Licensing Directorate
The Licensing Directorate processes all applications for product pre-authorisation and post-authorisation activities through established national and European procedures. This includes the granting, withdrawal, variation, revocation or suspension for all product related licences and authorisations. The directorate also processes applications for work-sharing of European procedures.
Post-Licensing Directorate
The Post-Licensing Directorate is responsible for the constant monitoring of the safety of medicines after authorisation ('pharmacovigilance' and 'advertising'). The Medicines Authority receives safety reports from within the EU and outside concerning authorised medicinal products and acts upon the information relating to the safety and quality of medicinal products.
Inspectorate and Enforcement Directorate
The two main activities of the Inspectorate and Enforcement Directorate are inspections of wholesalers, manufacturers/importers and pharmacies and the issue of their licences, their renewals and variations as well as the remit to carry out enforcement activities in line with the Medicines Act 2003 and its subsidiary legislation.
Strategy, Operations and Regulatory Affairs Directorate
The Directorate supports the Chairperson/ CEO in leading the development and execution of a plan to accomplish the Medicines Authority's goals and objectives. The Directorate is responsible for finance, administration, strategic operations, regulatory affairs, human resources, communication, public relations, legal services and other units/ activities as assigned by the Chairperson. The Directorate includes the Finance and Administration Unit (FAU) and the Operations and Regulatory Affairs Unit (ORAU). FAU is responsible for all financial, management accounting and administration of the Medicines Authority. ORAU is responsible for relevant corporate operations and the overall planning, monitoring and support of the operations and regulatory affairs at the Medicines Authority.
Advanced Scientific Initiatives Directorate
The Directorate (Advanced Scientific Initiatives) is responsible to establish identified scientific areas into centres of excellence and manage advanced initiatives in line with the strategy of the Malta Medicines Authority. The Directorate leads the development of best practice in the regulation of cannabis for medicinal and research purposes through guidance, review, technical, evaluation and stakeholder engagement, among other areas.
Medicines Intelligence and Access Unit
The Medicines Intelligence and Access Unit is responsible to manage a proactive and targeted approach to introduce and facilitate the adoption of best practices and enhance medicines intelligence and access. It supports industry and all stakeholders in increasing the access of medicinal products for the benefit of consumers.
Information and Communication Technology Unit
To deploy and maintain a robust and secure ICT infrastructure and application functionality to support the operations of the national competent Authority and legislation regulating the local pharmaceutical sector. Moreover new developments within the EU Telematics Programme are monitored to ensure that information systems comply with EU Directives.
Quality Management Unit
Responsible for the overall quality system of the Authority and to ensure that quality management is implemented in all areas. It·is responsible to plan and execute the internal audit programme of the Authority and to ensure that there is a system of continual improvement through the follow up of corrective and preventive action and Management Review. It coordinates the Benchmarking of the European Medicines Agency exercise of the Authority and ensures that follow up action is done.
Research, Scientific Affairs and Innovation Unit
The Research, Scientific Affairs and Innovation Unit is responsible to further the advancement of research, scientific affairs and innovation at the Authority. The Unit encourages research, thought, analysis, academia, knowledge dissemination and innovation in collaboration with other entities. It provides for horizon scanning for the identification of emerging trends that may require actions by the Authority management. The Unit contributes to the consolidation of EU expert views on emerging and challenging topics relevant to innovative therapies and technologies, flagging issues that need regulatory guidance. It identifies and builds strong liaison with potential innovation partners, develops proposals for funding and promotes the involvement and collaboration of local stakeholders in funding opportunities.
Organogram