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Andrew Parshad

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MDSAP: What Is It and How Does It Apply to my Medical Device?

Who Needs an MDSAP Certificate?

Anyone looking to manufacture a Class II, III or IV medical device in Canada requires a Medical Device Licence (MDL) for each product they sell. In order to obtain an MDL you need an ISO 13485 certificate that has been issued through the Medical Device Single Audit Program (MDSAP). These certificates are evidence that your company has an appropriate quality management system in place to ensure that only safe and effective medical devices are made available for sale.

How do I obtain an MDSAP certificate?

First you must implement a quality management system within your company that meets the requirements of ISO 13485. The areas covered by these practices include design and development, production, storage and distribution, installation, and servicing of medical devices. Once all applicable procedures are in place you must contact an auditor that has been authorized to issue MDSAP certificates. Only certificates issued by approved auditors will be recognized by Health Canada.

Note that these certificates include a scope of the types of products that your company is authorized to manufacture. For example, if you obtain an MDSAP certificate for the manufacture of medical gloves you can get an MDL for medical gloves but not for home pregnancy tests. The scope of the certificate must match the type of product being sold. If you need to expand the scope of your certificate you must contact your auditor.

Why is it called a single audit program?

Historically every country would require their own audit of medical device manufacturer’s quality management system. This led to a situation where a company looking to sell in 5 different countries would often require 5 different audits of the quality management system. In order to reduce the burdens associated with multiple audits, several countries banded together to form the Medical Device Single Audit Program. Certificates issued through MDSAP will satisfy the audit requirements for all participating countries.

Countries that currently recognize MDSAP certificates include:

  • Australia
  • Brazil
  • Canada
  • Japan
  • USA

Are there any exemptions? What if I have an ISO 13485 certificate but it’s not MDSAP?

Health Canada won’t accept any other ISO 13485 certificate even if it’s from a major market such as the European Union. The only exception that has ever been granted is for devices related to the COVID-19 pandemic. Health Canada created a special approval pathway for these devices that would allow non-MDSAP certified companies to obtain authorization to sell their products.

I don’t have an MDSAP certificate and I’m not interested in obtaining one. What are my options?

The only option in this case is to enter into a private label agreement with a company that has one. The company you partner with must already have an MDSAP certificate and an MDL for the product they will be making. You will need to submit a Private Label Licence Application to Health Canada that states that your business partner will be conducting all manufacturing work and the product is identical to the already licenced product in every way except brand name and the company name listed on the label.

How Quality Smart Solutions can help:

Quality Smart Solutions offers many avenues of support including full support for obtaining any Medical Device License. Our team is equipped with professionals who have extensive experience in the Canna, Pharmaceutical, Natural Health Product, Food and Medical Device industries.

30 Minutes Free Consultation
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Public Consultation on Medical Devices Clinical Trials Modernization Initiative

Health Canada has published a consultation paper on proposed changes to the regulation and oversight of clinical trials for drug, medical devices and natural health products (NHPs). The purpose of these changes is to improve the speed at which these trials are approved, to avoid stifling medical advances that could help improve the health of Canadians, and to improve transparency and regulatory oversight.

The proposed changes would integrate all health products into the same framework and feature:

  1. Proportional risk-based oversight 
  2. New regulatory agilities over the lifecycle of the trial 
  3. Greater transparency through registration and public disclosure of results
  4. A modernized compliance and enforcement regime (see figure 1)

Health Canada is accepting feedback on the proposed changes until 4 July 2021.

Agile Life Cycle

With the adoption of a more agile life cycle approach, Health Canada is looking to be able to give themselves the tools to oversee clinical trials in their entirety while better enabling sponsors to conduct innovative types of trials. As part of these changes, Health Canada will be able to authorize a trial rather than just the sale or importation of an investigational product, authorize a trial with multiple product types through a single authorization, and streamline the application requirements across all product lines for greater efficiency, while maintaining the protection of the health and safety of participants.

Under this scheme Health Canada will allow for the authorization of Master protocols that include multiple sub-studies for different therapies or indications for use. Types of proposed Master protocols include:

  • Basket trials, which investigate the safety/efficacy/effect of an investigational product across a variety of indications
  • Umbrella trials, which investigate the safety/efficacy/effects of several investigational products in a single indication
  • Platform trials, which investigate several investigational products in one or multiple indications in a highly dynamic design

By integrating all health products into a common framework, products from multiple categories can be approved under the same protocol. For medical devices this would result in an expansion of who can sponsor a clinical trial. It will now include independent investigators (such as a researcher, clinician or health care facility) in addition to the manufacturers and importers of medical devices. These changes will also result in any medical device trial being required to adhere to Good Clinical Practices (GCP).

Health Canada is also seeking to improve safety monitoring of clinical trials through improved clarity and increased authority to request information relating to adverse events including the ability to request an analysis of safety data while the trial is ongoing. This may include an assessment of safety signals to determine if the benefit/risk balance has changed during the conduct of the trial.

In this approach, Health Canada will have the ability to suspend or cancel either the whole trial or only a part of the trial if there’s a lack of efficacy or a safety concern.

Risk-Based Approach

All health products will follow a common risk-based approach to authorization. To do this they will create risk-based categories with differing levels of oversight and regulatory requirements for drugs and NHPs. The pre-existing risk-based device classification scheme for medical devices will be maintained and integrated into the new scheme. See figure below:

Source: www.canada.ca

Health Canada will be granted the authority to impose terms and conditions on a clinical trial authorization before and during the trial to address significant uncertainties or mitigate risks related to the product(s) being tested, or to the conduct of the trial. These terms and conditions may include:

  • More frequent safety reporting
  • Monitoring of specific populations because of potential increased risk (e.g. children, pregnancy)
  • Additional information to characterize and mitigate newly identified risks

To allow for greater trial participation from volunteers outside of major urban areas, changes will be made to allow for studies to take place remotely, without a physical visit to a trial site. Monitoring will be allowed using videoconferences with investigators, visits at home by study personnel, internet-based tools for data collection and reporting, and mobile technology such as biosensor devices.

Transparency

Health Canada is looking to expand on its current  Clinical Trials Database and is exploring new ways to publish clinical trial information. This may include mandatory registration of any trial conducted in Canada on an existing international registry of Health Canada’s choosing. Sponsors may be required to make the results of their trials available to all members of the public by publishing the information in this database. Health Canada is also proposing making this information available on its website to ensure it’s easy to find and available in both official languages.

Modernization of Compliance and Enforcement

Although Health Canada already has the authority to conduct inspections on clinical trial activities under Section 23 of the Food and Drugs Act, its activities have been limited to drugs. As part of the modernization, Health Canada will extend its compliance and enforcement to NHPs and medical devices. Inspections will be conducted using a risk-based and pro-active approach based on trial design, the medical condition under study, target population, and the risk classification of the investigational product. Health Canada will also implement a cyclical risk-based inspection approach that considers the compliance history and the volume of activities. Highly compliant entities would be inspected less frequently while less compliant ones would be inspected more frequently.

At present Health Canada only has direct oversight over the sponsors of the trials. Health Canada is proposing regulatory changes that would ensure that all third parties conducting trials on behalf of a sponsor are legally responsible for any activities they conduct. This would result in an increased regulatory burden for these third parties but will increase the safety of clinical trial participants by allowing Health Canada to require them to take corrective action instead of directing the sponsor to take the action against the third party.

Anticipated Outcomes for Stakeholders

Health Canada believes these changes will help encourage clinical trials in Canada by providing greater agility in oversight of the development of healthcare products, ensuring that regulatory requirements are proportional to risks, improving access to clinical trial information, creating a more streamlined approach that is better aligned internationally and leverage partnerships and provide leadership in Canada’s health ecosystem to further facilitate clinical trials in Canada.

How We Can Help

At Quality Smart Solutions, we provide you with the guidance to plan your Veterinary Health Products business, navigate the legal requirements, and acquire the appropriate license for your operations.

Quality Smart Solutions has a team of professionals to offer support from day one of starting your business, including formulation and label reviews, Veterinary Health Product notifications and more.

30 Minutes Free Consultation
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Cancellation of MDELs for Non-Compliance with Annual Licence Review Requirements

Cancellation of Medical Device Establishment Licence for A Non-compliance With Annual Licence Review Requirements

On May 27, 2021 Health Canada issued a bulletin about cancellation of Medical Device Establishment Licence (MDELs) for the sites that are not compliant with the annual licence review requirements. About 700 MDEL holders have not submitted an annual licence review application for the 2020/2021 fiscal year, and as a result Health Canada cancelled their MDELs. This means that these sites are not able to conduct their activities and must re-apply for a new establishment licence and pay the applicable fees. 

