Vol. 144, No. 19 — May 8, 2010

Natural Health Products (Unprocessed Product Licence Applications) Regulations

Statutory authority

Food and Drugs Act

Sponsoring department

Department of Health

REGULATORY IMPACT
ANALYSIS STATEMENT

(This statement is not part of the Regulations.)

Executive summary

Issue

When the NHPR came into force in 2004, an industry-led survey estimated that approximately 40 000 NHPs were already on the market, and did not comply with the new Regulations. Rather than taking immediate enforcement action to remove these products from the market, Health Canada used a risk-based approach for prioritizing compliance action for non-compliant products.

As of March 15, 2010, Health Canada has received approximately 47 180 product licence applications and has completed more than 37 000. However, there remain an estimated 10 000 products on the market for which applications have been filed with the Natural Health Products Directorate, but a decision to license or refuse has not been made. These products are categorized as:

— traditional medicines including traditional Chinese medicines, Ayurvedic and herbal medicines;

— non-traditional medicines including herbs, digestive enzymes, vitamins or minerals, and essential fatty acids;

— homeopathic medicines;

— personal care products (e.g. shampoos with health claims); and

— NHPs in food format (e.g. energy bars and juices with vitamins).

As a result of recent stakeholder feedback regarding the sale of unlicensed NHPs, Health Canada is of the opinion that a temporary solution is needed to allow Canadians access to products that meet certain safety criteria, while also making sure safety measures are in place to monitor products on the market, and to support the orderly transition of product licence applications that have been awaiting a full assessment by Health Canada.

Objectives

The regulatory proposal is to advance a temporary instrument for NHPs that have a product licence application awaiting review by Health Canada by expressly exempting them from the prohibition against sale in the NHPR.

The key objective of the proposal is to introduce a more appropriate level of safety oversight to these products. Products that meet certain safety criteria will be permitted to be sold lawfully while the applications are being processed. At the same time, key safety oversight measures will apply, including adverse reaction reporting, good manufacturing practices, and site licensing. In addition, the Regulations will maintain Health Canada’s ability to suspend a licence or to direct sales to stop. The proposal would also meet the objective of introducing greater stability and credibility in the regulatory environment for NHPs.

Description

Overview of regulatory proposal

The proposed Regulations would be made under the authority of the Food and Drugs Act and would apply to NHPs for which a product licence application was filed but a decision to issue or refuse a licence has not been made. The proposed Regulations would exempt these products from the prohibition of sale of the Natural Health Products Regulations (NHPR), if certain safety criteria are met. While exempt from the prohibition of sale, key on-market safeguards would apply, such as having to file safety information upon request from Health Canada, report adverse reactions, maintaining proper labelling and stop sale upon direction from Health Canada. As the application is processed, the NHP would be issued a product licence (represented by a natural health product number [NPN] or Drug Identification Number for Homeopathic Medicine [DIN-HM] on the product label) or refused one under the NHPR, and would therefore no longer be subject to the proposed exemption.

Application

These proposed Regulations would only apply to NHPs (as defined in the NHPR) for which a product licence application was filed with Health Canada and has not been withdrawn by the applicant, and until a decision to issue or refuse a product licence has been made by Health Canada.

Health Canada must assign an exemption number to any NHP to which these proposed Regulations would apply, before the later of 15 days after the proposed Regulations come into force, or 180 days from the date the application was submitted, if Health Canada had not made a decision to issue or refuse a licence in that time.

Product licence applicants would be notified in writing of the exemption number and the fact that the number would be posted on the Health Canada Web site, along with the product brand name and the applicant’s name, represented by the company name.

