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Drugs and Health Products

Questions from the Industry

Questions:

  1. How will the Natural Health Products Regulations impact industry?
  2. How will products be labelled under the Natural Health Products Regulations?
  3. I want to sell a natural health product in Canada , what do I have to do?
  4. How do I apply for a product or site licence?
  5. What is the process to import a natural health product to Canada?
  6. Once an application has been submitted to NHPD, what is the estimated time to receive an approval?
  7. What are the costs for submitting a product and/or site licence application for a natural health product or homeopathic medicine?
  8. Are cosmetics such as skin creams, shampoos, toothpastes, etc. regulated by the Natural Health Products Regulations?
  9. Do the compliance approach priority dates apply to only products with claims?
  10. How will the priority dates be applied for products containing more than one substance?
  11. Where do I find the Therapeutic Products Directorate (TPD) new drug list?
  12. Can I market my product without an NPN or DIN-HM?
  13. Is a monograph a proof of market authorization?
  14. Can I market my product once I have submitted my product licence application?
  15. Who is responsible for ensuring that the Quality Assurance Person and Third Party Auditor meet the regulatory requirements?
  16. How does the Natural Health Products Directorate define Quality Assurance Person?
  17. How does the Natural Health Products Directorate define Third Party Auditor?
  18. Will Health Canada recognize a Third Party Auditor as an in-house Quality Assurance Person for a natural health product company?
  19. Will Health Canada accept a Third Party Auditor as an in-house Quality Assurance Person for a number of natural health product companies?
  20. How does Health Canada assess the Quality Assurance Person and Third Party Auditor?
  21. How does Health Canada define education, training and experience?
  22. Will Health Canada assess the qualifications of a Third Party Auditor independent of a site licence application?
  23. Will Health Canada issue a Quality Assurance Person or a Third Party Auditor a reference number once their qualifications have been reviewed against the requirements set out in Part 3 of the Natural Health Products Regulations?
  24. Will Health Canada be establishing a system to accredit Quality Assurance Persons and Third Party Auditors for natural health products in the future?
  25. What is the status of vitamin K and submissions containing vitamin K?

Answers:

1. How will the Natural Health Products Regulations impact industry?

Industry will benefit from having a clear set of Regulations, specific to natural health products NHPs, that will reduce confusion regarding the applicable regulatory environment for NHPs and also serve to increase consumer confidence that the products they purchase are safe as they are regulated by the government.

Industry may benefit from a resulting long-term, stable demand for NHPs, and will be generally better able to compete domestically and internationally through recognition that Canadian NHPs meet regulatory requirements.

A site licence will be required for manufacturers, packagers, labellers, and importers of NHPs. One of the prerequisites that must be met before a site licence is issued is that good manufacturing practices are employed.

Each NHP will require a product licence to be sold. Industry will be able to provide consumers with more information about their NHPs as companies will now be required to state key information on their product labels.

2. How will products be labelled under the Natural Health Products Regulations?

Among other things, a natural health product label will include:

  1. the recommended use or purpose of the natural health product (NHP);
  2. the recommended route of administration;
  3. the recommended dose and duration of use of the NHP;
  4. the risk information relating to the NHP, including any cautions, warnings, contra-indications or known adverse reactions associated with its use;
  5. the name and address of the product licence holder, and if the NHP is imported, the name and address of the importer;
  6. the common name of each medicinal ingredient, and its proper name when that name is not a chemical name;
  7. the quantity per dosage unit or potency, if any, of the medicinal ingredients;
  8. a list of all non-medicinal ingredients;
  9. storage conditions, if any are recommended;
  10. the lot number and expiry date; and
  11. a description of the source material of the medicinal ingredients (e.g., for a herbal product, the part of the plant used, such as the root, for Vitamin C, source could be sodium ascorbate).

3. I want to sell a natural health product in Canada, what do I have to do?

In order to market your products in Canada, the Natural Health Products Regulations first require you to obtain the necessary product and site licences.

Product Licensing:

Before any natural health product can be sold in Canada, it must first undergo a pre-market review where it will be assessed for safety, efficacy, and quality. Evidence demonstrating this must be submitted to Health Canada by means of a product licence application (one for each product). Products, which meet the required criteria, will be authorized for sale and each issued a Natural Product Number (NPN) or Homeopathic Medicine Number (DIN-HM). Further information on this process is available in the Product Licensing Guidance Document.

