Adverse Reporting Programs

MCS manages Adverse Reaction Reporting Programs for the top companies in North America.

An Adverse Reaction is defined as a noxious and unintended response to a marketed health product which occurs at normal doses of the regulated product intended for use in the diagnosis, treatment or prevention of a disease.

A Serious Adverse Reaction is an adverse reaction that requires in-patient hospitalization or prolongation of existing hospitalization; causes a congenital malformation that results in persistent or significant disability or incapacity that is life threatening or that results in death.

In accordance with the Health Canada companies that hold marketing authorizations for regulated products are obligated to report any adverse reaction that occurs with their products.

MCS can assist product license owners with developing efficient systems for the receipt, evaluation and reporting of Adverse Reactions.

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