Applicants would be given 30 days to consent to the posting of this information and to provide a statement confirming that the product meets specific safety criteria. These would include confirming that the product is not

— a sterile product for ophthalmic use;

— a product that contains an ingredient that is prohibited from being sold in a drug under the Food and Drug Regulations (e.g. arsenic, mercury);

— to the best of the applicant’s knowledge, a product containing an ingredient that is likely to result in injury to the health of a consumer or purchaser, and whose presence in a natural health product or other drug has led to a recall or stop sale under the NHPR or the Food and Drug Regulations;

— recommended for use to treat, prevent or cure a serious disease (as listed in Schedule A of the Food and Drugs Act); or

— recommended for use in children under 12 years of age, or pregnant or breastfeeding women.

If the consent and statement were provided, and Health Canada was satisfied that the safety criteria were met, the exemption numbers would be posted on the Health Canada Web site, in addition to the product brand name and applicant’s name.

Once an exemption number is posted on the Health Canada Web site, the product licence applicant would be deemed to hold a product licence. The prohibition in subsection 4(1) of the NHPR against the sale of a product without a product licence therefore would not apply. This would allow the product to be sold subject to the provisions in these proposed Regulations and other key provisions in the NHPR.

If the applicant does not provide the statement regarding the safety criteria or consent to posting the information referenced above, or the products do not meet the safety criteria, the applicant would not be deemed to hold a product licence and would be subject to the prohibition of sale and all other requirements of the NHPR.

On-market requirements

Although exempted from the prohibition to sell without a product licence, these products would be subject to most of the remaining requirements in the NHPR.

The Minister would have the authority under sections 17–21 of the NHPR to direct an applicant to stop sales of product and to suspend or cancel a deemed licence to prevent injury to health. In addition, the Minister would have the authority under these proposed Regulations to suspend a deemed licence if they have reasonable grounds to believe the person has contravened the proposed Regulations or if it is later confirmed to be a product that does not meet the described safety criteria.

The on-market safety requirements in the NHPR for licensees to file safety information (section 16), to maintain records (section 23) and to report adverse reactions (section 24), would still apply.

In addition, the site licensing and good manufacturing practices requirements in Part 2 and Part 3 of the NHPR would also apply. This would ensure that all NHPs subject to the proposal would be manufactured, packaged, labelled, imported or stored in a licensed facility and in accordance with good manufacturing practices.

The requirements (sections 93 and 94) to include an NPN or a DIN-HM on the product packaging and labelling would not apply, as such numbers would not have been assigned in respect of these products. Instead, product licence applicants would be required to include the assigned exemption number on the label in a reasonable time, and when applicable, in accordance with the requirement for product numbers in these sections. In addition, the numbers must be shown on the label in accordance with sections 88 and 89 of the NHPR, to ensure that exemption number is clearly and prominently displayed, and readily discernible to consumers and retailers. It would be prohibited for an exemption number to be displayed on a label unless the exemption number is posted on the Health Canada Web site.

Sections 11–13 of the NHPR permit products with an NPN or DIN-HM to make post market changes by filing an amendment, a notification or a fundamental change. These post market changes would not be permitted for products to which an exemption number has been issued. Holders of an exemption number should notify Health Canada in writing of administrative changes, such as change of address, to their application already filed in accordance with section 5 of the NHPR.

Site licence information (information regarding importation, distribution, manufacturing, packaging, labelling or storing) would be required before commencing sale of the product. However, if the product is already being sold when it is issued an exemption number, this information would be required as requested by Health Canada, or if the product is an NHP that has been assigned a DIN, within 30 days. For the purpose of compliance and enforcement activities, the applicant would be required to inform Health Canada of the licensed sites.

For the purpose of compliance and enforcement activities, such as a product recall, applicants would be required to inform Health Canada of the licensed site that is conducting the regulated activities in relation to their product.

As well, the deemed licence holder, manufacturers, importers, or distributors who initiate a product recall would be required to provide the exemption number to Health Canada within three days of initiating a recall, in addition to the requirements set out in section 62 of the NHPR.

Sunset

These proposed Regulations would be repealed 30 months after they come into force.

Regulatory and non-regulatory options considered

The options outlined below were considered in the development of the proposed regulatory framework.

