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| 02575nam 2200361zi 4500 |
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| 001 | 9.898933 |
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| 003 | CaOODSP |
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| 005 | 20221107174959 |
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| 006 | m o d f |
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| 007 | cr ||||||||||| |
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| 008 | 210420s2021 quc o f00| 0 eng d |
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| 020 | |a9780660385297 |
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| 040 | |aCaOODSP|beng|erda|cCaOODSP |
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| 043 | |an-cn--- |
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| 086 | 1 |aEn84-240/2021E-PDF |
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| 245 | 00|aSupplementary guidance document for the notification and testing of new substances : |borganisms used in cell and gene therapy under schedule 1 of the New Substances Notification Regulations (organisms). |
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| 264 | 1|a[Gatineau, QC] : |bEnvironment and Climate Change Canada : |bHealth Canada, |c2021. |
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| 300 | |a1 online resource (62 unnumbered pages) |
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| 336 | |atext|btxt|2rdacontent |
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| 337 | |acomputer|bc|2rdamedia |
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| 338 | |aonline resource|bcr|2rdacarrier |
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| 500 | |aIssued 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. |
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| 500 | |aIssued also in HTML format. |
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| 500 | |a"December 2021." |
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| 520 | |a"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]. |
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| 650 | 0|aGene therapy|zCanada. |
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| 650 | 0|aStem cells|xResearch|zCanada. |
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| 710 | 1 |aCanada. |bEnvironment and Climate Change Canada, |eissuing body. |
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| 710 | 1 |aCanada. |bHealth Canada, |eissuing body. |
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| 775 | 08|tDocument 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) : |w(CaOODSP)9.898937 |
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| 856 | 40|qPDF|s988 KB|uhttps://publications.gc.ca/collections/collection_2022/eccc/En84-240-2021-eng.pdf |
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| 856 | 4 |qHTML|sN/A|uhttps://www.canada.ca/en/environment-climate-change/services/managing-pollution/evaluating-new-substances/biotechnology-living-organisms/cell-gene-therapy-guidance.html |
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