GDP & the Role of the Responsible Person

The MHRA have announced that:

“In the future all Responsible Persons (RPs) will need to possess a statement of eligibility to be named on a wholesale dealer licence. This will be a requirement for both new and existing RP’s and there will be a two year transition period for existing RPs to gain eligibility.  Statements of eligibility will only be issued to Responsible Persons who can demonstrate they have the required knowledge and competencies to properly fulfil their role and responsibilities.”

This is to be introduced as of 1st April 2011.

Details of the scheme may be found at:

www.mhra.gov.uk/Howweregulate/Medicines/Inspectionandstandards/GoodDistributionPractice/News/CON102799

Whilst our current GDP training course covers most of the areas detailed in the (draft) study guide published by the Agency, we will be carrying out a full review, and rewrite as required, to ensure that the course addresses the requirements identified by the MHRA as well as the practical advice our training is well known for.

As a training provider, we have to obtain a licence from the MHRA to be able to conduct the written exam required of the new process.  Applications forms are expected to be available to us early in the New Year and we will waste no time in signing up.

Consequently, we have suspended the previously-advertised course and will replace it with a new one that meets the scheme’s requirements.

To request further information on this course or to reserve a place (with no obligation) please contact us using the details below:

PO Box 3255,
Littlehampton,
BN17 9AD
Tel: 01903 730 622

e-mail: debra.stanfield@seerpharma.co.uk