1. Status quo

Currently, when the Natural Health Products Directorate receives a product licence application, a submission number is issued. A submission number is not a market authorization. According to section 4 of the NHPR, a product licence is required to sell an NHP in Canada. Once a full assessment of a product licence application is completed, a product is either licensed or rejected.

Health Canada’s current compliance approach to NHPs which have not received market authorization by way of an NPN or DIN-HM is described in the Compliance Policy for Natural Health Products. Under this policy, compliance action would be taken when products present an immediate risk to health. Generally, a product which has received a submission number is considered a low priority for enforcement action, unless a risk to human health has been identified.

Maintaining the status quo would not address stakeholder concerns regarding the sale of unlicensed NHPs and the uncertainty regarding their safety.

2. Exemption from prohibition to sell without a product licence for products with a product licence application filed before February 1, 2010

Natural health products for which a product licence application was filed before February 1, 2010, but has not been processed or withdrawn, would be exempt from the prohibition of sale in subsection 4(1) of the NHPR. Health Canada would assign and publish exemption numbers to each product. Manufacturers would be required to display the exemption number on their product label. In addition, these products would be subject to most of the remaining provisions of the NHPR, including

— Sections 15 (additional information or samples), 16 (safety information), 17 (direction to stop sale), 18–21 (suspend or cancel a licence), 23 (records), 24 (adverse reaction reporting);

— Part 2 (site licences);

— Part 3 (good manufacturing practices); and

— Part 5 (general), with the exception of sections requiring that the NPN or DIN-HM be listed on the NHP label.

The Regulations would no longer apply to a product when a decision is made to grant or refuse a product licence, when an application is withdrawn by the applicant or when the Regulations were repealed.

Product licence applications received after February 1, 2010, would not be granted an exemption, and a product licence would be required before the product can be sold in Canada.

This option would have provided benefits to Canadians, by making sure key safety measures were in place to monitor products currently being sold on the market while the product licence applications were being processed by Health Canada, and to product licence applicants who had filed applications before February 1, 2010, by supporting an orderly transition of the applications that are awaiting a licensing decision from Health Canada. However, the proposed use of a cut-off date as the only basis for establishing which products would be eligible for an exemption was viewed as unfair treatment based on targeted consultations with key stakeholders.

3. Exemption from prohibition to sell without a product licence if application is not processed 180 days after it was submitted, and product meets certain safety criteria

Natural health products for which a product licence application was filed but has not been processed, or withdrawn, would be exempt from the prohibition of sale in subsection 4(1) of the NHPR. The exemption must be provided by Health Canada through a process that is initiated no later than 180 days after the application was submitted, if the Minister has not within that time made a decision to issue or refuse a licence, and is satisfied that the product meets certain safety criteria. Note that some product licence applications will have been waiting for 180 days by the time the proposed Regulations is adopted. The exemption numbers would be assigned and would be published on the Health Canada Web site. Manufacturers would be required to display the exemption number on their product label within a reasonable time. In addition, these products would be subject to most of the remaining provisions of the NHPR, including

— Sections 15 (additional information or samples), 16 (safety information), 17 (direction to stop sale), 18–21 (suspend or cancel a licence), 23 (records), and 24 (adverse reaction reporting);

— Part 2 (site licences);

— Part 3 (good manufacturing practices); and

— Part 5 (general), with the exception of sections requiring that the NPN or DIN-HM be listed on the NHP label.

These Regulations would no longer apply to a product once a decision is made to grant or refuse a product licence, when an application is withdrawn by the applicant or when the Regulations are repealed.

