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NATURAL HEALTH
PRODUCTS REGULATIONS
Prepared from Health Canada

FOOD AND DRUGS ACT
Implementation of NHP
Regulations
Implementation of the Natural Health Products Regulations
  on January .1, 2004., and ap...
Natural Health Products
Regulatory Review
Guidance documents have been created to help the natural
  health product (NHP) ...
Identify licensed natural
health products
Stakeholders can identify licensed natural health products by
   looking for the...
NATURAL HEALTH PRODUCTS
•   A plant or a plant material, an alga, a bacterium, a fungus or a non-
    human animal materia...
Introduction
In Canada, natural health products and foods are regulated
   under the Food and Drugs Act (FDA) and its asso...
The product information
For every licensed product listed in the LNHPD, the following details are
   provided:

   Product...
What Is an Act?
An Act is a means by which laws are made. Generally,
  Acts begin in draft form ("bills") and can originat...
What Are Regulations?
Regulations (often referred to as delegated legislation
  or subordinate legislation) are a means of...
What Is the Canada
Gazette?
The Canada Gazette is the official newspaper of the
  Government of Canada and is published un...
What Are Guidance
Documents?
Guidance documents (sometimes called guidelines or
  directives) are important administrative...
The purpose of this
guidance document
Natural Health Products Directorate (NHPD) administers
  sections 9, 10, 30 and 31 o...
Offices & Programs
  The NHPD is composed of the following areas:

  Director General's Office

  Bureau of Business Plann...
Natural Health Product
Regulation in Canada
    The Regulations include provisions on:

    Product licensing;

    Site l...
Product Licensing
All natural health products require a product licence before
    they can be sold in Canada.
Obtaining a...
Site licensing
A system of site licensing requires that all
  Canadian manufacturers, packagers,
  labellers, and importer...
Good Manufacturing
     Practices (GMPs)
                                               This requires that appropriate
   ...
Adverse Reaction
Reporting Regulations require product
The Natural Health Products
  licence holders to monitor all advers...
Health Canada Concerns




          NHP - Health Canada /RK 08/03/2010
Clinical trials
A clinical trial is an investigation of a natural health
   product that involves human subjects and is
  ...
Barriers to introduction of new
medical product

                     Economic Viability




          Social             ...
Labelling
Standard labelling requirements are established to ensure consumers
   can make informed choices. Some of the in...
Natural Health Products: 53
Recommendations of the Standing Committee
on Health
 Table of Contents

    Recommendations re...
Compliance Policy for
Natural Health Products
The Regulations define what NHPs are and set out the
  requirements for thei...
Schedule I of the Natural Health
Products
The following are included natural health product substances:
   A plant or a pl...
Schedule 2 of the Natural Health
Products
The following are excluded natural health product substances:
   A substance set...
NATURAL HEALTH PRODUCTS
REGULATIONS
(1) These Regulations apply to
   (a) the sale of natural health products;
   (b) the ...
PRODUCT LICENCES
Prohibition
(1) Subject to subsections (2) and (3), no person shall sell a
    natural health product unl...
Licence Application
An application for a product licence shall be submitted to the Minister
   and shall contain the follo...
Licence Application
   v) a statement indicating whether it is synthetically manufactured;

 (d) a qualitative list of the...
Product Number
 (1) The Minister shall assign a product
 number to each natural health product in
 respect of which a prod...
Site Information
(1) Subject to subsection (2), the licensee shall provide the Minister with the following information
pri...
Records
(1) Every licensee who sells a natural health product shall
   maintain the following records:

  (a) a list of al...
Prohibition
(1) Subject to subsection (2), no person shall manufacture,
   package, label or import a natural health produ...
Licence Contents
A site licence shall set out the following information:

   (a) the name and address of the licensee;
   ...
Expiry of Site licence
(1) A site licence expires on the first
  anniversary of the day on which it was
  issued unless it...
GMP Specifications
 (1) Every natural health product available for sale shall comply with the specifications
 submitted in...
Premises
 (1) Every natural health product shall be manufactured,
 packaged, labelled and stored in premises that are desi...
Guidance Documents
   http://www.hc-sc.gc.ca/dhp-mps/prodnatur/legislation/docs/index-eng.php

   Overview of the Natural ...
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Natural Health Products Regulations

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Natural Health Products Regulations

