Categories
Blog

Benefits & requirements of using a medical device MDEL Import Agent

Medical Device Import License

Using a medical device import agent can offer several benefits, especially if you are navigating the complex process of importing medical devices into a new market or dealing with regulatory requirements that are unfamiliar to you. At the end of this blog, you’ll have a firm and developed idea of the regulatory requirements when importing medical devices and why our MDEL import agent can solve so many of your problems.

Here are some advantages to using a medical device import agent:

  1. Regulatory Expertise: Medical device import agents are often well-versed in the regulatory requirements and documentation needed for importing medical devices. They can help you navigate the complex regulatory landscape, ensuring your products meet all necessary compliance standards.
  2. Local Knowledge: Import agents know the target country’s local market conditions, business practices, and cultural nuances. This local knowledge can be invaluable in helping you tailor your approach to a specific market and make informed decisions.
  3. Navigating Customs: Importing medical devices involves dealing with customs procedures, duties, and taxes. Import agents are experienced in handling customs clearance and can expedite the process, reducing delays and potential complications.
  4. Supplier and Vendor Liaison: Import agents can establish and maintain relationships with suppliers and vendors in the source country. This can help streamline communication, negotiate favorable terms, and address any issues arising during the import process.
  5. Documentation Assistance: Importing medical devices requires extensive documentation, including regulatory filings, certificates, and quality control records. An import agent can help you compile and organize these documents to ensure a smooth import process.
  6. Risk Management: Import agents can help identify potential risks and challenges of importing medical devices. Their expertise can assist you in mitigating risks, ensuring product quality and safety, and addressing compliance concerns.
  7. Time and Cost Savings: Working with an import agent can save you time and resources by handling various logistics, administrative tasks, and compliance-related activities on your behalf. This allows you to focus on your core business operations.
  8. Networking and Connections: Import agents often have established networks and connections in the industry and market. This can open up opportunities for collaboration, partnerships, and distribution channels.
  9. Language Barrier: If you are importing medical devices into a country where the primary language differs from yours, an import agent can bridge the language gap and facilitate effective communication with local authorities, suppliers, and stakeholders.
  10. Compliance Assurance: Import agents are committed to ensuring that your medical devices comply with all relevant regulations, quality standards, and industry best practices. Their expertise can help you avoid costly compliance errors.
  11. Market Entry Strategy: Import agents can provide insights and advice on developing a successful market entry strategy, including pricing, distribution, and marketing considerations.

Choosing a reputable and experienced import agent with a strong track record in the medical device industry and the target market is essential. Conduct thorough research and due diligence before partnering with an import agent to ensure they can effectively meet your needs and support your business goals.

What are the regulatory requirements set by Health Canada?

If you’re looking to import medical devices into Canada, here’s a general overview of the process and key considerations:

  1. Determine Device Classification: Medical devices are classified into different risk classes (Class I, II, III, and IV) based on factors such as intended use, potential risks, and mechanisms of action. Determine the classification of your medical device using Health Canada’s Medical Device Classification System.
  2. Appoint a Canadian Representative (if required): Foreign manufacturers of medical devices may need to appoint a Canadian representative responsible for communication with Health Canada and other regulatory matters.
  3. Obtain a Medical Device Establishment License (MDEL): Companies that import, distribute, or sell medical devices in Canada must hold a Medical Device Establishment License (MDEL). This license demonstrates compliance with regulatory requirements.
  4. Submit Device License Application: Depending on the device class, you may need to apply for a Device License. This involves submitting an application to Health Canada and providing detailed information about the device, its intended use, and supporting documentation.
  5. Quality Management System (QMS): Manufacturers of Class II, III, and IV medical devices must have a compliant Quality Management System (QMS). Health Canada recognizes ISO 13485:2016 as the standard for medical device QMS.
  6. Prepare Technical Documentation: Compile technical documentation demonstrating your medical device’s safety, effectiveness, and quality. This documentation may include design and manufacturing information, labeling, instructions for use, risk assessments, and clinical data (if applicable).
  7. Register and List Devices: Depending on the classification, specific medical devices must be registered and listed with Health Canada’s Medical Devices Active Licence Listing (MDALL) database.
  8. Labeling and Packaging: Ensure your medical device’s packaging and labeling comply with Canadian regulations. Labels must include important information such as device identification, manufacturer details, lot or serial numbers, and instructions for use.
  9. Importer Records: Maintain accurate records of imported medical devices, including information about the manufacturer, product details, lot numbers, distribution, and any complaints or adverse events.
  10. Adverse Event Reporting: Establish procedures for reporting adverse events, complaints, and recalls related to your imported medical devices to Health Canada.
  11. Customs Procedures: Work with customs brokers to ensure smooth importation and compliance with customs requirements, including tariffs and duties.
  12. Importer Responsibilities: As an importer, you ensure that the medical devices you import meet Canadian regulatory requirements, including quality, safety, and labeling.

It’s important to note that the information provided is a general overview, and the specific requirements and steps may vary depending on factors such as device classification, intended use, and regulatory changes. To ensure accurate and up-to-date information, it’s recommended that you consult Health Canada’s official guidance documents, regulations, and resources related to importing medical devices into Canada. Additionally, seeking assistance from regulatory experts or consultants experienced in medical device importation can help you navigate the process successfully.

Categories
Blog

EFSA novel food submission, procedures & food panel guidance

CBD Products food and supplements Introduction:

The European Food Safety Authority (EFSA) provides regulatory guidance and oversees the approval process for novel foods in the European Union (EU). Novel foods are foods or ingredients not consumed significantly within the EU before May 15, 1997. If you are interested in submitting a novel food application to EFSA or seeking regulatory guidance, here are the general steps and considerations:

  1. Determine Novel Food Status: Determine whether your product falls under the novel food category according to the EU’s Novel Food Regulation (EU) 2015/2283. You must go through the approval process if your product is considered unknown.
  2. Pre-Submission Consultation (Optional): Before submitting a formal application, you can request a pre-submission consultation with EFSA. This allows you to discuss the novel food application process, potential data requirements, and other aspects with EFSA experts.
  3. Compile Scientific Data: Prepare a comprehensive dossier containing scientific and safety data for your novel food. This data should address the safety, nutritional profile, and any other relevant aspects of your product.
  4. Submit a Novel Food Application: Submit a formal novel food application to the European Commission and the competent authority of an EU Member State. The application should include detailed information about your product, its composition, production process, intended use, proposed labeling, and the scientific data supporting its safety.
  5. Risk Assessment by EFSA: Once the application is submitted, EFSA performs a thorough scientific risk assessment of the novel food. This assessment evaluates the safety of the novel food for human consumption, considering factors such as potential allergenicity, toxicity, and nutritional value.
  6. Public Consultation: EFSA may conduct a public consultation to gather input from stakeholders, including industry, consumers, and other interested parties.
  7. Opinion by EFSA: EFSA provides a scientific view on the safety of the novel food based on the data submitted and the risk assessment conducted.
  8. European Commission Decision: Based on EFSA’s opinion, the European Commission and EU Member States decided to authorize the novel food. If allowed, the novel food can be placed on the EU market.

Suppose you are considering submitting a novel food application. In that case, it is advisable to seek professional advice and guidance from regulatory experts familiar with the latest requirements and procedures.

The European Food Safety Authority (EFSA) procedure for evaluating novel foods and assessing their safety

The Novel Food Regulation (EU) 2015/2283 outlines the steps and requirements for the novel food authorization process. Remember that procedures and guidelines may have evolved since then, so it’s essential to consult the most up-to-date resources EFSA provides.

Here is a general overview of the EFSA novel food procedure:

  1. Application Submission: A company seeking authorization for a novel food application to a designated EU Member State. The application includes detailed information about the novel food, its composition, intended use, production process, labeling, and scientific data on safety.
  2. Validation: The EU Member State reviews the application for completeness and accuracy. If the application is deemed valid, the process continues.
  3. Initial Assessment: The EU Member State conducts an initial assessment of the novel food application and prepares a draft assessment report. This report includes information on the novel food’s safety, nutritional profile, and potential risks.
  4. Consultation with Other Member States: The draft assessment report is shared with other EU Member States and the European Commission. They have the opportunity to provide comments and feedback.
  5. EFSA Involvement: If there are no objections from Member States, the European Commission sends the application to EFSA for a scientific evaluation. EFSA’s Panel on Nutrition, Novel Foods, and Food Allergens (NDA Panel) is responsible for conducting the risk assessment of the novel food.
  6. EFSA Evaluation: The NDA Panel reviews the application, scientific data, and any additional information the applicant provides. EFSA evaluates the safety of the novel food for human consumption, considering factors such as potential allergenicity, toxicity, and nutritional value. EFSA may also consider the potential impact of the novel food on consumers with specific dietary needs.
  7. Public Consultation: EFSA may initiate a public consultation to gather input from stakeholders, including industry, consumers, and other interested parties. This consultation helps ensure that all relevant perspectives are considered.
  8. Scientific Opinion: Based on its evaluation, EFSA provides a scientific opinion on the safety of the novel food. This opinion is published and made available to the public.
  9. European Commission Decision: The European Commission and EU Member States use EFSA’s scientific opinion to decide on authorizing the novel food. If allowed, the novel food can be placed on the EU market.

To obtain the most accurate information on the EFSA’s novel food procedure and Novel Food regulations, visit the official EFSA website. To learn about the role of the NDA Panel, I recommend visiting the official EFSA website and reviewing the latest guidance documents and regulations. Did you know this process could also apply to products with CBD ingredients, learn more here:

Please contact our team for more information on food classification, ingredient feasibility questions, ingredient submissions, dietary supplement compliance, NHP compliance, and food labeling projects. Our specialists are here to help with the following services; Novel Food Notifications, SFCR License application, HACCP & PCP program, TMA License for Supplemented Foods, Nutrition Facts Table (NFT) Creation and label compliance!

