The role of the RPi is described in regulations 45AA & 45AB of the Human Medicines Regulations 2012 (as amended). The draft legislation is live but not yet approved by the Houses of Parliament.

The RPi will be responsible for implementing and ensuring the effectiveness of a system to confirm that the required QP certification has taken place for products that have been imported into the UK from countries on a list that will be maintained by the MHRA. The RPi must ensure that written evidence is available to demonstrate that each batch of product has been certified in accordance with Article 51 of Directive 2001/83/EC.

How do you become an RPi?

Check if you are eligible, what qualifications and experience do you have? Are you a member of a professional body with a published code of conduct? If you think that you maybe eligible, the MHRA will assess you and if you are accepted to be an RPi you will be named on their register.

If you would like further advice or your eligibility to be an RPi to be assessed by Pharmacy Consulting Ltd, prior to submission to the MHRA then please contact us. info@pharmacyconsulting.co.uk or call us on 01252 375362.