  1. 1. NATURAL HEALTH PRODUCTS REGULATIONS Prepared from Health Canada FOOD AND DRUGS ACT
  2. 2. Implementation of NHP Regulations Implementation of the Natural Health Products Regulations on January .1, 2004., and apply to all NHPs as of this date. NHPs with a valid Drug Identification Number (DIN) have six years (until December 31, 2009) to obtain a product licence under the Regulations. Natural Health Products Regulations came into force, a commitment was made to undertake a review of the regulations within the first three to five years of their implementation. This review has been launched further to that commitment and in consideration of challenges and issues which have been identified in the first three years of regulating NHPs. NHP - Health Canada /RK 08/03/2010
  3. 3. Natural Health Products Regulatory Review Guidance documents have been created to help the natural health product (NHP) industry The Review) is being undertaken as part of the Health Products and Food Branch's (HPFB) Blueprint for Renewal initiative, which aims at modernizing the regulatory system for all health products and food regulated by Health Canada. To help Canadians maintain and improve their health, Health Canada's Health Products and Food Branch strives to ensure that they have access to safe and effective health products, safe and nutritious food, and the information they need to make healthy choices. Protecting the health and afety of Canadians is our priority. NHP - Health Canada /RK 08/03/2010
  4. 4. Identify licensed natural health products Stakeholders can identify licensed natural health products by looking for the eight-digit Natural Product Number (NPN) or Homeopathic Medicine Number (DIN-HM) designation on the label The LNHPD is managed by Health Canada and includes information on licensed natural health products, such as vitamin and mineral supplements, herb and plant-based remedies, traditional medicines (such as Traditional Chinese Medicines or Ayurvedic [Indian] Medicines), omega 3 and essential fatty acids, probiotics and homeopathic medicines as well as many everyday consumer products, such as certain toothpastes, antiperspirants, shampoos, facial products and mouthwashes. NHP - Health Canada /RK 08/03/2010
  5. 5. NATURAL HEALTH PRODUCTS • A plant or a plant material, an alga, a bacterium, a fungus or a non- human animal material • An extract or isolate of a substance described in item 1, the primary molecular structure of which is identical to that which it had prior to its extraction or isolation • Any of the following vitamins: biotin, folate, niacin, pantothenic acid, riboflavin, thiamine, vitamin A, vitamin B6, vitamin B12, vitamin C, vitamin D, vitamin E, vitamin K1, vitamin K2, • An amino acid • An essential fatty acid • A synthetic duplicate of a substance described in any of items 2 to 5 • A mineral • A Probiotics NHP - Health Canada /RK 08/03/2010
  6. 6. Introduction In Canada, natural health products and foods are regulated under the Food and Drugs Act (FDA) and its associated regulations. Products that meet the definition “natural health product” in the Natural Health Products Regulations (NHPR) are subject to the FDA as it applies to a drug and to the NHPR. Products that are foods as defined in the FDA are subject to the FDA as it applies to food and to Parts A, B and D of the Food and Drug Regulations (FDR). A product, that is both a natural health product and a food is subject to the NHPR but is exempted from the FDA and its regulations as they apply to a food NHP - Health Canada /RK 08/03/2010
  7. 7. The product information For every licensed product listed in the LNHPD, the following details are provided: Product Name Product Licence Holder Natural Product Number (NPN) or Homeopathic Medicine Number (DIN-HM) Product's Medicinal Ingredients Product's Non-Medicinal Ingredients Product's Dosage Form Product's Recommended Use or Purpose (i.e. its health claim or indication) Risk Information Associated with the Product's Use (i.e. cautions, warnings, contra-indications and known adverse reactions) NHP - Health Canada /RK 08/03/2010
  8. 8. What Is an Act? An Act is a means by which laws are made. Generally, Acts begin in draft form ("bills") and can originate either in the House of Commons or in the Senate. For a bill to become law, it must be approved by both the House of Commons and the Senate and by the Governor General of Canada. Finally, a bill becomes law (an Act) through a formal process known as proclamation. Proclamation is done by the Governor in Council (Cabinet, i.e., the Prime Minister and his or her Federal Ministers). NHP - Health Canada /RK 08/03/2010
  9. 9. What Are Regulations? Regulations (often referred to as delegated legislation or subordinate legislation) are a means of making laws and should reflect policy objectives. Regulations are not made by Parliament but rather by someone to whom Parliament has delegated the authority to make them, In the case of the Food and Drugs Act, the Governor in Council (Cabinet) is given the power to make regulations. All regulations must be consistent with the authority under which they are made. They can't go beyond what the Act provides NHP - Health Canada /RK 08/03/2010
