MALTA Law and Practice Contributed by: Deo Falzon, Fenech & Fenech Advocates
1. Life Sciences Regulatory Framework 1.1 Legislation and Regulation In Malta, the regulation of medicinal products for human use is primarily governed by: • the Medicines Act (Chapter 458 of the Laws of Malta), which transposes Directive 2001/83/EC on the Community code relating to medicinal products for human use, and is also aligned with; • Regulation (EC) No 726/2004 laying down Commu- nity procedures for the authorisation and supervi- sion of medicinal products for human and veteri- nary use and establishing a European Medicines Agency; and • associated EU instruments and laws. The regulation of medical devices is achieved by vir- tue of: • the local subsidiary legislation S.L. 458.59, Medical Devices and In-Vitro Diagnostic Medical Devices Provision on the Maltese Market Regulations, and is aligned with; and • Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR). These Regulations are directly applicable in Malta without transposition and have repealed the previous Directives 93/42/EEC, 90/385/EEC, and 98/79/EC. The primary regulatory authority in Malta is the Malta Medicines Authority (MMA), which operates under the remit of the Ministry for Health. The Authority is tasked with regulatory oversight, including the evaluation, authorisation, inspection, pharmacovigilance, and post-market surveillance of medicinal products and medical devices. It functions as a semi-autonomous agency, established by law, and maintains operational independence in technical and scientific matters while being administratively linked to the central govern- ment. 1.2 Challenging Decisions of Regulatory Bodies Recommendations made by the Medicines Authority to the Licensing Authority relating to the marketing
authorisation of a medicinal product or to the suspen- sion, revocation, withdrawal or variance of a market- ing authorisation may be appealed before the Medi- cines Review Board. Decisions made by the Malta Medicines Authority (MMA) or the Superintendent of Public Health in their regulatory roles can be challenged through judicial review of administrative actions in Malta. These challenge proceedings are specific to medicinal products and medical devices. Other products may require different considerations. 1.3 Categories of Pharmaceuticals and Medical Devices Medicinal products in Malta are classified in accord- ance with Directive 2001/83/EC and national imple- menting measures under the Medicines Act. The main categories include: prescription-only medicines (POM): these require a prescription from a licensed healthcare professional and are solely dispensed by a pharmacist through a pharmacy; and over-the-counter (OTC) medicines: these are also dis- pensed by a pharmacist or under their supervision within a licensed pharmacy. For medical devices, classification is governed by the MDR and IVDR, which categorise devices based on risk, intended use and invasiveness: • medical devices: classified into Classes I, IIa, IIb, and III; and • in vitro diagnostic medical devices (IVDs): classified into Classes A, B, C, and D. Each classification determines the applicable con- formity assessment procedure and the involvement of notified bodies. Other classifications considered are custom-made devices, systems, and procedure packs.
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