The Medicines Control Agency's product licence database

The Medicines Control Agency (MCA) is the government department responsible for the licensing of medicinal products and pharmaceutical manufacturers and wholesalers within the UK. In 1985 it took delivery of a computer system (MEDSOLVE) intended to permit the recording of all of the details contained on the licences for the marketing of medicinal products in the UK. By 1988 it became apparent that a coherent information systems strategy for the Department of Health Medicines Division, as it then was, would require a new product licensing system, largely because greatly enhanced functionality was required. In addition, the old system made no provision for recording the history of a licence, so that if the specification of a product was changed no record of its previous state was preserved. It had also provided almost no on-line validation, but only an error report that could be acted upon or ignored as the user saw fit. The new requirements included both of these features. In 1990 the feasibility of using the logical design of MEDSOLVE as the core for the new system was considered but soon rejected when its inadequacies became fully apparent. Formulation details are at the core of MEDSOLVE and the new product licence system and are discussed in detail. The physical design, logical data structure, and data migration problems of MEDSOLVE are discussed.