The Confusion with Look-Alike Sound-Alike (LASA) Drugs

Health Canada has come out with a revised draft document on Look-Alike Sound-Alike (LASA) drugs. This guidance highlights the steps taken for proposed product names.

The Brand Name Assessment is a test method that tests proposed brand names to determine the likelihood that a new product could be confused with an existing product. This test is conducted by the sponsor in screen-based simulations for visual perception, auditory perception and short term memory.

Brand Name Assessments are required for non-prescription drugs. Prescription to non-prescription will require a name assessment, even if the name is not being changed.

Non-prescription drugs which require an assessment will not be eligible for a Category IV Monograph or Labeling Standard and will need to be submitted as a DINA – Labeling Only submission.

Comments by the CCTFA

The CCTFA has suggested that a clearer exemption statement be applied for Category IV drugs. Where the guidance mentions SPF products are exempt from Brand Name Assessments, it does not specifically state that Category IV products are exempt.

The CCTFA has proposed the document to include a statement such as: “This Guidance does not apply to Category IV drugs”. This would aid in clarifying the exemption criteria.

FPR consultants specialize in drug, cosmetic, medical device, and natural health product submissions. We would be more than happy to assist you with bringing your product to market compliance.

Health Canada has come out with a revised draft document on Look-Alike Sound-Alike (LASA) drugs. This guidance highlights the steps taken for proposed product names.

The Brand Name Assessment is a test method that tests proposed brand names to determine the likelihood that a new product could be confused with an existing product. This test is conducted by the sponsor in screen-based simulations for visual perception, auditory perception and short term memory.

Brand Name Assessments are required for non-prescription drugs. Prescription to non-prescription will require a name assessment, even if the name is not being changed.

Non-prescription drugs which require an assessment will not be eligible for a Category IV Monograph or Labeling Standard and will need to be submitted as a DINA – Labeling Only submission.

Comments by the CCTFA

The CCTFA has suggested that a clearer exemption statement be applied for Category IV drugs. Where the guidance mentions SPF products are exempt from Brand Name Assessments, it does not specifically state that Category IV products are exempt.

The CCTFA has proposed the document to include a statement such as: “This Guidance does not apply to Category IV drugs”. This would aid in clarifying the exemption criteria.

FPR consultants specialize in drug, cosmetic, medical device, and natural health product submissions. We would be more than happy to assist you with bringing your product to market compliance.