Privatsphäre-Einstellungen

Legal and Professional Duties of the Qualified Person

Christopher Burgess

Burgess Consultancy, Co. Durham (United Kingdom)

Correspondence: Dr. Christopher Burgess, Burgess Consultancy, ’Rose Rae’ The Lendings, Startforth Barnard Castle, Co. Durham DL12 9AB (UK), e-mail: chris@burgessconsultancy.com

The following paper addresses the legal and professional aspects of the Qualified Person primarily from a UK perspective. It confines itself to production and control of human medicines for the most part but much of what is discussed is relevant to veterinary and other Qualified Person sectors. Each member state incorporates the EU directives into national legislation and interprets the requirements. It is apparent that the manner in which a person is deemed suitable to perform the duties of the Qualified Person differs between member states.
A brief historical overview of the relevant EU directives is undertaken in order to place the UK procedures in context particularly regarding Articles 48 and 49 of EU directive 2001/83/EC and their relationship to Article 51.
The core of the paper is a discussion of the manner in which the UK has decided to implement the provisions for the Qualified Person in three aspects:

1. The manner of satisfying the qualification, knowledge and experience requirements
2. Eligibility and training
3. A professional code of conduct

The paper concludes with a short discussion of the duties of the Qualified Person both from a legal perspective and the new challenges arising from the changing GXP regulatory climate.

Key words Continuous professional development • EU directives • EU-GMP-Annex 16 • Qualified person, code of professional conduct, legal and professional duties • UK Medicines Act 1968