The Responsible Person (RP) is personally responsible for the implementation and maintenance of a GDP Quality System suitable for the company. The RP is responsible for the quality system and with that also additional responsibilities are defined in the EU GDP guidance or MHRA GDP Guideline. A Responsible Person import (RPi) holds a legal responsibility to ensure that batches of authorised medicines imported from countries on an approved list (this will be countries in the EEA) have been appropriately certified prior to being placed on the United Kingdom (UK) market.

WDA license holders do not have QPs. They operate a GDP quality system under responsibility of a Responsible Person (RP). The GDP quality system shall focus on the activities authorised under the WDA license (Procurement, Holding, Supply and Export) and it shall express a clear focus on accuracy and quality of records of operation. The RP shall have a defined reporting line with the registered WDA license holder.

For the UK market, from 01 Jan 2021, when the site holds a WDA license and distributes products certified under Article 51 of Directive 2001/83/EC then the site is obliged to appoint an RPi.

The responsibilities of RP include but not limited to:

  • Ensure there is a training program implemented for all personnel working under the GDP system.
  • Both suppliers and customers (to whom medicinal products are supplied) are regularly evaluated and approved by a suitable qualification program.
  • Authorised to decide on the final disposition of returned, recalled, reject or falsified products.
  • Authorised to decide that returned products can be included in saleable stock again, after a suitable documented evaluation.
  • Perform recall operations and shall ensure the recall process is functioning well in case its use is needed.
  • Ensure that complaints reported at the WDA holder are handled appropriately and reported to the involved MIA holder as soon as possible. The RP shall function as first point of contact for the complainant.

The responsibilities of RPi include but not limited to:

  • The RPi primary responsibility is to perform a release of product that is imported in to the UK, under a companies WDA(h) from countries on the approved list.
  • The RPi ensures that QP certification is complete and in order, alongside ensuring all temperature data is available and within specification The RP cannot legally do this.

Note: The RP and RPi could be the same person but with different job roles.

Further information can be found in: https://www.gov.uk/guidance/acting-as-a-responsible-person-import

By leveraging the expertise of a RP/RPi in your import process, MIAS will ensure that your products meet certification requirements, are properly documented, and remain compliant throughout their presence in the EU/UK market. Keep in mind that the specific responsibilities of the RPi may vary based on the product category and the applicable MHRA regulations, so close collaboration with them is essential to achieve and maintain compliant certification for your imports.

 

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