Administrative Processing of Submissions and Applications: Human or Disinfectant Drugs



Administrative Processing of Submissions and Applications: Human or Disinfectant Drugs


Posted: Wednesday April 18th, 2018

Author: Bhavesh Patel, C. Chem. 

On March 1, 2018, the guidance document “Administrative Processing of Submissions and Applications Involving Human or Disinfectant Drugs” (the “Guidance Document”) came into effect. The Guidance Document applies to drug submissions and applications involving biologics, radiopharmaceuticals, human pharmaceuticals and disinfectants regulated under the Food and Drugs Act. The coming into effect of the Guidance Document will be April 1, 2019 in respect of disinfectant drugs.

The Guidance Document describes when to file drug submissions and applications for administrative processing and also describes the roles and responsibilities of manufacturers. The Guidance Document also explains various document requirements and submission/application types, drug identification number issuance and notifications, labelling and fees. Of note, contact lens disinfectants have been removed from the document. 

Please see the below link for access to the Guidance Document.

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Reference:

https://www.canada.ca/content/dam/hc-sc/documents/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/guidance-administrative-processing-human-disinfectant-drugs/pub1-eng.pdf