Site Licensing:

The Natural Health Products Regulations require any Canadian site where natural health products are manufactured, imported, labelled, packaged, distributed, and/or stored to have a site licence. Businesses can choose to have a single site licence for all their operations (i.e. multiple sites) or an individual licence for each site. Site licences are obtained by demonstrating that the above mentioned activities are conducted in a manner that is congruent with the requirements of the Canadian Good Manufacturing Practices (GMPs) for NHPs.

Further information is available in the Site Licence Guidance Document. All application forms and templates are available on our Web site under the Applications and Submissions section.

There are no costs or fees associated with the submission and review of product and site licence applications.

Completed submission packages should be sent by mail or courier to:

Natural Health Products Directorate
Submission Management Division
2936 Baseline Road, Tower A
Ottawa, Ontario (CANADA)
K1A 0K9 (for courier K2H 1B3)
A.L. 3302B

Further questions regarding the product and site licensing process may be addressed to our Submission Management Division by fax at (613) 954-2877 or e-mail at nhp_applications_psn@hc-sc.gc.ca..

4. How do I apply for a product or site licence?

The product and site licence application forms and templates are available on our Web site under the Applications and Submissions section. At this time there are no costs or fees associated with the submission and review of product and site licence applications.

Product and Site Licence guidance documents have been developed to assist applicants in preparing their submissions.

Completed submission packages should be sent by mail or courier to:

Natural Health Products Directorate
Submission Management Division
2936 Baseline Road, Tower A
Ottawa, Ontario (CANADA)
K1A 0K9 (for courier K2H 1B3)
A.L. 3302B

Further questions regarding the product licensing process should be sent by fax at (613) 954-2877 or by email to Natural Health Product Licensing.

Site licensing process inquiries may be addressed by fax at (613) 948-9255 or or by e-mail to Natural Health Products Site Licensing.

5. What is the process to import a natural health product to Canada?

Canadian importers must have a site licence and the onus is on them to provide evidence that imported products come from sites that meet the Canadian Good Manufacturing Practices (GMPs), or equivalent standards. The Canadian importer is responsible for submitting a Quality Assurance Report for each site (foreign and domestic) with their site licence application. They must ensure that these reports are complete and that all requirements of the GMPs are being met. Site licences are only issued to Canadian sites (none are issued to foreign sites). Foreign manufacturers will be covered under the Canadian importer's site licence.

Further information on the importation of NHPs is outlined in Section 5 of the Site Licence Guidance Document.

All products, whether manufactured domestically or in a foreign site, must first undergo a pre-market review where it will be assessed for safety, efficacy, and quality. Evidence demonstrating this must be submitted to Health Canada by means of a product licence application (one for each product). Products, which meet the required criteria, will be authorized for sale and each issued a Natural Product Number (NPN) or Homeopathic Medicine Number (DIN-HM). Further information on this process is available in the Product Licensing Guidance Document.

6. Once an application has been submitted to NHPD, what is the estimated time to receive an approval?

The Natural Health Products Directorate has not yet established a performance standard for submission processing. As we begin to process more applications, we will be in a better position to determine an average time frame.

However, as per Section 6 of the Natural Health Products Regulations, single-ingredient product license applications referencing a monograph as the sole source of evidence are subject to a 60-day disposition (i.e. will be processed within 60 days of receipt). The 60-day disposition comes into effect on July 1, 2004.

7. What are the costs for submitting a product and/or site license application for a natural health product or homeopathic medicine?

Presently, there are no costs or fees associated with the submission and review of product and site license applications. However, the Natural Health Products Directorate will be initiating consultations with industry stakeholders on a proposed cost recovery framework for natural health products. As it has done in the past, the Directorate will undertake a transparent and collaborative process to ensure that this framework is appropriate for the natural health products industry.

8. Are cosmetics such as skin creams, shampoos, toothpastes, etc. regulated by the Natural Health Products Regulations?

Cosmetics are regulated as natural health products (NHPs) only if they meet both the function and substance components of the NHP definition.

The function component refers to the intended use of the product. For a product to be considered a NHP, it must be manufactured, sold or represented for use in:

  1. the diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state or its symptoms in humans;
  2. restoring or correcting organic functions in humans; or
  3. modifying organic functions in humans, such as modifying those functions in a manner that maintains or promotes health.

The substance component refers to the medicinal ingredients in a NHP. According to the definition, NHPs can only contain medicinal substances found on Schedule 1 of the Regulations, and must exclude substances found on Schedule 2.

Only if these two components are present will a product be considered a NHP and be subject to the Natural Health Products Regulations. The fact that a product contains natural substances does not necessarily translate into it being classified as a NHP.

