Jessica Koves

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Important Notice Regarding the Transition of COVID-19 Site Licenses

In March 2020, Health Canada introduced interim measures to expedite the issuance of site licences for alcohol-based hand sanitizers, to address the shortage of these products due to the COVID-19 pandemic. Alcohol-based hand sanitizers are considered natural health products (NHP) and all Canadian companies engaged in manufacturing, packaging, labelling, or importing a natural health product for sale, require a natural health product site licence.

However, as the demand for alcohol-based hand sanitizers stabilizes, the interim order is approaching an end. The Natural and Non-Prescription Health Products Directorate (NNHPD) of Health Canada has set forth that temporary COVID-19 site licences (COVID-19 SL) for manufacturing, packaging, labelling and/or importing alcohol-based hand sanitizers will expire on September 30, 2021. Health Canada issued a bulletin to all temporary COVID-19 SL holders that gave a 60-day notice period in advance for the end of interim measures.

Therefore, COVID-19 SL holders are presented with two options prior to licence expiry:

  1. Stop manufacturing, importing, packaging, labelling, or distributing alcohol-based hand sanitizers.
  2. Apply for a valid SL to continue producing hand sanitizer until you receive a decision on your application.

If the SL holder would like to continue activities beyond September 30, 2021, then a complete site licence application (SLA) must be submitted, as per Section 28 of the NHPR, by September 30, 2021, at 11:59 pm PST. The applicant will be required to complete the web SLA form and must select the “COVID-19 SL Transition” option. The applicant will also be required to demonstrate compliance with the Good Manufacturing Practices (GMPs) (i.e. Quality Assurance Report (QAR), and applicable testing, release, and batch records).

Once the SLA form is completed and GMP evidence documents are collected, the applicant then must retrieve the ePost Connect conversation thread. If the applicant does not have a COVID Applications conversation, Health Canada has recommended to contact the following e-mail address: hc.nnhpd-dpsnso.sc@canada.ca with the subject line “COVID transition – No applications conversation”. It is worth noting that any applications submitted through other means will not be accepted.

If Health Canada deems that the application requires more information to be sent, then an Information Request Notice (IRN) may be sent. The IRN will state a timeline and define the additional information required. Failure to respond adequately or on time will result in an application refusal.

The service standards normally in place for new applications will not apply to COVID-19 SL transition applications. Therefore, temporary COVID-19 SL holders will be allowed to continue activities under the temporary licence, until a decision is issued. The NNHPD is striving to issue an acknowledgement within 30 days of receiving the application. Please be advised, if you receive a site licence, you will be required to renew it within one year.

Alternatively, if you wish to discontinue activities under the COVID-19 SL licence, Health Canada has requested that you send an email to the following e-mail address; hc.nnhpd-dpsnso.sc@canada.ca ahead of the September 30, 2021, end date. The email will need to include a cover letter, reference your COVID-19 SL number and the discontinuation date.  

It is important to understand that if you choose to discontinue activities, you may liquidate the remaining stock that was imported or manufactured while the interim COVID-19 SL was valid. You will be asked to confirm that you have ceased licensable activities. Also, you must retain samples of your products and records to enable a recall should the need arise.

In the event you have already stopped or never carried out activities under your interim COVID-19 site licence, you can notify the NNHPD that you wish to discontinue your license ahead of the September 30 deadline, following the same directions as above. If you take no action, the activities listed on your interim COVID-19 SL will no longer be allowed after September 30, 2021.

How can Quality Smart Solutions help you regarding the COVID-19 SL transition? We offer site license application services that consist of preparing and submitting applications, as well as handling communication with Health Canada. Also, our sister company, Quality IMPORT Solutions, can be your importer of record. Our team of experts can handle all site licencing matters and are happy to help you with future projects or questions! Please find our contact information here: Contact our Compliance Experts to Discuss Your Needs.

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Consultation Period Extension: Proposal to Improve Natural Health Product Labelling

On June 26, 2021, Health Canada launched a consultation on a proposal to improve natural health product labelling. Health Canada held extensive pre-consultation with a wide array of stakeholders in the development of the policy and prior to publication in Canada Gazette, Part I. The Canada Gazette, Part I consultation period process allows all stakeholders to review the proposed regulations and comment on the analysis of the potential positive and negative effects of a proposal on the health, safety, security, the social and economic well-being of Canadians, businesses and on the environment.

Recognizing that the timing of this consultation coincides with the summer holiday period and that there are a number of consultations underway at Health Canada, which may also be of interest to industry, the Canada Gazette, Part I public comment period is extended to 90 days and will now close on September 24, 2021. The details of how you can provide your feedback on the proposed amendments to the Natural Health Products Regulations can be accessed on Consulting with Canadians web page.

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News

Proposal to Improve Natural Health Product Labelling

Natural Health Product Labelling

On June 25, 2021, Health Canada published a news release that announced proposed changes to the Natural Health Products Regulations. The proposed changes would directly affect natural health product (NHP) labelling requirements.

What are Natural Health Products?

As defined by Health Canada, natural health products are naturally occurring substances that are used to restore or maintain good health. They are often made from plants, but can also be made from animals, microorganisms, and marine sources.

A wide variety of NHP’s, such as vitamins, probiotics, and minerals, are used daily by many Canadians. The COVID-19 pandemic has increased the demand for these products, as consumers are becoming progressively self aware and are wanting to take more control of their own health.

Why Are Changes Being Proposed?

Health Canada is conscious of the growing usage of NHP’s among Canadians and is therefore trying to improve the understanding of NHP’s by proposing an amendment that will enhance plain language labelling. The goal of the amendment is to improve representation of key information on product labels to help consumers make more informed decisions.

The importance of labelling can be demonstrated by an online poll that was published by the Office of the Auditor General. The poll asked participants to rate different factors that influence the purchasing of NHP’s. The results of the poll identified that a product label was the second most important factor that influences consumer decisions, among other strong factors that were rated less significant, such as recommendations from family, and pricing.

What Are the Proposed Amendments?

The proposal by Health Canada includes four key elements that can be summarized below:

  1. A Product Facts Table:

    Includes important product information, such as warnings and directions for use, that would be presented in a standardized table.

  2. Clearly and prominently displayed label text:

    Rules would be introduced to improve NHP label legibility and readability (ie. minimum font size requirements).

  3. Labelling of food allergens, gluten, and aspartame:

    Priority food allergens, gluten and aspartame would be identified in the warning section of the label.

  4. Modernized contact information:

    A manufacturer may display either an e-mail address, telephone number or website instead of a postal address, as currently required.

 

If the proposal were to be registered as part of the Natural Health Products Regulations, there would be a transitional period of 3 years to allow NPN license holders to make the appropriate changes to product labels.

How to Participate in the Consultation

The public consultation for the proposal to improve natural health product labelling opened on June 26, 2021 and will close on September 4, 2021. Health Canada welcomes comments and feedback on the regulatory proposal from all interested parties.

Sources:

www.canada.ca, www.oag-bvg.gc.ca

How We Can Help

Quality Smart Solutions offers a Canadian natural health product label compliance service. This service includes a complete review of your NHP label to determine if all regulatory requirements are implemented. The label compliance service utilizes a collaborative approach between the experts and our clients to ensure a compliant label is produced for the Canadian market.

Our team of experts at Quality Smart Solutions are continuously staying educated on the evolving NHP labelling requirements. Please contact us to learn more about NHP labelling or about how we can help with your NHP label!

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