Categories
Blog

The ultimate guide to selling on Amazon Canada: A Step-by-Step Tutorial

sell on amazon canada Are you looking to tap into the immense potential of the Canadian market and boost your e-commerce success? Look only as far as Amazon Canada. With millions of active users and a rapidly growing customer base, selling on Amazon Canada can be a game-changer for your business. But where do you start? How do you navigate the complexities of setting up and optimizing your Amazon Canada account? Fear not because this ultimate guide is here to help you every step of the way.

From understanding the Canadian marketplace to creating compelling product listings and implementing effective marketing strategies, this step-by-step tutorial will equip you with all the knowledge and tools you need to succeed on Amazon Canada. Whether you’re a seasoned seller looking to expand your reach or a newbie exploring new avenues, this guide is your go-to resource for mastering the art of selling on Amazon Canada. So, let’s dive in and unlock the vast potential of this thriving e-commerce platform!

To learn about dietary supplement compliance for getting your NHPs ready for sale on Amazon Canada click here:   For compliance in every other product category click here:

What are the benefits of selling on Amazon Canada?

Selling on Amazon Canada has many benefits that can significantly boost your e-commerce business. Firstly, Amazon Canada offers access to a large and diverse customer base, allowing you to reach millions of Canadian shoppers actively looking for products online. The platform’s vast user base and robust infrastructure also provide high trust and credibility for buyers and sellers, making establishing your brand easier and building customer loyalty.

Another significant benefit of selling on Amazon Canada is the platform’s ease of use and convenience. Amazon takes care of the heavy lifting of logistics and customer service, allowing you to focus on growing your business. The platform streamlines the entire selling process, from inventory management to order fulfillment, making it a hassle-free experience for sellers. Additionally, Amazon’s fulfillment services, such as FBA (Fulfillment by Amazon), enable you to store your products in their fulfillment centers, handle order processing, and even offer Prime shipping options to your customers, giving you a competitive edge in the market.

Lastly, selling on Amazon Canada gives you access to powerful marketing and advertising tools that can help you increase your visibility and drive sales. With options like sponsored products, display ads, and brand stores, you can effectively promote your products and target specific customer segments, ensuring that the right audience sees your listings. These advertising options, combined with Amazon’s robust search engine optimization capabilities, help you increase your product’s visibility and ultimately boost your sales.

Understanding the Amazon marketplace regulatory, customs, and competition components in Canada

Before diving into selling on Amazon Canada, it’s essential to understand the unique characteristics of the Canadian marketplace. While Amazon Canada shares many similarities with its U.S. counterpart, there are some key differences that you need to be aware of to maximize your success.

First and foremost, the Canadian market has consumer preferences, cultural nuances, and regulatory requirements. It’s crucial to conduct thorough market research to identify the demand for your products in Canada and tailor your offerings accordingly. Pay attention to language preferences, product sizes, measurements, and any specific regulations or certifications that might be required for certain product categories.

Additionally, remember that the Canadian market has a smaller population than the United States. This means that competition may be less intense, but the customer base is also more limited. It’s essential to strike the right balance between targeting a niche market and ensuring sufficient customer demand for your products.

Lastly, consider the impact of international shipping and customs on your pricing and logistics. Shipping times and costs can vary significantly when shipping from outside Canada, so it’s crucial to consider these considerations when setting your prices and managing customer expectations. Offering competitive shipping options and clear communication about delivery times can help you stand out and provide a positive customer experience.

Setting up your Amazon Seller account

Setting up your Amazon seller account is the first step to selling on Amazon Canada. The process is straightforward and can be completed in a few simple steps.

1. Choose your seller account type: Amazon offers Individual and Professional seller accounts. The Individual account suits sellers who plan to sell fewer than 40 items monthly. In contrast, Professional performance is ideal for sellers with a higher sales volume. Consider your business needs and choose the account type best suits your requirements.
2. Register your account: Visit the Amazon Seller Central website and click the “Register now” button. You will be guided through the registration process, which includes providing your business information and bank account details and verifying your identity.
3. Set up your seller profile: Once your account is registered, you can set up your seller profile. This includes providing information about your business, such as your company name, address, and contact details. Take the time to fill out your profile completely and accurately; it will help build trust with potential customers.
4. Choose your fulfillment method: Amazon provides various fulfillment options, including FBA (Fulfillment by Amazon), FBM (Fulfillment by Merchant), and SFP (Seller Fulfilled Prime). Consider the pros and cons of each method and choose the one that aligns with your business goals and capabilities.
5. Set up your payment method: To receive payments from Amazon for your sales, you must set up your payment method. Amazon offers options such as direct deposit, Amazon Gift Card, or check. Choose the payment method that is most convenient for you.
6. Start listing your products: With your account set up, you can now start recording your products on Amazon Canada. Take the time to create compelling product listings that highlight the unique selling points of your products and optimize them for search visibility.

By following these steps, you’ll have your Amazon seller account up and running, ready to start selling on Amazon Canada.

We hope this post helped you understand the benefits of selling your products on Amazon.  As an official Amazon Canada compliance partner we can help ensure your products are compliant for sale across every Amazon product category.

Check out our Amazon seller compliance guide.

Categories
News

FDA Announces FSMA Food Traceability Proposed Rule

On Monday September 21st, the U.S. Food and Drug Administration (FDA) announced a proposed rule to establish additional traceability record keeping requirements for certain foods.

Although existing FDA regulations already require that certain records are established and maintained, it only forms a baseline for traceability record keeping. These additional proposed requirements will not only allow for standardization of records throughout the industry but will also allow the FDA to more quickly identify a source of contaminated product, reduce the scope of recalls and conduct more timely root-cause investigations.

A list of foods that will be subject to the proposed requirements has also be drafted and can be found here, “Food Traceability List”. The requirements of this proposed rule would only apply to foods that are on the FTL, which includes foods that have the listed foods as ingredients. However, the FDA encourages the voluntary adoption of these practices for all foods.

Key Features

Critical Tracking Events (CTEs)

Growing, receiving, transforming, creating and shipping have been identified as CTEs where records with Key Data Elements will be required. These records will need to contain the traceability lot code of the foods relevant to these elements.

Traceability Program Records

Additionally, any persons who manufacture, process, pack or hold foods that are listed on the FTL will be required to maintain traceability program records.

  • A description of relevant reference records – This traceability program record must include a description of the reference record including where on the reference record the traceability information appears.
  • A list of foods on the FTL that are shipped – Anyone who ships food that is listed on the FTL is required to keep a list of which listed foods they ship. This includes the traceability product identifier and the traceability product description for each food.
  • A description of how traceability lot codes are assigned.
  • Other information needed to understand the data provided within the require records.

Additional Requirements

The proposed rule would also require that:

  • Records be maintained as either original paper records, electronic records, or true copies. They must also be legible and stored in a way that will prevent deterioration or loss.
  • Traceability records must be provided to the FDA no later than 24 hours after the request is made.
  • An electronic sortable spreadsheet containing all relevant traceability information must be provided to the FDA within 24 hours of a request when necessary to assist during an outbreak, recall or other threat to public health.

Full details can be found here https://www.fda.gov/food/food-safety-modernization-act-fsma/fsma-proposed-rule-food-traceability?utm_medium=email&utm_source=govdelivery

Categories
Blog

What is a HACCP Plan and Food Handler’s (HACCP Certification) in 2023?

What is a HACCP Plan?

Food safety is always evolving and becoming more complex, as companies require constant updating with safety regulations and industry trends. Before discussing what a HACCP Plan is, let’s talk about the importance of Food Safety Training. According to Health Canada, an average of four million cases of foodborne illness occur every year, over 11,000 Canadians are hospitalized, and more than 200 people die. Food safety incidents are serious and should not be taken lightly. The solution to reducing and preventing such negative consequences is proper food safety training. HACCP Certification and Food Handler’s certification are two methods to ensure food safety procedures are put into place.

What is the Importance of your HACCP Plan?

Hazard Analysis Critical Control Points is a system that establishes safety guidelines in all stages of food production and processing. HACCP Plan Certification analyzes and manages physical, chemical, and biological hazards in food production and handling, all the way up to distribution and consumption of the food products.

There are 7 principles of HACCP Plan certification that ensure food products are consumed as safely as possible.

To be reputable and trustworthy, this certification is expected in any organization that is involved in the food production business. In countries like Canada and the USA, HACCP Plan Certification is mandatory and annually audited. Overall, this prevents risks that can lead to severe financial, legal, and health consequences.

What is the Importance of the Food Handler’s Certification?

For many of us, food handling practices are considered common sense, as they are such a frequent occurrence in everyday life. However, “common sense” is not on par with the level of professionalism required to serve food products to the public.

Food Handler's Certification

The majority of food-borne illnesses are caused by food-handling mistakes, improper food preparation, mishandling equipment, and poor personal hygiene. A Food Handler’s Certificate ensures front line workers must:

  • Understand how food becomes contaminated
  • Understand causes of food-borne illness
  • Know how to store, prepare, cook, and serve food
  • Know how to clean equipment, supplies, and surroundings

Obtaining a Food Handler’s certificate ensures the knowledge and skills are acquired to handle food safely at a higher standard. There are also numerous benefits that a Food Hander’s certificate can serve:

  • Protect the business reputation
  • Prevent customer complaints and media scrutiny
  • Reduce unnecessary operational costs such as pest control and food wastage

Avoid legal fines or business closures.

Why is Food Safety Training Essential?

The HACCP Plan and the Food Handler’s Certificate are important in today’s food industry, as consumers demand higher quality, and government agencies are critical in food safety measures. Food safety training is essential as it is mandatory in many countries. Legal and financial penalties can occur if companies and workers fail to obtain training.  Quality Smart Solutions delivers high-end training and consultation to help your business grow and comply with industry safety standards. To find out more on our services, do not hesitate to contact us.

Categories
Blog

Protecting Canadians from Unsafe Drugs Act

The Protecting Canadians from Unsafe Drugs Act (Vanessa’s Law) introduces amendments to the Food and Drugs Act that will improve Health Canada’s ability to collect post-market safety information, and take appropriate action when a serious risk to health is identified.