  10. 10. What Is the Canada Gazette? The Canada Gazette is the official newspaper of the Government of Canada and is published under the authority of the Statutory Instruments Act. It consists of three parts, Part I, Part II and Part III. Part I contains all formal public notices, official appointments, miscellaneous notices and proposed (draft) regulations from the government and private sectors Part II of the Canada Gazette contains regulations (as adopted by the appropriate authority) and certain other classes of statutory instruments. Part III of the Canada Gazette contains the most recent Acts of Parliament and their enactment proclamations. NHP - Health Canada /RK 08/03/2010
  11. 11. What Are Guidance Documents? Guidance documents (sometimes called guidelines or directives) are important administrative documents which support laws and regulations. Unlike laws and regulations, guidance documents do not have the force of law. However, they are important documents which set out how a department, regulatory authority or other body applies laws and regulations under their jurisdiction. They provide transparency in decision-making and fill in details sometimes missing from the strict nature of legal language in laws or regulations. NHP - Health Canada /RK 08/03/2010
  12. 12. The purpose of this guidance document Natural Health Products Directorate (NHPD) administers sections 9, 10, 30 and 31 of the Natural Health Products Regulations (the Regulations). Such procedures will be referred to herein as the "Reconsideration Process". It is the goal of the NHPD to attempt to resolve all disputes to which this Reconsideration Process may apply in a fair, transparent, and timely manner. The Reconsideration Process complements existing informal dispute resolution mechanisms at the NHPD such as discussions between the NHPD and applicants that may take place during the assessment of licence applications. NHP - Health Canada /RK 08/03/2010
  13. 13. Offices & Programs The NHPD is composed of the following areas: Director General's Office Bureau of Business Planning and Operations Bureau of Policy Development and Regulatory Affairs Bureau of Product Review and Assessment Bureau of Promotion, Liaison and Development Natural Health Product Research Program NHP - Health Canada /RK 08/03/2010
  14. 14. Natural Health Product Regulation in Canada The Regulations include provisions on: Product licensing; Site licensing; Good manufacturing practices; Adverse reaction reporting; Clinical trials; Labelling; and Provisions for a full range of health claims that will be supported by evidence. Products that fall within these Regulations include herbal remedies, homeopathic medicines, vitamins, minerals, traditional medicines, probiotics, amino acids and essential fatty acids. Information on natural health products that have been licensed for sale in Canada is available in the Licensed Natural Health Products Database. NHP - Health Canada /RK 08/03/2010
  15. 15. Product Licensing All natural health products require a product licence before they can be sold in Canada. Obtaining a licence requires submitting detailed information on the product to Health Canada, including: medicinal ingredients, source, potency, non-medicinal ingredients and recommended use(s). Once a product has been assessed and granted market authorization by Health Canada, the product label will bear an eight digit product licence number preceded by the distinct letters NPN (which stand for Natural Product Number), or, in the case of a homeopathic medicine, by the letters DIN-HM (which stand for Homeopathic Medicine Number). This number on the label will inform consumers that the product has been reviewed and approved by Health Canada for safety, efficacy and quality. NHP - Health Canada /RK 08/03/2010
  16. 16. Site licensing A system of site licensing requires that all Canadian manufacturers, packagers, labellers, and importers of natural health products be licensed. Sites must have procedures in place respecting distribution records and product recalls and for the handling, storage and delivery of their products, and demonstrate that they meet good manufacturing practice requirements. NHP - Health Canada /RK 08/03/2010
  17. 17. Good Manufacturing Practices (GMPs) This requires that appropriate standards and practices regarding Good Manufacturing Practices (GMPs) product manufacture, storage, for natural health products must be handling and distribution of natural employed to ensure product safety health products be met. The GMP for and quality. NHPs cover: specifications (product); quality assurance; premises; stability; records; equipment; sterile products; personnel; lot or batch samples, and sanitation program; recall reporting. operations; Information on the GMPs for NHPs is available in the operations; Good Manufacturing Practices Guidance Document NHP - Health Canada /RK 08/03/2010
  18. 18. Adverse Reaction Reporting Regulations require product The Natural Health Products licence holders to monitor all adverse reactions associated with their product. Serious adverse reactions must be reported to Health Canada through the Adverse Reaction Reporting Form Template. The Adverse Reaction Reporting System for natural health products assists Health Canada in issuing warnings and advisories, where appropriate, to the public. This type of reporting is an important part of a product authorization system based on risk assessment and risk management NHP - Health Canada /RK 08/03/2010
