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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

How We Can Help

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

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

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What is HACCP and Food Handler’s Certification

What is HACCP Plan

Food safety is always evolving and becoming more complex, as companies require constant updating with safety regulations and industry trends. Before discussing about What is HACCP Plan , let’s talk about the importance of Food Safety Training. According to Health Canada, an average of four million cases of food borne illness occurs 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.

Importance of HACCP Plan

Hazard Analysis Critical Control Points is a system that establishes safety guidelines in all stages of food production and processing. HACCP 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 seven principles of this 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 Certification is mandatory and annually audited. Overall, this prevents risks that can lead to severe financial, legal, and health consequences.

Importance of 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 become contaminated
  • Understand causes of food-born 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 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.

Food Safety Training is Essential

HACCP 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 is 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.

How We Can Help

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

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

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

How We Can Help

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

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

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

How We Can Help

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

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

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Post-Drug Identification Number (DIN) Changes

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

How We Can Help

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

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

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Regulatory requirements for Drug Identification Numbers (DINs)

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

How We Can Help

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

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

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Plain Language Labelling Regulations

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

How We Can Help

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

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

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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, Cannabis, 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.

How We Can Help

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

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

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

How We Can Help

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

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

30 Minutes Free Consultation
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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.

How We Can Help

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

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

30 Minutes Free Consultation

Resources

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

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Essentials Oils: Cosmetic or 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.

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 cannabis. Ask us for details or visit our website at www.qualitysmartsolutions.com.

How We Can Help

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

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

30 Minutes Free Consultation

Resources:

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

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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 Cannabis. Ask us for details or visit our website at www.qualitysmartsolutions.com.

How We Can Help

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

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

30 Minutes Free Consultation

Resources:

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.

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

How We Can Help

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

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

30 Minutes Free Consultation
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Navigating the Canadian Cannabis Market: What Type of Licence Do You Need?

The Cannabis Regulations were officially published in Canada Gazette Part II on July 11, 2018. The regulations outline several different types of licenses which will be issued to companies throughout the industry. These licenses are set in place to regulate the permitted activities associated with the cultivation, processing, testing, sale and research of cannabis.

Cultivation Licences

Cultivation licences are divided into 3 subclasses based on the area in which the cannabis is to be grown:

  1. Standard cultivation – for growing and handling of cannabis (dried, fresh, plants & seeds) in areas greater than 200 m2
  2. Micro-cultivation – for growing and handling of cannabis (dried, fresh, plants & seeds) in areas up to 200 m2
  3. Nursery licence – for growing cannabis (plants & seeds) in areas up to 50 m2.

Additionally, in order to receive approval of any type of cultivation licence, the applicant must have a master grower and alternate master grower on staff. These individuals must pass security clearance, are responsible for the cultivation, propagation and harvesting of the cannabis and must have sufficient knowledge in order to carry out these duties.

Processing Licences

Processing licences are issued to authorize the possession, manufacturing and sale of cannabis and cannabis products.

These types of licences are divided into 2 subclasses the quantity of cannabis processed on an annual basis:

  1. Standard processing – for quantities greater than 600 kg dried cannabis, or equivalent
  2. Micro-processing – for quantities up to 600 kg or more dried cannabis, or equivalent

In order to receive approval of for a processing licence, the applicant must have 1 trained quality assurance person and may have 1-2 alternate quality assurance person(s) on staff. These individuals are responsible to ensure the quality of the cannabis prior to sale and must pass security clearance. The quality assurance persons are also responsible to investigate and take corrective actions, if necessary, in response to all quality-related complaints. It is important to note that an application must be submitted and approved in order to make a change to the listed quality assurance persons. Therefore, it is beneficial to have more than 1 quality assurance person on your application.

