The Human Medicines Regulations 2012

General obligations of the licensing authority

178.  The licensing authority must—

(a) take all appropriate measures to encourage the reporting to it of suspected adverse reactions;

(b) facilitate reporting through the provision of alternative reporting formats in addition to web-based formats;

(c) take all appropriate measures to obtain accurate and verifiable data for the scientific evaluation of suspected adverse reaction reports;

(d) ensure that the public is given important information on pharmacovigilance concerns relating to the use of a medicinal product in a timely manner, through publication on the UK web-portal, and through other means of publicly available information as necessary; and

(e) ensure that all appropriate measures are taken to identify any biological medicinal product (including name and batch number) prescribed, dispensed or sold in the United Kingdom which is the subject of a suspected adverse reaction report through—

(i) the methods for collecting data, and

(ii) where necessary, the follow up of suspected adverse reaction reports.