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Health Canada and the Canadian Advertising Preclearance Agencies (APAs) share the common goal of maintaining integrity in health product advertising. The purpose of this guidance document is to inform staff and stakeholders of the different roles these organizations play in achieving this goal.

The objective of this guidance document is to assist industry and interested stakeholders (Market Authorization Holders (MAHs)) in developing a Risk Management Plan and Follow-up commitments when requested.

This labelling standard describes the requirements necessary to receive marketing authorization (a Drug Identification Number (DIN)) for oral decongestant non-prescription products containing phenylephrine hydrochloride as a single ingredient for use in adults and children 12 years of age and...