Categories
Medical Devices

Ensuring Predictability for Interim Orders Relating to COVID-19

Health Canada recently published an additional notice regarding all interim orders relating to COVID-19 and Medical Devices. This notice is showing the understanding from Health Canada that stakeholders require predictability for applicable regulatory aspects in respect to the interim orders.

The notice will be updated with links to notices regarding any consultations, and any related measures, as they are occurring/released.

The following outlines key information and updates that were delivered through this notice.

  • The flexibilities and regulatory oversight that has been provided through the use of these IOs will be maintained until at least the fall of 2021.
  • After the fall of 2021, regulatory amendments will be introduced that will allow for many of these temporary flexibilities to continue.
  • In the coming months, interested industry stakeholders, health system partners and other government departments will be consulted by Health Canada on the proposed regulations.

Interim Orders (IOs)

An IO is one of the fastest options for change available to the federal government to help make health products available to address larger-scale public health emergencies.

The objective of the Interim Orders is to expedite any necessary authorization for the importation, sale, and advertising of drugs used in relation to COVID-19 while taking into consideration urgent public health needs.

It allows for Medical Device Establishment Licences to be issued in relation to COVID-19 drugs in a manner that ensures pandemic related medical supplies remain accessible to all Canadians.

These Interim Orders further provide the Chief Public Health Officer of PHAC the ability to notify the Minister of a need to pre-position a promising COVID-19 drug in Canada. In order for a drug to be pre-positioned, the Government of Canada must have entered into a contract for its procurement and the manufacturer must have filed an application for the drug’s authorization in Canada, or abroad with a foreign reference regulator. Together, these measures help ensure Canadians have timely access to COVID-19 drugs.

A total of 5 interim orders have been issued in response to the COVID-19 pandemic since March 2020. These IOs have focused on making changes necessary to ensure that necessary Medical Device Licenses can be issued quicker in response to the current pandemic while also ensuring that the products and licenses continue to have sufficient oversight.

The following will summarize some important information from the currently issued IOs.

Importation and Sale of Medical Devices

Part 1 of the Regulations, with the exception of sections 52 to 56 and 63 to 65.1, no longer apply to the importation or sale of a COVID-19 medical device if the following conditions are met:

  1. the Minister determines that there is an urgent public health need for the importation or sale of the device;
  2. the manufacturer of the device has filed with the Minister an application for the authorization of importation or sale of the device in a form established by the Minister;
  3. the Minister has issued the authorization; and
  4. the authorization has not been cancelled.

All shipments of COVID-19 medical devices that are imported in Canada must be accompanied by a copy of the proper authorization for importation.

Permitting Exceptional Importation of Key Products

If a shortage of a specified medical device — or of its components, accessories, parts or consumable materials — has been reported or is likely to occur, the manufacturer and the importer of the device must each submit the following information to the Minister in both English and French in the form and manner determined by the Minister:

(a) the name and contact information of the manufacturer and of the importer;

(b) in the case of a Class II, III or IV device, the medical device licence number;

(c) the identifier of the device, including the identifier of any medical device that is part of a system, test kit, medical device group, medical device family or medical device group family;

(d) the name of the device and of any component or accessory of the device, including, if applicable, the model name;

(e) a description of the device;

(f) the date when the shortage began or is anticipated to begin; and

(g) the anticipated date when the manufacturer will be able to meet the demand for the device if that date can be anticipated.

This information must be submitted within 5 days after the manufacturer or importer becomes aware of a shortage. This also applies to any anticipated shortages

If any information previously submitted by the manufacturer or importer changes, the new information must be submitted to the Minister within 2 days after the change is made or 2 days after becoming aware of the change.

Once the shortage has been resolved and the manufacturer is once again able to meet the full demand for the medical device – or for its components, accessories, consumable material or parts – the manufacturer or importer will have 2 days to notify the Minister in writing to that effect.

Specified medical devices involved in the COVID-19 interim measures can be located on the Health Canada website within the COVID-19 Health Product Industry page. (https://www.canada.ca/en/health-canada/services/drugs-health-products/covid19-industry.html)

Prevention and Alleviation of Drug Shortages

As previously noted, the COVID-19 pandemic has caused an unprecedented demand for certain drugs and medical devices. As such, an interim order was issued in order to properly manage the subsequent drug shortages.

Under certain conditions;

  • Anyone who sells a drug may now be required to provide information that is relevant to a (potential) shortage of that drug relating to COVID-19.
  • The Minister of Health may also impose or amend terms and conditions placed on authorizations for selling drugs.

This Interim Order will assist with trending the usage of certain drugs in order to ensure all Canadians have uninterrupted access to the necessary COVID-19 related drugs.

