Andrew Parshad

Categories
Food Safety

How to Develop a HACCP Plan

The purpose of a Hazard Analysis Critical Control Points (HACCP) plan is to identify and control any hazards that may arise during the process of manufacturing, storing, distributing, and consuming food products. HACCP plans are meant to reduce, eliminate, and avoid risks that may negatively impact the consumer and the organization. They will vary based on the product, process and other factors that can occur in the facility. Developing a HACCP plan consists of 12 tasks with seven principles, which are further explained below.   

1: Establish a HACCP Team

The HACCP team consists of individuals possessing a wide range of disciplines and knowledge to contribute to the process of food safety. A typical team includes:

  • Team Leader: orchestrates and organizes the planning process; identifies the scope and specific problem(s) of the plan.
  • Specialist(s): provide consultation and formulation of the plan through their expertise and knowledge.
  • Front Line Staff: includes farmers, distributors, processors, etc.; have in-depth perspective on creating the food product.
  • Stakeholders: e.g. consumers, board of directors, departments, etc.

2: Describe the Product

A full description of the final product should have the following elements in order for the HACCP team to identify hazards in creating the product:

  • Ingredients, and their characteristics;
  • Formulation (aka “recipe”) of the product;
  • Process of packaging, storing, and transporting;
  • Shelf life.

3. Purpose of the Product

The team determines the main intent of how the product will be used. Will it be cooked, eaten directly, or require further processing? The team needs to identify its intended consumers and determine any vulnerabilities when using the product.  Lastly, the team should consider the effects of misuse or abuse of the product to the general population. 

4. Process Flow Diagram

A process flow diagram gives the HACCP team a broader view on the manufacturing process of the product. The diagram can also consist of a schematic of the facility, lending an easier understanding of the steps of each process.

5. On Site Confirmation of Flow Diagram

The HACCP performs a review of the operating/manufacturing process to determine the quality of the flow diagram. Multiple reviews can be done and compared to iron out deficiencies in the process.  The site for which the HACCP plan is being designed should be visited as many times as possible to make sure all relevant information is collected.

6. Identify and analyze hazards (Principle # 1)

While identifying potential hazards, the HACCP team must do some background research on the following:

  • Ingredients and materials used in the product
  • Activities performed in each step of the manufacturing process
  • Method of storage and distribution
  • Use/consumption of product

During analysis, the HACCP evaluates the product’s effects on human, environmental, and organizational interaction.

Control measures are considered once hazards are identified and analyzed during the manufacturing process. At times, organizations may have to hire external food safety consultants to offer different perspectives. 

7. Determine the Critical Control Points (CCPs) (Principle # 2)

A critical control point is a step in the process flow diagram that involves reducing, eliminating, and preventing food safety hazards. If CCPs are not in place, the production will stop and cannot continue further.

8. Establish Critical Limits for each CCP (Principle # 3)

A critical limit measures the maximum/minimum value of certain factors that have impact on reducing, preventing, and eliminating food safety hazards. Factors such as temperature, time, moisture level, and visual appearance are considered.

9. Establish a Monitoring Procedure (Principle # 4)

A general monitoring procedure consists of:

  • Ensuring critical limits of each CCP are being met;
  • Detecting any inefficiencies of the control measures;
  • Corrective actions need to be taken as quickly as possible to avoid and minimize loss of the product;
  • Observing or measuring samples using a statistically-based sampling plan;
  • Common measurements taken are time, temperature, moisture, and content.

10. Establish Corrective Actions (Principle # 5)

Corrective actions must be taken immediately if critical limits are not being met. Management and employees should be trained on how to perform and respond appropriately.

11. Verify the HACCP Plan (Principle # 6)

Once the plan is drafted and CCPs have been validated, the HACCP plan can then be verified. The team must evaluate if CCPs and control measures are effective. Internal auditing may be required to demonstrate ongoing commitment to complying and updating the HACCP plan. Asking questions, observing operational procedures, and collecting samples are just some of the ways to verify the plan.

