CHAPTER VIII

Post-authorisation safety studies

Scope
Article 36
1
This chapter applies to non-interventional post-authorisation safety studies initiated, managed or financed by a marketing authorisation holder under obligations imposed by a national competent authority, the Agency or the Commission in accordance with Articles 21a and 22a of Directive 2001/83/EC and Articles 10 and 10a of Regulation (EC) No 726/2004.
2
The marketing authorisation holder shall submit the study protocol, the abstract of the final study report and the final study report which have been provided in accordance with Articles 107n and 107p of Directive 2001/83/EC in English except for studies to be conducted in only one Member State that requests the study according to Article 22a of Directive 2001/83/EC. For the latter studies the marketing authorisation holder shall provide an English translation of the title and abstract of the study protocol as well as an English translation of the abstract of the final study report.
3
The marketing authorisation holder shall ensure that all study information is handled and stored so as to allow for accurate reporting, interpretation and verification of that information and shall ensure that the confidentiality of the records of the study subjects remains protected. The marketing authorisation holder shall ensure that the analytical dataset and statistical programmes used for generating the data included in the final study report are kept in electronic format and are available for auditing and inspection.
4
The Agency may publish appropriate templates for the protocol, abstract and final study report.

Definitions
Article 37
For the purposes of this chapter, the following definitions shall apply:
1. ‘Start of data collection’ means the date from which information on the first study subject is first recorded in the study dataset or, in the case of the secondary use of data, the date from which data extraction starts;
2. ‘End of data collection’ means the date from which the analytical dataset is completely available.

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)