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| 02141nam 2200349zi 4500 |
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| 001 | 9.940313 |
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| 003 | CaOODSP |
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| 005 | 20240712150847 |
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| 006 | m o d f |
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| 007 | cr |n||||||||| |
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| 008 | 240709e20210510onc ob f00| 0 eng d |
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| 040 | |aCaOODSP|beng|erda|cCaOODSP |
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| 043 | |an-cn--- |
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| 086 | 1 |aH164-377/2021E-PDF |
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| 245 | 00|aIssue identification paper : |bdrug-device combination products (DDCPS) : draft for consultation. |
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| 246 | 30|aDrug-device combination products (DDCPS) |
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| 264 | 1|a[Ottawa] : |bHealth Canada = Santé Canada, |cMay 10, 2021. |
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| 300 | |a1 online resource (13 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: Documentation de détermination des enjeux : produits mixtes médicaments-instruments médicaux : ébauche aux fins de consultation. |
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| 500 | |a"Draft date: 2021/05/10." |
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| 504 | |aIncludes bibliographical references (page 13). |
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| 520 | |a"This paper is intended to identify the key challenges associated with Health Canada’s oversight of drug-device combination products (DDCPs) as per Health Canada’s Policy on Drug/Medical Device Combination Products (the Policy). DDCPs are health products that combine drugs and medical devices as a single entity. For the purposes of this paper, a drug is considered to be a pharmaceutical, radiopharmaceutical, natural health product (NHP), biologic, cell, tissue, organ, gene therapy, or human blood and its components"--Objective, page 3. |
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| 650 | 0|aMedical instruments and apparatus|xGovernment policy|zCanada. |
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| 650 | 0|aDrugs|xGovernment policy|zCanada. |
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| 710 | 1 |aCanada. |bHealth Canada, |eissuing body. |
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| 775 | 08|tDocumentation de détermination des enjeux : |w(CaOODSP)9.940560 |
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| 856 | 40|qPDF|s265 KB|uhttps://publications.gc.ca/collections/collection_2024/sc-hc/H164-377-2021-eng.pdf |
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| 856 | 4 |qHTML|sN/A|uhttps://www.canada.ca/en/health-canada/programs/consultation-issue-identification-paper-drug-device-combination-products-draft/document.html |
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