Paragraph 28

(1)

This paragraph applies if the applicant—

(a)

requests the opportunity to make written representations, but fails to make those written representations within the period for doing so; or

(b)

requests the opportunity to make oral representations, but—

(i)

fails to provide a summary of those representations or the documents in support of them within the period for doing so, or

(ii)

fails to make oral representations at a hearing before the appropriate committee.

(2)

The appropriate committee must notify the licensing authority of that fact.

Notes on Part 3

F1: Words in Sch. 11 Pt. 3 heading substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 63(8)(a); 2020 c. 1, Sch. 5 para. 1(1)