Under European and Maltese legislation, in force in Malta from 1^st May 2004, all medicinal products to be placed on the Maltese market must be issued a marketing authorisation or licence. 

The Licensing Directorate deals mainly with the granting of authorisations and product licences for applications received through the different authorisation procedures, including the National procedure, the Mutual Recognition and Decentralised Procedures, application for a Parallel Import licence, application for an authorisation in accordance with article 126a of Directive 2001/83/EC, as amended, and borderline classification committee requests. 

The Licensing Directorate also processes all renewals, variations and article 61(3) notifications to marketing authorisations and licences, where applicable.

The applications are received by the Licensing Directorate scheduling section and following a check for payment of the correct fees, are forwarded for validation to a product coordinator. During validation, it is ensured that all required documentation is supplied and all valid applications are then listed for assessment.  During assessment, it is ensured that the conditions for quality, safety and efficacy for each medicinal product to be placed on the market are observed by a thorough review of all the documentation submitted by an assessor. 

During assessment, some issues might need to be resolved before the assessment can be finalised. Following assessment and positive finalization of the procedure, an authorisation or licence is then issued.

The products placed on the market must be in accordance with the approved product information, including the Summary of Product Characteristics, the package leaflet and labelling for all types of authorisations and licences.