NHP100 - NHP Regulations

Outline info
Last revision date 2018-07-20 11:48:36.917
Last review date 2018-07-20 11:48:49.534

Subject Title
NHP Regulations

Subject Description
This course provides an overview of the regulatory framework for Natural Health Products (NHPs) in Canada, and in other global jurisdictions. Course addresses product licensing; site licensing; clinical trial application process; labeling requirements; advertising; and differences between regulatory requirements for NHPs, pharmaceuticals, cosmetics, medical devices, and foods.

Credit Status
One credit toward the Fundamentals of Natural Health Products Certificate Program

Learning Outcomes
Upon successful completion of this subject the student will be able to:

  1. Explain the different aspects of NHP regulations in Canada.
  2. Compare differences between regulation of NHPs, pharmaceuticals, cosmetics, medical devices, and foods.
  3. Describe the regulatory requirements for product licencing, site licensing, and clinical trial applications, for NHPs in Canada.
  4. Compare Canadian NHP regulations with dietary supplement regulations in other global jurisdictions.
  5. Describe Canadian requirements for labelling of NHPs, and compare with those for U.S. dietary supplement labelling.

Cheating and Plagiarism
Each student should be aware of the College's policy regarding Cheating and Plagiarism. Seneca's Academic Policy will be strictly enforced.

To support academic honesty at Seneca College, all work submitted by students may be reviewed for authenticity and originality, utilizing software tools and third party services. Please visit the Academic Honesty site on http://library.senecacollege.ca for further information regarding cheating and plagiarism policies and procedures.

All students and employees have the right to study and work in an environment that is free from discrimination and/or harassment. Language or activities that defeat this objective violate the College Policy on Discrimination/Harassment and shall not be tolerated. Information and assistance are available from the Student Conduct Office at student.conduct@senecacollege.ca.

Accommodation for Students with Disabilities
The College will provide reasonable accommodation to students with disabilities in order to promote academic success. If you require accommodation, contact the Counselling and Disabilities Services Office at ext. 22900 to initiate the process for documenting, assessing and implementing your individual accommodation needs.


Topic Outline

Unit 1 Overview of the Canadian Regulatory Framework for NHPs
Governing Regulations and the role of Health Canada
Regulatory classification and differences from other classes (i.e. pharmaceuticals, cosmetics, medical devices, foods)
Unit 2 NHP Product Licensing
Product licence applications and submission processes
Class I, II and III applications
Modern health claims versus traditional health claims
NHP Ingredients Database (NHPID)
Licensed NHP Database (LNHPD)
Post-Market Notifications and Amendments
Unit 3 NHP Health Claims and Standards of Evidence
Pre-cleared information
Standards of Evidence and Quality Appraisal
Traditional Health Claims
Opportunities for Modern Health Claims
Unit 4 Site Licensing:
Site Licence applications and submission processes
Good Manufacturing Processes (GMPs) for NHPs
Standard Operating Procedures (SOPs)
International Trade Certificates (ITCs)
Unit 5 Global Regulations for Dietary Supplements - Part I
United States
The European Union (EU)
Unit 6 Product Labelling – NHPs vs. Dietary Supplements
Requirements for Labelling of NHPs (Canada)
Requirements for Dietary Supplements (U.S.)
Additional label claims (i.e. organic, GMO-free, allergen declarations / free-from statements, etc.)
Unit 7 Quality of NHPs
Characterization, Identification and Quantification Standards
Purity of medicinal ingredients
Deviations from monograph specifications
Quality amendments
Unit 8 Clinical Trials for NHPs
Clinical Trial Application processes and submission requirements
Quality Requirements for Investigational Product(s)
Research Ethics Applications
Regulatory activities during application review, after trial initiation, and close-out activities
Unit 9 Classification of Products at the NHP Interface
Regulatory Classifications
Interface I:  NHPs and Pharmaceuticals
Interface II:  NHPs and Cosmetics
Interface III:  NHPs and Medical Devices
Interface IV:  NHPs and Foods
Unit 10 Global Regulations for Dietary Supplements - Part II
Australia & New Zealand
South America
Unit 11 NHP Advertisement and Consumer Protection in Canada
Compliance and enforcement (roles of the HPFBI and CFIA)
Advertising pre-clearance (Advertising Standards Council and the MHPD)
Adverse Event (AE) reporting
Bill C-17 / Vanessa’s Law
Unit 12 Global Regulations for Dietary Supplements - Part III
ASEAN Region
Unit 13 Presentations
Unit 14 Final exam

