PART 11Pharmacovigilance

Obligations on licensing authority in relation to pharmacovigilance

Obligation on licensing authority to audit pharmacovigilance system180

1

The licensing authority must perform a regular audit of its pharmacovigilance system and report the results of that audit to the European Commission.

2

The results of the audit referred to in paragraph (1) must be reported to the European Commission—

a

on the first occasion no later than 21st September 2013; and

b

every two years after the first occasion.