12. Keep Records (Principle # 7)

Record keeping is an essential step of the HACCP plan due to the following:

  • Offers traceability and transparency
  • Ensures due diligence
  • Provides record of complaints with critical limits set
  • Identifies potential problems

Record keeping can be carried out in a number of ways, such as checklists or control charts. Manual and computer records are acceptable, but the documentation method should be designed such that it is appropriate for the size and nature of the organization. 

If you or your company is seeking assistance in implementing a HACCP plan we’re ready to serve you.  Quality Smart Solutions has a team of experts who can implement a HACCP plan, coach and train your staff. Get prepared now and 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 14 years in the areas of compliance and quality assurance for Dietary Supplements/NHPs, Foods, Cosmetics, Cannabis, Medical Devices, OTC drugs in Canada and the United States. Ask us for details or visit our website at www.qualitysmartsolutions.com.

Categories
Natural Product Number (NPN)

COVID-19 FIGHT: Hand sanitizers and disinfectants compliance – Canada and US

In light of the recent Coronavirus pandemic, the demand for antimicrobial products such as disinfectants and hand sanitizers are skyrocketing. The aim of this article is to help you to understand the regulatory requirements needed to bring your disinfectant products into the Canadian or the US market, as well as the current regulatory exemptions and interim measures in place to help respond to COVID-19.

Canada

Most chemical products represented for use in Canada as disinfectants/sanitizers are regulated as drugs under the Food and Drugs Act. The Natural and Non-prescription Health Products Directorate (NNHPD) is the regulatory body within Health Canada that assesses applications for these products. There are two main categories of these products – Disinfectant drugs and Human-Use Antiseptic Drugs.

Disinfectant Drugs

Disinfectant Drugs are disinfectants for use on non-critical medical devices and hard non-porous environmental surfaces and inanimate objects in domestic, industrial / institutional, hospital, food processing and/or barn premises. All disinfectant drugs are subject to pre-market assessment by NNHPD and will be assigned a Drug Identification Number (DIN) upon market authorization. All disinfectant drug applications must support the general safety, efficacy, and quality requirements, as well as the labelling requirements set out by the Food and Drugs Act and Regulations.

Health Canada has developed Monographs for Disinfectant Drugs that outlines the permitted active ingredients and concentrations, target microorganism classes, contact times, and associated use areas for these products to be licensed without the submission of additional evidence to Health Canada. The Monograph permits general claims such as “Kills viruses / fungi / bacteria / germs” and “Kills 99.99% of viruses / bacteria / fungi”. The Monograph application stream allows for an abbreviated review process and the approximate review timeline for a monograph Disinfectant application is 45 days.

When a proposed product or its labelling is outside the scope of a published Monograph, applicants are required to submit evidence to Health Canada to support the safety, efficacy and quality of the product when used in accordance with the label directions; these applications require a scientific assessment as part of their market authorization.   

Fabricators, packagers/labellers, distributors, importers and testers of Disinfectant Drugs are not required to obtain an establishment licence or meet GMP compliance requirements. However, they are still expected to meet the provisions of section 8 of the Food and Drugs Act, which denotes the prohibition on selling drugs manufactured under unsanitary conditions or that are adulterated.

Human-Use Antiseptic Drugs

The Human-Use Antiseptic Drugs are antiseptic skin products for human use that are intended for personal, professional, or commercial use. All Human-Use Antiseptic Drugs are subject to pre-market assessment by NNHPD and will be assigned a Natural Product Number (NPN) or Drug Identification Number (DIN) upon market authorization. Human-Use Antiseptic Drugs containing ingredients that meet the definition of natural health product substances as per the Natural Health Product Regulations are required to apply for a Natural Product Number (NPN). All other Human-Use Antiseptic Drugs are required to file an application for a Drug Identification Number (DIN). All applications must demonstrate that the product meet safety, efficacy, quality, and labelling requirements set out by the Food and Drugs Act and Regulations and Plain Language Labelling requirements (for DINs only).

