How can a QP eligible under the transitional provisions of the Clinical Trials Directive 2001/20/EC apply for an entry on the Register?
The new QPs required under this directive are eligible to be certificated by the Professional Bodies and to have an entry in the IoB Register of Eligible Qualified Persons. Those eligible for certification will be IoB members. They will have been named as a Qualified Person in an application for a clinical trials manufacturing authorisation made prior to 1 May 2006, and have been accepted to act as a QP for investigational medicinal products by the MHRA and named on the clinical trials manufacturing authorisation. Certification by a professional body is not essential in these circumstances, but such persons are nevertheless eligible for certification and are advised, in any event, to retain details of the licence(s) on which they were named. Please refer to the Guidance Notes. Applicants with at least 2 years experience under a manufacturers licence issued under Directive 2001/20/EC are eligible to apply under Category A. Please refer to the Guidance Notes.
