CHAPTER VIII

Post-authorisation safety studies

Format of post-authorisation safety studies
Article 38
Protocols, abstracts and final study reports for non-interventional post-authorisation safety studies shall be submitted in the format set out in Annex III.
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)