  19. 19. Health Canada Concerns NHP - Health Canada /RK 08/03/2010
  20. 20. Clinical trials A clinical trial is an investigation of a natural health product that involves human subjects and is intended: To discover or verify the product's clinical, Pharmacological or Pharmacodynamic effects; To identify any adverse events that are related to its use; to study its absorption, distribution, metabolism and excretion; or To ascertain its safety or efficacy. NHP - Health Canada /RK 08/03/2010
  21. 21. Barriers to introduction of new medical product Economic Viability Social Technical Acceptability Feasibility NHP - Health Canada /RK 08/03/2010
  22. 22. Labelling Standard labelling requirements are established to ensure consumers can make informed choices. Some of the information required on a natural health products label includes:  Product name  Quantity of product in the bottle  List of medicinal and non-medicinal ingredients  Recommended conditions of use (including use or purpose, dosage form, route of administration, dose, and any cautionary statements, warnings, contra-indications and possible adverse reactions associated with the product)  Any special storage conditions Further information on the labelling and packaging requirements for natural health products is available in the Labelling Guidance Document. NHP - Health Canada /RK 08/03/2010
  23. 23. Natural Health Products: 53 Recommendations of the Standing Committee on Health Table of Contents Recommendations re: Definitions Recommendations re: Expertise and Regulatory Structure Recommendations re: Safety Recommendations re: Quality/Good Manufacturing Practices Recommendations re: Efficacy Recommendations re: Product Licensing Recommendations re: Labelling Recommendations re: Section 3 and Schedule A of the Food and Drugs Act Recommendations re: Importation of Human-Use Drugs for Personal Use Recommendations re: Cost Recovery Recommendations re: Appeal Process Recommendations re: Informed Choice Recommendations re: NHP Practitioners Recommendations re: Enforcement Recommendations re: Aboriginal Healers Recommendations re: Plant Conservation Recommendations re: Transition Appendix A Appendix B NHP - Health Canada /RK 08/03/2010
  24. 24. Compliance Policy for Natural Health Products The Regulations define what NHPs are and set out the requirements for their sale, manufacture, packaging, labelling, importation, distribution, and storage. This document explains Health Canada's compliance policy with respect to these products. This document replaces and supersedes the Interim DIN Enforcement Directive (1998) which ceased to be in effect as of January 1, 2004, and, as it relates to NHPs as defined in the Regulations, the Therapeutic Products Compliance Guide (1999). NHP - Health Canada /RK 08/03/2010
  25. 25. Schedule I of the Natural Health Products The following are included natural health product substances: A plant or a plant material, an alga, a bacterium, a fungus or a non-human animal material An extract or isolate of a substance described in item 1, the primary molecular structure of which is identical to that which it had prior to its extraction or isolation Any of the following vitamins: biotin, folate, niacin, pantothenic acid, riboflavin, thiamine, vitamin A, vitamin B6, vitamin B12, vitamin C, vitamin D, vitamin E An amino acid An essential fatty acid A synthetic duplicate of a substance listed in any of 2 to 5 above A mineral A probiotic NHP - Health Canada /RK 08/03/2010
  26. 26. Schedule 2 of the Natural Health Products The following are excluded natural health product substances: A substance set out in Schedule C to the Act A substance set out in Schedule D to the Act, except for the following: a drug that is prepared from any of the following micro-organisms, namely, an alga, a bacterium or a fungus; and any substance set out on Schedule D when it is prepared in accordance with the practices of homeopathic pharmacy A substance regulated under the Tobacco Act A substance set out in any of Schedules I to V of the Controlled Drugs and Substances Act A substance that is administered by puncturing the dermis An antibiotic prepared from an alga, a bacterium or a fungus or a synthetic duplicate of that antibiotic NHP - Health Canada /RK 08/03/2010
  27. 27. NATURAL HEALTH PRODUCTS REGULATIONS (1) These Regulations apply to (a) the sale of natural health products; (b) the manufacture, packaging, labelling and importation for sale of natural health products; (c) the distribution of natural health products; and (d) the storage of natural health products for the purposes of any of the activities referred to in paragraphs (b) and (c). (2) For the purposes of these Regulations, a substance or combination of substances or a traditional medicine is not considered to be a natural health product if its sale, under the Food and Drug Regulations, is required to be pursuant to a prescription when it is sold other than in accordance with section C.01.043 of those Regulations. NHP - Health Canada /RK 08/03/2010