These amendments are designed to better protect a patient’s health and safety, and increase consumer confidence in therapeutic products on the market. The Act applies to therapeutic products, including: prescription and over-the-counter drugs, vaccines, gene therapies, cells, tissues and organs, and medical devices. The amendments brought to the Food and Drugs Act by Vanessa’s Law do not apply to natural health products, which continue to be regulated under the existing Natural Health Product Regulations (NHPR) of the Food and Drugs Act.

Key amendments to the Food and Drugs Act include:

New power for the Minister to require companies to modify or replace drug or medical device labels or packaging

In certain situations, the potential harm from the use of the therapeutic product may not be adequately reflected on the approved label. In addition, similar looking or sounding brand names or similar looking packaging may pose a risk to health and lead to prescribing and dispensing errors. When a determination is made that it is necessary to make revisions to prevent injury to health, the Minister of Health will now be able to direct an authorization holder to revise the label of a therapeutic product to include new harm information, or to change the brand name or packaging.

New power for the Minister to recall unsafe therapeutic products

The Minister of Health will now be able to order the removal of a therapeutic product from the marketplace when a product presents an imminent or serious risk to health.

New powers for the Minister to compel information, gather more information, require new tests or studies, monitor experience, and conduct product assessments

Over the course of a therapeutic product’s lifecycle, new information may raise questions about the product’s effect on health and safety. The Minister of Health will now have the authority to gather more information about the product. This can be done either by compelling persons to provide information for the purpose of assessing serious risks to health, or by requiring a therapeutic product authorization holder to compile information, conduct new tests or studies, or monitor experience. The Minister of Health may also direct a therapeutic product authorization holder to assess the benefits, harms and uncertainties of a product.

Tougher measures for those who do not comply

Fines and penalties for those who do not comply with the Act will be increased, to a maximum penalty of $5,000,000 or 2 years in prison, to better reflect the serious nature of the offence. Additionally, a person who knowingly makes a false or misleading statement to the Minister of Health, or who knowingly or recklessly causes a serious risk of injury in contravening the Act or its regulations, could face a higher fine or up to five years in jail, at the discretion of the court. An injunction power will also be added, such that, upon application of the Minister of Health, a court will be able to order a person to refrain from performing an act related to the commission of an offence under the Act.

Mandatory reporting of serious adverse drug reactions and medical device incidents by healthcare institutions

Certain healthcare institutions will be required to report serious adverse drug reactions and medical device incidents to the Minister of Health.

While most drugs are prescribed and used by patients outside of healthcare institutions, patients who experience serious reactions to drugs generally require hospitalization. Healthcare institutions, such as hospitals, are therefore in a unique position to identify and report serious adverse reactions. Certain healthcare institutions will now be required to report serious adverse drug reactions and medical device incidents to the Minister of Health.

New ability for the Minister to disclose confidential business information related to therapeutic product safety

The Minister of Health will now have the authority to disclose confidential business information about a therapeutic product if the Minister believes it is necessary to determine whether a therapeutic product presents a serious risk of injury to human health. As well, the Minister may now disclose confidential business information about a therapeutic product to a government, a person from whom the Minister seeks advice, or a person who carries out functions relating to the protection or promotion of human health or the safety of the public. This disclosure of info is authorized if the purpose of the disclosure is related to the protection or promotion of human health, or the safety of the public.

Obligation on therapeutic product authorization holders to make information about clinical trials publicly available

This new section places an obligation on therapeutic product authorization holders to ensure that prescribed information concerning any clinical trial is made public in a time and manner that will be set out in regulations. This could be accomplished by requiring mandatory registration of those trials on publicly accessible, well-established clinical trial registries.

If you want to be sure you are in compliance with the Canadian regulatory requirements, Quality Smart Solutions has a team of specialists who can assist you. 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, Canna, Medical Devices, OTC drugs in Canada and the United States. Ask us for details or visit our website at www.qualitysmartsolutions.com.

Categories
Blog

Reporting Adverse Reactions to Marketed Health Products

All marketed drugs and health products have benefits and risks. All health products are carefully evaluated before they are licensed in Canada. However, some adverse reactions or problems may become evident only after a product is in use by consumers. Reporting a suspected adverse reaction helps to identify potential safety issues and improve health product safety for all Canadians.

Every marketing authorization holder is required to report serious Adverse Reactions (AR) known to them involving their marketed health products, in accordance with the requirements of the Food and Drugs Act and the Regulations.

An Adverse Reaction is a noxious and unintended response to a drug taken at doses normally used, and is characterized by the fact that a causal relationship between the drug and the response is suspected. If the noxious and unintended response requires hospitalization, is life-threatening, or results in death, it is considered a Serious Adverse Reaction. Health professionals and consumers are also encouraged to report adverse reactions if they suspect an adverse event is related to a health product.

Every marketing authorization holder (MAH) should put into place written procedures for the receipt, evaluation, and reporting of ARs. Reporting of ARs electronically is the preferred and most reliable method for MAHs to comply with regulatory timelines.

Marketing authorization holders who do not yet meet the technical requirements to submit ARs electronically may continue to send AR reports to the Marketed Health Product Directorate (MHPD) by fax or postal mail. The regulatory reporting time clock is considered to start on the day when the MAH first receives all the information that satisfies the minimum criteria for an AR report. This date should be considered day ‘0’. The minimum criteria for an AR report includes the following components:

  1. An identifiable reporter (source)
  2. An identifiable patient
  3. A suspected health product
  4. An adverse reaction

Reporting Domestic Adverse Reaction

AR reports concerning reactions occurring in Canada, to a product that is marketed in Canada, are considered “domestic” AR reports.

In order to report in accordance with the Regulations, each MAH should report to MHPD within 15 calendar days of receiving the relevant information the following domestic reports:

  • serious ARs 
  • unusual failure in efficacy reports for new drugs

Reporting Foreign Adverse Reaction Reports

Foreign AR reports are those concerning reactions occurring outside Canada to a product that is marketed in Canada.

In order to report in accordance with the Regulations, each MAH should report to MHPD within 15 calendar days of receiving the relevant information the following foreign reports:

  • serious unexpected Adverse Reactions (An AR is considered ‘unexpected’ when its nature, severity or frequency is either not identified, or is not consistent with the terms or description used in the product labelling. In cases where the MAH is uncertain whether an AR is expected or unexpected, the AR should be treated as unexpected).

In addition, all foreign serious unexpected AR reports involving the MAH’s foreign products, with the same combination of active ingredients that is also marketed in Canada, must be reported to MHPD in accordance with the Regulations.

If you want to ensure you are in compliance with Canadian regulatory requirements with respect to reporting adverse reactions (ARs) to marketed health products, Quality Smart Solutions has a team of specialists who can assist you. 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, Canna, Medical Devices, OTC drugs in Canada and the United States. Ask us for details or visit our website at www.qualitysmartsolutions.com.

Categories
Blog

Post-Drug Identification Number (DIN) Changes

Cosmetic Regulations in Canada and USA All drugs subject to the Food and Drug Regulations are required to gain premarket authorization prior to issuance of a Drug Identification Number (DIN). After gaining authorization to market a drug, a sponsor may for various reasons wish to make changes to the drug or the information associated with the drug. For those drugs regulated under Part C, Division 1 of the Regulations (“Old Drugs”) the sponsor must comply filing requirements for post-DIN changes when undertaking any changes.

Health Canada recognizes that any change to a drug may impact the safety, efficacy or quality of that drug and/or the safe and effective use of that drug. To manage these risks, Health Canada requires the sponsor of a drug that has received a DIN and is not a New Drug to report changes to the drug via a DIN Application or Notification and any data (if applicable) to support the change.

Post-DIN changes filed through a Drug Identification Number (DIN) Application

The changes included in this reporting category shall be filed, along with any recommended supporting data, to Health Canada as a DIN Application. Any change that requires a DIN application to be filed may not be implemented prior to the review of the supporting data by Health Canada and confirmation that this data is acceptable in support of the change. If acceptable, a new DIN may be issued, or the existing DIN may be retained for the changed drug, and a No Objection Letter will be issued.

Examples of changes included in this reporting category:

  • Change in name of the manufacturer for a human, veterinary or a disinfectant drug.
  • Addition or change to the authorized route of administration.
  • Addition, deletion or change, including quantity, to the medicinal ingredients of the product.

Post-DIN changes filed through OSIP or SKMD Notification

The changes included in this reporting category should be filed, along with any recommended supporting documentation, to Health Canada as a notification, within 30 days of the change being implemented as defined in the Regulations. These notifications do not necessitate assessment by Health Canada.

Health Canada may, upon receipt of the notification:

– update its records;

– uphold the change;

– request that the change be undone, or;

– request that a DIN application be filed to support the change.

Although the sponsor is allowed to submit these notifications within 30 days of making the change, it is strongly recommended that notification be provided to Health Canada prior to the sale of the drug to enable a risk assessment of the change, and thus, better ensure the safety, efficacy and quality of the drug.

Examples of changes included in this reporting category:

  • Any change in the name of the Canadian importer of the product listed on the original HC/SC 3011.
  • The name of the contact for the Drug Identification Number ownership, regulatory contact and/or billing contact changes.

Post-DIN changes filed through Post-Authorization Division 1 Change, PDC/VPDC

The changes included in this reporting category should be filed, along with any recommended supporting documentation, to Health Canada as a notification, within 30 days of the change being implemented as defined in the Regulations. These changes will be assessed by Health Canada and a standard PDC/VPDC has a service standard of 30 days. If the change is deemed acceptable, a No Objection Letter will be sent to the sponsor. If the change is deemed to fall outside the scope of a notification, Health Canada may request the re-filing of a full submission through the issuance of a Not Satisfactory Notice (NSN). Please note that if a NSN has been issued, the sponsor should refile a new PDC/VPDC or other submission to effectuate the authorization of any new revisions or changes.

Examples of changes included in this reporting category:

  • Removing a therapeutic claim, indication, or condition of use (including removal of patient categories, claims about duration, onset of action, sterility etc.).
  • Additions or revisions to the adequate directions for use (that is, warnings, precautions, adverse event information etc.).

