The UK has come up with a plan for authorizing imports of pharmaceutical products in case it leaves the EU on October 31 without a Brexit deal in place.
The guidance provides a detailed description of the process to convert Parallel Distribution Notices (PDNs) – EMA confirmations required to distribute an authorized medicine from one EU member state to another free of marketing authorization — into UK Parallel Import Licenses (PILs) in the event of a no-deal Brexit.
PDN holders can opt-in to the fee-free conversion process for all or some of their PDNs by notifying the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) in a process the agency says requires “minimal information.”
If companies choose not to opt-in, their products will no longer be licensed for the UK market starting Nov. 1. [FDANews]