Annual Licence Review

An annual licence review (ALR) ensures that medical device establishment licence (MDEL) holders are complying with regulatory requirements associated with the Medical Devices Regulations. An ALR also ensures that their licence information is up-to-date.

As a courtesy, Health Canada sends an ALR application package to all active MDEL holders at the end of each calendar year. Health Canada also sends out 2 reminder notices to the licence contact person on file.

MDEL Holder Responsibilities

To continue doing business, active MDEL holders must submit an ALR application before April 1 of each year as per section 46.1 of the Medical Devices Regulations. Licence holders with a suspended MDEL do not need to apply.

Health Canada will cancel the MDEL for those licence holders who do not submit their ALR application within the required timeline. This authority is set out in section 51.1(b).

Under section 48, active MDEL holders must also notify Health Canada within 15 calendar days if they change their contact information. This includes changing the name or address of their establishment or the information of the establishment representative associated with their MDEL.

Cancellation of MDELs

Since the ALR deadline of April 1, 2021, about 700 MDEL holders have not submitted an ALR application for the 2020/2021 fiscal year. As this violates section 46.1, Health Canada have cancelled their MDELs and removed them from the active MDEL live listing.

MDEL holders whose establishment licence is cancelled are no longer authorized to conduct licensable activities (such as manufacturing, distributing or importing medical devices). They must cease their activities immediately once they receive their cancellation notice.

Resuming Licensable Activities

To resume licensable activities, companies whose MDEL has been cancelled must re-apply for a new establishment licence and pay the applicable fees. In line with the compliance and enforcement policy for health products (POL-0001), Health Canada carries out compliance monitoring activities. Cancelled MDEL holders may be subject to compliance and enforcement actions if Health Canada finds they are conducting non-compliant activities.

For more information on how to re-apply for a MDEL or if you need assistance filling your ALR please visit our website. Our Experts at Quality Smart Solutions continue to support your needs for medical devices, natural health products, foods, cosmetics and OTC drugs for North America. Contact us today to learn more about how we can support your compliance for Medical Device Establishment licence.

How We Can Help

Our Experts at Quality Smart Solutions also offer to support your needs for foods, cosmetics, OTC drugs and medical devices for North America.

Contact us today to learn more about how we can support your compliance needs during and after licensing!

30 Minutes Free Consultation

References:

Cancellation of MDELs for non-compliance with annual licence review requirements – Health Canada.

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Interim Order No. 2 Respecting the Importation and Sale of Medical Devices for Use in Relation to COVID-19

Interim Order

As of March 1, 2021, Interim Order No. 2 replaces Interim Order No. 1 Respecting the importation and sale of medical devices for use in relation to COVID-19. Interm Order No. 2 will continue to issue expedited authorizations for the sale or import of medical devices to deal with the current significant risk of COVID-19 to the health and safety of Canadians.

The Interim Order provides an expedited authorization pathway for:

  • new COVID-19 medical devices that are not yet licensed in Canada,
  • COVID-19 related uses for existing devices licensed under the Medical Devices Regulations or Interim Order No. 2 and
  • COVID-19 medical devices that leverage an authorization of a device from a trusted foreign regulatory authority, whereby the Minister would maintain the ability to request additional information on a case-by-case basis.

Interim Order No. 2 introduces new requirements for importers and distributors of COVID-19 medical devices to hold an MDEL, and for manufacturers to comply with bilingual labelling requirements. Both of these changes align with requirements in the Medical Devices Regulations.

Authorization for importation or sale by the manufacturer

Interim Order No. 2 provides COVID-19 medical device manufacturers an exemption from certain requirements of the Medical Devices Regulations, provided they have received an authorization for the importation or sale of their device(s) from Health Canada.

A manufacturer may submit an application for authorization under Interim Order No. 2. If an authorization is granted, the manufacturer may import or sell the COVID-19 medical device for which they hold an IO authorization in Canada. The manufacturer’s information and device information on the device label can then be cross-referenced against the IO authorization during importation and distribution, which is required to accompany the product during import.

Fees related to the submission of an application for a COVID-19 medical device authorization

Health Canada will waive all application fees for COVID-19 medical device authorizations subject to Interim Order No. 2 Respecting the Importation and Sale of Medical Devices for Use in Relation to COVID-19.

Quality Management System requirements related to the submission of an application for a COVID-19 medical device

Health Canada does not require manufacturers to provide a Medical Device Single Audit Program (MDSAP) certificate with their application for a COVID-19 medical device subject to Interim Order No. 2. Manufacturers will be required to share information to demonstrate that their products are of consistent quality and effectiveness. This can be demonstrated by either providing a copy of the manufacturer’s Quality Management System certificate to ISO 13485:2016, or by submitting evidence of Good Manufacturing Practices and its proper implementation.

Documentation required for importation

Under Interim Order No. 2, each shipment of a COVID-19 medical device that is imported into Canada must be accompanied by a copy of the Interim Order authorization. This document will be issued to the applicant upon authorization and will facilitate transport of the COVID-19 medical device(s) across the border, as it will be used as a signal that the device has been authorized under the Interim Order. Importers should rely on this mechanism to demonstrate to Health Canada that a shipment containing COVID-19 medical devices should be allowed access into Canada. References to Interim Order No. 1 on the authorizations can be read to be references to Interim Order No. 2.

Incident reporting 

Interim Order No. 2 requires that the holder of the COVID-19 medical device authorization for the importation or sale of the device report to Health Canada to comply with incident reporting requirements. 

Importers and distributors also must comply with mandatory reporting as outlined in the Medical Devices Regulations. Importers and distributors should also note that new regulations on mandatory reporting under the Medical Devices Regulations will come into effect on June 23, 2021, at which point importers will be expected to comply with the new regulations.

Requirement for importers and distributors to hold a Medical Device Establishment Licence (MDEL)

Under Interim Order No. 1, importers and distributors were not required to hold an active Medical Device Establishment Licence (MDEL) to import or distribute COVID-19 medical devices authorized under the IO. To enable risk-based regulatory oversight on the medical device supply chain and facilitate complete and rapid recalls of problematic devices when necessary, Health Canada has added this requirement to Interim Order No. 2.

Requirement to hold an MDEL

Interim Order No. 2 requires importers and distributors of COVID-19 medical devices to hold an MDEL and comply with certain requirements set out in the Medical Devices Regulations.

COVID-19 medical device importers and distributors:

  • have six months from the date that Interim Order No. 2 takes effect to obtain an MDEL and comply with relevant parts of the Medical Devices Regulations as defined in section 2(2)(a) of the Order (by September 1, 2021)
  • must submit applications for an MDEL within sufficient time to accommodate the service standard of 120 calendar days
  • are required to pay application fees, as well as annual fees, for as long as they hold an MDEL

MDEL holders are subject to other regulatory requirements, including record-keeping, reporting and inspections. Health Canada inspectors verify that the MDEL holder has the ability to conduct rapid, effective recalls of problematic devices when necessary.

Consult the existing Guidance Document for Mandatory Problem Reporting for Medical Devices for information on how to comply with those sections. Importers and distributors should also note that new regulations on mandatory reporting under the Medical Devices Regulations will come into effect on June 23, 2021, at which point importers will be expected to comply with the new regulations.

MDEL fees

Importers and distributors of any medical devices (including COVID-19 medical devices) who are required to hold an MDEL, must pay the associated MDEL fee, and comply with requirements set out in the Medical Devices Regulations.

For more information pertaining to MDEL fees, please review the Fees for the Review of Medical Device Establishment Licence Applications at the official website of Health Canada.

References

www.canada.ca 

How We Can Help

At Quality Smart Solutions, we provide you with the guidance to plan your Veterinary Health Products business, navigate the legal requirements, and acquire the appropriate license for your operations.

Quality Smart Solutions has a team of professionals to offer support from day one of starting your business, including formulation and label reviews, Veterinary Health Product notifications and more.

30 Minutes Free Consultation
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Why You Should Consider a Third-Party NHP Importer of Record?

NHP Impoter Record

Natural Health Products (NHPs) are regulated by Health Canada under the authority of the Food and Drugs Act and the Natural Health Products Regulations (NHPR) and must be licensed prior to marketing in Canada. Licensed NHPs are assigned an eight (8) digit Natural Product Number (NPN) or Homeopathic Medicine Number (DIN-HM). To be classified as an NHP, all of the medicinal ingredients in the product must be in Schedule 1 of the NHPR, not include any substances listed in Schedule 2 of the NHPR and be marketed for health reasons.

NHPs include traditional medicines; health supplements/vitamins; minerals; and bulk raw materials manufactured, sold or represented for use as NHPs. Cosmetics containing NHP ingredients and that meet both the function and substance components of the NHP definition are regulated as NHPs. 