  28. 28. PRODUCT LICENCES Prohibition (1) Subject to subsections (2) and (3), no person shall sell a natural health product unless a product licence is issued in respect of the natural health product. (2) No product licence holder, manufacturer, importer or distributor of a natural health product for which a product licence is issued shall sell the natural health product during any period that the sale of that natural health product is directed to be stopped under section 17. (3) No person shall sell a natural health product for which a product licence is issued (a) during the period of any suspension of the licence under section 18 or 19; or (b) after cancellation of the licence under paragraph 20(b). NHP - Health Canada /RK 08/03/2010
  29. 29. Licence Application An application for a product licence shall be submitted to the Minister and shall contain the following information and documents: (a) the name, address and telephone number, and if applicable, the facsimile number and electronic mail address of the applicant; (b) if the address submitted under paragraph (a) is not a Canadian address, the name, address and telephone number, and if applicable, the facsimile number and electronic mail address of the applicant's representative in Canada to whom notices may be sent; (c) for each medicinal ingredient of the natural health product, (i) its proper name and its common name, (ii) its quantity per dosage unit, (iii) its potency, if a representation relating to its potency is to be shown on any label of the natural health product, (iv) a description of its source material, and contd. NHP - Health Canada /RK 08/03/2010
  30. 30. Licence Application v) a statement indicating whether it is synthetically manufactured; (d) a qualitative list of the non-medicinal ingredients that are proposed for the natural health product and for each ingredient listed, a statement that indicates the purpose of the ingredient; (e) each brand name under which the natural health product is proposed to be sold; (f) the recommended conditions of use for the natural health product; (g) information that supports the safety and efficacy of the natural health product when it is used in accordance with the recommended conditions of use; (h) the text of each label that is proposed to be used in conjunction with the natural health product; (i) a copy of the specifications to which the natural health product will comply; and (j) one of the following attestations, namely, (i) if the natural health product is imported, an attestation by the applicant that the natural health product will be manufactured, packaged, labelled, imported, distributed and stored in accordance with the requirements set out in Part 3 or in accordance with requirements that are equivalent to those set out in Part 3, or (ii) if the natural health product is not imported, an attestation by the applicant that the natural health product will be manufactured, packaged, labelled, distributed and stored in accordance with requirements set out in Part 3. NHP - Health Canada /RK 08/03/2010
  31. 31. Product Number (1) The Minister shall assign a product number to each natural health product in respect of which a product licence is issued. (2) In the case of a natural health product that is a drug for which a drug identification number is assigned in accordance with subsection C.01.014.2(1) of the Food and Drug Regulations, the product number required under subsection (1) shall be the drug identification number. NHP - Health Canada /RK 08/03/2010
  32. 32. Site Information (1) Subject to subsection (2), the licensee shall provide the Minister with the following information prior to commencing the sale of the natural health product: (a) in respect of each manufacturer, packager, labeller and importer of the natural health product (i) the person's name, address and telephone number, and if applicable, the person's facsimile number and electronic mail address, and (ii) if the person conducts the activity in Canada, the number assigned to the site licence issued in respect of that activity; (b) the name, address and telephone number, and if applicable, the facsimile number and electronic mail address of each distributor of the natural health product; (c) the address of each building in which the natural health product is manufactured, packaged or labelled; (d) the address of each building in which the natural health product is stored for the purposes of importation or distribution; and (e) if the natural health product is imported, evidence demonstrating that the natural health product will be manufactured, packaged, labelled, imported, distributed and stored in accordance with the requirements set out in Part 3 or in accordance with requirements that are equivalent to those set out in Part 3. (2) If the natural health product is one in respect of which a drug identification number is assigned in accordance with subsection C.01.014.2(1) of the Food and Drug Regulations and at the time the product licence is issued in respect of the natural health product it is already being sold, the licensee shall provide the information referred to in subsection (1) within 30 days after the day on which the product licence is issued. NHP - Health Canada /RK 08/03/2010
