Regulation 212
SCHEDULE 33U.K.Transitional arrangements: pharmacovigilance
Pharmacovigilance system master fileU.K.
F11. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Textual Amendments
F1Sch. 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)
F22. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .U.K.
Textual Amendments
F2Sch. 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 studiesU.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 21stJuly 2012.U.K.
Reporting obligationsU.K.
F35. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Textual Amendments
F3Sch. 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)
F36. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .U.K.
Textual Amendments
F3Sch. 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)
F37. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .U.K.
Textual Amendments
F3Sch. 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)
F38. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .U.K.
Textual Amendments
F3Sch. 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 reportsU.K.
F39. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Textual Amendments
F3Sch. 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)
F310. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .U.K.
Textual Amendments
F3Sch. 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)