Not required to file

For changes where it is indicated in the guidance that no filing is necessary, the sponsor should maintain a record of the change in accordance with GMP and ensure that this information is made available to Health Canada if it is requested at any time.

Examples of changes included in this reporting category:

  • The pharmacopeial standard used at time of original market authorization has been revised (e.g. authorized as United States Pharmacopeia (USP) grade, but USP revises standard).
  • Change to the Universal Product Code, item or lot number.

If you want to be sure your post-authorization changes are in compliance with Canadian regulatory requirements, Quality Smart Solutions has a team of specialists who can assist you. 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, Canna, Medical Devices, OTC drugs in Canada and the United States. Ask us for details or visit our website at www.qualitysmartsolutions.com.

Categories
Blog

Regulatory requirements for Drug Identification Numbers (DIN Number Canada)

essential oil regulations ontario canada When Health Canada authorizes a drug to be marketed in Canada, a Drug Identification Number (DIN) is issued to the manufacturer and must be printed on the package labels. A DIN indicates that the evaluation of the drug determined that it met the relevant requirements of the Food and Drugs Act and its regulations, and the drug has a favourable risk/benefit profile. Manufacturers of prescription and non-prescription drugs must obtain a DIN before they are marketed in Canada. The DIN assigned to a drug is unique and serves as a tool to help in the post-market activities of products on the market, such as product identification and verification by health care professionals, recall of products, inspections, and quality monitoring. While the authorization of a drug includes the issuance of a DIN to the manufacturer, the DIN is the property of Health Canada.

DIN issuance by Health Canada to the manufacturer

Once a drug has been authorized for sale in Canada, Health Canada issues a DIN under Part C, Division 1 of the Food and Drug Regulations, which permits the manufacturer to market the drug in Canada. For drugs that meet the definition of a new drug under Part C, Division 8 of the Food and Drug Regulations, the drug is required to have a Notice of Compliance (NOC) in addition to a DIN, in order to be authorized for sale in Canada. The DIN is issued in the form of a Drug Notification Form (DNF). The DNF contains, in addition to the DIN, information that is specific to the drug as it has been authorized by Health Canada. DNFs are sent by email directly to the manufacturer by Health Canada. For manufacturers seeking authorization under Part C, Division 1 of the Food and Drug Regulations for drugs for human or veterinary use, no NOC is granted. Instead, the DIN, in the form of a DNF, represents the market authorization.

Issuance of a revised Drug Notification Form by Health Canada to the manufacturer

Any change that the manufacturer wants to make to one or more of the drug characteristics (i.e. Product name, manufacturer name, active ingredients, strength of active ingredients, dosage forms, route of administration) must be authorized by Health Canada before the DNF can be revised. A submission or application seeking authorization for the proposed changes must be filed. Changes to an authorized label to include or modify retail-specific branding elements (e.g., graphics, colour, and font, etc.) also may require a review and authorization by Health Canada before they can be introduced on the market. After the change is approved by Health Canada, a revised DNF with the same DIN or a new DIN may be issued to the manufacturer.  

Filing of market notifications by the manufacturer to Health Canada

As per section C.01.014.3 of the Food and Drug Regulations, the manufacturer has the obligation to notify Health Canada when it first sells a drug that has been issued a DIN. A manufacturer must submit a completed DNF to Health Canada within 30 days of first selling the drug. The DNF must be filled out, signed, and dated. All pages of the DNF must be returned to Health Canada. If a manufacturer has been issued a revised DNF, it must notify Health Canada when it begins to market the drug with the authorized change within 30 day of selling the drug with new changes.  

A market notification consists of:

  • A cover letter
  • A completed and signed DNF
  • Labelling material, when applicable

Filing of 12 months without sale notifications by the manufacturer to Health Canada

After a drug has been marketed, a manufacturer is obligated under the Food and Drug Regulations to report when 12 months have elapsed without a sale of its drug to Health Canada when the following conditions are met:

  • the drug has received an NOC and/or a DIN
  • the drug has been marketed; and
  • the drug has not been sold on the Canadian market for a period of 12 consecutive months

Manufacturers of all drugs are encouraged to report 12 months without sale within 30 days as this will allow Health Canada as well as patients, health care practitioners, and other health care stakeholders to have a clear and up to date picture of which drugs are available on the Canadian market. However, manufacturers of prescription drugs for human use must submit a notification to Health Canada within 30 calendar days after a period of 12 consecutive months without sale.

After a complete notification is received and processed, Health Canada updates the status of the drug in the Drug Product Database to “Dormant”. A drug that is deemed Dormant is still authorized for sale in Canada.

Filing of discontinuation of sale notifications by the manufacturer to Health Canada

The manufacturer must submit the notification of discontinuation of sale within 30 days after the sale of the drug was discontinued as per section C.01.014.7 of the Food and Drug Regulations. The date of discontinuation is when the manufacturer last sells its drug, not when it is last sold at retail. Health Canada cancels the DIN further to the receipt of the notification. 

The notification of discontinuation of sale from the manufacturer should be in writing on company letterhead and should provide the lot number and the expiry date of the last lot distributed in Canada, the discontinuation date, and signed by an authorized official.

If you want to be sure your products are in compliance with Canadian regulatory requirements associated with a DIN, Quality Smart Solutions has a team of specialists who can assist you. 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, Canna, Medical Devices, OTC drugs in Canada and the United States. Ask us for details or visit our website at www.qualitysmartsolutions.com.

Categories
Blog

Plain Language Labelling Regulations

plain language labelling, health canada labelling guidance The label and package are the first points of interaction between a health product and a consumer. Prior to the implementation of the Plain Language Labelling (PLL) initiative, the general practice in Canada was to present key information within blocks of text on the product label. This sometimes made it difficult for the consumer to easily identify information necessary for appropriate selection and proper use of the product. In some cases, the information appeared in small type, with poor contrast between the label text and the background. All of these factors can prevent the consumer from finding the information needed to make informed purchasing decisions in a timely manner.

As part of Health Canada’s PLL initiative, the outer label of non-prescription drugs is required by regulations to display a Canadian Drug Facts Table (CDFT) to place information required by the regulations in a standardized, easy-to-read format and in a consistent location on the label in order to enhance the safe and effective use of non-prescription drugs. The concept is similar to that of the Nutrition Facts Table for foods in Canada and the Drug Facts box required by the Food and Drug Administration for over-the-counter (OTC) drugs in the United States.

What are the Plain Language Labelling (PLL) Regulations?

The PLL Regulations impose new obligations on health products sponsors to:

  • Provide information in plain language;
  • Assess the name of their health products to avoid confusion;
  • Submit mock-ups of labels and packages for review;
  • Indicate how to report harm(s) on their product’s label;
  • Provide information in an easy-to-read and standardized format, and;
  • Provide a Canadian Drug Facts Table (CDFT).

What products are within the scope of the PLL Regulations?

The PLL Regulations apply to prescription and non-prescription pharmaceutical drugs, biologic drugs, radiopharmaceuticals and disinfectants. However, there are specific requirements that only apply to subsets of these products. For example, the Canadian Drug Facts Table requirement only applies to non-prescription drugs. These PLL Regulations do not apply to medical devices, veterinary drugs, drugs that are represented as being solely for use as a disinfectant on hard non-porous surfaces, or natural health products.

When do the PLL Regulations come into force for non-prescription drugs?

For non-prescription products, the PLL Regulations came into force on June 13, 2017. New PLL requirements will be applied to submissions received on or after the coming into-force date.

By June 30, 2021, all non-prescription drug products must be in full compliance with the PLL Regulatory requirements at the retail level.

What is the purpose of submitting label mock-ups?

The Plain Language Labelling Regulations obliges sponsors to provide Health Canada with full color 2-dimensional mock-ups of labels and packages that represents the information consumers and health professionals will see at the time of filing an application for a drug identification number. These mock-ups will be reviewed by Health Canada to ensure labels comply with existing regulatory requirements on labelling. The review will focus on (but is not limited to) comprehension, legibility, accuracy and valid application of the CDFT, and design elements such as font size, type, colour, and placement.

What flexibilities are available for the Canadian Drug Facts Table (CDFT)?

All products under the scope of the PLL Regulations must provide a CDFT. However, some products and package sizes may not present sufficient space to accommodate the CDFT in the standard format on the label. In some cases, an innovative label may be the most effective way to accommodate the space requirements of the CDFT. In other cases, a modified format with graduated flexibilities may be considered according to the criteria outlined in Table 3 of the Guidance Document: Labelling Requirements for Non-prescription Drugs.

If you want to be sure your product labels and packages are in compliance with Canadian Plain Language Labelling requirements, Quality Smart Solutions has a team of specialists who can assist you. 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, Canna, Medical Devices, OTC drugs in Canada and the United States. Ask us for details or visit our website at www.qualitysmartsolutions.com.

Categories
Blog

Consumer Advertising of Health Products

In continuation to the last article on Canadian legislations and requirements regarding the marketing of drugs and medical devices, this article will discuss some of the specific requirements concerning the advertising of health products towards consumers. The overriding principle lies within the Canadian Food and Drugs Act, which prohibits health product advertising which is false, misleading or deceptive, or is likely to create an erroneous impression regarding its character, value, quantity, composition, merit or safety. Health product advertising is any consumer-directed advertising of health products, including nonprescription drugs, natural health products, medical devices and vaccines, in all Canadian media. Canadian “media” include, but are not limited to: television, radio, mass print, billboards, transit, in-store promotional materials, direct mail, websites, e-mail, mobile, and social media. Here are some of the common items to watch out for:

Therapeutic claims, directions of use, and duration of use must be consistent with the terms of Marketing Authorization. 

A product’s terms of Marketing Authorization (TMA) sets out the claims authorized by Health Canada. These claims may be paraphrased, but must not directly or indirectly exceed the scope of the TMA. Any visuals, graphics, or schematics, should not be used to directly or indirectly suggest product benefits that exceed those found in the TMA.

