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Transition Guidance Document for Natural Health Products
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(PDF Version - 54 K)About this Guidance Document
This guidance document explains the provisions of Part 6 of the Natural Health Products Regulations, specifically sections 108 to 115, the provisions that govern the transition periods associated with the Regulations.
The transition provisions were developed in consultation with stakeholders to provide for staged implementation of the Regulations. This allows time for training, education and public awareness to help stakeholders comply with the Regulations.
The provisions set out a two-year transition period for site licensing, from January 1, 2004, to December 31, 2005, for manufacturers, packagers, labellers and importers of natural health products conducting activities in Canada before the coming into force date of January 1, 2004. The Food and Drug Regulations continue to apply until manufacturers, importers, packagers and labellers obtain a natural health product site licence.
There is a six-year transition period for product licensing, from January 1, 2004 to December 31, 2009, for natural health products with drug identification numbers (DIN) issued under the Food and Drug Regulations. The applicable provisions of the Food and Drug Regulations continue to apply for products with a DIN until they are licensed under the Natural Health Products Regulations. From January 1, 2004, all new products (i.e. products not previously on the market) that fit the natural health products definition (see Overview of the Natural Health Products Regulations Guidance Document) must comply with the Natural Health Products Regulations immediately and must be subject to the full licence application process in order to be sold in Canada.
All natural health products must comply with all the Regulations by January 1, 2010.
Boxes with the text of the Regulations appear in relevant locations throughout the document. A complete version of the Regulations is available on the Internet at Natural Health Products Regulations.
The definitions of terms used in this guidance document are provided in the Glossary. The information in this guidance document is based on the Natural Health Products Regulations that were published in the Canada Gazette, Part II, on June 18, 2003.
Contents
1.1 Product with a Drug Identification Number (DIN)
1.2 DIN Products applying for a Product Licence
1.3 Site Licence Information requirements for DIN applications
1.4 Adverse Reaction Reporting
3. Good Manufacturing Practices
3.1 Distribution of a Product With a DIN
3.2 Sale of a Product With a DIN
1. Product Licence
1.1 Product with a Drug Identification Number (DIN)
108. (1) Subject to section 110, a person may, without complying with these Regulations, sell a drug to which these Regulations apply that is assigned a drug identification number in accordance with section C.01.014.2 (1) of the Food and Drug Regulations, until the earlier of
- the day on which an application for a product licence in respect of the drug is disposed of or withdrawn, and
- December 31, 2009.
(2) A person who sells a drug under subsection (1) shall conduct that sale in accordance with the requirements of the Food and Drug Regulations.
The product licence provisions, except section 6 related to the 60-day disposition clause, will come into force on January 1, 2004 with a six year transition period for products with a DIN ending December 31, 2009.
During this transition period, the Food and Drug Regulations continue to apply for products with a DIN that fit the definition of a natural health product under the Natural Health Products Regulations (see Overview of the Natural Health Products Regulations Guidance Document), until the application for a product licence under the Natural Health Products Regulations has been approved or refused, or until December 31, 2009.
1.2 DIN products applying for a Product Licence
109. An application for a product licence that is made in respect of a drug referred to in subsection 108(1) on or before December 31, 2009 is not required to contain the information referred to in paragraph 5(g).
Since Health Canada has already assessed and approved the safety and efficacy of these products under the Food and Drug Regulations, applicants do not have to submit evidence of safety and efficacy required under section 5(g) of the Natural Health Products Regulations with the product licence application. All other information required under section 5 of the Natural Health Products Regulations will need to be submitted to the Natural Health Products Directorate.
As well, since many of these products have already been formulated, the non-medicinal ingredients (NMIs) currently being used may not meet the NHPD requirements. To meet the NHPDs requirements on NMIs please refer to the list of acceptable NMIs and the Combination Policy which are available in The Evidence for Safety and Efficacy of Finished Natural Health Products Guidance Document. For more information on a product licence submission, refer to the appropriate section of the Product Licensing Guidance document.
1.2.1 Products With a DIN Issued Before 1994
Therapeutic Products Directorate (TPD) issued new data requirements for DINs assigned before 1994 called the Policy for Changes in Manufacturer's name and/or Product name. Therefore, applicants with products that have a DIN issued prior to 1994 and that have not notified as per section C.01.014.3 of the Food and Drugs Act and Regulations would raise safety concerns with the NHPD and thereby must, under section 15 of the Natural Health Products Regulations, submit a complete product licence application (including all the required safety and efficacy data required by paragraph 5 (g)). For more information on submitting a full product licence application, refer to the appropriate section of the Product Licensing Guidance Document.