This option is recommended for the following reasons:

1. Allows for fair treatment across all product licence application types;

2. Offers benefits to industry by providing an orderly transition to full compliance with the NHPR;

3. Ensures Canadians have access to a full range of natural health products that are legally for sale; and

4. Allows Health Canada to more effectively manage the product licence application workload.

Benefits and costs

Cost-benefit statement		Base Year	Final Year	Total (PV) (i.e. after 30 months)	Average Annual
A. Quantified impacts ($)
Benefits	Industry	196 million	21 million	308 million	102 million
Cost	Industry (sponsors)	< 1 million	0	< 1 million	< 500,000
	Government of Canada	0	0	0	01
B. Quantified impacts in non-$
Positive impacts On Canadians: May prevent potential employment loss of some 500 full-time positions and 350 part-time positions depending on the scenario. On industry: Applicants filing a product licence application would have the benefit of a 180-day performance target following which an exemption would be required if a decision to issue or refuse a product licence had not been made.
C. Qualitative impacts
1. Consumers should benefit from continued access to NHPs that are on the market for which product licence applications have been filed but not yet fully processed by the Department. 2. Consumers would be assured explicitly that key on-market safeguards would be in place for those products affected by the regulatory proposal, and would have a mechanism to verify the regulatory status of the products. 3.  The proposal would reduce any potential legal liabilities of retailers that sell the affected products. 4. Health Canada would be able to provide additional regulatory formality and safety oversight to the NHPs that are currently sold on the market in technical non-compliance and managed with a compliance policy.

¹ This will be possible through the re-allocation of internal resources to process the approximately 10 000 unprocessed applications that have been filed with Health Canada and to meet the 180-day performance standard for all new product licence applications.

Baseline case and options for the analysis

In January 2010, the National Association of Pharmacy Regulatory Authorities (NAPRA) issued a position statement advising pharmacists not to sell marketed health products without a Drug Identification Number (DIN), a NPN or a DIN-HM. A DIN is a number assigned by Health Canada to a drug (prescription and non-prescription) when it is authorized under the Food and Drugs Regulations to be sold in Canada. An NPN (or a DIN-HM for Homeopathic Medicines) is assigned to a NHP when a product licence is issued under the NHPR. These numbers on product labels indicate to consumers, retailers and health professionals that the product has been assessed by Health Canada and has been found to be safe, effective and of high quality under the recommended conditions of use. The NAPRA position statement has also been adopted by some provincial Colleges of Pharmacists and is being implemented through the removal of products at the retail level and the cancellation or discontinuation of product purchases.

It is estimated that the NHPs affected by the proposed Regulations could represent a market value of approximately $935 million. These products are currently made available to Canadians through a number of retail channels, with an estimated 26% of the sales distributed by pharmacies.

There are at least two theoretical economic outcomes that could arise if Health Canada does not proceed with the regulatory proposal as outlined in the description.

In the first scenario, the potential impact is assumed to apply only to chain and independent pharmacies and their suppliers. In this case, individual pharmacists would likely consider the perceived health risks to their customers, and the legal risks to themselves in following the position statement of their governing body. As a retail channel, a pharmacy may also consider potential loss of market share to other retail channels.

The overall economic impact could range from $0 to $245 million for the initial year in this scenario, depending on the degree to which market discontinuation is implemented and the ability of other retail channels to pick up market shares.

A second possible scenario would see the removal of unlicensed products extended to other retail channels, other than pharmacies. In this scenario, the impact without government intervention could be $245 million and upward, with the full compliance of pharmacies. For example, if the whole retail sector decides to remove such products, approximately 34% of the products currently on the market could theoretically be removed, with an estimated market value as high as $935 million being taken out of the economy.

In both situations, it is expected that there may be a ripple effect on potential loss of employment over the next 30 months, from retailers through to manufacturers and producers while Health Canada is working to complete their assessment of the product applications. For example, a 3% impact on employment could translate into job loss of approximately 500 full-time and 350 part-time positions.

The benefits and costs of the regulatory proposal to specific stakeholders are outlined below. The complete cost-benefit analysis, including the approach and methodology, the baseline scenario, assumptions and considerations made for the purpose of estimations, source of data, as well as the detail calculations, can be found on the Health Canada Web site at the following address: www.hc-sc.gc.ca/dhp-mps/prodnatur/legislation/acts-lois/gazette1/regul-regle_cba-aca-eng.php.

