Acting as a Responsible Person (import) (RPi): MHRA concretises Eligibility Criteria

Recommendation

20 June 2023
Barcelona, Spain

GMP & GDP Forum 2023
Day 1 only

Since 1 January 2021, a wholesale dealer in Great Britain may only import Qualified Person (QP) certified medicines from the European Economic Area if certain checks are made by the Responsible Person (import) (RPi).

Last year, the Medicines and Healthcare products Regulatory Agency (MHRA) has published a Guidance called "Acting as a Responsible Person (import) ". The guidance describes the role of the Responsible Person (import) (RPi) and how to become a RPi. A summary can be found in our news archive. The guidance was now updated, listing extensive qualification requirements for RPi's.

Becoming a Responsible Person (import)

There are two stages to becoming named as a RPi: First the eligibility must be demonstrated. This is through a combination of relevant qualifications and experience. Furthermore, suitability must be demonstrated to be named on a specific WDA(H) licence.

Qualifications

According to the updated guidance, acceptable qualifications are "a diploma, certificate or other evidence of formal qualifications awarded on completion of a university or other higher education course of study in:

• pharmacy
• chemistry
• medicine
• biology or
• a related life science

Equivalent qualifications acceptable for RPi candidates include:

• Level 5 qualifications from Chartered Institute of Logistics and Transport
• A Quality Management System Lead Auditor or Pharmaceutical GMP Lead Auditor qualification awarded by Chartered Quality Institute

Other qualifications may also be acceptable."

Candidates must be able to demonstrate, for example by providing a curriculum vitae (CV), that they have a minimum of 2 years’ experience in performing the functions of a responsible person on a WDA(H). "Evidence of performing other functions, for example a quality assurance role for a pharmaceutical manufacturer, may also be considered equivalent."

For more information, please see the Guidance "Acting as a Responsible Person (import)".