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0019.866456
003CaOODSP
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006m     o  d f      
007cr cn|||||||||
008181231t20192020onc     o    f000 0 eng d
020 |a9780660291475
040 |aCaOODSP|beng|erda|cCaOODSP
043 |an-cn---
0861 |aH13-9/31-2019E-PDF
24500|aGuidance document : |bpost-notice of compliance (NOC) changes : framework document (pharmaceutical, biologic and radiopharmaceutical drugs for human use only).
24610|aPost-notice of compliance (NOC) changes : |bframework document (pharmaceutical, biologic and radiopharmaceutical drugs for human use only)
264 1|aOttawa, ON : |bHealth Canada = Santé Canada, |c2019.
264 4|c©2020
300 |a1 online resource (16 pages)
336 |atext|btxt|2rdacontent
337 |acomputer|bc|2rdamedia
338 |aonline resource|bcr|2rdacarrier
500 |aCover title.
500 |aIssued also in HTML format.
500 |a"Effective date: 2020/04/01."
500 |aIssued also in French under title: Ligne directrice : changements survenus après l’avis de conformité (AC) : document cadre (médicaments pharmaceutiques, biologiques et radiopharmaceutiques à usage humain seulement).
520 |a"After a new drug as defined in section C.08.001 of the Food and Drug Regulations has been granted a Notice of Compliance (NOC), it is not uncommon for sponsors to make changes to the drug. A post-NOC change is any change that is made to a new drug that has received a NOC pursuant to section C.08.004 of the Food and Drug Regulations. Many of these changes may be made to improve the quality of the drug product or the efficiency of the manufacturing process, or they could be made for marketing considerations. Changes to the labelling of a drug product could include adding new indications, improving the management of risk for a product by adding warnings, limiting the target population or changing the dosage regime etc."--Introduction, page 6.
650 0|aDrugs|xLabeling|zCanada.
650 0|aDrug approval|zCanada.
7101 |aCanada. |bHealth Canada, |eissuing body.
77508|tLigne directrice : |w(CaOODSP)9.866457
85640|qPDF|s260 KB|uhttps://publications.gc.ca/collections/collection_2021/sc-hc/H13-9-31-2019-eng.pdf
8564 |qHTML|sN/A|uhttps://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/post-notice-compliance-changes/framework-2019/document.html
986 |a180707