  • TMA for Nonprescription drugs: Labelling Standards/Category IV Monograph, approved product labels and product monographs
  • TMA for Natural Health Products (NHPs): Product Licence
  • TMA for Medical Devices: Medical Device Licence and approved Labels (Class II-IV)

For example, the authorized indication for product X is “Adequate calcium as part of a healthy diet may help prevent bone loss/osteoporosis.” An acceptable claim that you may use in advertising is, “Product X calcium supplement MAY assist in the prevention of osteoporosis”. An unacceptable claim would be, “Product X calcium supplement prevents osteoporosis”.

An advertisement must not suggest that a child is capable of making a rational decision regarding the use of the advertised health product.

Health product advertising must be overtly directed to adults only. An advertisement must not depict or encourage unsupervised use of drugs by children, or suggest that a child can self-diagnose or self-medicate. In addition, advertisements must not depict product storage in locations accessible to children. A child may approve of the taste of a medicine, but may not make recommendations concerning the use of the advertised product.

Terms that communicate a product is new, improved or reformulated may be used for a period of one year from the date it is first available for retail sale.

Examples of these terms include “new”, “improved”, “now available”, and “introducing”.The product attribute that is new or improved should be clearly specified, e.g. “improved taste”, “new format”.

When depicted or described, product performance must be consistent with the TMA and should not be exaggerated.

Hyperbolic terminology, e.g. “amazing”, “powerful”, “fantastic”, should not be used to exaggerate the therapeutic effect/benefit of a product or ingredient. Advertising should not suggest that a product is “potent” or has a “potent” formulation, or imply the product is powerful, strong or more effective based on the amount of medicinal ingredient(s).

All health products are authorized to be effective for the condition/symptoms they are designed to relieve/treat/prevent, and therefore, can claim to be “effective”, “strong enough”, “tough enough” or have the power to relieve/treat/prevent the condition/symptoms in question. However, it is unacceptable to suggest that the product in and of itself is “strong” or “powerful”.

An advertisement should not suggest that product use is “essential”. It is acceptable to communicate that one “needs or wants relief”. However, it is unacceptable to claim that a consumer “needs” a specific health product or ingredient.

For example, the authorized indication for product X is “For the treatment/management of acne.” An acceptable claim that you may use in advertising is “Clear your face. Fight acne with the power of Product X. It worked for me!” An unacceptable claim would be “Fight acne with powerful Product X!”

An advertisement should not directly or indirectly suggest that a product is effective for all individuals, or that it will be effective every single time it is used. Guarantees of overall product satisfaction or other non-therapeutic attributes (e.g. purity, quality or physical characteristics) are acceptable if true and supported.

For example, an acceptable claim that you may use in advertising is “Satisfaction guaranteed, or your money back”. An unacceptable claim would be “Guaranteed relief, or your money back”.

If you want to be sure your health products are advertised in compliance with Canadian legislations and requirements, Quality Smart Solutions has a team of specialists who can assist with developing messages that comply with the advertising provisions of Canadian federal legislations and are in accordance with Health Canada policies and guidance documents. 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, Canna, Medical Devices, OTC drugs in Canada and the United States. Ask us for details or visit our website at www.qualitysmartsolutions.com.

References Guidelines for Consumer Advertising of Health Products, 2018, Ad Standards, https://adstandards.ca/wp-content/uploads/2018/07/Consumer-Advertising-Guidelines-for-Marketed-Health-Products-EN.

Categories
Blog

Illegal Marketing of Drugs and Medical Devices in Canada

Health Canada is not only the national regulatory authority for issuing health product marketing authorizations, but it also oversees and enforces the regulatory requirements related to health product advertising. While smart marketing strategies are important for driving sales, it is also crucial to ensure those strategies comply with Canadian legislative and regulatory requirements.  

The Canadian Food and Drugs Act prohibits health product advertising which is false, misleading or deceptive, or is likely to create an erroneous impression regarding its character, value, quantity, composition, merit or safety. BEWARE of these common illegal marketing practices!

  • Promoting an Unauthorized Product:

Marketing of prescription drugs, non-prescription drugs, natural health products, as well as Class II, III and IV medical devices is prohibited unless the product is authorized for sale by Health Canada. All medical devices (with the exception of Class I devices) must obtain marketing authorization from Health Canada in the form of a Medical Device Licence before it can be marketed in Canada. All natural health products must obtain marketing authorization from Health Canada in the form of a Product Licence, and be assigned a NPN number. Similarly, all drugs (prescription and non-prescription drugs) must obtain approval from Health Canada and be assigned a DIN number.  

  • Promoting Unauthorized (Off-Label) use:

Prescription drugs, over-the-counter drugs, natural health products, as well as Class II, III and IV medical devices are authorized by Health Canada for specific indications. These products may not be marketed for uses beyond the scope of the Health Canada authorized indications or notified recommended uses. For example, if a particular opioid product is authorized by Health Canada to “treat moderate to severe pain”, you would be prohibited to claim that the product can be used to treat “mild pain”, or give misleading impression that the product is intended to be used in this manner.

  • Omitting or Downplaying Risks:

Marketing of drugs and medical devices to health care providers, including any promotional materials, must present product information in a balanced manner. Risk information including side effects, contraindications, warnings and precautions must be clearly presented and given the same prominence as the therapeutic benefits of the product. In addition, since all health products, including those derived from nature, carry some degree of risk, it is unacceptable to suggest that a product is “safe”, is “side effect free”, or has “no known side effects”.

  • Overstating Effectiveness:

Some companies may be tempted to promote their products by exaggerating their effectiveness. However, this is strictly prohibited. Promotional claims must not be directly or indirectly inconsistent with the scope of the Marketing Authorization, including the approved product licence, the product monograph, or the product label. For example, a drug may not be marketed as “providing relief within 2 days” when the approved product monograph indicates that the drug provides relief after 10 days.

  • Misleading Endorsements:

Endorsements, seals of recognized organizations, testimonials and quotations are only acceptable if they represent the honest and current opinions of the individuals or organizations. Furthermore, they must be consistent with the Health Canada-authorized indications for the product. Claims of endorsement by government authorities, such as Health Canada itself, are not permitted. While Health Canada authorizes products for sale for specific indications, you cannot advertise the product as “approved” or “endorsed” by Health Canada. Thus, only claims of Health Canada authorization are permitted, meaning you may claim the product is “authorized for sale by Health Canada”.

  • Misleading Comparative Claims:

A common advertising strategy is to promote products through comparisons with other products on the market. These comparisons may claim that their product is equivalent, non-inferior or superior to an established product in terms of effectiveness or safety based on scientific evidence or data. You cannot make any untrue or exaggerated comparative claims. The comparative claims must also be within the terms of the authorized indications of the compared products. In addition, all comparative claims must follow additional requirements outlined in the Therapeutic Comparative Advertising Directive.

  • Direct-to-Consumer Marketing of Prescription Drugs:

Direct-to-consumer marketing of prescription drugs is restricted. Any drug product listed in the Prescription Drug List is subject to Section C.01.044 of the Food and Drug Regulations. This prohibits consumer-directed prescription drug advertising beyond the drug’s name, price and quantity. This means, for example, that when a prescription drug is advertised by name to consumers, no reference can be made to its therapeutic use and/or benefits.

Illegal marketing of health products may potentially harm patients and adversely influence prescribing practices by health care providers. Therefore, Health Canada is always proactively monitoring drug and device marketing to enforce the existing rules around illegal advertising, and take action where necessary, including recommending criminal charges where appropriate. More information on Health Canada’s compliance and enforcement approach is available in the Inspectorate’s Compliance and Enforcement Policy (POL-0001).

If you want to be sure your health products are marketed in compliance with Canadian legislations and requirements, Quality Smart Solutions has a team of specialists who can assist with preparing and obtaining marketing authorization for your product or reviewing your promotional materials. 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, Canna, Medical Devices, OTC drugs in Canada and the United States. Ask us for details or visit our website at www.qualitysmartsolutions.com.

Categories
Blog

SFCR: What to expect when you’re inspected?

The Safe Food for Canadians Act (SFCA) and the Safe Food for Canadians Regulations (SFCR) are set to come into effect on January 15, 2019. The new regulations will require food businesses that import or prepare food for export/interprovincial shipping to have licences, as well as preventive controls that outline steps to address potential risks to food safety.

The Canadian Food Inspection Agency (CFIA) currently conducts inspections of production facilities, importers/exporters and retail outlets. Under the new SFCR, the manner in which the CFIA conducts these inspections may be enhanced and there are many reasons why CFIA will inspect your facility, including:

  • Verification of compliance against regulations
  • Investigation of complaints
  • Responding to industry request (i.e. import/export permits)
  • Following up on previous inspections
  • Investigation facility or product contamination

So, what will occur when CFIA inspects your facility under the new regulations?

Before Inspection:

  • Your company receives a notice from CFIA for inspection
  • An inspector will meet with your company to determine scope. Your Preventative Control Plan (PCP) will need to be provided at this time.
  • Inspector conducts initial walk through and confirms scope

During Inspection:

  • Inspector determines if the regulatory requirements have been met and completes an initial inspection report
  • Inspector determines if the elements of the preventative control are complete and effective

After Inspection:

  • The inspector will meet to discuss inspection results and the final report is given to your company
  • Your company takes corrective actions on any noted non-compliances identified during inspection
  • The inspector schedules a follow up inspection

If you want to be sure your food safety practises are in line with the new SFCR and will pass the CFIA’s inspection, 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 solution!

Quality Smart Solutions is an end-to-end compliance solutions expert which has been assisting clients for 10 years in the areas of Dietary Supplements/NHPs, Foods, Cosmetics, Medical Devices and OTC drugs. Ask us for details or visit our website at www.qualitysmartsolutions.com.

Resources

Canadian Food Inspection Agency. Inspection modernization. 2018-01-03. http://www.inspection.gc.ca/about-the-cfia/accountability/inspection-modernization/eng/1337025084336/1337025428609
Categories
Blog

Do you need a license to sell essential oils? Cosmetics & NHP

When it comes to topical essential oils, determining the correct regulatory pathway to ensure full compliance typically depends on how you wish to market the product. Do you intend your essential oil to be diluted and worn as a blissfully scented fragrance oil, or do you intend for the product to be used to help relax the consumer and offer some relief for that headache he or she has had all day? If you chose the former, then you can market your product under the Canadian cosmetic framework. If you choose the latter, then your product must be regulated as a Natural Health Product (NHP) in Canada.

