Malta European Region Updated: February 2017 This document contains links to websites where you can find national legislation and health laws. We link to official government legal sources wherever possible. Where we link to unofficial sources this is noted and users should take this into account before relying on these materials. We recommend checking with the relevant national government if you have questions about the currency or validity of any unofficial source of law. Legal system Mix of civil law and common law National law database Language: Link: Nature: Organisation responsible for the website: Maltese and English http://www.justiceservices.gov.mt/ Official law database Ministry for justice, culture and local government of Malta The health system and policy monitor: regulation (PDF) As part of its Health Systems in Transition (HiT) series the European Observatory on Health Systems and Policies systematically describes the functioning of health systems in countries as well as reform and policy initiatives in progress or under development. The HiT health system reviews cover the countries of the WHO European Region as well as some additional OECD countries. This PDF includes information about the country s regulation. To see the complete HiT report of this country go to: http://www.euro.who.int/en/about-us/partners/observatory/publications/health-system-reviews-hits
Search list of contents: Regulation Overview and publication details Regulation Malta 2 3 Page 1/4
Regulation Malta HIT: 2014 - Azzopardi Muscat N, Calleja N, Calleja A, Cylus J. HSPM Members: Department of Health Services Management, Faculty of Health Sciences, University of Malta HSPM Contributors: Azzopardi Muscat N, Buttigieg N, Grech K, Cylus J. Page 2/4
Malta - Regulation Malta: Regulation 2.8 Regulation 2.8.1 Registration and planning of human resources Registration of health care professionals is regulated by the Health-Care Professions Act. The registration of all such professionals is under the responsibility of the Superintendent of Public Health. Professional regulators are responsible for granting of licences, and maintaining and updating professional registers for each health profession. They also monitor professional and ethical standards and carry out disciplinary proceedings. With regard to nursing and paramedical professions, due to concerns over the supply of workers there has been engagement between the health authorities and Faculty of Health Sciences. As a result the capacity of this Faculty s nursing course has been increased and a drive for the recruitment of foreign nurses organized. Every year, the Ministry for Health presents a consolidated business plan and a human resource plan based on the needs of all health facilities and departments. All capacity building is thereafter negotiated with the Ministry for Finance, as it is responsible for coordinating all public sector requests. Long-term human resource planning typically involves health authorities and education authorities collaborating with the University of Malta to decide which courses should be offered and at what frequency. Recently the government has embarked on the local provision of specialized training. In addition, there is the local foundation programme, which prepares newly graduated doctors for full registration with the Medical Council. 2.8.2 Regulation and governance of pharmacies Legislation specifies criteria for opening new pharmacies, as well as the standards to be maintained. Current legislation does not allow for Internet pharmacies. Pharmacies can only purchase medicines from authorized wholesale dealers. The supply chain is regulated to minimize the risk of counterfeit medicines entering the supply chain. However when patients do purchase medicines from unauthorized Internet pharmacies, these cannot be regulated. In addition to the information on specific products available through published pack leaflets and summaries of product characteristics, the Medicines Authority which is tasked with protecting and enhancing public health through the regulation of medicinal products and pharmaceutical activities makes available additional medicines information to empower patients and to support rational medicines use. 2.8.3 Regulation and governance of pharmaceuticals Medicinal products are regulated through a national legal framework presented in the Medicines Act, Chapter 458 of the Laws of Malta and its subsidiary legislation. Based on this Act, the Superintendent of Public Health is the Licensing Authority for all regulatory functions. The Licensing Authority delegates some functions related to licensing and surveillance of medicinal products and clinical trials to the Medicines Authority. All products are authorized in line with procedures as specified in European legislation. Post-authorization, all medicinal products on the local market are monitored for their quality and for their safety. The list of all authorized medicinal products and the approved package leaflet and the summary of product characteristics are published on the website of the Medicines Authority. All products placed on the market must be manufactured in EU Good Manufacturing Practice (EU-GMP) certified and authorized facilities; products imported directly from outside the EU must first be tested and batch released. EU-GMP certificates issued by the Medicines Authority are recognized by partner countries through a European Mutual Recognition Agreement. Standards of EU Good Distribution Practice are applied for wholesale distribution. Medicinal products can only be brought into Malta from the EU through EU authorized wholesale dealers. Each authorized wholesale dealer must retain a registered pharmacist, who is responsible for all technical aspects of the operations carried out by the wholesale dealer. Advertising of prescription medicines is not allowed, consistent with EU law. Only information approved in Page 3/4
Malta - Regulation the summary of product characteristics is allowed in advertisements of non-prescription items. Sale of pharmaceutical items is only permitted within pharmacies. Legislation stipulates that, unless a prescriber specifically requests the dispensing of an originator drug, pharmacists can do product substitution at the pharmacy level as long as the product dispensed has the same active ingredient, dose and same dosage form as that prescribed. 2.8.4 Regulation of medical devices and aids Medical devices are regulated by the Malta Competition and Consumer Affairs Authority, which forms part of the Ministry for Social Dialogue, Consumer Affairs and Civil Liberties. The legislation on medical devices is fully in line with the EU legislation. 2.8.5 Regulation of capital investment On the basis of advice from the Health Policy and Strategy Board, the Minister for Health approves recommendations for capital investments commensurate with published health strategies. Such capital proposals also require clearance from the Ministry for Finance. Following EU accession, Malta has also been able to access European funds, including the European Regional Development Fund. Capital projects are managed by the Foundation for Medical Services from project planning to execution and handed back to the Ministry once complete and operational. All public procurement follows EU public procurement regulations. Page 4/4