Paragraph 5 Form of the documents contained in the pharmacovigilance system master fileF1

where appropriate, information may be provided in the form of charts or flow diagrams;

all documents must be indexed and archived so as to ensure their accurate and ready retrieval throughout the period for record-keeping; and

the particulars and documents may be presented in modules in accordance with the system delineated in detail in the guidance on good pharmacovigilance practices which applies by virtue of regulation 205B.