Intro to the Responsible Person import (RPi) Role

As the UK leaves the EU, the impact on the pharmaceutical industry is immense. This session is an overview of considerations to ensure compliant trading within Europe from 1 Jan 2021.

For up to date information on the current situation look here : https://www.gov.uk/guidance/acting-as-a-responsible-person-import-from-1-january-2021

Why Consider us for this session?

If you are currently working in a company who imports from any country outside the UK, from 1st January 2021, the company will need to nominate a Responsible Person for Imports (RPi).

The RPi has an important role in ensuring that only bona fide quality medicines are imported into the UK and ensuring appropriate systems are in place to control and evidence the process. To be a RPi  you must  have undergone suitable training and understand the industry in order to qualify for the role. RPi’s will have a legal responsibility to ensure that batches of authorised medicines imported from countries on an approved list, held by the MHRA, have been certified by a Qualified Person prior to being placed on the UK market. If you are a person named on the Qualified Persons register you be eligible to act as a RPi, however  you must still apply to be named on the RPi register

The course is beneficial for personnel involved in the pharmaceutical industry, to help them to obtain a more in-depth understanding of this new RPi role, how to register for to be  and the scope of the role.

Our RPi Introduction Includes

During the course we will cover, but will not be limited to the key subject areas listed below.

  • Implications of Brexit
  • QP Certification
  • The role of the RPi
  • The MHRA “White List”
  • Medical Devices
  • Marketing Authorisations
  • Clinical Trials

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