Cosmetic products that do not fall within the NHP definition are regulated under the Cosmetics Regulations of the Food and Drugs Act and are the responsibility of Health Canada's Cosmetics Program. For further information, you may wish to read the Frequently Asked Questions on this subject at.

9. Do the compliance approach priority dates apply to only products with claims?

No, the priority dates apply to products containing the specified substance set out in the respective priority regardless whether those products have claims or not.

10. How will the priority dates be applied for products containing more than one substance?

Natural health products (NHPs) containing more than one priority substance are considered "combination products." The priority associated with these combination products will be that of the highest priority ingredient. For example, an NHP containing a new drug (Priority 1) and a vitamin (Priority 5) will be considered a Priority 1 NHP.

11. Where do I find the Therapeutic Products Directorate (TPD) new drug list?

You can find the Listing of Drugs Currently Regulated as New Drugs. You can find the list of natural health products on the listing of drugs currently regulated as new drugs (April 1999 Edition) and their compliance priority categories in the Compliance Documents section of the NHPD web site.

12. Can I market my product without an NPN or DIN-HM?

All products must have valid market authorization prior to marketing in Canada. If your product has a valid DIN, you may continue to market your product until December 31, 2009 so long as the requirements for maintaining that DIN are met. If your product does not have any valid market authorization (i.e. NPN, DIN-HM or DIN), then you need to obtain a product licence for that product prior to marketing.

13. Is a monograph a proof of market authorization?

No, a monograph is not a proof of market authorization. It is a tool to facilitate the product licence application process.

14. Can I market my product once I have submitted my product licence application?

No, without a valid market authorization (product licence) you should not market your product.

15. Who is responsible for ensuring that the Quality Assurance Person and Third Party Auditor meet the regulatory requirements?

All Manufacturers, Packagers, Labellers and Importers of Natural Health Products are responsible for ensuring that their Quality Assurance Persons and Third Party Auditors are qualified under Sections 47 and 51 of the Natural Health Products Regulations.

Section 47 states

"Every natural health product shall be manufactured, packaged, labelled and stored by personnel who are qualified by education, training or experience to perform their respective tasks."

Section 51(1) states

  1. "Every manufacturer, packager, labeller, importer and distributor shall
    1. have a quality assurance person who
      1. is responsible for assuring the quality of the natural health product before it is made available for sale, and
      2. has the training, experience and technical knowledge relating to the activity conducted and the requirements of this Part; and
    2. investigate and record every complaint received in respect of the quality of the natural health product and, if necessary, take corrective action".

16. How does the Natural Health Products Directorate define Quality Assurance Person?

In the Good Manufacturing Practice Guidance Document, the Quality Assurance Person is defined as "The person who is responsible for assuring the quality of the natural health product before it is made available for sale. This person should be qualified by education/technical knowledge, training and experience relating to the specific activity (e.g., manufacturing, packaging, labelling and importing)".

17. How does the Natural Health Products Directorate define Third Party Auditor?

Third Party Auditor is defined as "An auditor who is independent of the company he or she is auditing and who is qualified by education, training and experience to conduct a natural health product good manufacturing practices site audit."

Note: the person who, under section 28(f) of the Natural Health Products Regulations, completes the Quality Assurance Report as part of the application for a site licence to demonstrate compliance with the requirements in Part 3, may or may not be the same Quality Assurance Person referred to in section 51 who is responsible for ensuring compliance with good manufacturing practices (GMPs) on a regular basis. However, if two different people perform these function, both must have the appropriate qualifications as noted above.

18. Will Health Canada recognize a Third Party Auditor as an in-house Quality Assurance Person for a natural health product company?

Yes. Health Canada will recognize a Third Party Auditor as an in-house Quality Assurance person as long as the person is qualified by education/technical knowledge, training and experience, and is able to complete the necessary requirements and responsibilities relating to GMPs set out in sections 47 and 51 of the Natural Health Products Regulations (see question 1 above).

19. Will Health Canada accept a Third Party Auditor as an in-house Quality Assurance Person for a number of natural health product companies?

Yes. Health Canada will accept a Third Party Auditor as an in-house Quality Assurance person for a number of natural health product companies at as long as the person is qualified by training experience and education, and is able to complete the necessary requirements and responsibilities relating to GMPs set out in section 51 of the Natural Health Products Regulations (see question 1 above).

20. How does Health Canada assess the Quality Assurance Person and Third Party Auditor?

The Quality Assurance Person and Third Party Auditor are assessed according to the requirements set out in Sections 47 and 51 of the Natural Health Products Regulations (see question 1 above).

