Terminology

The following is a list of the "key terms" and "acronyms" used within the Phama Industry:




Qualified Person (QP)
The Qualified Person is the person defined in Article 48 of the Directive 2001/83/EC and Article 53 of Directive 2001/82/EC as certifying release of medicinal products for shipment to market or for use in clinical trials. The primary legal responsibility of the Qualified Person is to certify batches of medicinal product prior to use. QP release is also required for medicinal products manufactured within the EU/EEA for export. In all cases, the Qualified Person is named on the relevant Manufacturer and Importer Authorisation (MIA). A manufacturer of finished medicinal products must have at their disposal the services of at least one Qualified Person.