(1997; 248 pages) [French]
1.4 Product licences
The issuance of product licences is pivotal to any system of drug control. The licence is a legal document that establishes the detailed composition and formulation of the product, the pharmacopoeial or other officially recognized specifications of its ingredients, its clinical interchangeability (in the case of multisource products), and its packaging, shelf-life and labelling. Of itself, this goes a long way towards establishing the assurances of quality, efficacy, and safety to which the system is directed. However, without a viable pharmaceutical inspectorate or access to an independent quality-control laboratory operating to standards that will ensure its credibility in the event of dispute, licensing provisions cannot be effectively enforced.