UK – MHRA issues post-transition orphan, Northern Ireland supply guidance

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) on Thursday issued post-transition guidance on orphan medicines designations and incentives, as well as guidance on supplying medicines from Great Britain to Northern Ireland.
 
The guidances are the latest in a suite of post-transition guidance from the agency as it prepares for the Brexit transition period to expire at the end of the year. (RELATED: MHRA posts suite of post-transition guidancesRegulatory Focus 2 September 2020; MHRA: Post-transition guidance on licensing medicinesRegulatory Focus 3 September 2020; Pharmacovigilance and QPPV: Post-transition guidance from MHRARegulatory Focus 4 September 2020).