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SCHEDULES

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

PART 4 U.K.Amendment of Part 5 (amendment of Part 5 (marketing authorisations))

64.  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)—U.K.

(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) ”.

Commencement Information

I1Sch. 2 para. 64 in force at 31.12.2020 immediately before IP completion day, see reg. 1