Benefits

Consumers

Consumers should benefit from the status quo by continuing to have access to the marketed NHPs. In addition, consumers would be assured explicitly that the products meet certain safety criteria, that key on-market safeguards would be in place for those products affected by the regulatory proposal, and that they would have a mechanism to verify the regulatory status of the product.

Industry

Manufacturers, distributors, importers and retailers of products that are covered by the scope of the proposal would be able to lawfully sell their products. The proposal would also allow the product licence applicant to differentiate clearly their exempted products from those that are prohibited from being on the market as well as differentiating the exempted products from licensed products.

Applicants filing a product licence application would have the benefit of a 180-day performance target following which an exemption would be required if a decision to issue or refuse a product licence had not been made.

It would reduce the risk to pharmacies of losing market share to other retail channels such as other NHP retail outlets. The proposal would prevent a ripple effect throughout the NHP sector, with the potential for creating job losses from the retail level upward.

Health care professionals (e.g. pharmacists)

The regulatory proposal should address the safety concerns that some health care professionals and their governing bodies have regarding public disclosure of product status, notification of final product licensing decisions, and on-market safety measures. In addition, the proposed Regulations would reduce any potential legal liabilities or professional practice issues of health professionals should they decide to continue selling the affected products.

Health Canada

It would allow Health Canada to process the applications for these products and address the legal and safety concerns of stakeholders, by providing access to products that meet certain safety criteria, while also making sure safety measures are in place to monitor products on the market.

Costs

Consumers

Consumers would not incur any costs, directly or indirectly, as a result of this proposal as its intent is to provide a legal framework for a group of products that are currently available. No action or activity would be required from consumers.

Manufacturers and distributors

Manufacturers and possibly distributors may incur some incidental costs, such as time spent to consent to the posting of the exemption number, product name and applicant name on the Health Canada Web site and to provide the statement that the product meets the specified safety criteria. However, the amount is likely to be very minimal. There is also the cost of labelling of products to display the exemption number assigned by Health Canada. The labelling would provide transparency for consumers and would allow its manufacturers to differentiate their products from those that do not comply with these proposed Regulations or the NHPR. Label statements such as “Health Canada approval pending” have currently been seen in business practice to promote a product. To keep the incremental cost and market disruption to a minimum, exemption numbers should appear on product labels within a reasonable time. For example, this could be within a number of months or at the next printing of the product labels.

Retailers

Like consumers, retailers would not likely incur any costs as a result of this proposal. Since the intent is to provide a legal framework for a group of products that are currently being sold in the Canadian marketplace, no action or activity would be required from the retailers.

Health care professionals (e.g. pharmacists)

As with consumers and retailers, health care professionals would not be expected to incur any additional costs following the implementation of this proposal.

Health Canada

Health Canada would expect to incur additional operational and administrative costs to implement this proposal. In general, this includes managing and administering the additional exempted products. To address increased administrative pressures, Health Canada would have to re-allocate internal resources to address unprocessed applications that have been filed and to meet the 180-day performance standard for all new product licence applications.

Activities such as ensuring on-market safeguards are properly executed or completing the unprocessed product licence applications would have occurred with or without the proposal. Thus, they have not been included in the analysis.

Rationale

The proposed Regulations would support the orderly transition of product licence applications awaiting full assessment while ensuring the implementation of key safety measures to monitor products being marketed currently. The proposal would allow consumers access to products that meet certain safety criteria and are subject to on-market safety measures, while avoiding significant market disruption.

The safety measures in the proposed Regulations would be equivalent to the measures to monitor and address safety issues for NHPs for which an NPN or DIN-HM has been issued. Adverse reaction reports would have to be filed on a mandatory basis. Site licence requirements would apply to ensure that all NHPs are manufactured, imported and distributed in compliance with good manufacturing practices. If a risk does begin to emerge, the application for the NHP could be re-prioritized. Site licences could be suspended or cancelled. If the risk is serious, other measures such as directing a manufacturer, importer or distributor to suspend or to stop sale of a product could be applied.

