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Author: Admin | 2025-04-28
Compliance (NOC) Changes – Quality Guidance, and the Questions and Answers: Plain Language Labelling Regulations for Prescription Drugs document.Pursuant to paragraph C.08.006(f) of the Food and Drug Regulations, Health Canada may request that the Sponsor revise the product monograph if, on the basis of new information, it is considered to be false, misleading, or incomplete in any respect. Whenever periodic reports on a drug are requested pursuant to paragraph C.08.008(a) of the Food and Drug Regulations, the Sponsor should determine whether significant changes should be made in the product monograph as a result of the additional information available.1.5 DistributionA copy of the most recently updated product monograph (including the Patient Medication Information) should be provided by the Sponsor to healthcare professionals whenever they request prescribing information or other information relevant to the clinical use of the drug. For products that have received an NOC and are marketed, the product monograph must be available in both official languages.The Healthcare Professional Information portion of the product monograph may also be made available as a package insert. This portion should therefore be provided in connection with the promotion or advertisement of the drug or included in reference manuals distributed or endorsed by the Sponsor. In addition, the Patient Medication Information may also be provided as part of the package insert for a drug product.A copy of the most recently updated product monograph (including the Patient Medication Information) should be provided to healthcare professionals prior to, or coincident with, the first direct promotion or marketing of a new drug, and to any healthcare professionals to whom the Sponsor sells a new drug before it is generally available.Additional information may be found in Health Canada's Guidance Document: Labelling of Pharmaceutical Drugs for Human Use.1.6 InquiriesFor general inquiries concerning the product monograph, please contact the Bureau
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