The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 No. 775

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

Amendment of regulation 97 (breach of pharmacovigilance condition) U.K.

94.—(1) Regulation 97 M1 , is amended as follows.

F1 (2) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(3) In paragraph (2), after “exceptional circumstances)” insert “ , regulation 60A (condition as to the testing of samples by the appropriate authority) ”.

Textual Amendments

F1 Reg. 94(2) omitted (31.12.2020 immediately before IP completion day) by virtue of The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 71

Commencement Information

I1 Reg. 94 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1

Marginal Citations

M1 Regulation 97 was substituted by S.I. 2014/1878.