(1997; 248 pages) [French]
1.5 Manufacturers’ and distributors’ licences
The pharmaceutical inspectorate is responsible for ensuring that pharmaceutical products comply with conditions set out in the licence up to the time that they are delivered to the end-user. Its functions are:
(a) to establish, through periodic formal inspections and spot-checks, that all categories of licence-holder are operating in accordance with their licensed activities, prevailing standards of good manufacturing practice, and other prescribed regulations;
(b) to maintain oversight of distribution channels, either by inspection and monitoring or by arranging for pharmacopoeial analysis of selected samples, with a view to ensuring that products are not subject to unacceptable degradation during transit and storage at the periphery.