Analytical Testing Licences

Holders of licences for analytical testing are authorized to possess and obtain cannabis by altering its chemical or physical properties by any means. A holder of an analytical testing licence is required to have 1 qualified head of the laboratory on staff and may have 1 or more alternate heads of the laboratory. Each head and alternate head of the laboratory must have a degree in science from a Canadian or accredited foreign university, have sufficient knowledge and experience to fulfill the required duties and be responsible for the test methods carried out. It is important to note that an application must be submitted and approved in order to make a change to the listed laboratory head or alternate. Therefore, it is beneficial to list more than 1 individual on your application.

Licence for Sale for Medical Purposes

Holders of a licence for the sale of cannabis for medical purposes are permitted to possess and sell cannabis products. Licence holders are permitted to sell as follows:

  • Cannabis products to licence holders (other than cultivation licence holders),
  • Cannabis products (i.e. Dried, fresh, plants and seeds) to a holder of a licence for micro-cultivation or standard cultivation
  • Cannabis products (i.e. plants and seeds) to a holder of a licence for a nursery
  • Cannabis products to hospital employees

Licence for Research

Holders of a licence for research are authorized to possess, produce and transport cannabis for research purposes only. The licence also authorizes the sale of cannabis plants and seeds to a licensed cultivator, another licensed researcher, a holder of a cannabis drug licence and to administer cannabis to a research subject.

Licence for Cannabis Drugs

Holders of licences for cannabis drugs are authorised to possess cannabis and manufacture and/or sell a drug containing cannabis. In order to be eligible for a cannabis drug licence, the manufacturing facility must possess a valid establishment licence as approved by Health Canada.

Holders of a cannabis drug licence must retain a senior person in charge who is responsible for the management of the cannabis-associated activities as authorized in the licence. Additionally, a licence holder must retain a qualified person in charge and may designate an alternate. A qualified person in charge must pass a security clearance, work at the facility, have a relevant post-secondary education, sufficient knowledge/experience with drugs and a familiarity with the applicable regulations. This person is responsible for supervising the cannabis-related activities as authorized under the licence and for ensuring that those activities comply with the Cannabis Regulations. It is important to note that an application must be submitted and approved in order to replace the senior person in charge, qualified person in charge or the alternate person in charge.

If you are looking to enter the Canadian cannabis industry, Quality Smart Solutions and its new division, Cannabis License Experts,  has a team of specialists who can assist you in obtaining the correct license for your business. 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, Cannabis, Medical Devices and OTC drugs. Ask us for details or visit our website at www.qualitysmartsolutions.com and www.cannabislicenseexperts.com.

How We Can Help

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

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

30 Minutes Free Consultation

Resources:

Cannabis Regulations: SOR/2018-144. Canada Gazette, Part II, Volume 152, Number 14. June 27, 2018 – http://www.gazette.gc.ca/rp-pr/p2/2018/2018-07-11/html/sor-dors144-eng.html

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Sunscreens – Canada and U.S. Regulatory Differences

Summertime has finally arrived and with it comes hot temperature 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 a 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 which 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.

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 in accordance with the Sunscreen Innovation Act (SIA), or
  2. The new drug approval process 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 Recognised 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 in accordance with 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.

In 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 which has been assisting clients for 10 years in the areas of Dietary Supplements/NHPs, Foods, Cosmetics, Medical Devices, and OTC drugs. 

How We Can Help

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

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

30 Minutes Free Consultation

Resources

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

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

How We Can Help

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

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

30 Minutes Free Consultation
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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, Cannabis, Medical Devices, and OTC drugs. Ask us for details or visit our website at www.qualitysmartsolutions.com.

How We Can Help

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

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

30 Minutes Free Consultation
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Cannabindiol in NHPs and Foods: The Current Truth

You might have heard a little something in the news recently about the legalization of Cannabis coming to Canada. Needless to say, we have all been hearing it. The government published the proposed Cannabis Act (Bill C-45) in May 2017 and more recently a corresponding consultation paper to seek feedback from stakeholders on the proposed laws & regulations surrounding the non-medical use of cannabis. Details and comments have been provided for the regulation of dried cannabis, cannabis oil, fresh cannabis, cannabis plants and cannabis seeds. But what does this mean for companies who want to bring their cannabinoid isolates to market?