The transparency measures, such as issuing and posting an exemption number, would allow retailers, consumers and health professionals to identify which products are subject to the exemption. This would improve the current administrative approach that does not overtly indicate which NHPs are being sold within the compliance policy.

Consultation

In February and March 2010, NHPD conducted informal consultations with an advisory committee to the Natural Health Products Directorate (Natural Health Products Program Advisory Committee), NAPRA, and the Ontario College of Pharmacists. The advisory committee included representation from industry, consumers, patients, health care professionals and academic organizations.

Overall, stakeholders were supportive of the regulatory proposal as a temporary mechanism to create stability in the regulatory environment for these products, while also providing a more appropriate level of formality and safety oversight to the sale of these products. The consultations resulted in feedback on a number of issues. Specifically, stakeholders wanted some assurance that the products covered by the proposal would be subject to some form of initial assessment by Health Canada, and that the proposal would provide regulatory authorities to monitor or respond to any safety issues that are identified. Stakeholders stressed the need for retailers and the public to be able to identify the products that are exempt from those that are licensed, and to have the status of those products updated as reviews are completed. Stakeholders also wanted assurance that the compliance and enforcement approach for NHPs would be normalized to be more consistent with other products, and for enforcement action to be taken against non-compliant products. Finally, stakeholders wanted some assurance that the proposal would be temporary in nature and would have a formal sunset date.

Health Canada has given consideration to all the comments. A more detailed summary of the consultations and the comments received is available upon request.

Implementation, enforcement and service standards

Implementation of the regulatory proposal would be supported by additional guidance for industry with respect to labelling requirements for the exemption number and enforcement strategies for the proposal.

The proposed Regulations would require that the exemption number be listed on the NHP label as soon as is reasonable. The intent of this requirement is transparency; it would enable consumers, retailers, health care practitioners, and others to determine which products are exempt from the prohibition against sale without a product licence. However, the addition of the exemption number to the label is not intended to be a significant burden to the NHP industry. Health Canada would take this into consideration in developing guidance for the implementation of this requirement. For example, current labelling practices require re-labelling, depending on the circumstances, within a 6- to 12-month period, or at the next printing of the label.

In order for NHPD to ensure that applicants have an opportunity to consent to the posting of the exemption number, product brand name and applicant name on the Health Canada Web site, NHPD would undertake an administrative process to notify affected applicants. Applicants would have 30 days to provide consent and the statement that the product meets the specified safety criteria. If an applicant does not provide this information within the 30 days or does not respond, the exemption number would not be posted and the product could not be sold on the market until the product licence application is fully processed and a product licence is granted. Through this process, product applicants would in effect be given an opportunity to exclude themselves from the exemption and to not have information regarding their product licence application disclosed publicly.

The Department employs a risk-based approach to ensure that the integrity of the regulatory system for marketed health products, including NHPs, is maintained through focussing compliance and enforcement activities on non-compliance that poses the greatest risk to the health and safety of Canadians. This non-compliance would include, for example, a product represented as an NHP, but which contains an undeclared prescription drug ingredient, an NHP making an unauthorized claim for a serious disease, or an unauthorized NHP that is marketed to children or pregnant women. Health Canada would continue to employ this risk-based approach.

Performance measurement and evaluation

The proposed Regulations would be repealed 30 months after coming into force. The desired outcome of the proposal would be to provide a temporary solution for the estimated 10 000 unprocessed product licence applications and to meet the 180-day performance standard for all new product licence applications. Product review performance would be monitored and reported on a quarterly basis.

Contact

Kyra Paterson
Senior Policy Analyst
Natural Health Products Directorate
Health Products and Food Branch
Health Canada
Qualicum Tower A, 3rd Floor
2936 Baseline Road
Address Locator 3303B
Nepean, Ontario
K1A 0K9
Email: nhp.exemption.psn@hc-sc.gc.ca

PROPOSED REGULATORY TEXT

Notice is hereby given that the Governor in Council, pursuant to subsection 30(1) (see footnote a) of the Food and Drugs Act (see footnote b), proposes to make the annexed Natural Health Products (Unprocessed Product Licence Applications) Regulations.

