CHAPTER I

Pharmacovigilance system master file

Maintenance
Article 4
1
The marketing authorisation holder shall keep the pharmacovigilance system master file up to date and, where necessary, revise it to take account of experience gained, of technical and scientific progress and of amendments to Directive 2001/83/EC and Regulation (EC) No 726/2004.
2
The pharmacovigilance system master file and its Annex shall be subject to version control and shall indicate the date when it was last updated by the marketing authorisation holder.
3
Any deviations from the pharmacovigilance procedures, their impact and their management shall be documented in the pharmacovigilance system master file until resolved.
4
Without prejudice to the requirements set out in Commission Regulation (EC) No 1234/2008 of 24 November 2008 concerning the examination of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products
, the marketing authorisation holder shall notify immediately the Agency of any change in the location of the pharmacovigilance system master file or changes to the contact details and name of the qualified person responsible for pharmacovigilance. The Agency shall update the Eudravigilance database referred to in Article 24(1) of Regulation (EC) No 726/2004 and, where necessary, the European medicines web-portal referred to in Article 26(1) of Regulation (EC) No 726/2004 accordingly.
OJ L 334, 24.11.2008, p. 7.
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)