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.
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.
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.
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.
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.
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