The Medicines and Healthcare products Regulatory Agency (MHRA) recently published guidance called “Acting as a Responsible Person (import) (RPi) from 1 January 2021”. The guidance describes the role of an RPi and how to become a RPi. Also of relevance is the guidance “Sourcing medicines for the Great Britain market from an approved country for import or Northern Ireland”. The RPi is described in regulations 45AA and 45AB of the Human Medicines Regulations 2012.
Since 1 January 2021, a wholesale dealer in Great Britain may only import Qualified Person (QP) certified medicines into Great Britain from countries on an approved country for import list (initially, this will be countries in the European Economic Area (EEA)) if certain checks are made by the RPi. For the purposes of relevant legislation Great Britain is classified as England, Wales and Scotland. If you undertook this activity before 1 January 2021 it is necessary to:
- Notify the MHRA within 6 months from 1 January 2021 of your intention to continue to import medicinal products from a country on the list.
- Within 2 years from 1 January 2021, nominate and have named on your wholesale dealer’s licence an RPi.
The RPi is responsible for implementing a system to confirm the following activities for imported products that have been imported into Great Britain from countries on the approved country for import list:
- That the required QP certification has taken place.
- That the required independent batch release certificate is available for biological products (referred to as “immunologicals and blood products” on a wholesale dealer license).
An EEA manufacturer or wholesaler may only supply a licensed medicine to a wholesaler in Great Britain. The sale and supply to an authorised person (hospital, doctor or retailer) must be from a UK licensed wholesaler. If you did not hold a wholesale dealer’s licence before 1 January 2021, in order to wholesale deal medicine, you will need to apply for a wholesale dealer’ licence. The requirement to name an RPi on the wholesale dealer’s licence will apply immediately to all new licence applications made from 1 January 2021 if you wish to import a licensed medicine from a listed country.
Criteria to become a RPi
There are two stages to becoming named as a RPi:
- Eligibility: This is through a combination of relevant qualifications and a minimum of 2 years’ experience in performing the functions of a Responsible Person (RP) on a Wholesale Distribution Authorisation (for medicines for human use) (WDA(H)) licence – which has replaced the old Wholesale Licence (WL) in the UK. Evidence of performing other functions, for example a quality assurance role for a pharmaceutical manufacturer, may also be considered equivalent. Everybody named on the QP’s register will also be eligible to act as an RPi but must still apply to be named on the RPi register. Once eligibility has been assessed and accepted by the MHRA, the person can be named on a register which will include all persons eligible to be named as a RPi.
- Suitability: This must be demonstrated to be named on each specific WDA(H). At the time of application, the MHRA will confirm whether the person is named on the register and check whether the experience is suitable for the proposed licence activity.
The RPi may delegate the activity of checking certification has taken place but remains responsible for ensuring the effectiveness of these checks. There is no requirement for each site on the WDA(H) to name its own RPi and the RPi does not have to be an employee of the licence holder but must be continuously contactable. However, if you are a contract RPi then you are expected to ensure you are able to dedicate the necessary time needed to carry out the services required and that you do not apply to act as RPi for too many companies. The RPi should also be a UK resident and proof of address will be requested upon application.
Products which do not require RPi oversight.
Medicinal products sourced from Northern Ireland for wholesale purposes is permitted under the supervision of an ordinary RP.
If a product has a UK or Great Britain marketing authorisation and is imported into Great Britain from outside the UK without QP certification from a country on the list, then this product will need to be QP certified before placement on the market. This certification is required to be performed under a UK manufacturing and import authorisation.
Products without a marketing authorisation (unlicensed products) in the UK, Northern Ireland, Great Britain or a listed country are permitted under the supervision of an RP. The MHRA must be notified of each importation that is for supply to the Great Britain market. Also, you do not need an RPi if the medicine is to be exported by the importer as an introduced medicine.
The Responsible Person (import) is a new role established to account for changes in the marketplace following Brexit. When importing medicinal products to the UK and Great Britain it is vitally important to determine whether you must appoint an RPi to your licence. Should you require an RPi, applications may be submitted to the MHRA who will confirm whether you are named on the register, and check whether your experience is suitable for the proposed licence activity.
Orphan Drug Consulting is available to discuss your compliance needs post-Brexit – please contact the team by clicking below:
The information presented within this blog is for illustration purposes only and is not to be considered as professional advice. Any information related to health contained within this article is not a substitute for appropriate medical advice from licensed healthcare professionals.