From 1 January 2021, a wholesale dealer in Great Britain may only import Qualified Person (QP) certified medicines from the European Economic Area (EEA) if certain checks are made by the ‘Responsible Person (import) (RPi)’.
The guidance published on 1 September 2020 describes how you can apply to be a RPi, and how to verify that QP certification of a medicine has been done in the EEA.
The registration scheme for RPi candidates will be applicable from 1 January 2021 and RPi applications may be submitted through the MHRA Portal after this date.
The Responsible Person (import) (RPi) is described in regulations 45AA and 45AB of the Human Medicines Regulations 2012 (as amended) and is responsible for implementing a system to confirm that the required QP certification has taken place for products that have been imported into Great Britain (England, Wales and Scotland) from countries on an approved country for import list (initially, this will be countries in the EEA).
In scope
- A UK or Great Britain licensed medicine for use in Great Britain
- A UK or Great Britain licensed medicine for supply to another third country
- A Northern Ireland or approved country licensed medicine for supply to fulfil special clinical needs
- A Northern Ireland or approved country licensed medicine imported as an introduced medicine for supply to another third country
- A Northern Ireland or approved country licensed medicine for use as a parallel import
Out of scope
There will products which will not require RPi oversight such as medicinal products sourced from Northern Ireland. For wholesale purposes they are out of scope of this guidance and this is permitted under the supervision of a Responsible Person (RP).
Products with a UK or Great Britain marketing authorisation that are imported into Great Britain from outside the UK without QP certification from a country on the list will require QP certification under a UK manufacturing and import authorisation before being placed on the market.
Products without a marketing authorisation in the UK, Northern Ireland, Great Britain or a listed country are outside the scope of this guidance. Importation of such products is permitted under the supervision of a Responsible Person (RP), with notification to the MHRA of each importation that is for supply to the Great Britain market.