Natural Health Products Regulations (2)


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Natural Health Products Regulations (2)

  2. 2. Implementation of NHP Regulations <ul><li>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. </li></ul><ul><li>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. </li></ul><ul><li>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. </li></ul>NHP - Health Canada /RK 08/03/2010
  3. 3. Natural Health Products Regulatory Review <ul><li>Guidance documents have been created to help the natural health product (NHP) industry </li></ul><ul><li>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. </li></ul><ul><li>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 safety of Canadians is our priority. </li></ul>NHP - Health Canada /RK 08/03/2010
  4. 4. Identify licensed natural health products <ul><li>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 </li></ul><ul><li>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. </li></ul>NHP - Health Canada /RK 08/03/2010
  5. 5. NATURAL HEALTH PRODUCTS NHP - Health Canada /RK 08/03/2010
  6. 6. Introduction <ul><li>In Canada, natural health products and foods are regulated under the Food and Drugs Act (FDA) and its associated regulations. </li></ul><ul><li>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.  </li></ul><ul><li>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).  </li></ul><ul><li>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 </li></ul>NHP - Health Canada /RK 08/03/2010
  7. 7. The product information <ul><li>For every licensed product listed in the LNHPD, the following details are provided: </li></ul><ul><li>Product Name </li></ul><ul><li>Product Licence Holder </li></ul><ul><li>Natural Product Number (NPN) or Homeopathic Medicine Number (DIN-HM) </li></ul><ul><li>Product's Medicinal Ingredients </li></ul><ul><li>Product's Non-Medicinal Ingredients </li></ul><ul><li>Product's Dosage Form </li></ul><ul><li>Product's Recommended Use or Purpose (i.e. its health claim or indication) </li></ul><ul><li>Risk Information Associated with the Product's Use (i.e. cautions, warnings, contra-indications and known adverse reactions) </li></ul>NHP - Health Canada /RK 08/03/2010
  8. 8. What Is an Act? <ul><li>An Act is a means by which laws are made. Generally, Acts begin in draft form (&quot;bills&quot;) 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. </li></ul><ul><li>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). </li></ul>NHP - Health Canada /RK 08/03/2010
  9. 9. What Are Regulations? <ul><li>Regulations (often referred to as delegated legislation or subordinate legislation) are a means of making laws and should reflect policy objectives. </li></ul><ul><li>Regulations are not made by Parliament but rather by someone to whom Parliament has delegated the authority to make them, </li></ul><ul><li>In the case of the Food and Drugs Act , the Governor in Council (Cabinet) is given the power to make regulations. </li></ul><ul><li>All regulations must be consistent with the authority under which they are made. They can't go beyond what the Act provides </li></ul>NHP - Health Canada /RK 08/03/2010
  10. 10. What Is the Canada Gazette ? <ul><li>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. </li></ul><ul><li>Part I contains all formal public notices, official appointments, miscellaneous notices and proposed (draft) regulations from the government and private sectors </li></ul><ul><li>Part II of the Canada Gazette contains regulations (as adopted by the appropriate authority) and certain other classes of statutory instruments. </li></ul><ul><li>Part III of the Canada Gazette contains the most recent Acts of Parliament and their enactment proclamations. </li></ul>NHP - Health Canada /RK 08/03/2010
  11. 11. What Are Guidance Documents? <ul><li>Guidance documents (sometimes called guidelines or directives) are important administrative documents which support laws and regulations. </li></ul><ul><li>Unlike laws and regulations, guidance documents do not have the force of law. </li></ul><ul><li>However, they are important documents which set out how a department, regulatory authority or other body applies laws and regulations under their jurisdiction. </li></ul><ul><li>They provide transparency in decision-making and fill in details sometimes missing from the strict nature of legal language in laws or regulations. </li></ul>NHP - Health Canada /RK 08/03/2010
