000 02243cam  22003978i 4500
0019.890884
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008200825t20202020onc     ob   f00| 0 eng d
020 |a9780660358901
040 |aCaOODSP|beng|erda|cCaOODSP
043 |an-cn---
0861 |aH13-9/25-2020E-PDF
24500|aGuidance document : |badministrative processing of submissions and applications involving human or disinfectant drugs.
264 1|aOttawa, ON : |bHealth Canada = Santé Canada, |c2020.
264 4|c©2020
300 |a1 online resource (24 pages)
336 |atext|btxt|2rdacontent
337 |acomputer|bc|2rdamedia
338 |aonline resource|bcr|2rdacarrier
500 |aCover title.
500 |a"Date posted: 2020/10/01."
500 |a"Pub.: 200167."
500 |aIssued also in HTML format.
500 |aIssued also in French under title: Traitement administratif des présentations et des demandes concernant les médicaments destinés aux humains ou les désinfectants.
504 |aIncludes bibliographical references.
520 |a"Pursuant to Part C, Division 1 and Division 8 of the Food and Drug Regulations (hereafter the Regulations), no manufacturer shall sell a drug in Canada unless a Drug Identification Number (DIN) [C.01.014 (1)] or DIN and Notice of Compliance (NOC) [C.08.002 (1)] have been issued by Health Canada, which grants market authorization for that product. Manufacturers must notify Health Canada of information changes pertaining to the manufacturer and drug product as set out by paragraph C.01.014.4 (b) of the Regulations"--Introduction, page 7.
650 0|aDrug approval|zCanada.
7101 |aCanada. |bHealth Canada, |eissuing body.
77508|tLigne directrice : |w(CaOODSP)9.890886
795 |tGuidance document : |w(CaOODSP)9.860041
85640|qPDF|s312 KB|uhttps://publications.gc.ca/collections/collection_2020/sc-hc/H13-9-25-2020-eng.pdf
85640|qHTML|sN/A|uhttps://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/administrative-processing-human-disinfectant-drugs-2019/document.html