The main difference between the manner in which cosmetics and topical NHPs are regulated often comes down to marketing. NHPs are required to carry a health claim on their labels whereas cosmetics are not permitted to make health claims. In the example above, the fragrance oil is considered a cosmetic, while the oil used for relaxation and headache relief is an NHP. It is important to note, that these 2 products (i.e. the cosmetic and the NHP) can be identified in the formulation and yet regulated via 2 different regulatory pathways in Canada. It typically comes down to the intended use of the product.

What is an Essential Oil?

Essential oils are natural products made from plants. They contain volatile compounds called terpenes, which give them their scent. These oils are used as aromatherapy treatments because they help with relaxation, stress relief, and pain management.

Why Should I Care About Licensing?

If you sell essential oils, you should care about licensing. This is because selling these oils requires a license from the state where you live. In some states, you must also register with the state before you can sell essential oils.

The Different Types of Licenses Available

There are two main types of licenses available for essential oil sellers: wholesale and retail. Wholesale licenses allow you to buy essential oils at wholesale prices and then resell them to customers. Retail licenses allow you to sell essential oils directly to consumers.

Which Type Is Right For Me?

If you’re just starting out as an essential oil seller, we recommend getting a wholesale license. This will give you access to more products than you would with a retail license, and you won’t have to worry about taxes until you start selling. However, if you plan to make a living selling essential oils, you should consider getting a retail license instead. It’s much easier to set up a business with a retail license, so you’ll save money by not having to pay sales tax upfront.

Health Canada (NNHPD) Cosmetic Notification submission

Health Canada defines aromatherapy as “a branch of botanical medicine which uses essential oils and other volatile/aromatic plant extracts for therapeutic or medicinal effect”. If you are looking to market your essential oils for their therapeutic purposes, the Natural and Non-Prescription Health Products Directorate (NNHPD) has published an aromatherapy monograph outlining the specific therapeutic indications of various commonly used essential oils. While this is an excellent resource, applicants are always permitted to submit their own evidence to support indications or oils which may not be present in the monograph.

If the therapeutic properties of the oil are not important to your marketing strategy, you may wish to consider marketing the essential oil as a cosmetic. Going the cosmetic route avoids some regulatory hurdles, such as product licensing and site licensing. To achieve compliance for a cosmetic, you require a compliant label and submission of a cosmetic notification to Health Canada within 10 days after the product is introduced into the Canadian market.

But wait! Isn’t there a third option for essential oils? If you are looking to sell your essential oils for use with a diffuser, then your product would be classified as either a consumer product or an NHP, depending on whether you wish to market the product for its health benefits. If the product is meant to be used only to add a pleasant aroma to any room, the product would be considered a consumer product. As discussed above, if the oil is intended to be diffused for use in aromatherapy, it would require licensing as an NHP prior to market access.

If you are interested in marketing essential oils in Canada, Quality Smart Solutions has a team of specialists who can assist you in determining the correct regulatory pathway for compliant market access.  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 10 years in the areas of Dietary Supplements/NHPs, Foods, Cosmetics, Medical Devices, OTC drugs and canna. Ask us for details or visit our website at www.qualitysmartsolutions.com.

Resources:

Aromatherapy — Essential Oils. December 8, 2015. http://webprod.hc-sc.gc.ca/nhpid-bdipsn/atReq.do?atid=aromatherap&lang=eng

Canada Consumer Product Safety Act (S.C. 2010, c. 21). May 23, 2018. http://laws-lois.justice.gc.ca/eng/acts/C-1.68/

Cosmetic Regulations (C.R.C., c. 869). June 14, 2007. http://laws-lois.justice.gc.ca/eng/regulations/C.R.C.,_c._869/index.html

Pathway for Licensing Natural Health Products Making Modern Health Claims. December 2012. https://www.canada.ca/en/health-canada/services/drugs-health-products/natural-non-prescription/legislation-guidelines/guidance-documents/pathway-licensing-making-modern-health-claims.html

Categories
Blog

Why EFSA’s Role as a Regulatory Authority is Important to Us

The European Food Safety Authority (EFSA) is a world renowned regulator which is known for its high scientific standards when it comes to food safety and claim substantiation. Formed in 2002 following several mishaps involving food safety, EFSA is responsible for the evaluation of scientific evidence and identification & communication of risks pertaining to safe practices in the areas of food & nutrition, animal feeds, animal health, plant protection and plant health.

Why are EFSA’s methods and findings important?

EFSA uses high level scientific evaluation to formulate their opinions. While some may argue their findings are only applicable to the European market, this is not entirely true. EFSA’s regulatory opinion is valued in many other jurisdictions. For example, in December of 2015 the Canadian Food Inspection Agency (CFIA), Canada’s science-based regulator of food, animals and plants, officially agreed to collaborate with EFSA for the collection, analysis and sharing of data pertaining to risk assessments. Both regulatory bodies also agreed to share views and expertise on methods for data collection, risk assessment and risk communication. Further to this, EFSA’s assessments are also highly regarded by regulatory officials at Health Canada. If you have obtained EFSA approval for a food ingredient or a health claim, it is likely that your evidence will be approved by Health Canada as well.

While it is up to EFSA’s team of experts to formulate the final opinion, they seek comments from stakeholders prior to finalization of their reports. Of particular interest to our industry is their current consultation. They are currently seeking consultation for the Guidance on the Requirements for Health Claims Related to Physical Performance.  This draft guidance outlines EFSA’s current view on the evidence required to support claims on muscle function, physical performance and physical capacity. The consultation is open until September 2, 2018 and comments are welcome from any interested party, but please note comments will be made public.

If you are marketing a workout supplement in Canada, the United States or Europe, EFSA’s draft guidance document is worth a read. If the evidence you have on file aligns with the final published views of EFSA, it is likely your claims will be substantiated. This is beneficial for your Canadian products since it will help facilitate the approval of your innovative natural health products geared to support muscle function & physical performance.

EFSA’s opinions may also benefit your American dietary supplements. If the evidence you have on file to substantiate your clear and meaningful claims matches that required for European approval, then it is likely that you have competent and reliable scientific evidence to render your health claims truthful and not misleading.

If you are interested in bringing a workout supplement to Europe, Canada or the United States, or if you would like to submit anonymous comments to EFSA on their draft Guidance on the Requirements for Health Claims Related to Physical Performance, Quality Smart Solutions has a team of specialists who can assist you.  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 10 years in the areas of Dietary Supplements/NHPs, Foods, Cosmetics, Medical Devices, OTC drugs and Canna. Ask us for details or visit our website at www.qualitysmartsolutions.com.

Resources:

European Food Safety Authority. Public consultation on the draft guidance on the scientific requirements for health claims related to muscle function and physical performance (revision 1). 16 July 2018. https://www.efsa.europa.eu/en/consultations/call/180716-0.
Categories
Blog

Food or NHP: Distinguishing Between a Natural Health Product and a Supplemented Food

Supplemented foods and natural health products (NHPs) can sometimes pose challenges when trying to determine the correct regulatory pathway to gain market access in Canada. Supplemented foods are broadly defined by Health Canada as pre-packaged products that are manufactured, sold or represented as foods, which contain added vitamins, minerals, amino acids, herbal or bioactive ingredients. While NHPs, which are sold in discrete dosage units, often contain these same ingredients, the 2 types of products are regulated through different pathways.

In order to determine the correct regulatory pathway for these types of products, Health Canada implements a risk-based approach in considering the composition of the product, how the product is marketed, the format of the product, public perception of the product & the history of use of the product.

Of these factors to consider, the main contributing factor is often product format. If a product looks like a food and is consumed as a food, it will likely be classified as a food regardless of the composition of the product. Products of this nature typically include fortified ready-to-drink beverages, bars and other conventional food formats. Alternatively, a product can be in a typical food format, such as a ready-to drink liquid, and still be classified as an NHP. This could be the case for a product which was marketed for its health benefits and sold in individual units of 90 mL (or less) or if the same product was sold with a measuring cup.

As indicated in the previous example, product representation is also a main factor in determining the classification of a product at the food-NHP interface. If the product is being marketed as a food (i.e. as a source of nutrition, hydration or for its delicious flavour) and/or being sold at the grocery store with other foods, the product is likely to be considered a food. It is important to note that inclusion of health claims on the label is not sufficient to classify the product as an NHP. If the product is deemed to be a food and the claim is found to be unacceptable, the product may be deemed a non-compliant food. In these cases, it is imperative to confirm product classification before going to market.

Product ingredients, perception and history of use are also considered when determining the classification of a food-like product. Inclusion of certain ingredients which are known to be used primarily for their health benefits and are not commonly found in foods will likely render the product an NHP. However, inclusion of an ingredient with medicinal properties is not enough to classify the product as an NHP on its own. In cases like these, Health Canada will also look at how the product will be perceived by the public and how similar product types have been historically used in addition to the format of the product and how it is being marketed.

In summary, Health Canada uses several factors when determining whether a product is a supplemented food or NHP. Special consideration should be given when trying to classify products in the following formats: ready-to-consume drinks, conventional food formats (including confectionary) and powders. If you are looking to bring one of these types of products to the Canadian market, Quality Smart Solutions has a team of experts who can assist you in determining the correct regulatory pathway for your innovative product. 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, Canna, Medical Devices and OTC drugs. Ask us for details or visit our website at www.qualitysmartsolutions.com.

Categories
Blog

Sunscreens – Canada and U.S. Regulatory Differences

Summertime has finally arrived and with it comes hot temperatures and intense ultraviolet rays. Exposure to ultraviolet light is known to be associated with early skin aging and skin cancer. While the best protection from the sun is to avoid exposure altogether there are times when this is not possible. Using an appropriately regulated sunscreen can offer protection from the sun’s harmful rays.

If you are looking to market sunscreen in Canada or the United States, there are a few things to consider.

