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For drug merchandise provided with reconstitution diluents that are not commercially obtainable in Canada or have not been assessed and authorized in reference to another drug submission with Well being Canada, data on the diluents ought to be provided in a separate Drug Product (“P”) portion, as a subsection below the relevant drug product part, as appropriate.
Medical products distributed beneath such a license could embrace radiochemicals that may be distributed to manufacturers, radiopharmacies, veterinarians, and broadscope medical use licensees for the manufacturing of radioactive medicine, as well as gamma steriotactical and teletherapy gadgets for radiation therapy use, and plutonium-powered cardiac pacemakers.
This doc is meant to provide guidance with regard to the Quality that’s (i.e.), Chemistry and Manufacturing portion of NDSs and ANDSs for drug substances of synthetic or semi-synthetic origin and their corresponding drug products which can be filed with Health Canada pursuant to Division C.08 of the Food and Drug Regulations.