Paragraph 7 Availability and location of the pharmacovigilance system master fileF1

The holder must ensure that the qualified person and nominated person (where a person is nominated under regulation 182(2A)) for pharmacovigilance have permanent access to the pharmacovigilance system master file.

For the purposes of regulation 182(2)(b), the licensing authority may limit its request to specific parts or modules of the pharmacovigilance system master file and the holder is to bear the costs of submitting the copy of the pharmacovigilance system master file.

The licensing authority may request the holder to submit a copy of the logbook referred to in paragraph 3(h) at regular intervals.