Health Canada is implementing a new policy to review drug and other health product names in response to concerns about "look-alike, sound-alike" names—names that are similar when written or spoken—and the errors in prescribing, dispensing or administering these products. This means that drug and other health product manufacturers will soon have to pass an additional hurdle in Health Canada’s premarket regulatory approval process.
The policy will be implemented on January 1, 2006 for Schedule C (radiopharmaceuticals), Schedule D (biologics), Schedule F drugs (prescription drugs) and prescribed drugs for human use.1 Natural health products,2 medical devices, over-the-counter drugs and veterinary drugs are also scheduled to become subject to the policy from July 1, 2006.
Under the new policy, Health Canada will review all proposed drug names included in a submission for marketing approval to ensure that (a) the name is unlikely to be confused with brand or generic names and thus cause medication errors, and (b) the brand name is not misleading (i.e., does not imply therapeutic claims). To determine whether the similarity between the two names is problematic, Health Canada will consider a variety of factors including marketing status (prescription versus over-the-counter), therapeutic category, dosage form, indications and directions for use, clinical setting for dispensing or use, packaging and labelling, patient populations, location on shelf and the potential for harm.
An initial review of the proposed drug name will take place within 90 days of the submission, and a second review will take place within 90 days of the drug’s anticipated approval date. The sponsors of the drug submission are encouraged to submit a prioritized list of up to two alternative names so that if Health Canada identifies the proposed name as potentially confusing, it will consider the alternative names. Sponsors are also encouraged to submit a risk assessment and evaluation of the product’s proposed name, supported with studies, data and analysis.
If sponsors have not submitted alternative proposed drug names or all the names have been rejected, the submission will be placed on "name hold" until a proposed alternative name is shown to be acceptable to Health Canada.
Although Health Canada will not undertake a review of the names of products that are already being marketed, it will monitor the names of these products as well as the names of products for which a name safety issue was not identified during the premarket approval process.
1. Prescribed drugs are neither over-the-counter products nor listed in Schedule F. Examples include potassium chloride and dextrose for injections.
2. These include herbal products, vitamins and minerals as well as a variety of consumer products that contain these substances. For example, many toothpastes and antiperspirants are classified as natural health products since they contain mineral compositions (fluoride, aluminum).
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