When the evidence required to support a product with a pre-1994 non- notified DIN can be found in a Natural Health Product Directorate monograph in The Compendium of Monographs, the applicant may simply reference that monograph in the application instead of providing all the supporting safety and efficacy data.
1.3 Site License Information requirements for DIN applications
112. If during the period beginning on January 1, 2004 and ending on December 31, 2005, the information referred to in section 22 is not available to the licensee prior to commencing the sale of the natural health product or within 30 days after the day on which the license is issued in respect of the natural health product, as the case may be, the licensee shall provide the information to the Minister immediately after it is available to the licensee.
Section 22(1) of the Natural Health Products Regulations requires all product licence applicants to provide the name, contact details and site licence number for all manufacturers, packagers, labellers and importers of the natural health product, prior to commencing sale of the product. Given that there is a two-year transition period for manufacturers, packagers, labellers and importers to obtain a site licence, the site licence number may not be available when applying for the product licence. When this is the case, the applicant must submit this information as soon as it becomes available, up to the end of the two-year transition period for site licensing (December 31, 2005).
If, by January 1, 2006, the licensee has not provided this information, the Natural Health Products Directorate will, under section 18(1) of the Natural Health Products Regulations, suspend the product licence.
1.4 Adverse Reaction Reporting
Natural Health Products Directorate adverse reaction reporting requirements come into effect for each product once it receives a product licence under the Natural Health Products Regulations. Products with a DIN that have not yet received a natural health product licence are subject to the adverse reaction reporting requirements of the Food and Drug Regulations.
See the Adverse Reaction Reporting Guidance Document for information on the adverse reaction reporting requirements of the Natural Health Products Regulations.
2. Site Licence
113. (1) A person who, before January 1, 2004, manufactures, packages, labels or imports for sale a drug to which these Regulations apply may continue to conduct the activity in respect of that drug without complying with the requirements of Parts 2 and 3, until the earlier of
- the day on which that person's application for a site licence to conduct that activity in respect of the drug is disposed of or withdrawn, and
- December 31, 2005
(2) A person who conducts an activity under subsection (1) shall conduct that activity in accordance with the requirements of the Food and Drug Regulations.
All companies manufacturing, packaging, labelling or importing natural health products in Canada must possess a valid site licence by December 31, 2005.
Those companies that already manufacture, package, label, or import natural health products or hold an establishment licence under the Food and Drug Regulations must obtain a site licence sometime between January 1, 2004 and December 31, 2005. During this transition period, the Food and Drug Regulations continue to apply until manufacturers, importers, packagers and labellers obtain a site licence.
Refer to the Site Licence Guidance Document for information on how to apply for a site licence.
3. Good Manufacturing Practices
As of January 1, 2006, all manufacturing, packaging, labelling, importing, distributing, and storing activities of natural health products must be carried out according to the requirements of Part 3 of Natural Health Products Regulations.
Between January 1, 2004, and December 31, 2005, the Food and Drug Regulations continue to apply until manufacturers, importers, packagers and labellers obtain a natural health products site licence.
A company must be fully compliant with the good manufacturing practices provisions in order to receive a site licence, and must submit evidence demonstrating compliance, in the form of a quality assurance report, with the site licence application. See the Site Licence Guidance Document and the Good Manufacturing Practices Guidance Document for information on these requirements.
3.1 Distribution of Products With a Drug Identification Number
114. (1) A person who, before January 1, 2004 distributes a drug to which these Regulations apply may continue to conduct the activity in respect of that drug without complying with the requirements of Part 3 until December 31, 2005.
(2) A person who conducts an activity under subsection (1) shall conduct that activity in accordance with the requirements of Division 2 of Part C of the Food and Drug Regulations.
Although they are not required to hold a site licence, companies that distribute natural health products with a DIN have until December 31, 2005 to become fully compliant with the good manufacturing practice requirements of Part 3 of the Natural Health Products Regulations.
From January 1, 2006 onwards, all distributors of natural health products in Canada must be fully compliant with the good manufacturing practices provisions of Part 3 of the Natural Health Products Regulations.
3.2 Sale of Products with a DIN
115. A person may sell a lot or batch of a drug referred to in section 108 that is not manufactured, packaged, labelled, imported, distributed or stored, as the case may be, in accordance with the requirements of Part 3 if:
- the lot or batch is manufactured, packaged, and labelled before January 1, 2006 and ,
- any manufacturing, packaging, labelling, importation, distribution or storage of the lot or batch that is not conducted in accordance with the requirements of Part 3 is conducted in accordance with the requirements of Division 2 of Part C of the Food and Drug Regulations.
