Regulatory Expectations for Contract RPs

Recommendation

13/14 December 2023

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Especially for smaller wholesalers, the concept of using an external Responsible Person (RP) might be useful. But there a few things which need to be considered. In one of its recent blogs, the U.K. Medicines and Healthcare Regulatory Agency MHRA is summarising this.

Responsibilities

The Licence Holder acts as contract giver and needs to demonstrate that the external RP is suitable. Before the co-operation starts, a contract between the two parties is needed. This contract should "cover the scope of the role, respective duties and responsibilities for the contracting parties, and the availability of the RP and should be regularly reviewed". But also the performance of the RP should be reviewed.

The external RP, acting as the contract acceptor, needs to understand the scope of the activities within the company's culture and system. "The defined responsibilities of the RP are wide ranging and appropriate tools should be in place, or implemented, to ensure that duties can be executed properly and appropriately", MHRA points out.
And the RP needs, besides sufficient experience, a proper training.

Specifics

Contract RPs may not be at the site all the time and may also act as contract RP for other companies. So it needs to be ensured that people are in place to give support when the RP is off-site. MHRA recommends that, "to assist with compliance, the RP should have a direct reporting line to the Licence Holder or managing director".

Possible problems

MHRA inspectors have seen that contract RPs implement a "generic quality system" rather than one which has been tailored to the Licence Holder.

If one contract RP is named on (too) many licenses, MHRA "may refuse variations to add RPs or propose a variation to remove the RP in question", especially when "critical concerns have been raised."

Often, the external RP is the only staff member who has a GDP background and knowledge and it can be a challenge to ensure GDP-compliance.