National Drug Scheduling (Canada)
Medical Market Consultants
Managing the Business of Science™
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In Canada the National Association of Pharmacy Regulatory Authorities (NAPRA) has implemented a national drug scheduling model which assures that the conditions for the sale of drugs are consistent across Canada. Submissions to evaluate the scheduling of drugs at the level of provincial pharmacies also require the analysis of clinical data previously submitted to Health Canada as well as consumer usage studies to help assess whether pharmacist intervention is required. These types of submissions are especially pertinent to Rx to OTC switches where the decision of dispensing product behind the counter or over the counter has implications on the safety of the product as well as market exposure.
Spectrum MMC has experience in applying scheduling factors and evaluating supportive information in order to assure the appropriate classification of your product.