The Quality Assurance Person and Third Party Auditor are also assessed against the specific activities (e.g., manufacturing, packaging, labelling etc.) and products (e.g., sterile or non sterile, homeopathic medicines) as stated in the site licence submission.

21. How does Health Canada define education, training and experience?

Education, training and experience are defined in the Good Manufacturing Practices Guidance Document for Natural Health Products.

Education refers to "The act or process of imparting or acquiring knowledge or skills; the learning of information by instruction, training, or study can be testified to by a degree, certificate or diploma

Training is defined as "To make proficient with specialized instruction and practice".

Experience refers to "Active participation in events or activities leading to the acquisition of knowledge or skills; the knowledge or skills retained from personally observing, encountering, or undergoing something.

22. Will Health Canada assess the qualifications of a Third Party Auditor independent of a site licence application?

No, Health Canada will not assess the qualifications of a Third Party Auditor independent of a site licence application.

Health Canada will only assess the qualifications of a Quality Assurance Person referred to under sections 28(f) or 51 of the Natural Health Products Regulations with a complete site licence submission. The assessment will be based on the education/technical knowledge, training and experience of the Quality Assurance Person for performing a site licence audit against the good manufacturing practices outlined in Part 3 of the Natural Health Products Regulations for the activities and products stated in the site licence submission. A complete site licence submission includes a site licence application form, a quality assurance report and, where appropriate, a supplementary quality assurance form for homeopathic medicine and a designated third party authorization form.

23. Will Health Canada issue a Quality Assurance Person or a Third Party Auditor a reference number once their qualifications have been reviewed against the requirements set out in Part 3 of the Natural Health Products Regulations?

No, Health Canada will not issue a reference number to the Quality Assurance Person or the Third Party Auditor as an endorsement of their qualifications. The education/technical knowledge, training and experience for a quality assurance person or third party auditor must be assessed against the specified activities and products referred to in the accompanying site licence submission.

24. Will Health Canada be establishing a system to accredit Quality Assurance Persons and Third Party Auditors for natural health products in the future?

Health Canada will continue to research and review options in this area but there are no immediate plans to establish an independent system for accreditation or recognition of the experience, education/technical knowledge and training for quality assurance personnel or third party auditors. It is the responsibility of the individual manufacturers, packagers, labellers and importers of natural health products to ensure that their personnel are adequately and appropriately qualified for the tasks they will be undertaking. The Natural Health Products Directorate will continue to consult with industry and stakeholders on this issue, to assess any future demands or needs in this area.

25. What is the status of vitamin K and submissions containing vitamin K?

Currently, vitamin K is an ingredient listed on Part II of Schedule F without qualifiers and is therefore not a natural health product (NHP). This means that, at this time vitamin K is only available by prescription. A Notice of Intent was posted in Canada Gazette, Part I, (CGI) on April 9, 2005, to add qualifiers to this ingredient on Schedule F. The Notice of Intent proposed to amend Part II of Schedule F to the Food and Drug Regulations of the Food and Drugs Act to provide exemptions to allow nonprescription status for:

  1. vitamin K1 and K2 in products intended for external use in humans; and
  2. vitamin K1 and K2 in oral dosage forms for use in humans when the maximum recommended daily dose is equal to or less than 120 micrograms (0.120 milligrams).

In a coincident amendment, it is also proposed to add vitamin K1 and K2 to Item 3 of Schedule 1, Included Natural Health Product Substances, to the Natural Health Products Regulations. However, the dosage forms and strengths of vitamin K remaining on Schedule F would not be considered to be natural health products in accordance with subsection 2(2) of the Natural Health Products Regulations.

The Natural Health Products Directorate (NHPD) is now accepting submissions for products that contain vitamin K as a medicinal ingredient (with some qualifiers, as indicated above) and the applications for products containing this ingredient will now be processed. Applicants that have reformulated a product containing vitamin K because of a Notice of Withdrawal will now be allowed to reformulate. Therefore, if an applicant has sent a submission for a product where vitamin K was removed from the list of ingredients and wish to re-introduce the ingredient to their product, they can send a fax to the NHPD requesting to add the ingredient back into their product application if the ingredient meets the qualifiers. The fax should be sent to the Submission Management Division, fax number (613) 954-2877, and the cover letter must clearly indicate that the reformulation is as a result of the descheduling process for vitamin K.

Although NHPD is now accepting submissions for vitamin K, it is important to note that no licences will be issued until the amendment to Schedule F is passed. A notice regarding the amendment will be posted on the Web site as soon as it is available.