Health Canada has an easy-to-follow policy on the importation of health products for commercial use. The Guidance Document on the Import Requirements for Health Products under the Food and Drugs Act and its Regulations (GUI-0117) outlines the requirements related to the importation of health products as defined by the Food and Drugs Act.

Health products commercially imported into Canada must meet all applicable requirements of the Food and Drugs Act and its Regulations including proper labelling, market authorization and establishment licenses. Here’s a summary of the licensing requirements for natural health products that are intended to be shipped to Canada for commercial purposes.

License Requirements for Natural Health Products:

Product license (NPN or DIN-HM) for each product.

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.

Site license for each importer located in Canada.

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.

Quality Import Solutions (QIS) has a valid Site License to import Natural Health Products and can act as an importer of record into the Canadian market. We have collaboration with fist-class third-party warehouses annexed to our site license that can provides storage services of NHPs in compliance with Canadians GMPs if needed.

The foreign manufacturer must be listed on the importer’s site license.

While site licences are only issued to Canadian sites (none are issued to foreign sites). Foreign manufacturers as well as packagers, labellers of NHPs must be annexed to a Canadian importer’s site licence. In order to annex a foreign site to importer’s site licence, each foreign site must provide GMP evidence to demonstrate compliance with Part 3, GMP, of the Natural Health Products Regulations in full.  

Why Use Quality IMPORT Solutions (QIS) as a Third-Party NHPs Importer of Record 

Using QIS as a third-party NHPs Importer of Record will give you the benefits outlined below:

  1. Flexibility to use multiple distributors and/or brokers or sell direct in Canada
  2. Acting as a neutral third party which helps eliminating packaging liability (Our Importer’s name is required on your NHP label) if you were to use a distributor as your NHP importer and if down the line the relationship doesn’t work or if you decide to switch to a new distributor, you would be required to either over-sticker or destroy packaging 
  3. Multiple geographical choices as we have warehouse and fulfillment partners (annexed to Quality IMPORT Solutions site licence) located across Canada improving speed to market based on your preferred destination point 
  4. Having the option to either sell to traditional retail outlet or to online venues like Amazon, Well.ca and others 
  5. Low resource cost as we have an experienced team of quality assurance who provide full product disposition to the Canadian market and manage your quality assurance obligations

More than 80% of Canadians consume natural health products (NHPs), so it’s a ripe market for brands that are willing to navigate the product registration and importation requirements outlined by Health Canada. Our team will help you navigate through the process of registration and importation of your NHPs. 

Our Experts at Quality Smart Solutions continue to support your needs for natural health products, foods, cosmetics, OTC drugs and medical devices for North America. Contact us today to learn more about how we can support your compliance for NHPs registration and importation.

How We Can Help

At Quality Smart Solutions, we provide you with the guidance to plan your Veterinary Health Products business, navigate the legal requirements, and acquire the appropriate license for your operations.

Quality Smart Solutions has a team of professionals to offer support from day one of starting your business, including formulation and label reviews, Veterinary Health Product notifications and more.

30 Minutes Free Consultation
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Validation of the Safe Food for Canadians Licence to Import

cfia fresh fruit and vegetable licence number

cfia fresh fruit and vegetable licence number | safe food for canadians licenceIn order for food that is regulated under the Safe Food for Canadians Regulations, to be imported into Canada, the importer must hold a valid Safe Food for Canadians (SFC) license.

This license is issued by the Canadian Food Inspection Agency (CFIA) and must be presented with the shipment at the border in order for importation to be approved. Please note that this licensing may not be obtained at the border and all documentation must be in order when the shipment arrives at the border for it to be eligible for import.

The CFIA has announced that as of March 15th, 2021 certain commodities may be rejected by the CFIA unless a valid SFC license is entered in the Integrated Import Declaration (IID). The following food commodities are included.

  • Meat
  • Fish
  • Dairy
  • Eggs
  • Processed Eggs
  • Processed Fruits or Vegetables
  • Honey
  • Maple
  • Fresh Fruits or Vegetables

The Safe Food for Canadians license number should be entered into the appropriate field exactly as it was issued. This field is entitled “Registration Number” and the format for the license number an 8-digit alpha-numeric code.

The provided SFC license number will be reviewed to ensure that the license is valid, covers the activity of importing food, and covers the specific commodity being imported.

If the license number is not valid, a reject message will be received in the importer or custom broker’s IID system. See the below chart for an explanation of reject messages that could be received. If you have multiple licenses, verify that you are entering the correct license number on the import declaration.

Reject MessageReason for RejectCorrective Actions
AIRS registration number is required. (893 – Safe Food License).When the registration number field is left blank.Enter your SFC license number in the registration number field.
License number must be 8-digit alpha numeric (A12B3CD4). Verify license in My CFIA.When a Y or N is entered, or the number provided is not in the CFIA database. (Check for typos)

Ensure your license number is entered correctly.

License number is either suspended, cancelled, or expired. Verify status in My CFIA.When the license number entered has been suspended, cancelled, or expired.If your license is suspended or cancelled, you will have to contact your local CFIA office. If your license has expired, you will have to apply for a new one using the My CFIA Portal.
License number is not valid for importing. Verify activity in My CFIA.When the license number entered is not issued for importing food.You can amend your license in your My CFIA portal to include “importing food” to your license profile.
License number entered does not cover food being imported. Verify license in My CFIA.When the license number entered is not issued for the food commodity that is being declared.You can amend your license in your My CFIA portal to include the commodity in your profile.

Please note you can amend your SFC license at any time utilizing the My CFIA Portal without incurring an additional fee.

Obtaining a Safe Food for Canadians License:

The first step involved in obtaining a Safe Food for Canadians license is to create a My CFIA Account. It is through the use of the My CFIA account that you can request license and export certifications as well as set up electronic payment methods. While enrolling, you can create one or more profiles for your business. This way if your company involves multiple site locations, you can have a profile for each site.

Once your My CFIA Account is created, you will need to then determine your license structure. Since the Safe Food for Canadians Regulations do not limit the number of licenses a person can hold, you can operate under a single license or multiple licenses. It all depends on what works best for your business!

In order to decide how many licenses you will request, you should take the following points into consideration.

  • There is a fee for each license requested.
  • A Preventative Control Plan must be implemented and maintained for each license you hold.
  • Since many foreign trading partners require unique identifiers for each location or establishment, you may want to ensure that each license you hold is only associated with one establishment is you deal with exportation.
  • If there is more than one license for a particular physical location, there cannot be any overlap in the food categories and activities covered by the license.

After you know which license(s) you wish to apply for, you should collect all the necessary details of your business that are required during the application process. The following must be entered into the Safe Food for Canadians License Application,

  • The activities being conducted.
  • The location of the establishment(s) where the activities will be conducted.
  • The category of food.
  • Attestations regarding the requirements of holding an SFCR License such as having a preventative control plan implemented within the facility and that the information provided within the application is complete and not misleading.

Once the application for licensure has been submitted you will receive an electronic message indicating whether your license was approved or if the CFIA must first inspect the business before the license can be issued.

If your license is approved, it can be found within your My CFIA account.

If the CFIA has indicated that an inspection is required first, this could be for several reasons. The CFIA utilizes a risk-based approach for inspecting new business with a variety of risk factors being selected to prioritize and manage the inspection activities. If you are requesting an export certificate or other permissions, this inspection may be a requirement of the importing country.

How We Can Help

At Quality Smart Solutions, we provide you with the guidance to plan your food business, navigate the legal requirements, and acquire the appropriate license for your operations.

Quality Smart Solutions has a team of professionals to offer support from day one of starting your business, including Hazard Analysis, SOPs, Preventative Control Plans (PCPs) and more.

30 Minutes Free Consultation

References:

Validation of the Safe Food for Canadians licence to import

Health Canada – Safe Food for Canadians Licence

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Q&A: Selling Hand Sanitizers in Canada during COVID-19 pandemic

With the need for hand sanitizers significantly increasing for healthcare personnel and individuals during the current COVID-19 pandemic do help prevent and reduce the spread of the coronavirus Health Canada is taking action with interim measures to increase the supply of these products. This post is to help answer questions related to these actions and help you make an informed decision as it relates to licensing and marketing your hand sanitizer.

1. What action is Health Canada taking to increase the supply of disinfectants and hand sanitizers?

On March 17, Health Canada announced actions they take as an interim measure to increase the supply of hand sanitizers and disinfectants.  A summary of these actions can be found here:

https://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2020/72623a-eng.php

2. I am a distiller of alcoholic beverages in Canada. Do I need any special license to make hand sanitizers?

There are 3 requirements to manufacture and sell hand sanitizers. You must obtain a Natural Product NPN license (if the hand sanitizer is ethanol or isopropyl alcohol based). Health Canada will expedite the licensing of these products. Second, you will require a site license to manufacture, package and/or label hand sanitizers.  Health Canada will expedite this licensing. Third, you will need to obtain a Specially Denatured Alcohol (SDA) registration. This is issued by the Canada Customs and Revenue Agency (CCRA).  Quality Smart Solutions can help you with all 3 of these requirements.

