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Pharmacovigilance
Marketing Authorisation Holders (MAHs) have a legal obligation, under Directive 2001/83/EC, as amended, to set up and maintain a system for Pharmacovigilance. This involves collection, collation and evaluation of information about suspected Adverse Drug Reactions (ADRs) to their medicinal products under normal conditions of use in the market place. This requirement must be met by generic pharmaceutical MAHs as well as the holders of the original licences.
Ivowen Limited can provide advice on setting up and maintaining workable pharmacovigilance system.
Additionally, we can aid you in the preparation and review of Periodic Safety Update Reports (PSURs).
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