Parallel Distribution Notices (PDNs) are no longer valid in Great Britain (England, Scotland, Wales) and are replaced by Parallel Import Licences which allow the products to be marketed in Great Britain only.
The MHRA has provided guidance for the process which they have put in place to convert PDNs into Parallel Import Licences for Great Britain at the end of the Transition Period.
Parallel Distribution Notices will remain valid in Northern Ireland and no regulatory action is required to continue to market products directly imported from EU into Northern Ireland only.
Summary of the process for converting PDNs to Parallel Import Licences
PDN holders are given the opportunity to opt-in to the conversion process for all or some of their PDNs by notifying the MHRA in writing as described below. This process requires minimal information from PDN holders.
If you choose not to opt-in, your product(s) will no longer be licensed in Great Britain and you will no longer be able to place them on the market in Great Britain.
The MHRA will allocate Product Licence (PL) numbers to PDNs based on the existing practice for determining how many separate national licences are needed across a product range. All pack sizes will be covered by a single PL number.
Parallel Import Licences will be valid for a single source country and a separate Parallel Import Licence will be issued for each source country you request.
There is no fee associated with the conversion from a PDN to a Great Britain Parallel Import Licence. However, a periodic fee of £307 will be due on 1 April 2021 for each Parallel Import Licence requested unless a request to cancel the Parallel Import Licences on 31 March 2021 has been notified to MHRA (firstname.lastname@example.org) no later than 31 December 2020.
If you would like to discuss how Fusion Pharma can support you with converting PDNs to PILs please email us at email@example.com or phone us on +44 (0) 203 1379 799.