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000
| 02252cam 2200445zi 4500 |
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| 001 | 9.884429 |
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| 003 | CaOODSP |
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| 005 | 20221107170850 |
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| 006 | m o d f |
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| 007 | cr cn||||||||| |
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| 008 | 200207t20202020onc ob f000 0 eng d |
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| 020 | |a9780660339962 |
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| 020 | |z9780660339979|q(incorrect) |
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| 040 | |aCaOODSP|beng|erda|cCaOODSP |
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| 043 | |an-cn--- |
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| 086 | 1 |aH14-311/2020E-PDF |
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| 245 | 00|aGuidance on drug establishment licences. |
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| 246 | 17|aGuidance on drug establishment licences, version 8 (GUI-0002) |
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| 264 | 1|aOttawa, ON : |bHealth Canada = Santé Canada, |c2020. |
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| 264 | 4|c©2020 |
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| 300 | |a1 online resource (45 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. |
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| 500 | |a"GUI-0002." |
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| 500 | |a"April 1, 2020." |
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| 500 | |a"Pub.: 190596." |
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| 500 | |aIssued also in HTML format. |
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| 504 | |aIncludes bibliographical references (pages 42-45). |
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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 with regards to drug establishment licence (DEL) requirements"--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, |eissuing body. |
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| 775 | 08|tDocument d'orientation sur les licences d'établissement de produits pharmaceutiques.|w(CaOODSP)9.884432 |
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| 795 | |tGuidance on drug establishment licences and associated fees.|w(CaOODSP)9.869653 |
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| 856 | 40|qPDF|s1.51 MB|uhttps://publications.gc.ca/collections/collection_2020/sc-hc/H14-311-2020-eng.pdf |
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| 856 | 4 |qHTML|sN/A|uhttps://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/establishment-licences/directives-guidance-documents-policies/guidance-drug-establishment-licences-drug-establishment-licensing-fees-0002/document.html |
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