Guidance document : administrative processing of submissions and applications involving human or disinfectant drugs.: H13-9/25-2020E-PDF
"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.
Permanent link to this Catalogue record:
publications.gc.ca/pub?id=9.890884&sl=0
| Department/Agency | Canada. Health Canada, issuing body. |
|---|---|
| Title | Guidance document : administrative processing of submissions and applications involving human or disinfectant drugs. |
| Publication type | Monograph |
| Language | [English] |
| Other language editions | [French] |
| Earlier edition | Guidance document : |
| Format | Electronic |
| Electronic document | |
| Note(s) | Cover title. "Date posted: 2020/10/01." "Pub.: 200167." Issued also in HTML format. Issued also in French under title: Traitement administratif des présentations et des demandes concernant les médicaments destinés aux humains ou les désinfectants. Includes bibliographical references. |
| Publishing information | Ottawa, ON : Health Canada = Santé Canada, 2020. ©2020 |
| Description | 1 online resource (24 pages) |
| ISBN | 9780660358901 |
| Catalogue number |
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| Subject terms | Drug approval -- Canada. |