Understanding the Role of a Responsible Person (Import) in the UK

1. Introduction to Responsible Person (import)

In the UK, certain imported products that do not have a UK marketing authorisation — such as medicines — are permitted to be brought into Great Britain (England, Scotland and Wales) under the supervision of a Responsible Person (import) (RPi). The role is defined in UK medicines legislation and is separate from the usual Qualified Person (QP) certification system that applies to products with marketing authorisations.
Source: Acting as a Responsible Person (import) - GOV.UK

The RPi must put in place systems to confirm that required certifications and checks have been completed before the product is placed on the Great Britain market. This includes qualifying evidence for QP certification where appropriate and, for biologicals, independent batch release certificates.
Source: Acting as a Responsible Person (import) - GOV.UK

2. Scope of the RPi Role

The Responsible Person (import) system applies when importing into Great Britain certain products from:

• Approved countries for import, and
• Products that otherwise would require UK marketing authorisation or independent batch release.
  Source: Acting as a Responsible Person (import) - GOV.UK

Examples include:

• A UK or Great Britain licensed medicine imported for use in Great Britain.
• A medicine imported for special clinical needs from an approved country.
• A Northern Ireland or approved country licensed medicine imported for export.
  Source: Acting as a Responsible Person (import) - GOV.UK

3. Key Responsibilities of the RPi

The RPi must implement and maintain a system to ensure that:

• QP (Qualified Person) certification has been carried out where required for each imported batch in accordance with UK regulations.
• Independent batch release certification for biological products is available where applicable (e.g., immunologicals and blood products).
  Source: Acting as a Responsible Person (import) - GOV.UK

The RPi may delegate tasks such as checking certificates, but retains overall responsibility for ensuring that certification and checks are effective and properly documented.
Source: Acting as a Responsible Person (import) - GOV.UK

4. Evidence of Certification

Written evidence is required to demonstrate compliance with UK requirements for each imported batch, particularly for QP certification as stipulated under human medicines regulations. Acceptable evidence may include documentation issued under the supervision of a qualified person from an approved country or documentation confirming independent batch release for biological products.
Source: Acting as a Responsible Person (import) - GOV.UK

The RPi should keep records of certification evidence and be prepared to provide these records for inspection by the UK regulatory authority if requested.
Source: Acting as a Responsible Person (import) - GOV.UK

5. Relationship with Qualified Person (QP) Certification

The RPi role ensures that imported products are appropriately checked against UK requirements when a UK marketing authorisation is absent and QP certification from an approved country may substitute or be required. This system helps safeguard product quality and patient safety when importing medicines or related products from outside the UK.
Source: Acting as a Responsible Person (import) - GOV.UK

6. Delegation and Accountability

While certain administrative functions may be delegated, the RPi remains accountable for ensuring the checks and certification systems are implemented and effective. This includes ensuring that all relevant evidence of certification or batch release is collected and available for regulatory oversight.
Source: Acting as a Responsible Person (import) - GOV.UK

7. Regulatory Importance

Acting as a Responsible Person (import) is a regulatory safeguard helping ensure product quality, safety, and compliance when medicines and related products are imported into Great Britain without a UK marketing authorisation. It helps bridge the gap between export from approved countries and lawful supply under UK law.
Source: Acting as a Responsible Person (import) - GOV.UK

8. Conclusion

The RPi plays a critical compliance role for importers of regulated products into Great Britain. By ensuring that QP certification, independent batch release (where needed), and documentation are properly confirmed and recorded, the RPi supports lawful supply and protects public health in the UK.
Source: Acting as a Responsible Person (import) - GOV.UK