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Guidance notes on collection of drug safety information by employees and agents of pharmaceutical companies

Guidelines for collection of adverse event reports

Publication date: 05/03/2013

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Any person employed directly by a pharmaceutical company or contracted to work for the company has a responsibility to report information about the safety of the company’s medicinal products to the company’s PV department.

In order to support UK industry in compliance, the ABPI Pharmacovigilance Expert Network (PEN) have updated the ABPI guidance on collection of safety information by employees and agents of pharmaceutical companies in line with the 2010 pharmacovigilance legislation, which came into force in July 2012.

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