Health Canada has also developed a Monograph for Antiseptic Skin Cleansers for certain personal domestic use Human-Use Antiseptic Drugs. Personal domestic use products are those that can be self-selected by a consumer from a retail outlet for their own personal household use as part of a daily skin cleansing routine to reduce transient organisms on the skin. The Monograph specifies the allowed medicinal (active) ingredients and their concentrations, indications, and adequate directions for use. The Monograph permits general claims such as “Kills harmful bacteria / germs” and “Antiseptic skin cleanser”. Products which meet the Monograph specifications can be submitted for review under the Monograph application stream which allows for an abbreviated review process. The approximate review timelines are 45 days and 60 days for monograph DIN applications and NPN applications respectively.

Products that are outside the scope of this Monograph must submit a DIN application or an NPN application with appropriate supporting safety, efficacy and quality data for assessment. For example, products making Antiviral claims, % reduction claims, or organism specific claims must submit supporting evidence such as in-vitro test data to demonstrate efficacy. In addition, a Drug Establishment Licence (for DIN products) or a Site Licence (for NPN products) is required for any person (business or individual) in Canada to fabricate, package, label, test, import, distribute, or wholesale a drug. These activities must be conducted in compliance with GMP requirements.  

Canada Summary

Regulatory requirements for hard surface disinfectant drugs

  • Drug Identification Number Application for market authorization
  • Products eligible for the Monograph application stream may receive approval in 45 days
  • Food and Drug Regulations compliant product label

Regulatory requirements for antiseptic skin cleansers (i.e. hand sanitizers)

  • Drug Identification Number (DIN) Application or Natural Health Product (NHP) Application for market authorization
  • Products eligible for the Monograph application stream may receive approval in 45 days (DIN application) or 60 days (NHP applications)
  • Food and Drug Regulations compliant product label
  • Manufacturers in Canada would need a Drug Establishment License (for DIN) or Site License (for NHP)
  • Manufacturers outside of Canada would need a Canadian importer with a Drug Establishment License (for DINs) or Site License (for NHPs).

US – Products regulated by Environmental Protection Agency

In the United States, chemical germicides formulated as sanitizers, disinfectants, or sterilants used on environmental surfaces and non-critical surfaces are regulated by the United States Environmental Protection Agency (EPA), under the authority of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). Under FIFRA, any substance or mixture of substances intended to prevent, destroy, repel, or mitigate any pest (including microorganisms but excluding those in or on living humans or animals) must be registered before sale or distribution. To obtain a registration, a manufacturer must submit specific data about the safety and effectiveness of each product. For example, EPA requires manufacturers of sanitizers, disinfectants, or chemical sterilants to test formulations by using accepted methods for microbiocidal activity, stability, and toxicity to animals and humans. The manufacturers submit these data to EPA along with proposed labeling. If EPA concludes the product can be used without causing “unreasonable adverse effects,” then the product and its labeling are registered, and the manufacturer can sell and distribute the product in the United States.

Pesticides produced by foreign manufacturers and imported for sale or distribution in the United States must comply with all requirements applicable to domestic producers. This includes registering the pesticide product and obtaining an EPA Pesticide-Producing Establishment number before starting production. In addition, regulations require an importer to submit to EPA a Notice of Arrival of Pesticides and Devices (EPA Form 3540-1) for review and determination as to whether the shipment should be sampled and/or permitted entry into the United States.

US – Products regulated by Food and Drug Administration

Antiseptics are antimicrobial drugs used on living tissue and thus are regulated by Food and Drug Administration (FDA) under the Food, Drug and Cosmetic Act. The FDA has established OTC (Over-the-Counter) monographs for drugs that are generally recognized as safe and effective (or GRAS/GRAE), which are published in the government’s Code of Federal Regulations (CFR). A Monograph is a regulatory standard for ingredients, covering acceptable ingredients, doses, formulations, indications, and labeling. Any OTC product that conforms to a finalized monograph may be manufactured and marketed without the need for FDA pre-approval. Any drug product that does not comply fully to an OTC monograph will require FDA approval under a new drug application (NDA) or abbreviated new drug application (ANDA) prior to marketing. In addition, all drug products must comply with the standardized labelling requirements as outlined in the CFR. 

