CHAPTER I

Pharmacovigilance system master file

Structure of the pharmacovigilance system master file
Article 1
1
The information in the pharmacovigilance system master file shall be accurate and reflect the pharmacovigilance system in place.
2
The marketing authorisation holder may, where appropriate, use separate pharmacovigilance systems for different categories of medicinal products. Each such system shall be described in a separate pharmacovigilance system master file.
All medicinal products for which the marketing authorisation holder obtained a marketing authorisation in accordance with Directive 2001/83/EC or Regulation (EC) No 726/2004 shall be covered by a pharmacovigilance system master file.
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)