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Article 35 Format of periodic safety update reportsF1

United Kingdom

Original text. Later amendments are not shown.

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.

Annotations

Textual amendments

F1

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)