The Human Medicines Regulations 2012 No. 1916

PART 11 Pharmacovigilance

Obligations on licensing authority in relation to pharmacovigilance

Obligation on licensing authority to audit pharmacovigilance system

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.