Canadian Sunscreen Requirements

In Canada, sunscreens can be classified as either Natural Health Products (NHPs) or non-prescription drugs, depending on the ingredients they contain. Commonly used natural ingredients include titanium dioxide, zinc oxide, and p-aminobenzoic acid. Marketing a product containing these ingredients would require a Natural Product Number (NPN) unless the product also contains ingredients that are not naturally derived, such as avobenzone, oxybenzone, octinoxate, or other recognized drug ingredients as outlined in the Natural and Non-Prescription Health Products Directorate’s (NNHPD’s) sunscreen monograph. For products that contain drug ingredients, a Drug Identification Number (DIN) would be required.

It is important to note that all Canadian sunscreen products must include a statement to the effect of “helps prevent sunburn” and display the appropriate Sun Protection Factor (SPF) value on the label. Companies are also permitted to market their sunscreen products with a ‘Broad Spectrum SPF’ value provided that test results demonstrate a critical wavelength of? 370 nm for the product.

There are however a few labeling statements that are not permitted by Health Canada. Statements that suggest the product completely blocks the penetration of the sun’s rays (e.g. sunblock) are not acceptable. Those that suggest the product helps to prevent cancer or photo-aging are also not permitted and the product cannot claim to filter out other UV rays apart from UVA/UVB. These are not the only non-permitted statements but rather are those which are most commonly misused.

In summary, if you are looking to market a sunscreen in Canada, you need to determine whether it will be classified as a drug or an NHP, prepare the appropriate application, and label your product according to the criteria as set out in the NNHPD sunscreen monograph and the appropriate set of governing regulations.

key requirements you should be aware of before bringing your sunscreen product to the Canadian market:

  1. Product Classification and Registration:

    • In Canada, sunscreens are classified as natural health products (NHPs) or non-prescription drugs, depending on their active ingredients and intended use. Check the classification of your product to determine the applicable regulatory pathway.
    • If your sunscreen is classified as an NHP, you need to apply for product registration with the Natural and Non-prescription Health Products Directorate (NNHPD) of Health Canada.
    • If your sunscreen is classified as a non-prescription drug, you must follow the regulatory requirements outlined by Health Canada’s Health Products and Food Branch (HPFB).
  2. Labeling and Packaging Requirements:

    • Sunscreen product labels must be bilingual (English and French) and meet specific format and content requirements outlined in the Food and Drugs Act and Regulations.
    • Labels should include the product’s drug identification number (DIN) or natural product number (NPN) if applicable.
    • Ensure accurate SPF (Sun Protection Factor) labeling and UV protection claims.
    • Sunscreens must also include usage instructions, precautions, and any required warnings.
  3. Sun Protection Factor (SPF) Testing:

    • SPF testing is essential to determine the effectiveness of your sunscreen product. Testing should be conducted by Health Canada’s guidelines.
    • Ensure that your product provides the level of sun protection claimed on the label.
  4. Safety and Efficacy Data:

    • Provide data on the safety and efficacy of your sunscreen product, including information on the active ingredients, formulation, and potential side effects.
    • Ensure that your product is safe for use on the skin and does not cause adverse reactions.
  5. Stability Testing:

    • Conduct stability testing to assess the product’s shelf life and ensure that it maintains its effectiveness and safety over time.
    • Data from stability studies should be submitted to Health Canada as part of the regulatory requirements.
  6. Good Manufacturing Practices (GMP):

    • Comply with GMP standards to ensure the quality, safety, and consistency of your sunscreen product.
    • Facilities involved in the production of sunscreen should adhere to GMP guidelines.
  7. Notification and Reporting:

    • Report any adverse reactions or safety issues associated with your sunscreen product to Health Canada promptly.
    • Maintain records of complaints and adverse events and provide these to Health Canada as needed.
  8. Packaging and Dosage Forms:

    • Ensure that your sunscreen product’s packaging and dosage forms meet Health Canada’s requirements and guidelines.
    • Different dosage forms, such as creams, lotions, sprays, and sticks, may have specific regulatory considerations.
  9. Health Canada Notifications and Submissions:

    • Prepare and submit all required documentation, including product labeling, safety and efficacy data, stability testing results, and any other relevant information, to Health Canada.
    • Comply with Health Canada’s notification and submission procedures and timelines.
  10. Compliance with International Standards:

    • Familiarize yourself with international sunscreen standards, such as those from the International Organization for Standardization (ISO), and align your product with these standards for broader market acceptance.
  11. Market Surveillance and Compliance Reporting:

    • Implement a system for market surveillance to monitor the safety and compliance of your sunscreen product after it is on the market.
    • Report any updates or changes to the product, labeling, or formulation to Health Canada as required.

It is essential to work closely with regulatory experts or consultants familiar with Canadian sunscreen regulations to navigate the complex requirements effectively. Failing to meet these regulatory obligations can result in delays in product approval or market withdrawal, potentially harming your business’s reputation. Compliance with Canadian sunscreen regulations ensures that your product is safe and effective for consumers in the Canadian market.

U.S. Sunscreen Requirements

Sunscreens in the United States are regulated as drugs through 2 pathways:

  1. The Over-the-Counter (OTC) monograph process outlined in 21 CFR part 330 and accordance with the Sunscreen Innovation Act (SIA), or
  2. The new drug approval process is outlined in 21 CFR part 314.

The United States Food and Drug Administration (FDA) has categorized sunscreen products by type and published several final rules. If you are looking to market a sunscreen product in the U.S., it is advisable to consult the FDA’s published final rules to verify if your product meets the indicated conditions. If the conditions as set out by the FDA are met and the product also complies with the FDA’s general regulations for OTC drugs then the FDA considers the sunscreen to be Generally Recognized as Safe and Effective (GRASE) and not misbranded.

Regulation through the OTC monographs was once the only option for sunscreen products, but in 2014, the FDA published the Sunscreen Innovation Act (SIA) to allow for an expedited review process for new sunscreen ingredients. The SIA functions to supplement the Time and Extent Application (TEA) regulation, as outlined in 21 CFR part 330.14(c), which together allows anyone (not only sponsors) to request that an active sunscreen ingredient be recognized as GRASE and not misbranded when used by the criteria set out in a final sunscreen order. This collaborative framework has allowed for a new process by which OTC active sunscreen ingredients or combinations of ingredients can be deemed GRASE and not misbranded when used according to the conditions set out in an administrative order.

To gain GRASE status for a new sunscreen ingredient, initial eligibility of the ingredient is determined by the FDA. If the ingredient is deemed eligible for review, data supporting the safety and efficacy of the ingredient is to be submitted by either the sponsor or the public.  If the provided evidence is deemed acceptable, a final GRASE determination in the form of an administrative order is made by the FDA within 60 days of data submission.

In summary, if you are looking to market a sunscreen product in the U.S., it is advisable to first check the OTC final rules for sunscreens and if your ingredient(s) is/are not present, then look into preparing a GRASE data submission.

If you are looking to expand your business into the U.S. or Canadian sunscreen market, we can assist you in confirming which regulatory framework best suits your innovative sunscreen product. Contact us today to discuss how we can be your solution!

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

Resources

Non-prescription Sunscreen Drug Products – Format and Content of Data Submissions. Guidance for Industry. U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER). Nov 2006.

Regulatory Policy Information for the Sunscreen Innovation Act. U.S. Food and Drug Administration.  May 22, 2018. https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/ucm434843.htm

Rulemaking History for OTC Sunscreen Drug Products. U.S. Food and Drug Administration. April 27, 2018. https://www.fda.gov/drugs/developmentapprovalprocess/developmentresources/over-the-counterotcdrugs/statusofotcrulemakings/ucm072134.htm#time

Sunscreen Innovation Act. November 26, 2014. https://www.congress.gov/bill/113th-congress/senate-bill/2141/text

Sunscreen Monograph – Version 2.0. Health Canada. July 7, 2013. http://webprod.hc-sc.gc.ca/nhpid-bdipsn/atReq.do?atid=sunscreen-ecransolaire&lang=eng

Categories
Blog

Safe Food for Canadians Regulations: How Does it Affect You?

The Safe Food for Canadians Act (SFCA) and the Safe Food for Canadians Regulations (SFCR) are set to come into effect on January 15, 2019. Under the new legislation and corresponding regulations, certain companies involved in the manufacturing, distribution, handling and sale of food will be required to implement regulatory changes to improve food safety in Canada.

Regulatory changes which are being implemented under the SFCA and corresponding SFCR focus on 5 core areas: licensing, preventative controls, traceability, labelling & standards of identity/grade and organic certification.  The focus of this article is to highlight the main changes associated with these new requirements.

Licensing

Certain food businesses will need to be licensed. Food businesses involved in any of the following activities will be required to have a licence by January 15, 2019 in order to maintain food production/handling activities:

  • Importation of food
  • Manufacturing, processing, storing, packaging, or labelling food to be exported or sent across provincial or territorial borders
  • Exportation of food that requires an export certificate
  • Slaughtering of food animals for export or shipment across provincial or territorial borders
  • Handling and storage of imported meat products in their imported condition for inspection by the Canadian Food Inspection Agency (CFIA).

Preventative Controls

Preventative control measures will need to be implemented by most businesses by the coming of force of the SFCR. The preventative control measures are to be documented in a Preventive Control Plan (PCP) as outlined in Part 4, Division 6 of the SFCR. However, certain businesses will be exempt from this regulation, including businesses with $100,000 or less in gross annual food sales and exporters of non-meat and non-fish products.

Traceability

Requirements to assist with the traceability of food through the market will come into effect with SFCR. These requirements will affect your business if you are involved in any of the following food-related activities:

  • Importation
  • Exportation
  • Distribution across provincial or territorial borders
  • Manufacturing, processing, storing, packaging or labelling food to be exported or sent across provincial or territorial borders
  • Growing/harvesting fresh fruits or vegetables which are to be shipped internationally or across provincial or territorial borders
  • Slaughtering of food animals for export or shipment across provincial or territorial borders
  • Handling and storage of an imported meat product in its imported condition for inspection by the CFIA
  • Selling food to consumers at the retail level

As a note, restaurants and other similar businesses are not subject to the traceability requirements.

