RPi (MHRA) beginner’s point of view and reason.

The UK has now got out of the EU (BREXIT complete). As a WDA(H) you will need to transition from RP to RPi as advised by the MHRA. You have 2 years to do this as an existing licenced distributor if you notified the MHRA accordingly within 6 months from 1^st January 2021.  Any new WDA(H) will require a Responsible Person import (RPi) from the point of application (2).

The then named RPi will perform specific functions to satisfy the safety MHRA requirements. This requires the gathering of specific written evidence to confirm or verify a medicinal product has been processed and handled according to the manufacturer’s specification and regulatory authority guidelines (1). This can only occur after the implementation of a robust checking system to support WDA(H) activities.

My point of view on this is that the role is moving to a position that is held to a code of ethics that are in line with the professional bodies recognised by the MHRA.

For example, the Royal Society of Biology has a code of conduct that members must adhere to (3). This is reflected in the other named bodies who can have a member as RPi (4,5,6,7,8). MHRA has through this process unified the standard to which the RP role did not have before under the RPi role. This brings wholesale pharmaceutical distribution in line with the health care sector placing individuals that are proud to operate to a set standard looking to build on the existing systems to enhance operations and reassure the public that safety is at the forefront of all activity.

Insight of the above then the question is are you compliant or BREXIT proofed?

Ref:

1. https://www.gov.uk/guidance/acting-as-a-responsible-person-import
2. https://www.gov.uk/guidance/sourcing-medicines-for-the-great-britain-market-from-an-approved-country-for-import-or-northern-ireland
3. https://www.rsb.org.uk/images/Code%20of%20Professional%20and%20Ethical%20Conduct.pdf
4. https://www.rpharms.com/publications/the-mep
5. https://www.psni.org.uk/psni/about/code-of-ethics-and-standards/
6. https://www.rsc.org/globalassets/03-membership-community/join-us/membership-regulations/rsc-code-of-conduct-final.pdf
7. https://ciltuk.org.uk/membership/individual/code-of-conduct
8. https://www.quality.org/article/cqi-and-irca-professional-code-conduct