Domestic and foreign establishments that manufacture, repack, or re-label drug products in the United States are required to register their facilities with the FDA. They are also required to provide the FDA with a current list of all commercially marketed drug products. Drug products are identified and listed using a unique, three-segment number, called the National Drug Code (NDC), which serves as a universal product identifier for drugs. This information helps the FDA maintain a catalog of all drugs in commercial distribution in the United States. Foreign drug establishments whose drugs are imported into the United States are also required to register with FDA, identify a U.S. Agent, and submit drug listing information for their drugs intended for commercial distribution in the United States.  

US Summary

Regulatory requirements for hard surface disinfectant products

  • Obtain product registration with the United States Environmental Protection Agency (EPA)
  • EPA approved product label
  • Obtain an EPA Pesticide-Producing Establishment number
  • Importers need to submit a Notice of Arrival of Pesticides and Devices to EPA for approval

Regulatory requirements for antiseptic skin cleansers (i.e. hand sanitizers)

  • May be manufactured and marketed without FDA pre-approval If the product is fully compliant to a FDA OTC monograph
  • Any product that does not comply fully to an OTC monograph will require FDA approval under a new drug application (NDA) or abbreviated new drug application (ANDA).
  • Code of Federal Regulations compliant product label
  • Establishment Registration with the FDA
  • Drug Product Listing with NDCs
  • A U.S. Agent is required for Foreign drug establishments whose drugs are imported into the US

COVID-19 regulatory exemptions and Health Canada interim measures

In light of the unprecedented demand and urgent need for disinfectants and hand sanitizers during the COVID-19 pandemic, as an interim measure, Health Canada will facilitate the importation of the following:

  • Products that are already authorized for sale in Canada but are not fully compliant with Health Canada requirements
  • Products that are not authorized for sale in Canada but are authorized or registered in the United States or an MRA country.

Importers of products that fall under these categories are required to notify Health Canada prior to importation.

In addition, manufacturers and distributors of authorized hard surface disinfectants with the following anti-virus claims are allowed to make indirect efficacy claims for SARS-CoV-2 (the virus that causes COVID-19).

  • broad-spectrum virucide or
  • specific claim against a specific coronavirus, such as MERS-CoV, SARS-CoV, or human coronavirus strain 229E

Health Canada is also prioritizing the review of applications for market authorization related to disinfectants or hand sanitizers. If you or your company is looking to market your disinfectant or antiseptic products in Canada, now is the time act.

Quality Smart Solutions has a team of specialists who can provide product licensing, label compliance, and import solutions for you.  We have licensed over 5000 NPNs and DINs including hand sanitizers and disinfectants.  We are also a licensed importer of record for disinfectant natural health products through our sister company, Quality IMPORT Solutions. Get prepared now and 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, Cannabis, Medical Devices, OTC drugs in Canada and the United States. Ask us for details or visit our website at www.qualitysmartsolutions.com.

References

Guidance document – Disinfectant drugs https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/disinfectants/disinfectant-drugs.html

Guidance document – Management of Disinfectant Drug Applications

https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/disinfectants/management-disinfectant-drug-applications.html

Guidance Document – Human-Use Antiseptic Drugs

https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/human-use-antiseptic-drugs.html

Guidance Document: The Management of Drug Submissions and Applications

https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/management-drug-submissions/industry/document.html

Pesticide Registration Manual: Chapter 4 – Additional Considerations for Antimicrobial Products https://www.epa.gov/pesticide-registration/pesticide-registration-manual-chapter-4-additional-considerations

Pesticide Registration Manual: Chapter 1 – Overview of Requirements for Pesticide Registration and Registrant Obligations https://www.epa.gov/pesticide-registration/pesticide-registration-manual-chapter-1-overview-requirements-pesticide

Safety and Effectiveness of Consumer Antiseptic Rubs; Topical Antimicrobial Drug Products for Over-the-Counter Human Use https://www.federalregister.gov/documents/2019/04/12/2019-06791/safety-and-effectiveness-of-consumer-antiseptic-rubs-topical-antimicrobial-drug-products-for

Development & Approval Process | Drugs https://www.fda.gov/drugs/development-approval-process-drugs#:~:text=FDA%20approval%20of%20a%20drug,risks%20for%20the%20intended%20population.

