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• Health Canada Sante Canada Health Products and Food Branch Direction generale des produits de sante et des aliments APR 23 2014 Biologics and Genetic Therapies Directorate 200 Tunney's Pasture Driveway Address Locator # 0702A OTT AW A, Ontario KIA OK9 14-105128 - 593 To: Establishments involved in the radiolabelling of blood components Subject: Discontinued supply of Pentaspan® as a drug in Canada Health Canada has been informed by Bristol Myers Squibb that they have discontinued the availability of Pentaspan® as a drug in Canada. In addition to being used as a "drug" for distribution under the Food and Drug Regulations, Health Canada is aware that Pentaspan® has been used in Canada as a "reagent" in several types of cell processing techniques, one of which is the radiolabelling of blood components. The Food and Drug Regulations do not apply to drugs being imported by clinicians for use as reagents during the radiolabelling of blood components. For this reason, the Health Products and Food Branch Inspectorate will not recommend refusal of entry of reagents that are imported for such use, provided the reagents meet the following criteria: • the product is labelled as a "reagent", "for use as a reagent in the radiolabelling of blood components" • the product is distributed directly to the clinician performing the radiolabelling or to the establishment where the radiolabelling will be performed • the product is not re-distributed in Canada where it could be misrepresented as a drug and then used for therapeutic indications that have not been approved .. .12 Canada -2 For additional information, please contact: [email protected] Office of Policy and International Collaboration Biologics and Genetic Therapies Directorate Health Canada Thank you for your continued cooperation. ~'--Robin Chiponski Director General HPFB Inspectorate Director General Biologics and Genetic Therapies Directorate