Need to know about Responsible Person import (RP-i)

by | Mar 26, 2019 | Blog

In the event of the UK leaving the EU without a deal, a wholesale dealer may import Qualified Person certified medicines form the EEA if certain checks are made by the Responsible Person import (RPi)

RP-i has an important role in ensuring that only bona fide quality medicines are imported into the UK and ensuring appropriate systems are in place to control and evidence the process. To be a RP-i  you must  have undergone suitable training and understand the industry in order to qualify for the role. RP-is will have a legal responsibility to ensure that batches of authorised medicines imported from countries on an approved list, held by the MHRA, have been certified by a Qualified Person prior to being placed on the UK market. If you are a person named on the Qualified Persons register you be eligible to act as a RPi, however  you must still apply to be named on the RPi register

RP-is do not have to be an employee of the licence holder, they can be a  contractor. Pharmacy Consulting Ltd can provide RP-i services to your  business. Pharmacy Consulting Ltd runs RPi training monthly in several location across the country. If you prefer they can come to your site to deliver  bespoke RPi training. If you wish to find out more information please contact PCL, or check their website for future training dates and availability. If you are interested in contracting RP-i services , then please e-mail: [email protected] or call us on 01252 375362.

Testimonials

Having just completed the very informative API and Clinical Trail course (thank you Shankar) I was reminded of the traps we can fall into whereby we try to keep ourselves in our little boxes. At the MHRA symposium, I have heard several times comments such as:- “no, I’m not doing the GMP day as it’s not relevant to me” or “GDP? Oh, that doesn’t apply to us as we are manufacturers”. I am sure these comments were made well out of the earshot of MHRA personnel and on the face of it see… Read more
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