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| 01893cam 2200373zi 4500 |
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| 001 | 9.869653 |
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| 003 | CaOODSP |
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| 005 | 20221107162916 |
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| 006 | m o d f |
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| 007 | cr ||||||||||| |
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| 008 | 190311s2019 onc |ob f000 0 eng d |
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| 020 | |a9780660299860 |
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| 040 | |aCaOODSP|beng|erda|cCaOODSP |
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| 043 | |an-cn--- |
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| 086 | 1 |aH14-311/2019E-PDF |
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| 245 | 00|aGuidance on drug establishment licences and associated fees. |
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| 264 | 1|a[Ottawa] : |bHealth Canada = Santé Canada, |c2019. |
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| 300 | |a1 online resource (53 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 sur les licences d’établissement de produits pharmaceutiques et les frais associés. |
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| 500 | |aCover title. |
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| 500 | |a"GUI-0002." |
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| 500 | |a"April 8, 2019." |
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| 504 | |aIncludes bibliographical references (pages 50-53). |
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| 520 | |a"This guide is for companies in the drug manufacturing industry. It will help to facilitate understanding and compliance with Part C, Division 1A of the Food and Drug Regulations (FDR), and the Fees in Respect of Drugs and Medical Devices Regulations with regards to drug establishment licence (DEL) requirements and associated fees"--Purpose, page 6. |
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| 650 | 0|aPharmaceutical industry|xLicenses|zCanada. |
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| 650 | 0|aPharmaceutical industry|xSafety regulations|zCanada. |
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| 650 | 0|aPharmaceutical policy|zCanada. |
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| 710 | 1 |aCanada. |bHealth Canada. |
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| 775 | 08|tDocument d’orientation sur les licences d’établissement de produits pharmaceutiques et les frais associés.|w(CaOODSP)9.869656 |
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| 794 | |tGuidance on drug establishment licences.|w(CaOODSP)9.884429 |
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| 856 | 40|qPDF|s571 KB|uhttps://publications.gc.ca/collections/collection_2019/sc-hc/H14-311-2019-eng.pdf |
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