The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019

Amendment of regulation 104 (consideration of application) U.K.

[F1 100.— (1) Regulation 104 (consideration of application) is amended as follows.

(2) After paragraph (6) insert—

“(7) In the case of an application under the unfettered access route, the licensing authority may grant a COR(GB) (notwithstanding paragraph (3)) where the licensing authority—

(a) has considered the application under the unfettered access route and the accompanying material,

(b) is satisfied that the applicant has complied with the application requirements, and

(c) is satisfied that the conditions in regulation 103(1A) will continue to be met.

(8) The licensing authority may refuse to grant an application under the unfettered access route where it is of the opinion that it would represent a risk to public health to do so.”.]

Textual Amendments

F1 Reg. 100 substituted (31.12.2020 immediately before IP completion day) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 77

Commencement Information

I1 Reg. 100 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1