Brexit: Acting as a Responsible Person (import) (RPi)

The Medicines and Healthcare products Regulatory Agency (MHRA) has recently published a Guidance called "Acting as a Responsible Person (import) from 1 January 2021". The guidance describes the role of the Responsible Person (import) (RPi) and how to become a RPi.

Background

From 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). "The RPi is responsible for implementing a system to confirm that the required QP certification has taken place for products that have been imported into Great Britain from countries on an approved country for import list (initially, this will be countries in the EEA)."

The Role of the Responsible Person (import)

The guidance explains the role of the RPi in detail. It states that the RPi "should ensure that written evidence is available to demonstrate that each batch of product has been QP certified as required in Article 51 of Directive 2001/83/EC."

"Batch certification by a QP may be confirmed using evidence such as:

• Batch certificate confirming QP certification in accordance with Article 51 of Directive 2001/83/EC)
• A copy of the 'control report' (Appendix II to EU Good Manufacturing Practice Annex 16)
• Statement of certification (ad-hoc, confirming certification in accordance with Article 51 of Directive 2001/83/EC)
• Reference to company internal systems (e.g. global Enterprise Resource Planning system) that shows batch certification
• Confirmation that the final manufacturing step (other than batch certification) of an authorised medicine has been performed by a Manufacturing and Import Authorisation holder in a listed country. A copy of the Marketing Authorisation and technical agreement with the manufacturer should be available to place reliance on this supply chain control
• For medicines authorised in a listed country, batch certification may be verified by confirming that the medicine has been purchased from an authorised wholesaler after it has been 'placed on the market' in the listed country"

Working as a Responsible Person (import)

The Guidance points out, that a RPi has an important role in ensuring the safe control of medicines. A RPi needs training and an understanding of the industry in order to qualify for the role. A RPi has the "legal responsibility to ensure that batches of authorised medicines imported from countries on a list have been appropriately certified prior to being placed on the Great Britain market."

Becoming a Responsible Person (import)

There are two stages to becoming named as a RPi:

• Eligibility: First the eligibility must be demonstrated: This is through a combination of relevant qualifications and experience. It is also expected that RPis are a member of a professional body with a published code of conduct. Once eligibility has been assessed and accepted by MHRA, the person can be named on a register. The register will include all persons eligible to be named as a RPi.
• Suitability: Furthermore, suitability must be demonstrated to be named on a specific WDA(H) licence. At the time of application, MHRA will confirm whether the person is named on the register, and check whether the experience is suitable for the proposed licence activity.