The Licensing System

Abstract

The licensing system is the chief novel feature of the Act, and lies at the heart of all of the control over medicines. The system is designed to ensure that medicinal products (and certain other substances and articles) are of good quality, safe and efficacious and are manufactured and dealt with under optimal conditions. The system also enables batches of products to be traced and withdrawn from sale with the minimum of delay should they prove subsequently to be defective in any respect. This is achieved by a system of batch numbers and records kept by manufacturers and wholesalers. The system utilises three types of licence and two types of certificate each of which permits a person (including a ‘legal person’, e.g. a company) to engage in certain specified activities. It may therefore be necessary for a company to hold two or even three types of licence in certain cases. A fee is normally payable for each licence. It is an offence to engage in any of the controlled activities unless one holds the appropriate licence(s) (section 45(1)).