Expedited access to disinfectants, hand sanitizers and personal protective equipment to help limit the spread of COVID-19, as well as swabs for testing https://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2020/72623a-eng.php

Categories
Natural Product Number (NPN)

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

Doctor hands using washing hand with Alcohol Sanitizer isolate on a white background. Promoting people use face mask to protect themselves from virus infection in Corona virus crisis 2020

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, Cannabis, Medical Devices, OTC drugs in Canada and the United States. Ask us for details or visit our website at www.qualitysmartsolutions.com.

 

Categories
Food Safety

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, Cannabis, Medical Devices, OTC drugs in Canada and the United States. Ask us for details or visit our website at www.qualitysmartsolutions.com.

 

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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Categories
Natural Health Products (NHP)

Natural Health Product Brand Name Guidance

mdel license application

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 Cannabis for Canada and the United States. Ask us for details or visit our website at www.qualitysmartsolutions.com.

Categories
News

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 Cannabis for Canada and the United States. Ask us for details or visit our website at www.qualitysmartsolutions.com.

 

 

Categories
Natural Product Number (NPN)

Business considerations when applying for a Natural Product Number (NPN)

mdel license application

Just 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

Categories
Natural Health Products (NHP)

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

Categories
Cannabis Solutions

Summary of the Proposed Approach to the Regulation of Cannabis

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 Cannabis.  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, cannabis tracking system, cannabis products, packaging and labelling, cannabis for medical purposes, health products and cosmetics containing cannabis and miscellaneous issues.  The government’s intent is to have the Cannabis Act be approved before July 2018.  Here are the main takeaways from the proposed Cannabis 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 cannabis 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 cannabis.  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.

 

Cannabis 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 cannabis licensed producers. This new proposed system would expand on this platform.

 

Cannabis Products and Forms

Five classes of cannabis would be permitted for sale including dried cannabis, cannabis oil, fresh cannabis, cannabis plants and cannabis 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 cannabis products.  Tamper evident, child-resistant packaging. Limits of 30 grams of dried cannabis per single package and 2.1 Litres for cannabis 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 cannabis symbol will be created to prevent accidental ingestion for products with more than 10 ppm of THC.

 

Medical Cannabis

The regulations for medical cannabis, 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 Cannabis

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

 

Miscellaneous Issues

Amendments to the current ACMPR and NCR based on this proposed Cannabis 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 Cannabis

 

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

 

Categories
News

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.

 

Categories
News

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.

Categories
News

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.

Categories
News

Meet with QSS at Expo East, CHFA East and Supply Side West!

September is just around the corner and it’s tradeshow season time!  It’s our busiest month of the year attending shows, meeting with clients and prospects.   We’re going to be at two shows in three weeks.   Both Natural Products Expo East, in Baltimore and CHFA East in Toronto will run on the same week in mid-September.  Expo East is a great show to see upcoming trends in Natural Health Products, Foods and Cosmetics.  Here’s some quick information about each show:

Hosted in Baltimore, Maryland, Natural Products Expo East is the second largest Health and Wellness tradeshow in North America (with Natural Products Expo West being the largest).  There will be approximately 1500 booths  representing various categories including Dietary Supplements, Health & Beauty, Pet Products and Foods.  The tradeshow is from September 14 to 16.  Three of our team members will be attending including President and Founder, Andrew Parshad.

CHFA East takes place in downtown Toronto at the Metro Toronto Convention Center September 16 and 17.   This is the largest Canadian Health and Wellness tradeshow (with CHFA West in Vancouver being the second largest).  Four of our team members including Andrew Parshad will be attending year.

