In preparation for ASC preclearance of therapeutic comparative advertising claims, ASC’s Standard Operating Procedures (SOPs) are now available to help advertisers ensure that their claims are consistent with the Health Canada requirements.

These SOPs describe the steps that the Consumer Drug Section will follow to evaluate a therapeutic comparative claim and to determine whether it is compliant with the Health Canada Therapeutic Comparative Advertising Directive and Guidance Document.

There are three separate SOPs that encompass the three therapeutic areas: i) Efficacy, ii) Onset/Duration of Action and iii) Side Effect Profile/Safety Information.

SOPs:

Efficacy
Onset/Duration of Action
Side Effect Profile/Safety Information
Submission Requirements Checklist
Claim Review Process