SCHEDULES
SCHEDULE 11Advice and representations
F1PART 1APaediatric Decisions
Application of this Part13A
This Part applies to a proposed decision by the licensing authority—
a
to refuse to agree a paediatric investigation plan (including a waiver or deferral proposed to be included in that plan), or to agree such a plan otherwise than in accordance with the request for agreement;
b
to refuse to agree a modification to a paediatric investigation plan (including a waiver or deferral which is, or is proposed to be, included in that plan), or to agree such a modification otherwise than in accordance with the request for the modification;
c
to impose, revoke or refuse to grant a waiver of the obligation under regulation 50A(3) to provide to the licensing authority the results of all studies performed, and details of all information collected, in compliance with an agreed paediatric investigation plan; or
d
to revoke a waiver which was agreed as part of an agreed paediatric investigation plan.
Sch. 11 Pt. 1A inserted by S.I. 2019/775, reg. 63(3A) (as inserted by The Human Medicines and Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/1385), reg. 1, Sch. 1 para. 7(5)); 2020 c. 1, Sch. 5 para. 1(1)