How we can help

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

References

https://www.canada.ca/en/health-canada/services/drugs-health-products/covid19-industry/ensuring-predictability-interim-orders-notice.html

https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/announcements/interim-order-importation-sale-medical-devices-covid-19.html

https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/covid19-interim-order-drugs-medical-devices-special-foods.html

https://www.canada.ca/en/health-canada/services/drugs-health-products/covid19-industry/drugs-vaccines-treatments/interim-order-drug-shortages/notice.html

Categories
News

Additional Packaging and Labelling Requirements for Alcohol Based Hand Sanitizers in Beverage Containers

On October 5, 2020, the Natural and Non-Prescription Health Products Directorate (NNHPD) sent a notice to all Canadian product licence holders to announce a new policy being introduced to help reduce unintentional ingestion of alcohol-based sanitizers packaged in beverage containers.

Due to the COVID-19 pandemic and global supply shortages, the high demand for alcohol-based hand sanitizer has led to significant shortages in raw materials, products and standard packaging material. The Government of Canada issued guidance to industry on acceptable packaging materials and sizes for hand sanitizer products to ensure their availability during the COVID-19 pandemic. Manufacturers were encouraged to consider the appearance of their containers to avoid potential confusion by consumers. However, such packaging shortages have resulted in the use of unconventional types of containers such as beverage or food containers. These containers include water bottles, sports drink bottles, soda bottles, wine and liquor bottles, and children’s food pouches.

The additional flexibilities that were provided to industry on acceptable packaging materials and sizes are outlined below:

  • Any food or pharmaceutical grade packaging can be used to package hand sanitizers (for instance, bottles, bags, pouches), provided that it is chemically resistant to the hand sanitizer.
  • Although hand sanitizers are generally packed in clear (see-through) containers, appropriately graded packaging that is opaque (for example, white, coloured) can also be used.
  • Health Canada does not regulate the size of hand sanitizer packaging:
    – As long as the formulation is identical to what has been authorized by us, any size of packaging that ensures appropriate shelf-life will suffice.
    The same Natural Product Number (NPN) can be used for different container sizes.
  • Keep the size of the opening on the container small to prevent evaporation (for instance, no wide-mouth containers
    – large openings increase the surface area where alcohol and other ingredients can evaporate, lessening the effectiveness of the product.
  • Label large-format containers used for bulk packaging as refill containers
  • Use only lids designed for use with the container to prevent contamination and evaporation
  • Use packaging that is not re-sealable only once, as this may be prone to contamination and evaporation once opened
  • Make refill formats compatible with existing pump or lid components

Furthermore, suppliers were encouraged to facilitate or advise users to continue to recycle used containers in accordance with the recommended practices and waste management systems available locally.

Unfortunately, the use of beverage containers for alcohol-based hand sanitizers may increase the risk of unintentional ingestion, as consumers are led to believe that these products are consumable products at first glance. These product packaging materials/labels and branding may be similar to the labels and branding of known alcoholic beverages or bottled water resulting in confusion of hand sanitizer for water or other beverages. Accidental ingestion of alcohol-based hand sanitizers could cause serious harm or even be fatal, particularly in children, because of the high alcohol content. Data from the Canadian Poison Control Centres (PCCs) show that the number of reported incidents related to hand sanitizer has increased in 2020 compared to 2019, up to 4.5 fold higher on a month-to-month basis.

Currently, alcohol-based hand sanitizers must comply with:

  • the packaging and labelling requirements of the Natural Health Products Regulations (NHPR)
  • Health Canada’s safety and efficacy standards as outlined in the Antiseptic Skin Cleansers monograph

All hand sanitizer products authorized for sale by Health Canada have an eight-digit Drug Identification Number (DIN) or Natural Product Number (NPN) on the label, and are listed on the List of Hand Sanitizers Authorized by Health Canada.

Currently, under the Antiseptic Skin Cleansers monograph, hand sanitizer labelling must include the following caution/warning statements:

  • For external use only
  • When using this product avoid contact with eyes. If contact occurs, rinse thoroughly with water.
  • Stop use and ask/ consult a doctor/ physician/ health care practitioner/ health care provider/ health care professional if irritation develops.
  • Keep out of reach of children. If swallowed, call a poison control centre or get medical help right away.
  • Flammability warning Keep away from open flame and sources of heat. (if the product contains ethanol or isopropanol)

In addition to these requirements, products cannot be marketed in a manner that misleads the consumer about its composition or safety. Otherwise, they may be viewed as contravening section 9 of the Food and Drugs Act and enforcement action may be taken by Health Canada. Under the Antiseptic Skin Cleansers monograph, hand sanitizers are permitted to make the following claims on product labelling:

