Directorates and Units

 

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 and manufacturers/ importers 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.

Scientific and Regulatory Operations 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 administration, strategic operations, regulatory affairs, human resources, communication, public relations, legal services and other units/ activities as assigned by the Chairperson. Pharmacy inspections in accordance with the Medicines Act and international standards are also within the remit of this Directorate.

Advanced Scientific Initiatives Directorate

The Directorate provides for horizon scanning, technical assistance and scientific support to government and non-governmental entities and liaison with potential innovation partners including individuals, organisations, and universities. It encourages collaboration with academia through the fellowship programme and promotes the involvement of local stakeholders in European research funding opportunities. The Directorate co-ordinates the research output of the Malta Medicines Authority and dissemination of knowledge through publications, workshops, and similar ventures. The Advanced Scientific Initiatives Directorate reviews applications for import and wholesale distribution of cannabis-based preparations to be placed on the market in Malta and applications for the production of cannabis for medicinal and research purposes.

Medicines Intelligence and Access Unit

On the 27th November 2014, a new unit was established within the Medicines Authority ‘The Medicines Intelligence and Access Unit’. The 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. The unit is also responsible of carrying out assessments and inspections in line with the objectives of the Malta Medicines Authority.

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, Continuous Improvement and Internal Audit 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.

Educational Planning and Academic Development Unit

The Educational Planning and Academic Development Unit merges research, training and education into the regulatory environment, strengthening the commitment of the Malta Medicines Authority towards sustainable development and innovation. The Academy serves as a key platform within the Authority’s portfolio, through which educational planning and academic development unfold. Primary initiatives include the organisation of interactive advanced level courses on varied aspects of regulatory sciences that meet the needs of stakeholders by offering the opportunity to exchange views, enhance competence and overcome challenges. Through wide-ranging collaborations, the Academy provides a forum for national and international participants who share a vision for excellence in patient centred endeavours.

Medical Device Unit

The regulatory role of the Medical Device Unit in the Malta Medicines Authority is to manage the operations as the Maltese Competent Authority for medical devices. This includes the monitoring of all medical devices placed on the local market, while making sure that they are safe for the public and that they funcion as intended.

For the Medical Device landing page click here.

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