At the end of the transition period, the UK will have in place arrangements for the continued authorisation of medicinal products. Great Britain Parallel Distribution Notices will no longer be valid in Great Britain (England, Scotland, Wales) and will be replaced by Parallel Import Licences. Northern Ireland Parallel Distribution Notices will remain valid in Northern Ireland and no Regulatory action is required to continue to market products directly imported from the EU into Northern Ireland.
There is no fee associated with the conversion from a PDN to a Great Britain PIL. Periodic fee of £307 will be due on 1 April 2021 for each PIL requested.
How to opt in PDN holders have been provided with a list of PDNs understood to be valid on 31 December 2018. This list will be updated before the end of the transition period. Some PDNs refer to EU licence numbers which are not listed in the current product information available on the EMA website. These presentations may no longer be valid and PILs will not be issued for them unless you specifically request one.
You must return the list no later than 21 days after the end of the transition period. It will not be possible to convert further PDNs after the end of this 3-week period.
The latest list will be applied when a new PIL is granted. This information must be returned before any PIL numbers can be issued. It will take some months to issue all of the PILs required.
A change of UK reference product variation will be applied to each PIL by the MHRA at no fee at a later date. The PILs produced as part of this process will use the EMA/EC annexes for the label and leaflet documents.