The Administrative Burden Baseline provides Canadians with a clear metric on the total number of requirements in federal regulations and associated forms that impose administrative burden on business. This baseline contributes to the openness and transparency of the federal regulatory system.
All federal regulations that are administered by Health Canada that have requirements that impose administrative burden on business are identified below. The total count for 2021 is 20,526, which is a net increase from the 2020 count of 20,058. The increase is largely due to new and enhanced measures in Health Canada's response to the COVID-19 pandemic, and to a lesser degree due to amendments and coming into force of some provisions in the Food and Drug Regulations, Medical Devices Regulations, Natural Health Products Regulations, and Safety of Sperm and Ova Regulations.
The total June 30, 2014 baseline count is 15,649 and can be viewed on the June 30, 2014 Administrative Burden Baseline Count page.
Administrative Burden Baseline count:
The Administrative Burden Baseline counts for the Canadian Environment Protection Act, 1999 are posted on Environment and Climate Change Canada's website. Please visit Environment and Climate Change Canada's Administrative Burden Baseline Page to view this count.
The Administrative Burden Baseline count for the Police Enforcement (Cannabis Act) Regulations are posted on Public Safety and Emergency Preparedness Canada's website. Please visit Public Safety Canada's Administrative Burden Baseline page to view this count.
Title of act: Department of Health Act
The Administrative Burden Baseline counts for the Department of Health Act are posted on the Public Health Agency of Canada's website. Please visit the Public Health Agency of Canada's Administrative Burden Baseline page to view these counts.
Title of act: Food and Drugs Act
| Title of regulation |
SOR/CRC/SI Number |
2021 count |
| Blood Regulations |
SOR/2013-178 |
372 |
| Cannabis Exemption (Food and Drugs Act) Regulations |
SOR/2016-231 |
0 |
| Cosmetic Regulations |
C.R.C., c. 869 |
24 |
| Establishment Licence Fees Remission Order (Indication of an Activity in respect of a COVID-19 Drug) |
SOR/2020-213 |
2 |
| Fees in Respect of Drugs and Medical Devices Order |
SOR/2019-124 |
404 |
| Food and Drug Regulations |
C.R.C., c. 870 |
4137 |
| Interim Order No. 2 Respecting Clinical Trials for Medical Devices and Drugs Relating to COVID-19 |
|
453 |
| Interim Order Respecting Drug Shortages (Safeguarding the Drug Supply) |
|
3 |
| Interim Order No. 2 Respecting Drugs, Medical Devices and Foods for a Special Dietary Purpose in Relation to COVID-19 |
|
147 |
| Interim Order No. 2 Respecting the Importation and Sale of Medical Devices for Use in Relation to COVID-19 |
|
366 |
| Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19 |
|
64 |
| Interim Order respecting the prevention and alleviation of shortages of drugs in relation to COVID-19 |
|
1 |
| Marketing Authorization for Food Additives That May be Used as Anticaking Agents |
SOR/2012-202 |
0 |
| Marketing Authorization for Food Additives That May be Used as Bleaching, Maturing, or Dough Conditioning Agents |
SOR/2012-203 |
0 |
| Marketing Authorization for Food Additives That May be Used as Carrier or Extraction Solvents |
SOR/2012-216 |
0 |
| Marketing Authorization for Food Additives That May be Used as Colouring Agents |
SOR/2012-204 |
0 |
| Marketing Authorization for Food Additives That May be Used as Emulsifying, Gelling, Stablilizing or Thickening Agents |
SOR/2012-205 |
0 |
| Marketing Authorization for Food Additives That May be Used as Firming Agents |
SOR/2012-207 |
0 |
| Marketing Authorization for Food Additives That May be Used as Food Enzymes |
SOR/2012-206 |
0 |
| Marketing Authorization for Food Additives That May be Used as Glazing or Polishing Agents |
SOR/2012-208 |
0 |
| Marketing Authorization for Food Additives That May be Used as pH Adjusting Agents, Acid-Reacting Materials or Water Correcting Agents |
SOR/2012-211 |
0 |
| Marketing Authorization for Food Additives That May be Used as Preservatives |
SOR/2012-212 |
0 |
| Marketing Authorization for Food Additives That May be Used as Sequestering Agents |
SOR/2012-213 |
0 |
| Marketing Authorization for Food Additives That May be Used as Starch-Modifying Agents |
SOR/2012-214 |
0 |
| Marketing Authorization for Food Additives That May be Used as Sweeteners |
SOR/2012-210 |
0 |
| Marketing Authorization for Gluten-free Oats and Foods Containing Gluten-free Oats Regulations |
SOR/2015-114 |
0 |
| Marketing Authorization for Food Additives That May be Used as Yeast Foods |
SOR/2012-215 |
0 |
| Marketing Authorization for Food Additives with Other Generally Accepted Uses |
SOR/2012-209 |
0 |
| Marketing Authorization for Maximum Residue Limits for Veterinary Drugs in Foods |
SOR/2013-87 |
0 |
| Medical Devices Regulations |
SOR/98-282 |
1149 |
| Natural Health Products Regulations |
SOR/2003-196 |
1631 |
| Processing and Distribution of Semen for Assisted Conception Regulations |
SOR/96-254 |
56 |
| Safety of Human Cells, Tissues and Organs for Transplantation Regulations |
SOR/2007-118 |
70 |
The Administrative Burden Baseline counts for the Patent Act are posted on Industry, Science and Economic Development Canada's website. Please visit Industry, Science and Economic Development Canada's Administrative Burden Baseline page to view this count. For the Patented Medicine Regulations, please visit the Patented Medicine Prices Review Board's Administrative Burden Baseline page to view the count.
Total count: 20,526
Previous years' counts for Health Canada are available on the Health Canada Acts and Regulations web page or upon request.
Contact information:
Departmental Regulatory Affairs
Health Canada
200 Eglantine Driveway, 5th Floor
dra-arm@hc-sc.gc.ca