Currently, cannabis and cannabis-derived isolates are primarily governed under Controlled Drugs and Substances Act (CDSA) and the Food and Drugs Act (FDA). Under the current CDSA and its corresponding Access to Cannabis for Medical Purposes Regulations (ACMPR), cannabis and its derivatives are regulated as controlled substances meaning that only authorized persons are permitted to use, produce and sell cannabis or its derivatives, such as Cannabidiol (CBD) or Tetrahydrocannabinol (THC). Further to this, the current ACMPR allows for registered persons access to fresh/dried cannabis, cannabis oil and for licensed producers to handle, sell and produce only cannabis and cannabis oil. Unfortunately, these regulations do not allow for the production and sale of CBD isolates.

While the government intends to regulate cannabis concentrates at a later date, in the present day isolates such as CBD would be regulated as narcotics. Since the regulation of CBD is not governed under the current ACMPR exemption, we default to the Narcotic Control Regulations. Under these regulations, a dealer’s license is required for the production, handling, distribution & sale of a narcotic. Furthermore, the licensed dealer must have on staff a qualified person in charge, such as a pharmacist/medical doctor/veterinarian/dentist who is registered with a provincial professional licensing authority, or alternatively, an individual who possesses a degree in an applicable science (e.g. pharmacy, medicine, dentistry, veterinary medicine, pharmacology, organic chemistry or chemical engineering) from a recognized Canadian University (or foreign equivalent). In addition to this, the qualified person in charge must also have no criminal conviction within the previous 10 years of their adult life and a product license would be required for the sale of CBD.

In comparison, a licensed producer under the current ACMPR requires a senior person in charge who is an adult and is familiar with the act and regulations which govern the licensed producer’s activities.

As outlined above, there is currently a big difference in the regulatory work which would be required for the marketing of isolated CBD when compared to that required for the production of fresh/dried cannabis & cannabis oil.

Moving forward….

In the proposed legislation which is set to come into force this summer, companies can apply for a standard processing license which includes the production, packaging & labelling of cannabis products, including synthesized phytocannabinoids, and the manufacturing of products such as pre-filled oil capsules. A standard processing licence would also authorize related activities, including but not limited to possession, transportation, storage, and the intra-industry sale of cannabis to other federally recognized licence holders or authorized sellers with a separate authorization for the sale of these products to medical patients and the general public.

Moreover, it has been proposed that a scientific evidence-based licensing pathway will be undertaken for cannabis-containing health products, such as prescription/non-prescription drugs, natural health products, medical devices, veterinary drugs and veterinary health products and that the licensing will be governed by the Food and Drugs Act. It is important to note that market access for already approved health products will be maintained. Applications for new cannabis-containing products which provide no more than 10 ppm THC will continue to be accepted for review and this framework will continue to be applied to new products until regulations governing these types of cannabis-containing products have been implemented.

What about edibles?

It has been proposed that the use of cannabis-containing foods with a maximum THC content of 10 mg will be permitted. The recently obtained consultation comments highlighted the importance of allowing for the use of edibles to occur at the same time as dried/fresh cannabis, cannabis oil, cannabis plants and cannabis seeds. This is in response to the original statements in the proposed Cannabis Act stating that the regulations governing the manufacturing, sale and use of these products will be finalized at a later date. The government intends to have regulations for these types of products in effect in 2019.

In summary, until the proposed Cannabis Act comes into force, the current regulatory framework is being upheld for cannabis-containing products. Companies can continue to market their Cannabis-containing health products as outlined in the current Food and Drugs Act and Controlled Drugs and Substances Act. What this means for CBD isolates is that in order to manufacture and sell a product containing CBD you would have to be a licensed dealer, employ a qualified person in charge, carry out the outlined duties as per the current Narcotic Control Regulations and obtain a product license.

Since it is the aim of the government to maintain market access for cannabis-containing products through the transition, you may wish to get a head start on your regulatory work. Quality Smart Solutions has a team of specialists who can assist you in becoming a licensed producer or a licensed dealer. 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.