Mode of Instruction
Lecture and discussion

Prescribed Texts
Natural Health Products Regulations: http://laws.justice.gc.ca/eng/regulations/SOR-2003-196/index.html

Draft Consumer Health Product Framework http://www.hc-sc.gc.ca/dhp-mps/consultation/natur/chp_frwk_cadre_psc-eng.php

Food and Drugs Act: http://laws.justice.gc.ca/eng/acts/F-27/

Pathway for licensing natural health products making modern health claims http://www.hc-sc.gc.ca/dhp-mps/prodnatur/legislation/docs/modern-eng.php

Pathway for licensing natural health products used as traditional medicines http://www.hc-sc.gc.ca/dhp-mps/prodnatur/legislation/docs/tradit-eng.php

Site Licensing Guidance Document http://www.hc-sc.gc.ca/dhp-mps/prodnatur/legislation/docs/slgd-drle-eng.php

Clinical Trials for NHPs Guidance Document http://www.hc-sc.gc.ca/dhp-mps/prodnatur/legislation/docs/clini_trials-essais_nhp-psn-eng.php

Consumer Advertising Guidelines for Marketed Health Products (for Non-prescription Drugs including Natural Health Products) http://www.hc-sc.gc.ca/dhp-mps/advert-publicit/pol/guide-ldir_consom_consum-eng.php

Quality of Natural Health Products Guide http://www.hc-sc.gc.ca/dhp-mps/prodnatur/legislation/docs/eq-paq-eng.php

Reference Material

Required Supplies

Promotion Policy

Grading Policy
A+ 90%  to  100%
A 80%  to  89%
B+ 75%  to  79%
B 70%  to  74%
C+ 65%  to  69%
C 60%  to  64%
D+ 55%  to  59%
D 50%  to  54%
F 0%    to  49% (Not a Pass)
EXC Excellent
SAT Satisfactory
UNSAT Unsatisfactory

For further information, see a copy of the Academic Policy, available online (http://www.senecacollege.ca/academic-policy) or at Seneca's Registrar's Offices.

Modes of Evaluation

  • Assignments are due at the beginning of the class on which they are due.
  • A late penalty of 10% per day is assessed for late assignments, including those not handed in at the beginning of class when due.
  • Material will not be accepted after one week following the due date and/or when the marked material is returned to students, whichever comes first.
  • Assignments are to be prepared by computer.

Absenteeism and Exams
  • Students should be aware that absenteeism almost guarantees an inability to achieve satisfactory grades.
  • Students who are absent for an examination due to an emergency (e.g., motor vehicle accident, hospitalization or death in the family) may provide official documentation within five days of the missed exam and be provided a deferred exam at a later date. Official documentation includes a death notice or an original doctor’s certificate identifying the date, length of time expected absence and the specific reason for the absence. Examinations missed without official documentation and approval result in a grade of zero.
  • There are no deferred options for missed tests. The value of missed tests, at the discretion of the Faculty, will be added to other evaluation components.

English Proficiency
  • All written work should demonstrate the following characteristics for clarity and conciseness:
-writing is consistent with the rules of English grammar
-spelling and punctuation are correct
-sentences are structured correctly
-main ideas are supported with specific, relevant examples and reasons
-work flows logically through supporting statements/paragraphs
-work is arranged in correct format (e.g., as a report, essay)
-up to 10% of the final grade may be deducted on all work if the above English competencies are not met.
Format for Assignments
  • Students must use the standard, APA style for quoting sources.   Help is available at:  http://library.senecacollege.ca

Grading is based on the following marking scheme:
Assignment #1 10%
Assignment #2 10%
Assignment #3 15%
Quiz #1 10%
Quiz #2 10%
Presentation 15%
Final Exam  30%
Other Evaluation Considerations
The student is expected to comply with the Safety Rules for working in the laboratory, sign the safety contract, and WILL NOT UNDER ANY CIRCUMSTANCES WEAR CONTACT LENSES in the laboratory.  The student will know where all safety equipment is located in the laboratory and will be familiar with WHMIS concepts and signage.


Approved by: Denis Gravelle