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Month: January 2020

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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.

FAQs

What counts as an Adverse Reaction (AR)?

An AR is any noxious, unintended response to a health product used at normal doses, where a causal relationship is suspected. If it leads to hospitalization, death, or is life-threatening, it’s deemed serious.

Marketing authorization holders (MAHs) are legally responsible for reporting all serious ARs they know of. Additionally, healthcare professionals and consumers are encouraged (though not legally required) to report suspected incidents .

  • Domestic serious ARs: MAHs must report to Health Canada within 15 calendar days of gaining all required information.

  • Foreign serious unexpected ARs: Same 15-day window applies

A foreign AR is “serious” and occurs to a product marketed in Canada, but the reaction’s nature, severity, or frequency is not described on the Canadian label. Such ARs are reportable within 15 days.

Each AR report needs:

  1. Reporter identity

  2. Patient details

  3. Suspected product

  4. Description of the adverse reaction
    Reporting time starts when all four are known.

Electronic submission is preferred and counts as timely. MAHs without electronic capability can use fax or mail, with clock starting on receipt of full info via any method.

All ARs are submitted to Health Canada’s Canada Vigilance Program, managed by the Marketed Health Products Directorate (MHPD).

Yes. Domestic reports include any serious ARs and unusual efficacy failures. Foreign reports only include serious and unexpected ARs that align with Canadian marketed products.

Adverse reaction reporting is a key component. Alongside spontaneous reporting, Health Canada uses line listings, narrative reports, and periodic summary submissions to track product safety.

  • Establish written AR procedures

  • Monitor for and document ARs from all sources (consumers, HCPs, literature)

  • Report serious domestic ARs and foreign serious unexpected ARs within 15 days

  • Use electronic reporting where possible.

References

Reporting Adverse Reactions to Marketed Health Products – Guidance Document for Industry, Health Canada, 2018 https://www.canada.ca/en/health-canada/services/drugs-health-products/reports-publications/medeffect-canada/reporting-adverse-reactions-marketed-health-products-guidance-industry/guidance-document.html

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Post-Drug Identification Number (DIN) Changes

Cosmetic Regulations in Canada and USA

Cosmetic Regulations in Canada and USAAll 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.

References

Guidance Document: Post-Drug Identification Number (DIN) Changes, 2019/04/18, Health Canada, https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/post-drug-identification-number-changes.html

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Regulatory requirements for Drug Identification Numbers (DIN Number Canada)

essential oil regulations ontario canada

essential oil regulations ontario canadaWhen 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.

References

Guidance Document: Regulatory requirements for Drug Identification Numbers (DINs), June 19, 2019, Health Canada, https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/regulatory-requirements-drug-identification-numbers/document.html

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Plain Language Labelling Regulations

plain language labelling, health canada labelling guidance

plain language labelling, health canada labelling guidanceThe 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.

FAQs

What are Plain Language Labelling (PLL) Regulations?

They are Health Canada requirements mandating that prescription and non-prescription drugs use clear, easy-to-understand packaging, including standardized layouts and terminology.

A CDFT is a mandatory, standardized table on the outer label of non-prescription drugs that organizes key information—such as active ingredients, uses, warnings, and directions—for easy consumer comprehension.

The PLL rules apply to prescription and non-prescription pharmaceutical drugs, biologics, radiopharmaceuticals, and disinfectants—but do not apply to medical devices, veterinary drugs, disinfectants only for hard non-porous surfaces, or natural health products.

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Manufacturers must submit label and package mock-ups for Health Canada review to ensure formats are legible, clear, accurate, and follow the specified CDFT design.

Yes. Health Canada allows graduated flexibilities and alternative formats—such as innovatively designed labels or smaller CDFTs—for products or packages with limited label space.

Labels must use easy-to-read fonts (e.g., Helvetica Neue) with defined sizes and high contrast (e.g., black on white), clear bullets, bilingual text, and proper information hierarchy.

Absolutely. All labels must include a Canadian-based contact—phone, email, or website—to report product concerns, in both English and French, on both outer and inner labels

The regulations don’t legally extend to NHPs, but Health Canada recommends applying plain-language formatting (like a Product Facts Table) for consumer clarity.

PLL enhances consumer safety by making vital drug information understandable at a glance—minimizing dosing errors and misinterpretation, much like food nutrition tables do for eating choices.

References

Guidance document: Labelling Requirements for Non-prescription Drugs, 2018-09-28, Health Canada https://www.canada.ca/en/health-canada/services/drugs-health-products/natural-non-prescription/legislation-guidelines/guidance-documents/labelling-requirements-non-prescription-drugs.html

Guidance Document: Questions and Answers: Plain Language Labelling Regulations for Non-prescription Drugs, 2018-09-28, Health Canada https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/guidance-document-questions-answers-plain-language-labelling-regulations-non-prescription-drugs-contact-lens-disinfectants.html

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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.

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Illegal Marketing of Drugs and Medical Devices in Canada

Illegal Marketing of Drugs and Medical Devices in Canada

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.

References

Canadian Food and Drugs Act, 2019-06-21, https://laws-lois.justice.gc.ca/eng/acts/f-27/

Inspectorate’s Compliance and Enforcement Policy (POL-0001), 2018-12-21, https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/good-manufacturing-practices/policies-standards/compliance-enforcement-policy-0001.html

Stop illegal marketing of drugs and devices, Health Canada, 2019-08-29, https://www.canada.ca/en/health-canada/services/drugs-health-products/marketing-drugs-devices/illegal-marketing/stop.html

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