3. Which countries does Health Canada recognize as being licensed and approved hand sanitizers?

The countries where authorization was obtained that Health Canada will accept as equivalent to Canadian regulations, in the interim,  include the following:

Argentina
Australia
Austria
Belgium
Canada
Taiwan
Croatia
Cyprus
Czech Republic
Denmark
Estonia
Finland
France
Germany
Greece
Hong Kong
Hungary
Iceland
Indonesia
Iran
Ireland
Israel
Italy
Japan
Latvia
Lichetenstein
Lithuania
Malaysia
Malta
Mexico
Netherlands
New Zealand
Norway
Poland
Portugal
Romania
Singapore
Slovak Republic
Slovenia
South Africa
South Korea
Spain
Sweden
Switzerland
Thailand
Turkey
Ukraine
United Kingdom
USA

These countries are members of the Pharmaceutical Inspection Co-operation Scheme (PIC/S).

4. If I have a hand sanitizer license and/or authorization from one of these countries does this mean I can sell hand sanitizers in Canada?

Yes.  A Natural Health Product Number (NPN) or Drug Identification Number (DIN) isn’t required, in the interim, if the hand sanitizer is authorized in one of these countries. You will also need to partner with a Health Canada licensed importer.  Quality Smart Solutions can complete a HC Disinfectant Sanitizing Form on your behalf prior to your shipment to Canada.

5. My hand sanitizer is registered in the United States but my label is based on  FDA regulations. Can I sell this in Canada?

As an interim measure, if you are registered with the FDA your USA, English only label will be acceptable in Canada.  We can complete the HC Disinfecting Santizing Form on your behalf detailing the US registration and the Health Canada importer you would be using.

6. How can Quality Smart Solutions help me?

We can assist you with licensing your hand sanitizer. We have extensive experience having registered over 5000 Natural Health Products successfully obtaining Natural Product Number (NPN) licences for hundreds of companies worldwide including many hand sanitizer companies.  Our sister company, Quality IMPORT Solutions, is a Health Canada licensed importer of Natural Health Products.  We currently import several hand sanitizer brands.  If you are planning to manufacture your hand sanitizer in Canada we will complete your SDA registration of your facility with CCRA.

Quality Smart Solutions is an end-to-end compliance solutions expert which has been assisting clients for 11 years in the areas of Dietary Supplements/NHPs, Foods, Cosmetics, Canna, Medical Devices, OTC drugs in Canada and the United States. Ask us for details or visit our website at www.qualitysmartsolutions.com.

How We Can Help

Our Experts at Quality Smart Solutions also offer to support your needs for foods, cosmetics, OTC drugs and medical devices for North America.

Contact us today to learn more about how we can support your compliance needs during and after licensing!

30 Minutes Free Consultation
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Foreign Supplier Verification Program – USA & Canada agreement?

Under the Food Safety Modernization Act (FSMA), the United States (U.S.) started graduated enforcement of the Foreign Supplier Verification Program (FSVP) in May 2017.

FSVP (Foreign Supplier Verification program) requires U.S. importers (regulated by US FDA) to verify that food imported into the United States has been produced in a manner that meets applicable U.S. safety standards. Similar to the Safe Food for Canadian Regulations, Canadian importers will soon have to verify and prove to CFIA the food they are importing meets the regulations and standards.

What does this mean for US Importers of Canadian foods?

Canada and the U.S. have a Food Safety Systems Recognition Arrangement (FSSRA). The FSVP provides modified requirements to U.S. importers when they import food that is covered under the FSSRA from Canadian manufacturers that are in good regulatory standing with the Canadian Food Inspection Agency (CFIA).

Does this mean we can finally see an alliance between the US FDA and CFIA?? That is the intention of the FSSRA and, fingers crossed, this will make it easier for US and Canadian imports and exports.

The FSSRA applies to foods regulated by the US FDA including:

  • fruit and vegetables
  • shelled eggs
  • dairy (except “Grade A” milk and milk products)
  • fish (except farmed catfish, catfish products and molluscan shellfish
  • maple
  • honey
  • processed products; and
  • manufactured foods

What does this mean for the Canadian food industry?

Canadian food manufacturers who process food for export will require a licence under the Safe Food for Canadians Regulations (SFCR). When the SFCR comes into force, the CFIA will publish a listing of SFCR licensed food manufacturers as the method to certify that they are operating in good regulatory standing if they comply with SFCR requirements. To be considered to be operating in good regulatory standing under the SFCR, the federally licensed establishments will need to operate with an acceptable Preventive Control Plan (PCP) and maintain acceptable traceability documents in order to be placed on the listing of SFCR licensed food manufacturers.

If you are currently federally registered and/or licensed with CFIA:

If you operate an establishment that is currently registered with the CFIA, you will need to have an acceptable Preventive Control Plan (PCP) and traceability documentation process in place in order to obtain a license when the SFCR comes into force. Your registration and the federally registered lists currently available may be used by U.S. importers to indicate your good standing until all food manufacturers are licensed and the new list of SFCR licence holders comes into effect.

If your business is already federally registered or licensed at the time that the SFCR comes into force, you can maintain your exporting activities while you make the necessary changes to transition to the SFCR licensing system.

If you are NOT currently federally registered and/or licensed with CFIA:

Businesses in certain food sectors (i.e. manufactured foods, non-federally registered sector, etc.), which have traditionally NOT required federal registration and/or licensing, will now need to be licensed to demonstrate that your company is in good regulatory standing. Like a registered facility, you will need to have an acceptable a PCP and a traceability documentation process in place in order to obtain a licence when the SFCR comes into force.

Food businesses seeking to begin or continue exports to the U.S. will need to be licensed when the SFCR comes into force if they want to be on the Canadian list of licence holders in ‘good standing’ in order for US importers to apply the modified FSVP requirements.

The CFIA encourages all Canadian food businesses exporting to the U.S. to prepare for the SFCR as it comes into force. Being federally licensed and listed with the CFIA will eliminate the burden of documentation for importers and exporters of US FDA regulated foods. Businesses do not need to apply for an SFCR licence at this time, but as the transition to the new regulations takes place, you will be able to apply for the new licence online or access information about the licence and regulations through your My CFIA account.

If you want to be sure your food safety practises are in line with the new SFCR and export requirements, Quality Smart Solutions has a team of specialists who can assist with preparing and implementing a PCP or reviewing your documents and conducting an audit of your facility. Get prepared now and contact us today to discuss how we can be your food safety solution!

Quality Smart Solutions is an end-to-end compliance solutions expert which has been assisting clients for 11 years in the areas of Dietary Supplements/NHPs, Foods, Cosmetics, Canna, Medical Devices, OTC drugs in Canada and the United States. Ask us for details or visit our website at www.qualitysmartsolutions.com.

How We Can Help

Our Experts at Quality Smart Solutions also offer to support your needs for foods, cosmetics, OTC drugs and medical devices for North America.

Contact us today to learn more about how we can support your compliance needs during and after licensing!

30 Minutes Free Consultation
Resources Canadian Food Inspection Agency. Inspection modernization. 2018-01-03. http://inspection.gc.ca/food/sfcr/exports/requirements-library/fsvp/eng/1521203122812/1521203165440
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Natural Health Product Brand Name Guidance

Natural Health Product Brand Name Guidance

Brand names are an important part of your marketing strategy, but as many of us know firsthand there is a difference between what the marketing team wants to say and what the regulatory authorities will let you get away with. Consideration needs to be taken to ensure your brand name is as compliant as your health claims since a brand name is essentially an extension of your health claims.

As part of the review process, the Natural and Non-precription Health Products Directorate reviews your brand name in addition to your health claims. They expect that the name you choose for your product reflects the approved product claims. For example, if you want to market a product containing vitamin B12 which is licensed for the claim “Helps to maintain the body’s ability to metabolize nutrients” you will not be permitted to use any reference to weight management as part of the brand name. Other brand name challenges we have come across is the use of the term ‘detox’. This term is reserved exclusively for products which support liver function or the elimination of waste from the body.

Another challenge is having a brand name which implies treatment of a condition but only being able to receive a licence for an antioxidant claim. For example, the marketing team wants to call the product “Low Dose Lutein for Eye Health” and market the product to support eye health in conditions such as cataracts and age-related macular degeneration.  However, when we review Health Canada’s monograph for Marigold extracts and isolates (including lutein) we see this eye health claim is based on quantities of at least 6 mg lutein per day.  If the ‘low dose lutein’ product provides less than 6 mg lutein per day, Health Canada will only permit the use of the product for antioxidant purposes. In which case, using a brand name which speaks to the products efficacy for eye health would be considered non-compliant.

