CHAPTER I

Pharmacovigilance system master file

Availability and location of the pharmacovigilance system master file
Article 7
1
The pharmacovigilance system master file shall be located either at the site in the Union where the main pharmacovigilance activities of the marketing authorisation holder are performed or at the site in the Union where the qualified person responsible for pharmacovigilance operates.
2
The marketing authorisation holder shall ensure that the qualified person for pharmacovigilance has permanent access to the pharmacovigilance system master file.
3
The pharmacovigilance system master file shall be permanently and immediately available for inspection at the site where it is kept.
Where the pharmacovigilance system master file is kept in electronic form in accordance with Article 5(3), it is sufficient for the purposes of this Article that the data stored in electronic form is directly available at the site where the pharmacovigilance system master file is kept.
4
For the purposes of Article 23(4) of Directive 2001/83/EC, the national competent authority may limit its request to specific parts or modules of the pharmacovigilance system master file and the marketing authorisation holder shall bear the costs of submitting the copy of the pharmacovigilance system master file.
5
The national competent authority and the Agency may request the marketing authorisation holder to submit a copy of the logbook referred to in point 8 of Article 3 at regular intervals.
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)