  12. 12. The purpose of this guidance document <ul><li>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 &quot;Reconsideration Process&quot;. </li></ul><ul><li>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. </li></ul><ul><li>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. </li></ul>NHP - Health Canada /RK 08/03/2010
  13. 13. Offices & Programs <ul><li>The NHPD is composed of the following areas: </li></ul><ul><li>Director General's Office </li></ul><ul><li>Bureau of Business Planning and Operations </li></ul><ul><li>Bureau of Policy Development and Regulatory Affairs </li></ul><ul><li>Bureau of Product Review and Assessment </li></ul><ul><li>Bureau of Promotion, Liaison and Development </li></ul><ul><li>Natural Health Product Research Program </li></ul>NHP - Health Canada /RK 08/03/2010
  14. 14. Natural Health Product Regulation in Canada NHP - Health Canada /RK 08/03/2010
  15. 15. Product Licensing <ul><li>All natural health products require a product licence before they can be sold in Canada. </li></ul><ul><li>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). </li></ul><ul><li>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). </li></ul><ul><li>This number on the label will inform consumers that the product has been reviewed and approved by Health Canada for safety, efficacy and quality. </li></ul>NHP - Health Canada /RK 08/03/2010
  16. 16. Site licensing NHP - Health Canada /RK 08/03/2010
  17. 17. Good Manufacturing Practices (GMPs) <ul><li>specifications (product); </li></ul><ul><li>premises; </li></ul><ul><li>equipment; </li></ul><ul><li>personnel; </li></ul><ul><li>sanitation program; </li></ul><ul><li>operations; </li></ul><ul><li>operations; </li></ul>NHP - Health Canada /RK 08/03/2010
  18. 18. Adverse Reaction Reporting NHP - Health Canada /RK 08/03/2010
  19. 19. Health Canada Concerns NHP - Health Canada /RK 08/03/2010
  20. 20. Clinical trials NHP - Health Canada /RK 08/03/2010
  21. 21. Barriers to introduction of new medical product NHP - Health Canada /RK 08/03/2010
  22. 22. Labelling <ul><li>Standard labelling requirements are established to ensure consumers can make informed choices. Some of the information required on a natural health products label includes: </li></ul><ul><li>Product name </li></ul><ul><li>Quantity of product in the bottle </li></ul><ul><li>List of medicinal and non-medicinal ingredients </li></ul><ul><li>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) </li></ul><ul><li>Any special storage conditions </li></ul><ul><li>Further information on the labelling and packaging requirements for natural health products is available in the Labelling Guidance Document . </li></ul>NHP - Health Canada /RK 08/03/2010
  23. 23. Natural Health Products: 53 Recommendations of the Standing Committee on Health NHP - Health Canada /RK 08/03/2010
  24. 24. Compliance Policy for Natural Health Products NHP - Health Canada /RK 08/03/2010
  25. 25. Schedule I of the Natural Health Products NHP - Health Canada /RK 08/03/2010
  26. 26. Schedule 2 of the Natural Health Products NHP - Health Canada /RK 08/03/2010
  27. 27. NATURAL HEALTH PRODUCTS REGULATIONS NHP - Health Canada /RK 08/03/2010
  28. 28. PRODUCT LICENCES Prohibition NHP - Health Canada /RK 08/03/2010
  29. 29. Licence Application <ul><li>An application for a product licence shall be submitted to the Minister and shall contain the following information and documents: </li></ul><ul><li>( 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, </li></ul><ul><ul><li>(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. </li></ul></ul>NHP - Health Canada /RK 08/03/2010
  30. 30. Licence Application NHP - Health Canada /RK 08/03/2010
  31. 31. Product Number NHP - Health Canada /RK 08/03/2010
  32. 32. Site Information NHP - Health Canada /RK 08/03/2010
  33. 33. Records NHP - Health Canada /RK 08/03/2010
  34. 34. Prohibition NHP - Health Canada /RK 08/03/2010
  35. 35. Licence Contents NHP - Health Canada /RK 08/03/2010
  36. 36. Expiry of Site licence <ul><li>(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 . </li></ul><ul><li>(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. </li></ul>NHP - Health Canada /RK 08/03/2010
  37. 37. GMP Specifications <ul><li>(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. </li></ul><ul><li>(2) The specifications shall contain the following information: </li></ul><ul><li>( 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. </li></ul><ul><li>(3) The specifications and every change to those specifications shall be approved by a quality assurance person. </li></ul>NHP - Health Canada /RK 08/03/2010
  38. 38. Premises NHP - Health Canada /RK 08/03/2010
  39. 39. Guidance Documents NHP - Health Canada /RK 08/03/2010