PharmaLexperts – taking a pragmatic approach to Brexit….
On 01 September 2020, MHRA laid out the future requirements for placing medicines on the UK market after the end of the Brexit transition period on 31 December 2020. Our team which includes SMEs from the UK and the EU, are here to work with you to map out the impact on your operations and offer cohesive, practical solutions to assist you with a smooth transition.
Key Changes for Pharmaceutical Products and Import/Export
- Centrally Authorised Market Authorisations (CAP MAs): CAP Mas will automatically be converted into GB MAs (England, Wales & Scotland) on 01 January 2021, existing CAPs will remain valid for marketing products in Northern Ireland. Once the required GB MAs are issued then the MA Holder will have 24 months from the end of transition to submit appropriate amended artwork and a further 12 months (36 months total) to then transition to releasing stock in compliant packaging with the PLGB Authorisation numbers on the packaging.
- Parallel Distribution Notices/Parallel Import Licences: Parallel Distribution Notices (PDNs) will no longer be valid in Great Britain (Excluding NI) and will be replaced by Parallel Import Licences (PIL) which will allow the products to be marketed in Great Britain only.
- Responsible Person (Import): From 01 January 2021, a wholesale dealer in Great Britain (excluding NI) 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 new guidance has given clarity in that products sourced from Northern Ireland to Great Britain for wholesale purposes are permitted under the supervision of a Responsible Person (RP) and do not require an RPi.
- Wholesale Distribution Authorisation Holder: New timelines are also included on updating the WDA and notifying the MHRA on the intention to continue to import from a country which is on the MHRA’s approved country for import list. WDA holders should now notify MHRA in writing before 01 July 2021 of their intention to continue to import medicinal products from a country on the list, and they must submit a change to their WDA licence before 01 January 2023 to list a Responsible Person (import) (RPi) who will carry out those specific functions.
- Continuity of Supply: Pharmaceutical MIA and WDA holders now need to familiarise themselves with these revised rules to start preparing their QMS and operations for the upcoming changes, ensuring a smooth transition and continuity of their import/export business.
- Approved Country for import list: RPis are not required if a medicine is imported from an approved country for import list (currently EEA), is not licenced in the UK or the listed country and is intended as special medicinal product or is an Introduced Medicine (Intended for onward export). In these cases the WDA holder must notify the MHRA in writing before 01 July 2021 of their intention to continue to only import medicinal products from the listed country, to which this exemption applies.
In all other circumstances a WDA is required including If you source a medicine without an authorisation in UK or Great Britain from Northern Ireland for supply to the Great Britain market.
- Active Substances: Written confirmation will be required from 01 Jan 2021 for each shipment of Active Substances manufactured in Great Britain that is exported to the EEA or Northern Ireland.
We will follow up with additional details/clarifications as more information becomes available and, in the meantime, please feel free to contact us at firstname.lastname@example.org for additional information.