Guidance notes on the collection of adverse events and product complaints from market research programmes

Guidelines for collecting adverse events and product quality complaints from market research programmes
Publication date:  22/04/2013
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Pharmaceutical companies are legally required to collect and report adverse events and product complaints for their medicinal products. This requirement relates to all areas of a pharmaceutical companies activity and includes market research.

To support companies with compliance, the ABPI Pharmacovigilance Expert Network and the British Healthcare Business Intelligence Association (BHBIA) have updated the 2009 ‘Guidance notes on the collection of adverse events and product complaints from market research programmes’ in light of the new pharmacovigilance legislation which was approved at the end of 2010, with an implementation date of July 2012.

The updated version has been revised to be consistent with the new legislation and re-organised and expanded to improve clarity although the overall requirements remain largely unchanged. It has also been shared with the Medicines and Healthcare Products Regulatory Agency.

Document size: 1.9MB



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