000
| 02189cam 2200373zi 4500 |
---|
001 | 9.899686 |
---|
003 | CaOODSP |
---|
005 | 20221107175205 |
---|
006 | m o d f |
---|
007 | cr ||||||||||| |
---|
008 | 210511e202108##onc o f000 0 eng d |
---|
020 | |a9780660388168 |
---|
040 | |aCaOODSP|beng|erda|cCaOODSP |
---|
043 | |an-cn--- |
---|
086 | 1 |aH164-273/2021E-PDF |
---|
245 | 00|aGuidance document : |bregulatory requirements for drug identification numbers (DINs). |
---|
264 | 1|a[Ottawa] : |bHealth Canada = Santé Canada, |cAugust 2021. |
---|
264 | 4|c©2021 |
---|
300 | |a1 online resource (32 pages) |
---|
336 | |atext|btxt|2rdacontent |
---|
337 | |acomputer|bc|2rdamedia |
---|
338 | |aonline resource|bcr|2rdacarrier |
---|
500 | |aTitle from cover. |
---|
500 | |aIssued also in French under title: Ligne directrice : exigences réglementaires associées à une identification numérique attribuée à une drogue (DIN). |
---|
500 | |aIssued also in HTML format. |
---|
500 | |a"Administrative changes date: 2021/06/28." |
---|
520 | |a"When Health Canada authorizes a drug to be marketed in Canada, a Drug Identification Number (DIN) is issued to the manufacturer and printed on the package labels. A DIN indicates that the evaluation of the drug determined that it met the relevant requirements of the Food and Drugs Act and its Regulations and the drug has a favourable risk/benefit profile. Manufacturers of prescription and non-prescription drugs must obtain a DIN before they are marketed in Canada. Market authorization of a drug may require the additional issuance of a Notice of Compliance (NOC)"--Introduction, page 9. |
---|
650 | 0|aDrugs|xLabeling|zCanada. |
---|
710 | 1 |aCanada. |bHealth Canada, |eissuing body. |
---|
775 | 08|tLigne directrice : |w(CaOODSP)9.899687 |
---|
795 | |tGuidance document : |w(CaOODSP)9.874552 |
---|
856 | 40|qPDF|s1.23 MB|uhttps://publications.gc.ca/collections/collection_2021/sc-hc/H164-273-2021-eng.pdf |
---|
856 | 4 |qHTML|sN/A|uhttps://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/regulatory-requirements-drug-identification-numbers/document.html |
---|