Natural Health Products Regulations in Canada – A High Level Overview
As a result of consultation with Canadian consumers, academic institutions, health care practitioners and industry stakeholders on the situation of Natural Health Products (NHP), a report comprising 53 recommendations was issued. Based on these recommendations, Health Canada modified the Food and Drug Act, and, on January 1st 2004, came in force the Natural Health Products Regulations. The regulations aimed at giving Canadians access to safe and effective Natural Health Products of high quality and also with enough information on their labels so that consumers can make a decision on which product is suitable for their specific needs.
The Regulations set out requirements for: product (Product Licence), manufacturers and importers (Site Licence), Good Manufacturing Practices, clinical trials, packaging and labeling and finally transitional provisions.
A clear definition of a Natural Health Product was included in the Regulations and reads as follows:
Natural Health Product means a substance set out in Schedule I or a combination of substances in which all the medicinal ingredients are substances set out in Schedule I, a homeopathic medicine or a traditional medicine that is manufactured, sold or represented for use in:
(a) The diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state or its symptoms in humans;
(b) Restoring or correcting organic functions in humans; or
(c) Modifying organic functions, such as modifying those functions in a manner that maintains or promotes health.
Schedule I is a list of substances that are classified as Natural Health Product Substances. Here is the list:
- A plant or a plant material, an alga, a bacterium, a fungus or 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 described in any of items 2 to 5
- A mineral
- A probiotic
Part 1- PRODUCT LICENCES
Before it is authorised for sale in Canada, each NHP must be issued a Product Licence identified by a Natural Product Number (NPN) given by the Natural Health Product Directorate (NHPD) a new entity created within Health Canada.
An application for a NPN must be filed and be reviewed by NHPD before the product is authorised for sale in Canada. The application must include qualitative list of active ingredients, their source, dose, potency, the list of non-medicinal ingredients, the recommended use, proposed labelling material including claim, dosage, precautions and warnings. Evidence of efficacy and safety must be supplied and found acceptable by NHPD. Once Health Canada has assessed a product and decides that it is safe, effective and of high quality, it issues a product licence along with a NPN. This number is printed on the label and informs the consumer that the product has been evaluated by Health Canada.
There are three types of applications depending on the type of active substance and proposed health claims. Some substances at precise dosage are described in monographs issued by NHPD. For this type of application called compendial, it is not required to file evidence of efficacy and safety provided the label complies with the information present in the monograph.
Some substances may have been used at a certain dosage for more than two generations. Applications for products using these substances are classified as traditional application. Evidences taken from traditional resources documentation are sufficient. For all other products application, classified as non-traditional, modern scientific evidence such as clinical trial data are required to support claim and safety.
Part 2 –SITE LICENCES
The NHP Regulations apply to the sale, manufacture, packaging, labelling, importation, distribution and storage of NHPs. Some of these activities can only be done once a Site Licence has been issued. Any person or company that wants to manufacture, package, label, import NHPs must obtain a Site Licence before starting its activities. Retailers do not require a licence. In order to get a site licence, the applicant must demonstrate that the operations are performed in compliance with a quality system as described in part 3 of the Regulations: Good Manufacturing Practice. The NHPD issued a guidance document called Quality Assurance Report that guides the applicant through performing an audit of its premises and activities in accordance with the GMP requirements. Evidence of compliance must be added to the report for assessment by NHPD.
A Site Licence is issued for one year and must be renewed by filing a licence renewal application along with evidence of GMP compliance. After three consecutive years, the licence may be issued for a period of two years and after nine years, the licence will be issued for a period of three years.
PART 3 – GOOD MANUFACTURING PRACTICES
In brief, the GMP for NHPs includes specifications for raw materials and packaging components and compliance with these specifications before approval for use; as well as specifications for finished products and testing against their specifications before approval for sale is given by the person responsible for quality assurance. The Regulations specifies design of premises and equipment that shall be such to avoid contamination and mix up.
Personnel qualification, education and training are also regulated.
A sanitation program must be in place and shall include pest control program, procedures for effective cleaning of the premises and the equipment. Requirements for health and hygienic behaviour are also part of the GMPs.
Records must be ceated and kept for each lot or batch of product. These records include manufacturing and packaging documentation, testing results, copy of printed material and quality assurance release for sale. Stability data must be available for each product sold in Canada. Samples of each lot of product distributed or imported must be kept for a period of not less than expiry date plus one year.
Distribution records must be maintained in order to be able to recall a product from the market.
Part 4 - Clinical trials
Part 4 of the Regulations is titled Clinical trials involving human subject. Before conducting a clinical trial with an NHP, the sponsor must apply for an authorization, the application must contain a copy of the protocol and a copy of the statement as it will be set in the informed concent form that states the risks and benefits. Information on the natural health product, ingredients, dosage, etc. must also be provided for assessment. Good Clinical Practices must be adhered to.
Adverse reaction reporting system in these Regulations is similar to the system now in place for pharmaceuticals. Regulations require product licence holders to monitor all adverse events associated with their products. Serious and unexpected adverse reactions must be reported to Health Canada.
Labeling requirements of NHPs are set out in the Regulations. The label of an NHP must show:
- Its recommended use or purpose
- Its dosage form
- Its recommended route of administration
- Its recommended dose
- Its recommended duration of use, if any, and
- Its risk information, including any cautions, warning, contra-indications or known adverse reactions associated with its use.
- The common name and proper name of each medicinal ingredient and each non-medicinal ingredient that it contains
- A description of the source material of the medicinal ingredients
- Its storage conditions
- Its brand name
- Its NPN (Natural Product Number)
- The net amount in the package
- The name and address of the product licence holder (or importer)
- The quantity of each medicinal ingredient per dosage unit
- Lot number and expiry date
Many countries have regulated their NHPs in a similar way that Canada did. People take NHPs for their medical properties. Therefore NHPs are closer to drugs than to food. By assessing the efficacy, safety and quality of NHPs, the authorities ensure consumers are informed of the recommended use of NHPs as well as their quality.
About the author
Melvin Dionne, pharmacist
Consultant in Canadian regulatory affairs
Having received a B.Sc. in pharmacy from the university of Montreal, Melvin Dionne worked in the Canadian pharmaceutical industry field for twenty five years. During these years, he occupied senior positions. The last twelve years as VP of scientific affairs, he was in charge of regulatory affairs, quality control and quality assurance.
In 1999, he created Services Pharmaceutiques Melvin Dionne inc (SPMD) and acts as its president today. This consulting firm offers its services in drugs, natural health products and cosmetics regulatory affairs and quality assurance. Among the services offered there is the presentation of drugs applications, natural health products applications, as in Canada, these are regulated in a similar way that drugs are. SPMD also offers to set up quality systems compliant to Good Manufacturing Practices (GMP), a standard that regulates manufacturing and packaging of drugs and natural health products (NHP). SPMD also offers initial and continuing GMP training to pharmaceutical firms and NHP manufacturers and packagers for employees of all departments and levels. Mr Dionne is also the co-founder of a contract manufacturer and packager of NHPs in Canada. Since 2004, Sol-Labo offered its services to many owners of NHPs that prefer to leave to experts the production of their products thus ensuring compliance at all time.
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