Health Canada has issued a Guidance Document: Data Protection under C.08.004.1 of the Food and Drug Regulations that outlines how Health Canada will administer the Regulations Amending The Food And Drug Regulations (Data Protection). The guidance applies to pharmaceutical, biological and radiopharmaceutical drugs that receive Notices of Compliance on or after June 17, 2006 (including relevant products for veterinary use but not veterinary biologics). The Guidance Document purports to provide further information as to what is an innovative drug, the scope of data protection for combination drugs, the criteria for the determination of whether pediatric studies will qualify for additional data protection, the applicability of the provisions where the product is withdrawn from the market and the process for assessing whether a drug qualifies for data protection. The Guidance Document is not a legal instrument and does not impose any new obligations regarding data protection.
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