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| 02155nam 2200385zi 4500 |
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| 001 | 9.866809 |
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| 003 | CaOODSP |
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| 005 | 20221107162138 |
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| 006 | m o d f |
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| 007 | cr cn||||||||| |
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| 008 | 190108e201911 onc o f000 0 eng d |
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| 020 | |a9780660235646 |
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| 040 | |aCaOODSP|beng|erda|cCaOODSP |
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| 043 | |an-cn--- |
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| 086 | 1 |aH13-9/13-2019E-PDF |
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| 245 | 00|aGuidance document : |bfees for the right to sell drugs. |
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| 246 | 30|aFees for the right to sell drugs |
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| 264 | 1|aOttawa, Ontario : |bHealth Canada = Santé Canada, |cNovember 2019. |
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| 264 | 4|c©2019 |
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| 300 | |a1 online resource (11 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: Ligne directrice : frais à payer pour le droit de vendre un médicament. |
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| 500 | |a"Pub.: 180725." |
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| 500 | |aIssued also in HTML format. |
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| 520 | |a"Once a drug is authorized for sale in Canada, industry must pay an annual fee to retain the right to sell the drug in Canada. Health Canada has charged fees since 1995 in order to recover some of the associated costs with post-market regulatory activities such as assessing safety signals and trends and communicating about risks. This document provides guidance on how fees for the right to sell drugs will be administered in accordance with the Food and Drugs Act and as stipulated in the Fees in Respect of Drugs and Medical Devices Order and the Regulations Amending and Repealing Certain Regulations Made under the Financial Administration Act"--Introduction, page 6. |
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| 650 | 0|aDrug approval|zCanada. |
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| 650 | 0|aFees, Administrative|zCanada. |
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| 710 | 1 |aCanada. |bHealth Canada, |eissuing body. |
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| 775 | 08|tLigne directrice : |w(CaOODSP)9.866810 |
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| 795 | |tGuidance document |w9.856866 |
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| 856 | 40|qPDF|s232 KB|uhttps://publications.gc.ca/collections/collection_2021/sc-hc/H13-9-13-2019-eng.pdf |
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| 856 | 4 |qHTML|sN/A|uhttps://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/fees/right-to-sell-drugs-2019/document.html |
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