Commission Implementing Regulation (EU) No 520/2012 of 19 June 2012 on the performance of pharmacovigilance activities provided for in Regulation (EC) No 726/2004 of the European Parliament and of the Council and Directive 2001/83/EC of the European Parliament and of the Council (Text with EEA relevance)

[F1Article 35U.K.Format of periodic safety update reports

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.]

Textual Amendments

F1Regulation 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)

Commission Implementing Regulation (EU) No 520/2012Show full title

[F1Article 35U.K.Format of periodic safety update reports