  33. 33. Records (1) Every licensee who sells a natural health product shall maintain the following records: (a) a list of all ingredients contained in each lot or batch of the natural health product that has been made available for sale; and (b) records containing sufficient information to enable the recall of every lot or batch of the natural health product that has been made available for sale. (2) The records shall be maintained by the licensee for a period of one year following the expiry date of the natural health product to which that record relates. NHP - Health Canada /RK 08/03/2010
  34. 34. Prohibition (1) Subject to subsection (2), no person shall manufacture, package, label or import a natural health product for sale unless (a) the person holds a site licence issued in respect of the activity; and (b) the person conducts the activity in accordance with the requirements set out in Part 3. (2) No person who holds a site licence shall manufacture, package, label or import a natural health product for sale (a) during the period of any suspension of the licence under section 39 or 40; or (b) after cancellation of the licence under paragraph 41(b). NHP - Health Canada /RK 08/03/2010
  35. 35. Licence Contents A site licence shall set out the following information: (a) the name and address of the licensee; (b) the site licence number; (c) each activity that the licensee is authorized to conduct and a statement indicating whether the activity is authorized to be conducted in respect of a natural health product in sterile dosage form; (d) if the licensee is authorized to manufacture, package or label a natural health product, the address of each building in which the licensee is authorized to conduct that activity; and (e) if the licensee is authorized to import a natural health product, the address of each building in which the licensee is authorized to store that natural health product. NHP - Health Canada /RK 08/03/2010
  36. 36. Expiry of Site licence (1) A site licence expires on the first anniversary of the day on which it was issued unless it is renewed in accordance with section 36. (2) A site licence that is renewed in accordance with section 36 expires on the day on which the renewal period ends unless the licence is further renewed in accordance with section 36. NHP - Health Canada /RK 08/03/2010
  37. 37. GMP Specifications (1) Every natural health product available for sale shall comply with the specifications submitted in respect of that natural health product under paragraph 5(i) and with every change to those specifications made by the product licence holder. (2) The specifications shall contain the following information: (a) detailed information respecting the purity of the natural health product, including statements indicating its purity tolerances; (b) for each medicinal ingredient of the natural health product, detailed information respecting its quantity per dosage unit and its identity, including statements indicating its quantity and identity tolerances; (c) if a representation relating to the potency of a medicinal ingredient is to be shown on a label of the natural health product, detailed information respecting the potency of the medicinal ingredient, including statements indicating its potency tolerances; and (d) a description of the methods used for testing or examining the natural health product. (3) The specifications and every change to those specifications shall be approved by a quality assurance person. NHP - Health Canada /RK 08/03/2010
  38. 38. Premises (1) Every natural health product shall be manufactured, packaged, labelled and stored in premises that are designed, constructed and maintained in a manner that permits the activity to be conducted under sanitary conditions, and in particular that (a) permits the premises to be kept clean and orderly; (b) permits the effective cleaning of all surfaces in the premises; (c) permits the natural health product to be stored or processed appropriately; (d) prevents the contamination of the natural health product; and (e) prevents the addition of an extraneous substance to the natural health product. (2) Every natural health product shall be stored under conditions that will maintain the quality and safety of the natural health product. NHP - Health Canada /RK 08/03/2010
  39. 39. Guidance Documents http://www.hc-sc.gc.ca/dhp-mps/prodnatur/legislation/docs/index-eng.php Overview of the Natural Health Products Regulations Guidance Document :http://www.hc- sc.gc.ca/dhp-mps/prodnatur/legislation/docs/regula-regle_over-apercu-eng.php Guidance Document for Industry - Reporting Adverse Reactions to Marketed Health Products* :http://www.hc-sc.gc.ca/dhp-mps/pubs/medeff/_guide/2009-guidance- directrice_reporting-notification/index-eng.php Advertising: http://www.hc-sc.gc.ca/dhp-mps/advert-publicit/pol/guide- ldir_consom_consum-eng.php Contact: Natural Health Products Directorate Health Products and Food Branch Health Canada Address locator: 3302A 2936 Baseline Rd., Tower A Ottawa, Ontario K2H 1B3 NHP - Health Canada /RK 08/03/2010

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