Interested persons may make representations concerning the proposed Regulations within 30 days after the date of publication of this notice. All such representations must cite the Canada Gazette, Part I, and the date of publication of this notice, and be addressed to Kyra Paterson, Natural Health Products Directorate, Health Canada, Qualicum Tower A, 3rd Floor, 2936 Baseline Road, Ottawa, Ontario K1A 0K9 (email: nhp.exemption.psn@hc-sc.gc.ca).

Ottawa, April 29, 2010

JURICA ČAPKUN
Assistant Clerk of the Privy Council

Her Excellency the Governor General in Council, on the recommendation of the Minister of Health, pursuant to subsection 30(1) (see footnote c) of the Food and Drugs Act (see footnote d), hereby makes the annexed Natural Health Products (Unprocessed Product Licence Applications) Regulations.

NATURAL HEALTH PRODUCTS (UNPROCESSED PRODUCT LICENCE APPLICATIONS) REGULATIONS

Application

1. These Regulations apply to a natural health product in respect of which

(a) a product licence application has been submitted to the Minister in accordance with section 5 of the Natural Health Products Regulations and has not been withdrawn; and

(b) the Minister has not issued a product licence under section 7 of those Regulations nor sent a notice under subsection 9(1) of those Regulations.

Exemption number — assignment

2. (1) The Minister must assign an exemption number to a natural health product to which these Regulations apply before the later of

(a) 15 days after the day on which these Regulations come into force, and

(b) 180 days after the day on which the product licence application for the product was submitted in accordance with section 5 of the Natural Health Products Regulations.

Exemption number — notice

(2) The Minister must, before the deadline imposed under subsection (1), send to the person who submitted the product licence application for the product a notice that sets out

(a) the exemption number; and

(b) the fact that the person has 30 days after the date indicated on the notice to submit to the Minister, in the form established by him or her, the following documents, failing which the person will not be deemed to have been issued a product licence for the product under subsection 3(1):

(i) a consent to the posting of their name, the exemption number and the brand name of the product on the Health Canada website, and

(ii) a statement by the person confirming that the product is not described in any of subparagraphs (3)(a)(i) to (v) nor, to the best of the person’s knowledge, in paragraph (3)(b).

Information — posting on website

(3) The Minister must, for each natural health product for which a consent and statement are submitted in the form established by the Minister before the end of the period referred to in paragraph (2)(b), post on the Health Canada website the information referred to in subparagraph (2)(b)(i) unless

(a) the product is

(i) a sterile product for ophthalmic use,

(ii) a drug referred to in any of sections C.01.036, C.01.036.1, C.01.040 or C.01.040.1 of the Food and Drug Regulations or a drug that is adulterated within the meaning of section C.01.038 of those Regulations,

(iii) recommended for use as a treatment, preventative or cure in respect of a disease, disorder or abnormal physical state referred to in Schedule A to the Food and Drugs Act,

(iv) recommended for use in children under 12 years old, or

(v) recommended for use in pregnant or breast-feeding women; or

(b) the Minister has reasonable grounds to believe that the product contains an ingredient that is likely to result in injury to the health of a purchaser or consumer and whose presence in a natural health product or other drug has led to

(i) a recall of that product or other drug, or

(ii) the sale of that product or other drug being stopped under section 17 of the Natural Health Products Regulations or section C.01.013 of the Food and Drug Regulations, respectively.

Information — non-posting

(4) The information referred to in subparagraph (2)(b)(i) in respect of a natural health product may be posted on the Health Canada website only if

(a) the documents referred to in paragraph (2)(b) were submitted to the Minister, in the form established by him or her, before the end of the period referred to in that paragraph;

(b) the product is not described in any of subparagraphs (3)(a)(i) to (v); and

(c) the Minister has no reasonable grounds to believe that the product is described in paragraph (3)(b).

