Responsible Person for Import (RPi)

Course Overview

Since the UK left the European Union (EU), this created a challenge with regards to the importation of medicinal products manufactured in the EU and the EEA (European Economic Area) into the United Kingdom (UK).  This was created due to a difference in policy from the UK and the EU.  Medicinal products manufactured in the UK need to be certified by a Qualified person (QP) prior to batch release.  As the UK is no longer in the EU (they are considered a third party), batches manufactured in the UK need to be QP certified again, for a second time, on importation into the EU.  This is NOT the same for product manufactured in the EU/EEA, when being imported into the UK.  As product will need to have been QP certified within the EU/EEA prior to batch release, the UK has decided that this second QP certification is not necessary.  However, in order to ensure that the right checks have taken place, the role of the Responsible Person for Import (RPi) was created.  A unique position in the UK.  The responsibility of the RPi is to ensure that as a batch is imported into the UK, that QP certification did take place within the EU.  This is specific kind of Responsible Person (RP), and these initial checks only need to take place for the first time that a batch is imported into the UK.  A conventional RP will have responsibility of the batch after this initial importation.

The UK regulatory authority, the Medicines and Healthcare Products Regulatory Authority (MHRA) has produced guidance on the roles and responsibility of the RPi, including how you can become an RPI.  This course covers all that you need to know, if you wish to become and work as an RPi.

Dates available to book

This course is available for in-house presentation, either on-site or virtually. Please contact us for further details.

Who will the course benefit?

This course will benefit anyone who wishes to become an RPi.  In addition, the course will be of benefit to anyone currently working as a RP, to enable them to understand any specific requirements regarding this role.  The course will also be of benefit to Senior Management and Wholesale Dealers Authorisation (WDA) holders, to gain an appreciation of the importance of this role, as we as people involved in pharmaceutical logistics and supply chain.

Course Overview

Since the UK left the European Union (EU), this created a challenge with regards to the importation of medicinal products manufactured in the EU and the EEA (European Economic Area) into the United Kingdom (UK).  This was created due to a difference in policy from the UK and the EU.  Medicinal products manufactured in the UK need to be certified by a Qualified person (QP) prior to batch release.  As the UK is no longer in the EU (they are considered a third party), batches manufactured in the UK need to be QP certified again, for a second time, on importation into the EU.  This is NOT the same for product manufactured in the EU/EEA, when being imported into the UK.  As product will need to have been QP certified within the EU/EEA prior to batch release, the UK has decided that this second QP certification is not necessary.  However, in order to ensure that the right checks have taken place, the role of the Responsible Person for Import (RPi) was created.  A unique position in the UK.  The responsibility of the RPi is to ensure that as a batch is imported into the UK, that QP certification did take place within the EU.  This is specific kind of Responsible Person (RP), and these initial checks only need to take place for the first time that a batch is imported into the UK.  A conventional RP will have responsibility of the batch after this initial importation.

The UK regulatory authority, the Medicines and Healthcare Products Regulatory Authority (MHRA) has produced guidance on the roles and responsibility of the RPi, including how you can become an RPI.  This course covers all that you need to know, if you wish to become and work as an RPi.

Course Content

This three-hour course covers the following:

  • The EU and UK regulations for an RP
  • The difference between and RP and an RPi
  • The MHRA’s guidance on the RPi
  • How you become an RPi
  • Products that require RPi oversight, and those that do not
  • The physical movements of goods and their control
  • What does an RPi have to do and what can be delegated
  • What information the RPi needs to see in order to remain compliant
Course Cost

£395 per delegate, plus 20% VAT (tax). Course will be charged in GB pounds.

Delegates from outside the UK, but within the European Union (EU) will not be charged 20% VAT (sales tax), if they supply their own company’s national VAT number when booking.   Please select “Tax exempt” when booking and enter your company VAT number.  VAT will not be charged for any delegates coming from outside the UK or EU.

What’s included?

The cost includes:

  • Electronic copies of slides and any supplementary notes and handouts.
  • Course attendance certificate.
  • Full tutor support and access during course times.
Payment

Payment can be made by cheque, electronic transfer, credit or debit card. Payment must be made before the course start date. Either payment or a Purchase Order number will be required to secure a place on the course.

If you plan to pay by credit card then you should first look at this helpful information.

Alternatively, if you want to discuss any aspect of this training course then please send an email with your enquiry or call +44 1635 866699.

Based outside the UK

If so, be sure to pick the “Tax Exempt” option in the payment method list when you are  making a booking.  If you are based in the EU then you must also enter your VAT number to qualify to be exempt from VAT.

Group Booking Discount

Book 2 or more individuals from the same company for the same course date to get a 10% discount off each booking.  This discount is applied automatically when you make a booking.  If you are from an NHS organisation or a registered charity, then please contact us for special discounts.

Course Times

09.00 – 12.00 (UK time).

Meet the expert tutors

Dominic Parry

Dominic Parry

Susan Navarro

Susan Navarro

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+44 1635 866699

info@inspiredpharma.com

Inspired Pharma Training Ltd,

5 Westbrook Court, Sharrow Vale Road,

Sheffield, S11 8YZ, United Kingdom.