If you are looking to appease your marketing department while keeping the product brand name fully compliant, Quality Smart Solutions has a team of specialists who can assist in achieving innovative brand name compliance for your products.  Contact us today to discuss how we can be your solution!

Quality Smart Solutions is an end-to-end compliance solutions expert which has been assisting clients for 11 years in the areas of Dietary Supplements/NHPs, Foods, Cosmetics, Medical Devices, OTC drugs and Canna for Canada and the United States. Ask us for details or visit our website at www.qualitysmartsolutions.com.

How We Can Help

Our Experts at Quality Smart Solutions also offer to support your needs for foods, cosmetics, OTC drugs and medical devices for North America.

Contact us today to learn more about how we can support your compliance needs during and after licensing!

30 Minutes Free Consultation
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Amazon.ca removing non-compliant Natural Health Products in October

In September  Amazon.ca notified every Natural Health Product vendor (whether they had an NPN or not) that, effective in October 2018 they will be removing all products that don’t have a Natural Health Product Number.   Here’s the email they sent to sellers:

AMAZON NOTICE TO SELLERS OF NATURAL HEALTH PRODUCTS

Dear Seller,

Pursuant to Canadian laws and regulations, all non-prescription drugs, supplements, and natural health products (“NHPs“) that are sold in Canada must be assigned a registration number by Health Canada.

We are updating our product registration templates to require either a Natural Product Number, Drug Identification Number or a Homeopathic Medicine Number to list these products on our site.

From October 2018, Amazon will remove drugs, supplements, and NHPs that do not have registration numbers associated with them in the catalog from the site. If your product is impacted, you can identify the ASINs and contact Seller Support.

To back-fill the required compliance information for your existing products, you can do so through the single item setup in Seller Central or through an Inventory Template file. More information about listing drugs, supplements and NHPs can be found here: https://sellercentral.amazon.ca/gp/help/external/200164490

Amazon.ca, in recent months, had been taking a proactive approach for new products listed on their site whereby if a brand didn’t have an NPN they couldn’t be listed. However, prior to this policy implementation many products were listed without an NPN.  Clearly there was significant pressure on Amazon from border officials, Health Canada and likely shareholders to tighten up their policy.

For international (ie. outside Canada) companies shipping dietary supplements to Canada there are 3 requirements as summarized on  NHPLicenseExperts.com which includes:

  1. A Natural Product Number
  2. A compliant Natural Health Product label
  3. An importer of record if you are shipping a finished product into Canada.

Some of the biggest brands like Amazing Grass, Dr. Bronner’s Barlean’s, Goddess Garden, SmartyPants and many more rely on our end-to-end NHP License solution.

The good news is that we are your one-stop shop solution for all three of these requirements.  Working with hundreds of clients and brands we offer competitive rates having prepared thousands of NPNs over the last 12 years.   Ask about our new client NPN registration offer to help you continue your business on Amazon.ca and your business in the Canadian marketplace.

Quality Smart Solutions is an end-to-end ompliance solutions expert which has been assisting clients for 11 years in the areas of Dietary Supplements/NHPs, Foods, Cosmetics, Medical Devices, OTC drugs and Canna for Canada and the United States. Ask us for details or visit our website at www.qualitysmartsolutions.com.

How We Can Help

At Quality Smart Solutions, we provide you with the guidance to plan your Veterinary Health Products business, navigate the legal requirements, and acquire the appropriate license for your operations.

Quality Smart Solutions has a team of professionals to offer support from day one of starting your business, including formulation and label reviews, Veterinary Health Product notifications and more.

30 Minutes Free Consultation
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Business considerations: Natural Product Number Application NPN

MDEL medical device establishment licence listing

mdel license application canadaJust a little background information first before I talk about the business aspect of capitalizing on your NPN.  NPN stands for Natural Product Number. It is a license that is issued by Health Canada and required for a dietary supplement (the term used in Canada is Natural Health Product) to legally be sold in Canada.  The NPN is required to have at least one health claim associated with the license. Obtaining a license can take 10 days to 210 days depending on the product ingredients and whether they are within the scope of Natural Health Product (NHP) Monographs (class 1 or 2 NHPs) or not (Class 3).

Timing is crucial to get the highest ROI and timely return for your NPN. This will depend on when your business generates the most revenue for the desired NPN.  For example, sunscreen products would typically generate most of their revenue between the summer months, May to September. Retail stores (particularly food, drug, mass stores) set their planograms and orders much earlier to ensure on-shelf presence in advance of the season start so preplanning is important, starting with a timeline when to apply for an NPN.  In this example of natural sunscreen products (those with titanium dioxide and zinc oxide) these are class 1 NPNs so license is issued in 10 days. Based on lead times of various other factors (label print run, manufacturing) a reasonable time should be considered to start the process to deliver on time and not miss those key selling months. Why is this so important? If an NPN were prepared late, packaging completed mid season and delivery of packaged goods late in the summer, in this example, there could be inventory sitting that becomes short dated (in this sunscreens example, shelf life is1 to 2 years) or worse, doesn’t sell, possibly delisting or repeat orders not placed for the next season thereby depreciating your ROI for your NPN!

In the case with a class 3 NPN, that could take up to 210 days (7 months) after submission acknowledgement, a more long term planning launch strategy is needed. Some retailers, for example,  won’t begin dialogue with a branded company until they have an NPN.   Most natural health products see most of their sales between September to February. Diet and Sports Nutrition companies see a significant portion of new business in the “new years resolution period” between December to February. Let’s look at a hypothetical example, of a class 3 NHP that would start in 2016. Here’s how a Canadian launch planning could be mapped out to gain the most revenue and the soonest to NPN issuance:

  • August 2016 – begin on a class 3 NHP application
  • Mid August/early September 2016 – submit class 3 NHP application
  • mid September/Early October 2016 – acknowledgement letter of class 3 NHP submission indicating that it will take up to 180 days, 30 days after the date of the letter (total 210 days) to meet the performance target to obtain an NPN
  • April 2017 – if you are a foreign company and manufacturing, shipping finished product from outside of Canada your manufacturer, labeller and packager have to be annexed to a Canadian importer. This process can take 30 to 90 days for approval
  • May 2017 – latest when the class 3 NHP will be issued an NPN (based on an October acknowledgement letter receipt). Safe now to schedule the manufacturing of approved NPN product.
  • Mid May/early June 2017 – bilingual compliant NHP label ready to print
  • Late June/early July 2017 – printed packaging ready
  • June to August 2017 – manufacturing of approved NPN product (based on manufacturer lead time which is dependent on raw material availability, seasonality peaks, line time queue from other manufacturer clients). Typical lead time of manufacturers is 4 to 12 weeks.
  • Mid August – ship to retail or warehouse
  • September 2017  – Product launch

This scenario is a best case situation.   There are many factors that come into play upstream such as ingredient safety and efficacy substantiation, formula feasibility, researching substitute ingredients if one or more ingredient in the original formula aren’t meeting safety parameters and other considerations (these are some areas we look at with our clients applying for NPNs).

Here are general rules of thumb when to begin the NPN license process prior to launch date:

Class 1 – at least 6 months

Class 2 – at least 7 months

Class 3 – at least 13 months

In each of these cases, if annexing your manufacturer to a Canadian importer site license is required, this should start at least 5 months before product launch.

If you have any questions we are happy to help. Feel free to contact us.

Quality Smart Solutions is an end-to-end compliance solutions expert helping clients for 10 years in the areas of Dietary Supplements/NHPs, Foods, Cosmetics, Medical Devices and OTC drugs. 

Our business development solution division, Quality IMPORT Solutions, can act as your Dietary Supplement Importer into the Canadian market and connect you with reputable brokers and distributors that cover the Canadian market from coast-to-coast. Ask us for details or visit our website at www.qualitysmartsolutions.com

How We Can Help

Our Experts at Quality Smart Solutions also offer to support your needs for foods, cosmetics, OTC drugs and medical devices for North America.

Contact us today to learn more about how we can support your compliance needs during and after licensing!

30 Minutes Free Consultation
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Compliance Monitoring 2017 Report of Natural Health Products sites

In the winter and spring of 2017 Health Canada inspectors visited 23 companies. The program was called a compliance monitoring to check if a small subset of companies who hold a site license for manufacturing and importing adhere to the Good Manufacturing Practice requirements.  Prior to this monitoring program there had not been an on-site inspection program for Site License holders.  To date, there has only been a “paper audit” whereby sites are required to submit documentation when renewing their site license.  On site inspections would occur if there was concern (through a trade complaint or similar consumer action) as to activities and GMP adherence.

