review Committee and other staff members, where relevant and discussion on any guidelines that have an impact on the items discussed in the Committee.
Members: Director Inspectorate and Enforcement and Medicines Inspectors.
Summary: The Inspection Review Group (IRG) within the Inspectorate and Enforcement Directorate is a forum where Inspectors and Assessors are both represented on this group. Mainly this meeting is a technical meeting pertaining to inspections where serious inspection findings are referred to for discussion and decisions to be made on the cases referred. Furthermore situations requiring specific inspections, such as during assessment, for-cause inspections, product related inspections etc. can be requested through, discussed at and planned in the IRG.
Members : The Licensing Authority (Chair), Legal Advisor of Licensing Authority, CEO of Medicines Authority and Director Inspectorate & Enforcement as permanent members. Investigating medicines inspectors / enforcement officers are invited members on the committee and Post-Licensing Director is invited for issues related to advertising of medicinal products.
Summary: Solely focusing on enforcement issues and so the mandate is to discuss and decide cases of investigated complaints which will have resulted or will result in an enforcement action. Meeting on ad hoc basis i.e. when there are cases to discuss and / or follow up.
Members: All Management
Summary: The Information Systems Meetings within the Medicines Authority discusses new IT requirements requested by line managers and provides updates about on-going projects. Decisions are taken by management about various IS related matters.
Members: Operations and Regulatory Affairs Manager – Health and Safety Officer (Chair), Health and Safety Workers Representative, Fire Officers.
Summary: The committee is responsible for the implementation of the occupational health and safety legislation and the promotion and implement of health, safety and wellbeing initiatives targeted to employees.
Members: CEO, Licensing Director, Operations and Regulatory Affairs Manager, Quality Manager, Quality Assessors, Pharmacist, Finance and Administration Executive.
Summary: The Communications and Public Relations Working Group meets to discuss and recommend to management the communications and public relations policy and roadmap of the Medicines Authority.
Members: CEO, Licensing Director, Quality Manager, Assessors and Pharmacist.
Summary: The Availability Working Group was set up in 2012, with the initial remit to study the list of products authorised to be placed on the market in Malta and to establish which therapeutic areas are not covered. The remit will be extended to liaise directly with the marketing authorisation holders or their representatives such that the Medicines Authority gets information on the marketing status of authorised medicinal products. It is planned that this information is made available to prescribers and patients. Companies will be involved in this exercise and problems encountered that may hinder placing products on the market will be discussed.
Sir Temi Żammit Buildings,
Malta Life Sciences Park,
San Ġwann SĠN 3000
Telephone: 356 2343 9000 (from 7:30 to 15:45)
Helpline: 356 2343 9111 (from 9:00 to 12:00)
Fax: 356 2343 9161