Anyone may sell a lot or batch of a natural health product with a DIN that was not manufactured, packaged, labelled, imported, distributed or stored according to Part 3 of the Natural Health Products Regulations, as long as these activities were carried out according to the requirements of Division 2 of Part C of the Food and Drug Regulations and the product was manufactured, packaged and labelled before January 1, 2006.
4. Clinical Trials
110. A sale or importation of a drug to which these Regulations apply that, before January 1, 2004, is authorized for the purposes of a clinical trial under Division 5 of Part C of the Food and Drug Regulations shall continue to be regulated under that Division.
The clinical trials provisions of the Natural Health Products Regulations come into force on January 1, 2004.
Any sale and importation of a natural health product for a clinical trial authorized before that date continue to be regulated according to Division 5 of Part C of the Food and Drug Regulations. Authorizations after that date are regulated according to Part 4 of the Natural Health Products Regulations.
For further information, refer to the Clinical Trials Guidance Document.
5. Labelling
111. Until December 31, 2009, a person may sell a lot or batch of a drug referred to in section 108 that is not labelled or packaged in accordance with the requirements of Part 5 if the lot or batch is packaged in accordance with the requirements of the Food and Drug Regulations.
All natural health products with a DIN are required to be labelled and packaged according to Part 5 of the Natural Health Products Regulations by December 31, 2009.
While the Natural Health Products Directorate recommends that new labels that meet the requirements of the Natural Health Products Regulations be used once a product licence is issued, old label stock may be used throughout the transition period for natural health products currently on the market and have DINs. However, new labels that comply with the Natural Health Products Regulations should be commissioned for the next print run for use once any existing label stock is gone.
For example, a manufacturer who has a DIN produces 100 units of ginseng on July 31, 2003. On April 1, 2004, the product receives its product licence from the Natural Health Products Directorate, but 50 units of the original 100 units remain. These remaining 50 units may be sold until December 31, 2009 with the original labels.
New products not previously on the market before January 1, 2004 must comply fully with the labelling and other requirements of the Natural Health Products Regulations, before being sold in Canada. For more specific labelling information please refer to the Labelling and Packaging section of the Product Licensing Guidance Document.
Glossary
Adverse reaction. A noxious and unintended response to a natural health product that occurs at any dose used or tested for the diagnosis, treatment or prevention of a disease or for modifying an organic function.
Batch. A quantity of product in the processing stage, homogeneous within specified limits, produced according to a single manufacturing order and as attested by the signatories to the order.
Clinical trial. An investigation in respect of a natural health product that involves human subjects and that is intended to discover or verify its 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.
Distributor. A person who sells natural health products to another person for the purpose of further sale by that other person.
DIN (drug identification number). A numerical code assigned to each drug product marketed under or in accordance with the Food and Drugs Actand Food and Drug Regulations.
Good manufacturing practices. Measures to ensure an overall effective approach to product quality control and risk management. They apply to places, people, processes and products with respect to which activities are being conducted. Please refer to Part 3 of the Natural Health Products Regulations and the Guide to Good Manufacturing Practices for Natural Health Products.
Importer. A person who imports a natural health product into Canada for the purpose of sale.
Lot. A quantity of any natural health product in dosage form, a raw material or a packaging material, homogeneous within specified limits, constituting all or part of a single batch and identified by a distinctive lot number which appears on the label of the finished product.
Manufacturer. A person who fabricates or processes a natural health product for the purpose of sale, but does not include a pharmacist or other health care practitioner who, at the request of a patient, compounds a natural health product for the purpose of sale to that patient.
Natural health product. A substance set out in Schedule 1 or a combination of substances in which all the medicinal ingredients are substances set out in Schedule 1, a homeopathic medicine or a traditional medicine, which is manufactured, sold, or represented for use in
- The diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state or its symptoms in humans;
- Restoring or correcting organic functions in humans; or
- Modifying organic functions in humans, such as modifying those functions in a manner that maintains or promotes health.
However a natural health product does not include a substance set out in Schedule 2, any combination of substances that includes a substance set out in Schedule 2 or a homeopathic medicine or a traditional medicine that is or includes a substance set out in Schedule 2.
Sell. Includes offer for sale, expose for sale, and have in possession for sale and distribute, regardless of whether the distribution is made for consideration (Section 2 of the Food and Drugs Act).
