Summary: Guidance Document- Post-Notice of Compliance (NOC) Changes: Safety and Efficacy


The Framework, Safety and Efficacy and Quality guidance documents apply to sponsors intending to make post approval changes to new drugs (i.e., changes to a drug that have received a NOC pursuant to section C.08.004 of the Food and Drug Regulations).

Who this guide is for

Sponsors of pharmaceuticals, biologics, and radiopharmaceutical drugs for human use.

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For assistance

Contact us:

Bureau of Policy, Science and International Programs
Therapeutic Products Directorate
Health Canada
1600 Scott Street
Holland Cross, Tower B
2nd Floor, Address Locator 3102C1
Ottawa, Ontario
K1A 0K9
Facsimile: 613-941-1812

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