SCHEDULES

SCHEDULE 2Amendment of the Human Medicines (Amendment etc.) (EU Exit) Regulations 2019

PART 4Amendment of Part 5 (amendment of Part 5 (marketing authorisations))

I164

In regulation 87 (post authorisation requirements in relation to UK marketing authorisations with paediatric aspects and advanced therapy medicinal products), in the inserted regulation 78B (post authorisation requirements in relation to UK marketing authorisations for advanced therapy medicinal products)—

a

in the heading to the regulation for “UK marketing authorisations” substitute “ UKMA(GB) ”;

b

for “UK marketing authorisation” in each place it appears substitute “ UKMA(GB) ”.