SCHEDULES

Regulation 212

SCHEDULE 33 U.K.Transitional arrangements: pharmacovigilance

Pharmacovigilance system master file U.K.

F1 1.  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

F1 Sch. 33 para. 1 omitted (31.12.2020) by virtue of The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 178; 2020 c. 1, Sch. 5 para. 1(1)

F2 2.  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . U.K.

Textual Amendments

F2 Sch. 33 para. 2 omitted (31.12.2020) by virtue of The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 178; 2020 c. 1, Sch. 5 para. 1(1)

Post-authorisation safety studies U.K.

3.  Regulations 198, 199, 200, 201 and 202 (provisions relating to post authorisation safety studies) do not apply to post authorisation safety studies commenced before 21st July 2012.

4.  Regulation 210(3)(g) (offences relating to pharmacovigilance obligations under Regulation (EC) No 726/2004) does not apply to post authorisation safety studies commenced before 21st^{July 2012. U.K.}

Reporting obligations U.K.

F3 5.  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

F3 Sch. 33 paras. 5-10 omitted (31.12.2020) by virtue of The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 178 (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 140); 2020 c. 1, Sch. 5 para. 1(1)

F3 6.  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . U.K.

Textual Amendments

F3 Sch. 33 paras. 5-10 omitted (31.12.2020) by virtue of The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 178 (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 140); 2020 c. 1, Sch. 5 para. 1(1)

F3 7.  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . U.K.

Textual Amendments

F3 Sch. 33 paras. 5-10 omitted (31.12.2020) by virtue of The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 178 (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 140); 2020 c. 1, Sch. 5 para. 1(1)

F3 8.  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . U.K.

Textual Amendments

F3 Sch. 33 paras. 5-10 omitted (31.12.2020) by virtue of The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 178 (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 140); 2020 c. 1, Sch. 5 para. 1(1)

Periodic safety update reports U.K.

F3 9.  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

F3 Sch. 33 paras. 5-10 omitted (31.12.2020) by virtue of The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 178 (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 140); 2020 c. 1, Sch. 5 para. 1(1)

F3 10.  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . U.K.

Textual Amendments

F3 Sch. 33 paras. 5-10 omitted (31.12.2020) by virtue of The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 178 (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 140); 2020 c. 1, Sch. 5 para. 1(1)