How We Can Help

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

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

30 Minutes Free Consultation

Resources:

 

A Framework for the Legalization and Regulation of Cannabis in Canada: The Final Report of the Task Force on Cannabis Legalization and Regulation. December 2016https://www.canada.ca/en/services/health/marijuana-cannabis/task-force-marijuana-legalization-regulation/framework-legalization-regulation-cannabis-in-canada.html

 

Legislative Background: An Act respecting cannabis and to amend the Controlled Drugs and Substances Act, the Criminal Code and other Acts (Bill C-45). May 2017http://www.justice.gc.ca/eng/cj-jp/marijuana/c45/c45.pdf

 

Proposed Approach to the Regulation of Cannabis. November 2017https://www.canada.ca/en/health-canada/programs/consultation-proposed-approach-regulation-cannabis/proposed-approach-regulation-cannabis.html

 

Proposed Approach to the Regulation of Cannabis: Summary of Comments Received During the Public Consultation. March 19, 2018.https://www.canada.ca/en/health-canada/services/publications/drugs-health-products/summary-comments-public-consultation-regulation-cannabis.html#2.2

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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!

How We Can Help

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

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

30 Minutes Free Consultation
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Collagen & Gelatin: Not Your Average Protein Sources

Hydrolyzed collagen and gelatin are animal-based proteins that have recently gained popularity within the food and supplement industry. Gelatin and collagen possess similar amino acid profiles, including essential amino acids which the body uses for internal protein and collagen synthesis.

These wonderful benefits have made collagen and gelatin hot ingredients in Canadian food products. However, it is important to note that while providing the consumer with essential amino acids, gelatin and collagen are not considered complete proteins. For those who might be wondering “What is a complete protein?” a complete protein is defined by the Canadian Food Inspection Agency (CFIA) as a protein source which provides all essential amino acids. Additionally, food products which provide a complete protein source and have a Protein Rating of 20 or more are considered by the CFIA to be sources of protein and can be labelled in this manner. When it comes to gelatin and collagen, the CFIA has given them a Protein Efficiency Rating of ‘0’ meaning they are low quality proteins and thus would not contribute to a ‘source of protein’ claim.

Wanting to use innovative protein-based ingredients as sources of protein and label products in this manner is not a novel idea for the industry. A few years back we saw companies using cheaper alternatives to whey protein, such as free amino acids and creatine monohydrate, and declaring them as protein sources. While amino acids and creatine are known to be involved in protein synthesis within the body, they would not contribute to a ‘source of protein” claim on the food product’s label.

As for our new hot protein sources, collagen and gelatin, they can be included as ingredients in a food product, however you must be cautious of how you are marketing the product. As discussed above, positioning the ingredients as contributing to a source of protein claim would not be considered compliant. You also cannot market your food product as a source of amino acids or call out any of the amino acids provided by collagen or gelatin. Having said this, there are ways to market your gelatin and/or collagen containing-products if calling out amino acids is important to you. The Natural and Non-Prescription Health Products Directorate (NNHPD) has published a monograph for hydrolyzed collagen which allows for the following protein-focused claims to be used on the product label:
• Source of the essential amino acids histidine, isoleucine, leucine, lysine, methionine, phenylalanine, threonine, valine which are used for the maintenance of good health and involved in protein synthesis
• Source of the non-essential amino acids alanine, arginine, aspartic acid, glutamic acid, glycine, proline, serine, tyrosine which are involved in protein synthesis
• Source of the essential amino acid lysine to help in collagen formation.

Our team of labelling and licensing specialists at Quality Smart Solutions are available and ready to discuss any regulatory challenges or marketing questions you may have. 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 Medical Marijuana. Ask us for details by calling 1-800-396-5144 or visit our website at www.qualitysmartsolutions.com

[1] Protein Rating = Protein in a Reasonable Daily Intake x Protein Efficiency Ratio (CFIA, 2016)

How We Can Help

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

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

30 Minutes Free Consultation