Article 5: Form of the documents contained in the pharmacovigilance system master file

1.   Pharmacovigilance system master file documents shall be complete and legible. Where appropriate, information may be provided in the form of charts or flow diagrams. All documents shall be indexed and archived so as to ensure their accurate and ready retrieval throughout the period for record-keeping.

2.   The particulars and documents of the pharmacovigilance system master file may be presented in modules in accordance with the system delineated in detail in the guidance on good pharmacovigilance practices.

3.   The pharmacovigilance system master file may be stored in electronic form provided that the media used for storage remain readable over time and a clearly arranged printed copy can be made available for audits and inspections.

4.   The marketing authorisation holder shall record in the logbook referred to in point 8 of Article 3 any alteration of the content of the pharmacovigilance system master file made within the last five years, with the exception of the information referred to in point 1(b) to (e) of Article 2 and in Article 3. The marketing authorisation holder shall indicate in the logbook the date, the person responsible for the alteration and, where appropriate, the reason for the alteration.