The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 No. 1488

SCHEDULES

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

PART 10 U.K. Amendment of Part 11 (amendment of Part 11 (Pharmacovigilance))

128.  In regulation 160 (amendment of regulation 200 (amendment to study protocols for required studies))— U.K.

(a) for paragraph (2) substitute—

“(2) In paragraph (2) for “to the body specified in paragraph (3)” to the end substitute—

“to—

(a) the body specified in paragraph (3) and the licensing authority (where not otherwise required by paragraph (3)), where the authorisation for the product is a UKMA(NI) or UKMA(UK);

(b) the licensing authority, where the authorisation for the product is a UKMA(GB),

before their implementation.”.”;

(b) for paragraph (3) substitute—

“(3) In paragraph (4)—

(a) after “protocol is submitted” insert “ only ”;

(b) after “paragraphs (2) and (3)(a)” insert “ (and is not submitted to the Pharmacovigilance Risk Assessment Committee) ”.”;

(c) omit paragraphs (4) and (5).

Commencement Information

I1 Sch. 2 para. 128 in force at 31.12.2020 immediately before IP completion day, see reg. 1