Obligation on licensing authority to audit pharmacovigilance system
This section has no associated Explanatory Memorandum
180.—(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.