Abstract
The design of a database of medicinal products presents conceptual questions for which there is not a unique answer. The reason for this is that medicinal products relate to the procedures for marketing authorisation and regulatory practice has diverged between regions and organisations. Some of these issues refer to the definition of medicinal products; the relationship between types of pharmaceutical forms and the format of the strength; the definition of pack size; the relationship between strength and pack size.
This paper describes the way in which these aspects have been addressed within the IMP project, but without pretending to be a definitive solution. The EMP medicinal product database and the ELS tracking system for licensing, developed within the IMP project funded by the IDA Programme, are used by the European Commission in support to marketing authorisation of centralised medicinal products.
Aspects not covered here include the relationship between products and markets, the implications derived from the change of proprietary names, and the relation between therapeutic indications and products.
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