The license renewal is predicated on a trust and honor system.  The result of the monitoring program was an indication that on-site visits were clearly long overdue.  This was not a full site inspection that is typically conducted with Drug Establishment license holders every two or so years. Rather there was evaluation of particular areas in focus. The result of the visit resulted in action taken ranging from indicating deficiencies to correct to stop sale and recall of certain products.  In some cases the site license was revoked.  Nearly half all visits found significant deficiencies. Based on this report this is likely be the start of  additional and larger scale compliance monitoring programs that may evolve into a standard on-site inspection program similar to that conducted at drug establishment sites.

Here’s the link to the 2017 report on Natural Health Products facility compliance monitoring:

https://www.canada.ca/en/health-canada/services/inspecting-monitoring-drug-health-products/compliance-monitoring-reports/2017-reporting-compliance-monitoring-natural-health-products.html?utm_source=CHFA+Member+Newsletter&utm_campaign=21f318ca1e-Health+Canada+Releases+Report+on+Compliance+M&utm_medium=email&utm_term=0_d5b19cdfa3-21f318ca1e-49747337

How We Can Help

Our Experts at Quality Smart Solutions also offer to support your needs for foods, cosmetics, OTC drugs and medical devices for North America.

Contact us today to learn more about how we can support your compliance needs during and after licensing!

30 Minutes Free Consultation
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Summary of the Proposed Approach to the Regulation of Canna

Large Indoor Marijuana Commercial Growing Operation With Fans, Greenhouse, Equipment For Growing High Quality Herb. Cannabis Field Growing For Legal Recreational Use in Washington State

On November 21, 2017 the Canadian Minister of Health announced the Proposed Approach to the Regulation of Canna.  The public consultation 60-day period has begun for feedback on the proposed rules which are primarily to layout the framework and regulations around recreational marijuana with medical marijuana rules, for the most part, being status quo.  The consultation paper covers 8 areas including Licenses, permits and authorizations, security clearances, canna tracking system, canna products, packaging and labelling, canna for medical purposes, health products and cosmetics containing canna and miscellaneous issues.  The government’s intent is to have the Canna Act be approved before July 2018.  Here are the main takeaways from the proposed Canna Act :

Expansion of License categories

Currently the license categories include cultivation, processing and selling of medicinal marijuana. The new proposal will allow for an expansion of the cultivation license including micro cultivation, microprocessing and nursery licenses.   Also, outdoor cultivation would be permitted (as opposed to the current regulations that allow for indoor cultivation that is only allowed) though a dwelling house would be prohibited from conducting any licensed activity.  Import and Export of medical canna and industrial hemp would be allowed.

Security Clearances

The current system has a strict security clearance of individuals with any previous criminal record not being permitted to obtain clearance for producing or distributing canna.  Under the proposed regulations, this will be determined on a case-by-case basis whereby individuals who are considered low risk may be granted clearance.

Canna Tracking System

A National tracking system (likely through a public online platform) would be created with the intent to prevent unauthorized activities and/or deter organized crime from conducting activities.  This system would likely be similar to the Establishment License system for drugs and medical devices.  There is currently a monthly tracking system in place for medical canna licensed producers. This new proposed system would expand on this platform.

Canna Products and Forms

Five classes of canna would be permitted for sale including dried canna, canna oil, fresh canna, canna plants and canna seeds.   Edibles such as foods or beverages would be permitted. Currently capsules and creams are not allowed under the ACMPR framework.  However, with the proposal various forms such as capsules, topical application creams and oils would be permitted and likely licensed similar to the NHP and DIN regulations.  There would be limits set on the amount of THC allowed per dosage unit set at 10 mg.

Packaging and Labelling

Adopting the labelling standards of tobacco products, the proposed labelling requirements would limit graphics, colours and other packaging aesthetics to deter youths from purchasing recreational canna products.  Tamper evident, child-resistant packaging. Limits of 30 grams of dried canna per single package and 2.1 Litres for canna oil would be set.  Labelling requirements would include such items as product name, description, THC/CBD content and warnings to KEEP OUT OF REACH OF CHILDREN. Health warning statements would be mandatory similar to tobacco products. A Standardized canna symbol will be created to prevent accidental ingestion for products with more than 10 ppm of THC.

Medical Canna

The regulations for medical canna, as outlined in the ACMPR, would remain mostly the same with the access for patients being modified to allow for greater than a 30 day supply if a licensed seller cannot fill multiple orders within a 30-day period.

Health Products and Cosmetics with Canna

Health products such as prescription, non-prescription (OTC) drugs, natural health products (NHP), veterinary drugs, veterinary health products (VHP) and medical devices with canna may be permitted based on scientific evidence that demonstrate safety and efficacy of these combination products.  Furthermore, cosmetics (which currently prohibit canna derived ingredients) may be allowed under the proposed Canna  Act.

Miscellaneous Issues

Amendments to the current ACMPR and NCR based on this proposed Canna Act would be implemented. Qualifications for designated analysts of suspected seized controlled substances would be determined. Amendments to the practitioners to prescribe, administer and provide based on respective provincial regulations.

The complete proposed document can be found here:

 Proposed Approach To the Regulation of Canna

Quality Smart Solutions is ready to assist companies seeking expert Canada Canna regulatory and quality assurance assistance under the current ACMPR framework for license applications and we will be prepared to assist companies on the forthcoming Canna Act framework.  Contact us today how we can be your solution!

How We Can Help

Our Experts at Quality Smart Solutions also offer to support your needs for foods, cosmetics, OTC drugs and medical devices for North America.

Contact us today to learn more about how we can support your compliance needs during and after licensing!

30 Minutes Free Consultation
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Canada Natural Health Product (NHP) Labelling Revision Update for Products Containing Green Tea Extract (GTE)

On November 14, 2017 the Natural and Non-prescription Health Products Directorate (NNHPD) announced that there are several updates to the NHP Monograph for Green Tea Extract based on reports from Canada and worldwide that there may be a link, albeit the risk is rare, of the use between green tea extract and risk of a rare and unpredictable liver injury.  The risk statement is already required with products falling within the scope of the current Green Tea Extract monograph. The updated monograph will elaborate on these warnings and risk statements.  As well, the subpopulation of children and adolescents will be excluded from the monograph and will be restricted to adults 18 years and older.

The following changes to and additional risk statements will be required (with new verbiage in bold):

  • “If you have a liver disorder, consult a healthcare practitioner prior to use. Stop use if you develop symptoms of liver trouble such as yellowing of the skin/eyes (jaundice), stomach pain, dark urine, sweating, nausea, unusual tiredness and/or loss of appetite and consult a healthcare practitioner”
  • “Rare, unpredictable cases of liver injury associated with green tea extract-containing products have been reported (in Canada and internationally)”

Products that contain Green Tea Extract as a non-medicinal ingredient are required to report the amount of EGCG in the green tea and required to add the above stated risk statements.

As Health Canada must be notified stating companies containing GTE either as medicinal or non-medicinal ingredient the dates are as follows:

GTE as a non-medicinal ingredient and quantity of EGCG  – December 14, 2017

GTE as a medicinal ingredient attestation – November 14, 2018

If you have a NPN licensed product containing Green Tea extract either as a medicinal ingredient or non-medicinal ingredient please contact Quality Smart Solutions today to assist you in notifying Health Canada about this important label update.

How We Can Help

At Quality Smart Solutions, we provide you with the guidance to plan your Veterinary Health Products business, navigate the legal requirements, and acquire the appropriate license for your operations.

Quality Smart Solutions has a team of professionals to offer support from day one of starting your business, including formulation and label reviews, Veterinary Health Product notifications and more.

30 Minutes Free Consultation
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FDA proposes extended dates for Nutrition Facts and Supplement Facts labels compliance

This past June 2017 the Food and Drug Administration (FDA) put a hold on the compliance dates for Nutrition Facts and Supplement facts compliance dates.  The compliance dates were scheduled for July 26, 2018 for companies with annual sales over $10 million and July 26, 2019 for companies with sales over $10 million.   Scott Gotlieb sent a tweet out in mid-September that FDA would propose a 18 month delay on the compliance dates so we knew this was coming soon.

The new dates are as follows:

January 1, 2020 – companies with annual sales over $10 million

January 1, 2021 – companies with annual sales under $10 million

The details of these changes to the Nutrition Facts tables can be found here.

Quality Smart Solutions has been implementing the new Nutrition Facts and Supplement Facts table regulations for our clients for the last 12 months so they are future-proofed.  We are experts in US Food and Dietary Supplement label compliance. Contact us today if you are seeking affordable US label review assistance.

How We Can Help

At Quality Smart Solutions, we provide you with the guidance to plan your Veterinary Health Products business, navigate the legal requirements, and acquire the appropriate license for your operations.

