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Supplementary guidance document for the notification and testing of new substances : organisms used in cell and gene therapy under schedule 1 of the New Substances Notification Regulations (organisms).: En84-240/2021E-PDF

"This supplementary guidance document is intended to complement the Guidelines for the Notification and Testing of New Substances: Organisms (the Guidelines) and provides specific guidance to notifiers on addressing information requirements under Schedule 1 (for release anywhere in Canada, which includes clinical trials) of the New Substances Notification Regulations (Organisms) [the Regulations] for substances that are animate products of biotechnology used in cell and gene therapy and administered to human patients"--page [2].

Permanent link to this Catalogue record:
publications.gc.ca/pub?id=9.898933&sl=0

Publication information
Department/Agency
  • Canada. Environment and Climate Change Canada, issuing body.
  • Canada. Health Canada, issuing body.
TitleSupplementary guidance document for the notification and testing of new substances : organisms used in cell and gene therapy under schedule 1 of the New Substances Notification Regulations (organisms).
Publication typeMonograph
Language[English]
Other language editions[French]
FormatDigital text
Electronic document
Note(s)
  • Issued also in French under title: Document d’orientation supplémentaire pour la déclaration et les essais de substances nouvelles selon l’annexe 1 du Règlement sur les renseignements concernant les substances nouvelles (organismes) : organismes utilisés en thérapie cellulaire et génique.
  • Issued also in HTML format.
  • "December 2021."
Publishing information
  • [Gatineau, QC] : Environment and Climate Change Canada : Health Canada, 2021.
Description1 online resource (62 unnumbered pages)
ISBN9780660385297
Catalogue number
  • En84-240/2021E-PDF
Subject terms
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