An RPi, otherwise known as a Responsible Person for import, is now a crucial role for the import of products from the EU.

We are now a third country to the EU and vice versa, so the medicinal goods are not parallel traded products but imports. They will need to ensure that products being imported have the correct QP certification and the required independent batch release certificate (for biological products).

Although (as with a regular RP), they can delegate these duties, they do however remain responsible for them.

As with a ‘normal’ RP you are responsible for ensuring Good Distribution Practice compliance is implemented and maintained throughout the company’s operations and documentation; so you must remain continuously contactable. If you are not an employee of the company, there should be a contract in place that outlines the responsibilities and duties of the RPi as well as the time that will be spent on the site.

What is Required to Become an RPi?

To be approved as an RPi you must be able to demonstrate (with evidence) that you have the correct qualifications and experience, as well as being able to show that you are a member of a professional body (that has a published code of conduct) – the MHRA have a register containing all approved RPis.

Qualifications that will be looked for during the application process are either:

• A university degree/higher education course in pharmacy, chemistry, medicine, biology or related life science.
• A level 5 qualification from the Chartered Institute of Logistics and Transport.
• A QMS or Pharmaceutical GMP Lead Auditor qulification from the Chartered Quality Institute.

You will also need to show that you have a minimum of 2 years’ experience of acting as an RP on a WDA, as well as experience/training with import (or parallel trading) procedures, regulations, and Good Distribution Practice compliance.

Professional body memberships (checked during application) that the MHRA deem acceptable are:

• Royal Society of Biology
• Royal Society of Chemistry
• Pharmaceutical Society of Northern Ireland
• Royal Pharmaceutical Society
• Chartered Institute of Logistics and Transport
• Chartered Quality Institute

Many companies are now finding that they need a Responsible Person (imports).
It is very important that you have one who is experienced and has sufficient training and competence, otherwise the MHRA could suspend your licence, if the training and relevant competence is seriously lacking.
If you want your current Responsible Person to become an RPi, it is vital that they have the correct qualifications and experience in order to be approved. All and any applications to become an RPi must be completed through the MHRA portal.

Training, Backup and Support

If you have questions on this subject or you need additional training to attain the required qualifications expected of a Responsible Person (imports), then get in touch with us using the contact form below for more information on our services.
Alternatively, take a look through our training courses via the link button shown.