CHAPTER VII

Periodic safety update reports

Format of periodic safety update reports
Article 35
1
Electronic periodic safety update reports shall be submitted in the format set out in Annex II.
2
The Agency may publish templates for the modules set out in Annex II.
Regulation revoked in part (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), reg. 1, Sch. 9 para. 1(t) (subject to transitional provisions in S.I. 2012/1916, Sch. 33A); 2020 c. 1, Sch. 5 para. 1(1)