RPI (Responsible Person – Import) Update

 

Since our last blog on the RPi (Responsible Person – Import) role, there have been some updates to the information available on what the role entails and what is needed to become one. It is a very important role for importing medicinal products from the European Union as post-Brexit, we are now classed as a third country to them and vice versa. This means there won’t be any parallel traded products, but imports.

What is the RPi responsible for?

The RPi needs to check that imported products have the correct QP certification and the required independent batch release certificate (for biological products). As with a ‘regular’ RP they will be able to delegate these duties but always remain responsible for them, so the RPi must stay involved at least at a minimum level (e.g; overseeing them).

The RPi is responsible for Good Distribution Practice compliance being implemented and maintained throughout the company including operations, personnel and documentation. If they are not an employee of the company (a Contract RPi), they must be continuously contactable and a contract must be in place detailing their responsibilities and duties. (This contract must be viewable at an inspection as a matter of course).

The RPi’s Requirements

There are certain conditions that need to be met for an individual to become an approved Responsible Person (imports), which includes having evidence of the correct qualifications and experience as well as showing your membership to a professional body (that has a published code of conduct). There is an MHRA register listing all approved RPi’s. (Use this for due diligence checks before hiring anyone).

During the application process the qualifications that will be looked for 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 qualification from the Chartered Quality Institute.

You will need to show evidence that you have a minimum of 2 years’ experience of acting as an RP on a Wholesale Distribution Licence (e.g. references from previous jobs). Experience in and/or training on import (or parallel trading) procedures, regulations, and compliance will also need to be demonstrated; training records and certificates are a good example of evidence that can be used.

Professional body memberships deemed acceptable by the MHRA, which will be checked during your application:

• 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

There will now be a number of companies that need a Responsible Person (imports). When looking for one make sure you are performing checks to ensure they are experienced and have completed sufficient training; your licence could be suspended if this is not the case. If you are looking to have your current RP as your RPi, you must think about whether they have the correct qualifications and experience to be approved. RPi applications will be completed through the MHRA Portal.

Do you have any questions about being or hiring an RPi? Contact us using the form at the foot of this page with your requirements and we can arrange a consultation to discuss how our services can help you.

Also, take a look at the courses on our training website and other associated posts related to this subject. We run a monthly popular all-day intensive GDP course online via Webinar. This covers all 10 chapters of the current EU GDP Guidelines and will include licences inspection preparation etc.