Supply Side West is the largest natural ingredients and solutions provider show in North America.  Three team members will be attending including Andrew Parshad.

 

Quality Smart Solutions offers regulatory expertise for Natural Health Products (Dietary Supplements), Foods and Cosmetics. We also have a broker and distributor network if you are looking for a partner in the Canadian market.

Quality IMPORT Solutions offers Importer of Record services for companies looking to sell Dietary Supplements in Canada.

Here’s a summary of the September shows and dates we’ll be attending:

Natural Products Expo East – September 14-16

CHFA East – September 14-17

Supply Side West – September 26 to 28

Contact us today!

Categories
News

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.

Categories
Drug Identification Number (DIN)

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.

Categories
News

CHFA West – May 12 to 15

Quality Smart Solutions will be at CHFA West in Vancouver from May 12 to 15.  Are you looking for an expert in FDA Dietary Supplement regulations?  Need a bilingual food, cosmetic or NHP label?  Looking for an importer of record?  We offer these and many more solutions.  Please contact us at info@qualitysmartsolutions or Andrew at 1-800-396-5144 ext. 4 to arrange a meeting.

Quality Smart Solutions is a proud member of the Canadian Health Food Association.

Categories
News

VITAFOODS EUROPE 2015 – May 6 and 7 – Meet to discuss USA and Canada Regulatory Compliance Solutions

Quality Smart Solutions will be in Geneva, Switzerland attending VitaFoods Europe on May 6 and 7.  

If you are seeking assistance in regulatory compliance for USA and Canada for Dietary Supplements, Cosmetics or Foods or are seeking assistance in distribution and/or brokerage solutions please contact us at 1-800-396-5144 ext.4  and book an appointment with us.  Andrew Parshad, President of Quality Smart Solutions will be in attendance and would be happy to meet with you and answer any questions you may have in establishing your Consumer Health Product business in North America.

See  you in Geneva!

Categories
News

NATURAL PRODUCTS EXPO WEST – 3 reasons why you MUST meet with Quality Smart Solutions!

We’re going to be attending Natural Products Expo West in Anaheim over the 4 day event, from March 5 to 8 and there’s three reasons why you must meet with Quality Smart Solutions:

  1. Distribution – Several of our distributor partners from Canada will be in attendance at Expo West.  It’s the perfect opportunity for you to get distribution and retail environment as well as the regulatory landscape questions answered at the same time!!  Book an appointment with us during the show and let us know what channel your focus is (independent health foods, food drug and mass or both) and we’ll bring a distributor/broker partner that fits your needs. 
  2. Canada Regulatory Solutions – whether it’s Natural Health Products (obtaining an NPN to be authorized to sell your Dietary Supplements in Canada), Foods (conventional or specialized foods that require a temporary market authorization license), cosmetics (label review and notification) or importer on record solutions, let’s talk.
  3. USA Regulatory Solutions – Did you know that Quality Smart Solutions offers Compliance solutions for Dietary Supplements? Whether it’s a label review, substantiation dossier, in need of a US Agent or Registration of your Food/Dietary Supplement site, we are your solution! Our US regulatory expert has over 10 years experience and has reviewed over 1000 labels.  High End Solutions without the High End Fees! 

 NATURAL PRODUCTS EXPO WEST. Let’s meet!      

Categories
Dietary Supplements

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.

Categories
News

Supply Side West – October 8 & 9. Booth 22145. Book a Meeting To Discuss SOLUTIONS For You!

mdel license application

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

In the meantime, view our SUPPLY SIDE WEST email!

Categories
Natural Health Products (NHP)

A New NHPD 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:

Class Current Timeframe Future timeframe
1 – High level of certainty
– (eg. Monographs, AbLs, Category IV/TPD labeling		 60 days 10 days
2 – Medium level of certainty – a combination of pre-cleared information and high quality data from peer reviewed published journals 180 days 30 days
3 – Low level of certainty – clinical trial evidence and full pre-market assessment 180 days 180 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.

Categories
Dietary Supplements

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.

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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:

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

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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.