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Drugs and Health Products
Policies
Policy documents are interpretations of the purpose and intent of the Food and Drugs Act and Regulations.
- Notice: Categorization of Therapeutic Products at the Device / Drug Interface [2012-05-31]
- Notice - To All Persons Interested in Importing, Advertising or Selling Electronic Smoking Products in Canada [2009-03-27]
- Notice - Release of Final Guidance Document and Revisions to Six Guidances and Policies [2006-01-03]
- Drug/Medical Device Combination Products Policy [2005-11-30]
- Priority Review of Drug Submissions Policy [2007-12-20]
- Absence of Ingredient Statements for Nonprescription Drugs [2000-11-03]
- Appeals Procedures for Drug Submissions [2003-04-04]
This Policy is no longer in effect. It has been replaced by the Guidance: Reconsideration of Final Decisions Issued for Human Drug Submissions. - Assignment of Drug Identification Numbers (DINs) According to Product Name [1998-04-14]
- Assignment of Drug Identification Numbers for Drug Products in Kits [1997-07-21]
- Bioequivalence of Proportional Formulations: Solid Oral Dosage [1996-03-07]
- Canadian Reference Product [1995-12-04]
- Changes in Manufacturer's Name and/or Product Name [2001-01-03]
- DIN: A Brand Name Product with Different Fragrances, Flavours or Colours [1993-07-14]
- Disclosure of New Drug Submission Evaluation Reports to the Provinces [1993-01-01]
- Factors for listing drugs in Schedule F [1999-08-09]
- Filing of SNDSs, SANDS, NCs and X-REFs [1996-05-10]
- Herbs (Medicinal) in Traditional Herbal Medicine
With the introduction of the Natural Health Products Regulations in 2004, homeopathic products are now considered to be natural health products. Please consult the Natural Health Products Directorate (NHPD) website for information on filing a Product License Application for homeopathic products. If you are enquiring about homeopathic products licensed as a DIN with the Therapeutic Products Directorate prior to 2004, please contact BGIVD_Enquires@hc-sc.gc.ca. Kindly note that all homeopathics previously assigned a DIN must have filed for a Product License Application with NHPD by December 31, 2009. - Herbs used as Non-medicinal Ingredients in Nonprescription Drugs for Human Use [1995-09-22]
- Inclusion of Women in Clinical Trials during Drug Development [1996-09-25]
- Interpretation of "Identical Medicinal Ingredient" [2003-07-09]
- Issuance of Drug Identification Numbers for New Drugs [1996-09-10]
- Issue Analysis Summary: Regulatory strategy for pharmaceutical products with photo co-carcinogenic potential [1999-04-15]
- Labelling of Professional Samples of Drugs [1994-02-11]
- Labelling of Special Containers [1990-04-04]
- Modified FDA Format Drug Submissions for Products in Human Use [1997-10-23]
- New Active Substance [1991-06-05]
- Orphan Drugs [1997-01-16]
- Policy Development in the Therapeutic Products Programme: A Reference Guide [1998-05-01]
- Policy on Drug/Medical Device Combination Products - Decisions [1999-05-01]
- Policy: Submissions for Generic Topical Drugs [1990-09-24]
- Regulatory Requirements for Vitamin/Mineral Supplements in Nonprescription Drug Products
With the introduction of the Natural Health Products Regulations in 2004, non-injectable vitamin and mineral supplements previously regulated by TPD are now classified as natural health products. - Submissions for Generic Parenteral Drugs [1990-03-01]
- Submissions for Topical Non-Steroidal Anti-inflammatory Drugs (Topical NSAIDs) [1998-07-22]