Quality Smart Solutions has a team of professionals to offer support from day one of starting your business, including formulation and label reviews, Veterinary Health Product notifications and more.

30 Minutes Free Consultation
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Changes to Regulation of Veterinary Health Products (VHP) in Canada

Cat with Green Eyes takes a Pill

As discussed in an earlier post (PLL – Plain Language Labeling: What it means and how it affects you), the Food and Drugs Act (F&DA) underwent drastic revision after the thalidomide crisis of the 1960s. While some amendments have been introduced since then, the F&DA has remained mostly untouched. In 2014, the Regulations Amending the Food and Drug Regulations were passed in order to address several issues that were identified over the previous 50 years. One set of these amendment impacts the registration of veterinary health products, defined as low-risk products such as vitamins, minerals, traditional and homeopathic medicines for companion and food-producing animals. These products promote the health and wellbeing of animals but do not diagnose or treat disease.

On May 17, 2017, the final publication in the Canada Gazette, Part II of the Regulations Amending the Food and Drug Regulations (Veterinary Drugs – Antimicrobial Resistance) formalizes the existing voluntary Interim Notification Pilot Program (INPP).  The regulations are scheduled to come into effect on November 13, 2017.

Background

Health Canada’s INPP for veterinary health products (VHPs) has been in place since 2012. Health Canada leveraged a third-party organization North American Compendiums (NAC – www.lrvhp.ca) and the Canadian Animal Health Institute, launched a voluntary pilot program to launch a pilot as a mechanism to assess how well a risk-based, streamlined process would work to register such products and all learnings were to inform a more permanent program. Nearly 1000 products have been successfully notified by Canadian manufacturers and importers for sale in Canada.

The Veterinary Drugs Directorate of Health Canada will administer the Notification Program that will build on the current pilot’s process structure. The notification of VHPs, the requirements for VHP substances or ingredients as included on List C: Veterinary Health Products, and the reporting of adverse events remains intact.

Rules For VHPs
The risk-based notification program for VHPs will require:

  • companies to notify Health Canada 30 days before selling a VHP or making a change to a marketed VHP
  • All active, homeopathic and traditional medicine substances permitted in VHPs are listed in List C: Veterinary Health Products and must be labeled accordingly
  • labels to state “Veterinary Health Product”
  • mandatory reporting of serious adverse drug reactions to Health Canada
  • adherence to the Good Manufacturing Practices (GMPs) in the Natural Health Products Regulations

How Does This Impact You?

For companies with existing valid notifications, their labels will be transferred over to the new system and companies must update their labels within 18 months, or sooner at the next labeling cycle. New registrants can notify according to the old rules until October 13, 2017, and all VHPs will be required to comply with the new rules as of November 13, 2017.

How QSS Can Help

Our Quality Smart Solutions (QSS) team takes great pride in our client-focused, solutions-oriented approach to resolving your issues and challenges.  Not only will we review your labels to assess your compliance with the new regulations, but we will also submit the registrations and work with the regulator on your behalf. Further to this, we will work with you to make sure you and your supply chain meet GMP. QSS is your solution to ensuring you are compliant with Health Canada’s VHP requirements. Contact Quality Smart Solutions today at 1-800-396-5144 ext. 4 or fill out our online page by clicking here.   To see all we have to offer in regulatory compliance and quality assurance solutions, visit us at www.qualitysmartsolutions.com.

How We Can Help

At Quality Smart Solutions, we provide you with the guidance to plan your Veterinary Health Products business, navigate the legal requirements, and acquire the appropriate license for your operations.

Quality Smart Solutions has a team of professionals to offer support from day one of starting your business, including formulation and label reviews, Veterinary Health Product notifications and more.

30 Minutes Free Consultation
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Import Solutions for Natural Health Products – Our New Website!

Our sister company, Quality IMPORT Solutions has a new website with all the information you need to make an informed decision when choosing an importer for your natural health products and what makes Quality IMPORT Solutions different than other providers.  You visit the site at www.qualityIMPORTsolutions.com.

How We Can Help

At Quality Smart Solutions, we provide you with the guidance to plan your Veterinary Health Products business, navigate the legal requirements, and acquire the appropriate license for your operations.

Quality Smart Solutions has a team of professionals to offer support from day one of starting your business, including formulation and label reviews, Veterinary Health Product notifications and more.

30 Minutes Free Consultation
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PLL – Plain Language Labeling: What it means and how it affects you

BACKGROUND

Originally implemented in 1920 after the inception of the Federal department of Health in 1919, the Food and Drugs Act (F&DA) underwent drastic revision after the thalidomide crisis of the 1960s. While some amendments have been introduced since then, the F&DA has remained mostly untouched. In 2014, the Regulations Amending the Food and Drug Regulations were passed in order to address several issues that were identified over the previous 50 years.

Many of the 2014 changes allocated to the Minister more power to demand action in the face of identified risk, i.e. the power to request recalls products affected by emergent safety issues, or request immediate package label revisions to include warnings in reaction to newly identified risks in a mandate called Vanessa’s Law. Along with this and other sets of changes, amendments were passed in order to promote consumers’ understanding of drug labels at the point of purchase.

The new Canada Plain Language Labeling (PLL) requirements apply these amendments to the regulations. The intention was seemingly simple: to provide important information to consumers in plain language in an easy to read format, so product names are not confusing and it is clear how to report harms caused by the purchased drug.

IMPACT TO INDUSTRY

These PLL requirements for prescription and non-prescription pharmaceutical drugs, biologic drugs, and radiopharmaceuticals were phased in per drug product type. The Health Canada Labeling Guidance Regulations took effect for prescription products as of June 13, 2015, and for non-prescription products, more recently as of June 13, 2017.

Overall, much more work must be done upfront before submitting application packages to the regulator for pre-market approval. As such, graphic design work must be done in parallel to submission preparation. Health Canada will no longer accept unformatted label text; however, it will accept annotated written text, in lieu of mock-ups, to reflect proposed changes to the inner/outer labels as part of Notifiable Change (NC) submissions or Post-Authorization Division 1 Change submissions (PDCs).

If you plan to submit a new or amend a DIN, NDS, SNDS, or to amend your existing drug product license, you are affected by this.

CANADA LABELING REQUIREMENTS

Information on the label must be expressed in plain language in a way that does not impede the user’s understanding. Health Canada’s expectation is for all existing labels to be updated with PLL labels over time and for all new drug applications to consider the following aspects of their labeling:

Brand name: Your product’s brand name cannot resemble any other DIN product, a kit, or a radiopharmaceutical. HC may request evidence. Look-alike sound-alike (LASA) drug product names refer to names of different drug products that are similar when written or spoken. Such similarities may cause confusion and result in errors when self-selecting, prescribing, transcribing, dispensing, or administering a drug product, introducing a risk of harming the user/patient/consumer if the wrong medication is prescribed or improperly dosed/administered.

Contact information: Inner and outer labels must display information that allows the consumer to contact the party responsible for the product in Canada for guidance if any problems occur. At least one method of contact should be listed, such as a toll-free number, email address, or website. The licensee can decide who can be the initial contact. Note that biologic drugs and radiopharmaceuticals are exempt from this requirement.

Mock-up requirement: Mock-up labels of every label to be used for the drug must be provided to Health Canada upfront with the product license application submissions instead of at the DIN activation stage (i.e. as part of market notification). These labels are market-ready and fully bilingual, in full color and actual size. This includes package inserts. Health Canada  Labeling reviewers will review font size and type, color; and placement (including proximity, overlap, and panel location) of key elements of an inner/outer label. Only editable labels (i.e. not locked PDF files) are accepted, meaning those which enable reviewers to verify the font type and sizes. A locked file impedes reviewers from making annotations to the labels. Provide the font size and typestyle upfront in the Certification doc, required to accompany the submission. When Health Canada label reviewers know the font size and typestyle of labels at the beginning of a review, they are able to review labels more efficiently. Specific labeling requirements exist for product monographs and various package insert/pamphlet/leaflet formats. Mock-ups must also be submitted with administrative for changes to manufacturer or product name.

Canadian Drug Facts Table (CDFT): A formatted table of the required information is mandatory only for non-prescription drugs only so that consumers are fully informed at the point of sale. Good Label and Package Practices must be applied, and all formatting rules must be followed.

PLL applies to prescription and non-prescription pharmaceutical drugs, biologic drugs, and radiopharmaceuticals.

