Article 1: Structure of the pharmacovigilance system master file

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.