Application for product licence

(5) A statement referred to in subparagraph (2)(b)(ii) that is submitted to the Minister in respect of a natural health product is, for the purposes of the Natural Health Products Regulations, deemed to be part of the product licence application for the product.

NHPR — licence deemed issued

3. (1) As of the time the information referred to in subparagraph 2(2)(b)(i) is posted on the Health Canada website in respect of a natural health product, the person who submitted the product licence application for the product is deemed, for the purposes of the Natural Health Products Regulations, to have been issued a product licence for the product.

No longer deemed

(2) The person is no longer deemed to have been issued a product licence for the natural health product as of the time

(a) the person withdraws the product licence application;

(b) the Minister issues a product licence for the product under section 7 of those Regulations or sends a notice in respect of the product under subsection 9(1) of those Regulations; or

(c) these Regulations are repealed.

NHPR — greater certainty

(3) For greater certainty, in respect of a natural health product for which a product licence is deemed to have been issued,

(a) the prohibition on sale set out in subsection 4(1) of the Natural Health Products Regulations does not apply; and

(b) subsections 4(2) and (3) of those Regulations apply.

NHPR — non-application

(4) The following provisions of the Natural Health Products Regulations do not apply in respect of a natural health product for which a product licence is deemed to have been issued:

(a) sections 11 to 13;

(b) paragraph 18(1)(b);

(c) section 22;

(d) paragraph 62(c);

(e) subparagraph 93(1)(a)(ii); and

(f) subparagraph 94(1)(a)(vii).

Suspension — additional power

4. (1) In addition to the power set out in paragraph 18(1)(a) of the Natural Health Products Regulations, the Minister may also, subject to subsection 18(2) of those Regulations, suspend a product licence that is deemed to have been issued if the Minister has reasonable grounds to believe that

(a) the person to whom the licence is deemed to have been issued has contravened these Regulations; or

(b) the natural health product to which the licence relates is described in any of subparagraphs 2(3)(a)(i) to (v) or in paragraph 2(3)(b).

Suspension under subsection (1)

(2) A suspension under subsection (1) is deemed to be a suspension under section 18 of the Natural Health Products Regulations.

Site information — sale not yet commenced

5. (1) Subject to subsection (2), a person who is deemed to have been issued a product licence for a natural health product must provide the Minister with the information referred to in subsection 22(1) of the Natural Health Products Regulations before commencing the sale of the product.

Site information — already for sale

(2) If the natural health product is already for sale on the day on which the product licence for the product is deemed to have been issued, the person must provide the information to the Minister

(a) if the 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, within 30 days after that day; or

(b) in any other case, on request.

Recall

6. In addition to the information set out in section 62 of the Natural Health Products Regulations, every manufacturer, importer or distributor referred to in that section who commences a recall of a natural health product for which an exemption number is posted on the Health Canada website must provide the Minister with the exemption number for the product within three days after the day on which the recall is commenced. The same rule applies to a person who is deemed to have been issued a product licence for a natural health product and who commences a recall of the product.

Labelling — exemption number

7. (1) A person who is deemed to have been issued a product licence for a natural health product must ensure that the product’s exemption number, preceded by the designation “EN”, is shown within a reasonable time on the label for the product in accordance with

(a) section 88 and, if applicable, section 89 of the Natural Health Products Regulations; and

(b) the requirements that apply to product numbers in section 93 and, if applicable, section 94 of those Regulations.

Prohibition — label

(2) A person must not display an exemption number on the label of a natural health product unless the number is posted on the Health Canada website in accordance with subsection 2(3).

Repeal

8. These Regulations are repealed on the day that is 30 months after the day on which they come into force.

Coming into force

9. These Regulations come into force on the day on which they are registered.

[19-1-o]

Footnote a
S.C. 2005, c. 42, s. 2

Footnote b
R.S., c. F-27

Footnote c
S.C. 2005, c. 42, s. 2

Footnote d
R.S., c. F-27

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