TIPS

To facilitate your adherence to PLL and Health Canada’s review and approval of your drug submissions, consider the following points:

  • Research Brand names to ensure they do not resemble other brand names, common names, or proper names of products/chemical entities that are currently available for sale in Canada.
  • Wording for contact information most often seen is “For questions or to report problems, please contact…” or “Questions or concerns?”, followed by the contact information.
  • Provide only editable labels (i.e. not locked PDF files) to the QSS reviewer and as part of the submission.
  • Provide the font size and typestyle used in the label upfront in the accompanying Certification document
  • Review the specific formatting requirements for product monographs and package insert/pamphlet/leaflet. Leverage QSS’s expertise for strategic advice in your unique circumstance. We believe in a no-nonsense approach to help you navigate regulatory hurdles without sacrificing your business goals.

HOW WE CAN HELP

Our Quality Smart Solutions (QSS) team takes great pride in our client-focused, solutions-oriented approach to resolving issues and challenges.  With expertise in OTC, ANDS drug submissions, label review, and French translation, we provide Health Canada Labeling Guidance to ensuring you are compliant with Health Canada’s Drug Regulations.   Contact Quality Smart Solutions today at 1-800-396-5144 ext. 4 or fill out our online page by clicking here.   To see all we have to offer in regulatory compliance and quality assurance solutions, visit us at www.qualitysmartsolutions.com.

How We Can Help

Our Experts at Quality Smart Solutions also offer to support your needs for foods, cosmetics, OTC drugs and medical devices for North America.

Contact us today to learn more about how we can support your compliance needs during and after licensing!

30 Minutes Free Consultation
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Top 3 things to consider when planning to sell your Dietary Supplement in CANADA

Some companies make the assumption that selling a dietary supplement product in Canada is no different than selling in the United States.   There are, in fact, several distinct differences.  As you plan to enter the Canadian market there are several points to consider.  

  1. You need to obtain a Natural Product Number (NPN). This is a license issued by Health Canada for Dietary Supplements. The process to obtain a license can take 10 to 210 days depending on the ingredients in the formula.  There is currently a pilot program which is trying to ensure that 95% of applications receive a license in 30 days. This program concludes at the end of February and initiatives, technology and processes will be improved to hit this target.
  2. You must have a compliant label, both in terms of content and layout as well as a bilingual label that is in both English and French.
  3. Your manufacturing facility has to be annexed to a Natural Health Product site licensed importer (these licenses are only issued to Canadian businesses).  Often distributors hold an import site license but it is not necessary or a requirement that the distributor also be your importer on record.  Depending on your needs and strategy for Canada, it may be preferable to work with a third party importer that is separate from the distributor. 

Quality Smart Solutions can assist you in these three areas.  In addition, we have a national network of distributors and brokers in Canada to fit your distribution and channel needs.  We are more than just a consulting firm. We are YOUR end-to-end solution for a compliant and successful Canadian launch. Contact us today or call us at 1-800-396-5144.

How We Can Help

Our Experts at Quality Smart Solutions also offer to support your needs for foods, cosmetics, OTC drugs and medical devices for North America.

Contact us today to learn more about how we can support your compliance needs during and after licensing!

30 Minutes Free Consultation
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A New NHPD Ingredient Database Monograph Coming Soon?

Health Canada recently announced their initiative to modernize the regulatory framework for health products and foods. This is required due to a variety of factors, such as new and emerging science breakthroughs and public health threats worldwide. The modernization is also based on public input regarding the need for greater transparency. The Canadian federal government published a Red Tape Reduction program in January 2012, and some of the reasons for change also stem from this report.

The NHPD recently released a Standards of Evidence document that is currently under consultation review by stakeholders. This consultation review is set to end August 21, 2012. The document takes a risk based approach to health claims and may allow lower risk claims to be made based on non-human studies (e.g. In vitro animal studies) as long as safety data in humans is available. Essentially this review and licensing will be based on three class levels, each having a level of risk. In addition to this license evaluation approach there are new timelines proposed. The chart below illustrated the current and future timelines:

ClassCurrent TimeframeFuture timeframe
1 – High level of certainty
– (eg. Monographs, AbLs, Category IV/TPD labeling		60 days10 days
2 – Medium level of certainty – a combination of pre-cleared information and high quality data from peer reviewed published journals180 days30 days
3 – Low level of certainty – clinical trial evidence and full pre-market assessment180 days180 days

Based on the amount of information that the NHPD has gathered over the last 8 years and pre-cleared information through NHPD monographs, the anticipation is that 99% of all product license applications would be reviewed in 30 days or less. With the Exemption number program set to expire in February, the NHPD is under the gun to clear the backlog and introduce a new process. After UPLAR expires in February, the mandate will be in place so that products will not be allowed for sale unless an NPN is issued.

These new target review timelines are a major requirement forcing companies to set dates for products on shelf with their retail partners. The new framework will hopefully prevent any future backlogs. Based on the rapid response that Quality Smart Solutions has seen in the past year, from license submission to license issuance for our clients, it is encouraging that the NHPD will meet their target of clearing the backlog and repeal UPLAR without further extension of the regulations past the due date. We also anticipate many more monographs to be published between now and next February. Quality Smart Solutions will keep you updated as this new approach develops and becomes reality.

How We Can Help

Our Experts at Quality Smart Solutions also offer to support your needs for foods, cosmetics, OTC drugs and medical devices for North America.

Contact us today to learn more about how we can support your compliance needs during and after licensing!

30 Minutes Free Consultation
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Beware: More Bullets in Russian Roulette Game With The FDA!

Often the dietary supplement landscape in the United States has been referred to as the “Wild, Wild West” with many companies taking the approach of “gunslinger,” thinking they can say anything on their label in terms of both marketing and health claims. Many companies have done due diligence to be compliant with FDA and FTC regulations. Others are playing Russian roulette with the FDA & FTC, stating unsubstantiated structure-function claims or even preventative claims (which are not allowed on U.S. labels for dietary supplements) with their advertising and marketing material.

Fortunately, the FDA is taking a more aggressive stance on this and sending warning letters, which can go as far as issuing a recall or stopping the sale of products. The FDA action doesn’t just target marketers of dietary supplements, it targets the manufacturers also. Inspection of dietary supplement manufacturers, packagers, labelers and storage facilities has shown some to be non-compliant. If non-compliance is observed these sites are issued an FDA Form 483. If a “483” is not responded to with corrective and preventative actions, warning letters will be issued.

The FDA is arming their “compliance gun” with more bullets so that fewer dietary supplements can get away with playing the game of Russian roulette. Some of these “bullets” include:

  • No prior notice to conduct site audits
  • Checking more dietary supplement labels to ensure that claims made are substantiated, not misleading, and are not preventative claims. Since products may be sold at retail locations or online, FDA agents are checking these outlets more frequently.

You DO NOT want to be playing games with the FDA. The damage goes beyond a recall. Public notices are sent out by the FDA on their official website and through various media outlets. With social media picking up these feeds, a company’s reputation could be permanently ruined and it could mean the end of business.

Quality Smart Solutions is your dietary supplements regulatory partner. Have us be your due diligence “eyes and ears” for your product packaging, labeling and marketing to ensure that you are FDA and FTC compliant.

How We Can Help

Our Experts at Quality Smart Solutions also offer to support your needs for foods, cosmetics, OTC drugs and medical devices for North America.

Contact us today to learn more about how we can support your compliance needs during and after licensing!

30 Minutes Free Consultation
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Keeping An Eye On The Global Health Products Landscape

Significant changes are occurring in the global regulatory landscape as of late, and this is just another example of how the world is evolving into a single global marketplace. Products marketed in the United States may be in Brazil after having cleared the regulatory hurdles of that country. Products made in Korea may be in Canada after receiving an acknowledgment letter or NPN. With globalization, various regulatory hurdles must be overcome for each country or region where entry is desired. Quality Smart Solutions is involved in this global market, and our clients span the globe. We will keep you informed through news feeds which we regularly update on our website.

Other ways to follow Quality Smart Solutions are:

How We Can Help

At Quality Smart Solutions, we provide you with the guidance to plan your Veterinary Health Products business, navigate the legal requirements, and acquire the appropriate license for your operations.

Quality Smart Solutions has a team of professionals to offer support from day one of starting your business, including formulation and label reviews, Veterinary Health Product notifications and more.

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Thank you for visiting us at the NATURAL PRODUCTS EXPO WEST in Anaheim, California in March!

We hope you found it as successful as we did. Feel free to email us at

info@qualitysmartsolutions.com or give us a call at 1-800-396-5144.

How We Can Help

At Quality Smart Solutions, we provide you with the guidance to plan your Veterinary Health Products business, navigate the legal requirements, and acquire the appropriate license for your operations.

Quality Smart Solutions has a team of professionals to offer support from day one of starting your business, including formulation and label reviews, Veterinary Health Product notifications and more.

30 Minutes Free Consultation
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Quality Smart Solutions is a global consulting firm, engaged in providing strategic support for products including NHPs, pharmaceuticals, and medical devices, in areas such as Regulatory Support, Site Licensing, Clinical Development and more.

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