This guidance will apply from exit day in line with the Human Medicines Regulations (Amendment etc.) (EU Exit) Regulations 2019.
In a no-deal Brexit, the UK will need to put in place arrangements for the continued authorisation of medicinal products.
This guidance provides detailed description of the process we have put in place to convert your Parallel Distribution Notices (PDNs) into Parallel Import Licences (PILs) in the event of a no-deal Brexit.
How to convert your PDN to a PIL
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, following the day the UK leaves the EU your product(s) will no longer be licensed in the UK and you will no longer be able to place them on the market in the UK.
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.
PILs will be valid for a single source country and a separate PIL will be issued for each source country you request.
There is no fee associated with the conversion from a PDN to a UK PIL…