Labelling, Standards of Identity and Grades

Food labelling requirements, standards of identity and grades requirements from the former Consumer Packaging and Labelling Act, Canada Agricultural Products Act, Meat Inspection Act, Fish Inspection Act, and their respective regulations and been consolidated into the SFCA and SFCR. Furthermore, the CFIA has published documents outlining specific requirements on standards of identity and grades for certain types of foods.

Organic Products

As per section 13 of the SFCR, organic products must be certified organic according to the Canadian Organic Standards. More specifically, compliance with section 13 of the SFCR is required for imported or nationally distributed products which are making an organic claim or products which bear the Canada Organic Logo, regardless of shipping destination.

Most companies have until January 15, 2019 to bring their business practises in line with the SFCR for most food-related practises. Quality Smart Solutions has a team of regulatory specialists who can assist with the assessment of your food-related activities. Contact us today to discuss how we can be your solution for your Canada food safety and label compliance needs!

Quality Smart Solutions is an end-to-end compliance solutions expert which has been assisting clients for over 10 years in the areas of Dietary Supplements/NHPs, Foods, Cosmetics, Canna, Medical Devices and OTC drugs. Ask us for details or visit our website at www.qualitysmartsolutions.com.

Categories
Blog

Plain Language Labelling for OTCs & NHPs

Health Canada implemented the Plain Language Labelling (PLL) initiative to help make the labels for non-prescription health products easier to read and understand for the consumer. These regulations are currently in effect for new non-prescription drug applications and the criteria outlined is recommended to be applied to Natural Health Products (NHPs) as well.

What is required under the Plain Language Labelling initiative?

The PLL initiative requires the addition of a Canadian Drug Facts Table (CDFT) to the outer labels of non-prescription drugs and provides the option to use a Product Facts Table (PFT) on the outer labels of NHPs. The CDFT/PFT is to contain specific, easy to understand information to ensure the consumer is able to make an appropriate product choice. The information presented in the CDFT/PFT is to be concisely written at a grade 6 to 8 level and is to be free of technical language.

There are 4 types of CDFTs: 1. Standard CDFT format, 2. CDFT with graduated flexibilities, 3. innovative labels, and 4. CDFTs for Category IV products, mouthwash & toothpaste.

The standard CDFT format is the basic format for which all companies should aim to comply with. The following list outlines the mandatory information which is to be included under the heading ‘Drug Facts’ for non-prescription drugs, or in the case of NHPs, under the heading ‘Product Facts’:

  • Active ingredient(s) / Medicinal ingredient(s)
  • Purpose(s) (This section is omitted for NHPs)
  • Use(s)
  • Warnings
    • Warnings specific to route of administration (e.g. for external use only)
    • Statement regarding Reye’s Syndrome
    • Allergy alert
    • Flammability warning
    • Choking
    • Alcohol/liver/stomach bleeding warning
    • Sore throat warning
    • Dosage warning
    • Sexually transmitted diseases (STDs) alert
    • Do not use – List all contraindications
    • Ask a doctor or [pharmacist/healthcare practitioner] before use if you – include warnings for persons with pre-existing health conditions
    • When using this product – list side effects associated with use
    • Stop use and ask a doctor if – include adverse effects which would result in a discontinuation of the product
    • Other warnings
    • Keep out of reach of children
  • Directions – include dose instructions, duration, route of administration, maximum daily dose
  • Other information (e.g. storage conditions, directions for disposal, sodium/calcium/potassium content, nutritional information for NHPs)
  • Inactive ingredients / Non-medicinal ingredients listed either in alphabetical order or in descending order of predominance by their proportion in the product. Include here additional information such as “gluten-free, lactose-free, etc.”.
  • Questions? – include full numeric representation of a telephone number, an email address, website address, postal address or any other information that enables communication with a contact person in Canada for the consumer to obtain information about the product or to report concerns/adverse events.

If a heading or subheading is not applicable, it is to be omitted from the CDFT/PFT.

All information in the CDFT is to be in Helvetica Neue type font, 55 Roman for text or 75 Bold for headings. If this style is unavailable, other font types are acceptable and outlined in the guidance. Specific font sizes have been set for titles, headings, subheads and text. The colour scheme has been set to 100% line black on white, or where black is not available, the colour must be displayed in the strongest contrasting colour being used (100% screen black, dark blue, dark brown, dark green and dark purple are acceptable). Additional formatting conditions for use of bullets, capitals, text alignment, box frame, hairlines & rules are outlined in the guidance.  

In some situations, the package may not contain enough room for the required information in both official languages to fit into a standard CDFT format. In this case, Health Canada has allowed for graduated flexibilities to gain space on the label and prevent the need for larger packaging or innovative labels. These flexibilities allow for the modification of mandatory formatting and the movement of some information from the CDFT to another part of the label or to a leaflet. The types of modifications which are permitted must be implemented in a step-wise manner as outlined in the guidance.

In the cases where all levels of graduated flexibilities have been implemented and the required labelling information still does not fit within the CDFT, the choice to use an innovative label can be made. The use of innovative labels, such as peel-backs, fold-outs, or a tags attached to the product, is only permitted when all graduated flexibilities have been unsuccessfully utilized. It is important to note that there are also specific formatting flexibilities which can be applied to innovative labels.

For Category IV drug products, mouthwashes and toothpastes the DFT on the outer product label must include, at a minimum, the following information:

  • ‘Active ingredients’ or “Medicinal Ingredients” for an NHP (‘Purpose’ is not required)
  • ‘Uses’ (if not present on the principal display panel)
  • ‘Warnings’ – Point of selection warnings (as per the approved Monograph and Guidance Documents) to assist the consumer in product selection
  • ‘Directions’ (to assist in appropriate product selection, including any age-specific restrictions)
  • ‘Inactive ingredients’ or ‘Non-Medicinal Ingredients’ for NHPs
  • ‘Questions?’ and contact information
  • A statement directing consumers to a URL where they can view a complete CDFT.

Formatting flexibilities are also available for Category IV products, mouthwashes and toothpastes.

While the inclusion of a CDFT or PFT comprises a large component to the PLL initiative, the guidance also outlines some additional formatting criteria for information presented outside the CDFT or PFT, such as type style & size, placement of information, use of white space & colour, appropriate use of abbreviations, bilingual labelling, appropriate use of branding & logos, label permanence and proper presentation of the expiry date & lot #.

If you are currently marketing non-prescription drug products in Canada, it is important to note that these products must be in full compliance with the PLL regulations at the retail level by June 30, 2021. As for those marketing NHPs, the PLL guidelines offer a labelling strategy to help your product stand out to the consumer. Quality Smart Solutions has a team of labelling specialists who can assist you in adopting the PLL guidelines at your next label run. 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 over 10 years in the areas of Dietary Supplements/NHPs, Foods, Cosmetics, Canna, Medical Devices, and OTC drugs. Ask us for details or visit our website at www.qualitysmartsolutions.com.

Categories
Blog

Imminent Changes to the Current Canada Natural Health Product (NPN) Licensing timelines

In October 2014, the Natural and Non-prescription Health Products released a policy to manage the overall application review process.  It brought a streamlined and predictable timeline when NPNs would be issued (prior to this, there was a massive backlog of applications, NPNs sometimes took several years go be issued and many companies were selling natural health products before an NPN Health Canada was issued, utilizing the submission number as an equivalence to authorization where Health Canada was not enforcing the regulations of NPN Health Canada requirements to sell an NHP).

It was anticipated that the number of NHP applications would decrease since this policy came into effect.   Though class 2 and 3 application volume has been steady, the number of class 1 applications has been significantly increasing.  Given the size of the Canadian retail market and the number of Natural Health Products available on the market, in theory, a saturation point should have been met.  There are several reasons for this volume increase, particularly for class 1.  One reason is our trade partner to the south.  The US economy is hot, unemployment levels are at record lows and recent corporate tax cuts have fueled business growth and expansion.  Naturally, the next destination for many US companies in Canada given its similar culture, buying power, and a higher per capita consumption of health and wellness products than in the United States.  Another reason is the exportation.  Here at Quality Smart Solutions, we’ve had a number of clients in the past few years who are obtaining NPNs (mostly class 1) for the sole purpose of exportation.  Certain countries take the NPN as an equivalency to their regulations which helps expedite approval and distribution in the respective jurisdiction.

Since fall 2017 we have noticed performance targets, particularly for some class 3 applications being missed.  This missed timeline has been a few weeks to 2 months past the performance target deadline!  These were the first signs that NNHPD’s resources were stretched and they couldn’t keep up with the inflow of applications.   The goal was to ensure the quality of applications reviewed remained consistent and performance targets were met.

The proposed NHP Management of Applications Policy Update includes the following:

 CurrentProposed
Performance Service Standard

Class 1:

10 business days

Class 2:

30 calendar days

Class 3:

30 calendar days for screening + 180 calendar days to review

Class 1:

60 calendar days (target of 30)

Class 2:

90 calendar days (target of 45)

Class 3:

210 calendar days

IRNAs little as 2 days to respondAs little as 5 days to respond
Post License AmendmentNot required for Class 1 if changes are within monograph scopeChanges required for all products aligning with NHPR Sections 11 & 12
Submission optionsPaper by mail, ePost or DVD/CD by mailePost or DVD/CD by mail

A proposed Electronic Product License Amendment and Notification Form (PLAN) will be created to ensure data captured is in a consistent format.

It is anticipated this new policy update of NPN Health Canada will be published in fall 2018 and fully implemented by the end of the year.

Now is the time to submit your class 1 and 2 Natural Health Products under the current service standard timelines!  Quality Smart Solutions can conduct a comprehensive review of your Natural Health Product and determine what classification your product will fall under.  Licensing, Labelling, and Importer of Record.  We are your end-to-end solution provider.  Contact us today!

We use cookies to display personalized content, analyze site traffic, provide recommendations, and ensure you have a great browsing experience. By continuing to use our site, you consent to our use of cookies. Privacy Policy.