  • Antiseptic (skin) cleanser
  • Medicated (skin) cleanser
  • Antibacterial (skin) cleanser
  • Kills harmful bacteria/germs
  • Effective in destroying (harmful) bacteria to provide antiseptic cleansing
  • For personal hand hygiene to help prevent the spread of bacteria

To reduce the likelihood of any further incidents of hand sanitizer ingestion, the Natural and Non-Prescription Health Products Directorate (NNHPD) is implementing a new policy requiring an alternative closure as well as an additional warning statement and symbol, to alcohol-based hand sanitizers packaged in a beverage containers.

To develop this policy document, Health Canada reviewed existing labelling requirements for other health products and consulted with experts in labelling of food and health products, industry stakeholders, consumer and patient groups, provincial and territorial governments as well as other government departments.

These measures must be put in place no later than 8 weeks after this policy comes into effect, allowing existing stock to be used up. Therefore, hand sanitizers packaged in beverage containers and distributed after November 27, 2020, must have an appropriate closure along with the warning statement and graphic. Distribution in Canada of alcohol-based hand sanitizers packaged in beverage containers without these measures must stop after this date.

Beverage or food containers that are unable to accommodate the required closures and, as such, should not be used for hand sanitizers include beer and soda cans, food and beverage pouches, tetra packs and vaping cartridges.

The intent of this new policy is to ensure hand sanitizer products packaged in beverage containers:

  • are presented to the public in a manner consistent with their market authorization
  • use a simple and symbol-based warning and
  • include the use of a closure to help prevent unintentional ingestion and injury to health

These measures are especially important for hand sanitizers that are produced by companies that:

  • are associated with beverages or other ingestible products
  • use the same containers and visual branding elements as beverages or other ingestible products

Specific details on the packaging and labelling requirements under this new policy (use of both an alternative closure and an additional warning statement and symbol) for alcohol-based hand sanitizers packaged in a beverage container are outlined below:

  • Closures such as a pump or dispensing cap are conspicuous and are not generally used on beverage containers. Such closures will help to differentiate hand sanitizer packages from beverages or other ingestible products. By having to open or use the container in this way, the consumer will understand the product is not to be consumed. These types of closures will be required for alcohol-based hand sanitizers packaged in beverage, drinking or food containers.
  • Section 95 of the Natural Health Product Regulations requires safety seals or security packaging for all natural health products, including alcohol-based hand sanitizers. These measures will continue to be required. They assure consumers that the product has not been opened or tampered with before purchase. However, they are not sufficient to reduce unintentional ingestion and do not meet the requirements outlined in this policy.
  • Acceptable closures include:
    – Pumps
    Dispensing caps (maximum width/diameter of opening should be no more than 20% of the width of the cap):
           – flip top lids
    disc top caps (like those on cream-type cosmetic products)
    any cap or dispensing lid that forces interaction with the product and
    is not listed below as an unacceptable closure
    other closures that clearly differentiate the hand sanitizer container from a beverage container and force consumer interaction
  • Unacceptable caps or closures include:
    – drinking spouts
    beer bottle caps
    conventional twist-off caps or lids
    corks
  • A warning statement on the front label is considered an effective way to inform consumers that the product is not a beverage. Symbols or pictures used along with a warning statement also help to communicate potential health risks.
  • Additional labelling requirements include a front-of-pack warning featuring a red octagon with the text “Do not drink / Ne pas boire” and “Health Canada / Santé Canada.” Attributing the warning to Health Canada will lend credibility, as the public recognizes Health Canada’s role to protect the health and safety of Canadians.
  • This warning must include the text “Do not drink / Ne pas boire”
    – bolded black text on a white background
    English and French text on separate lines in either official language order
    font size is proportional to the size of the container, label and branding of the hand sanitizer:
    equal to or greater than the product’s brand name or a minimum of 22-point font
    acceptable font types include non-decorative sans serif fonts, such as Arial and Helvetica
    letters cannot touch
  • the text “Health Canada / Santé Canada”
    – black text on a white background
    font size can be 50% smaller than warning text (minimum font size is 11 point, Helvetica font, letters cannot touch)
  • a symmetrical octagon graphic symbol that:
    precedes the warning statement
    is red in colour and framed or enclosed with a black border of a minimum of 1 point weight on the white background
    is in the same height as the stacked warning statement
  • The graphic symbol, warning statement and Health Canada attribution must appear together within a black border, of at least 1 point, with a white background to ensure visibility. The warning should appear on the top 50% of the main display panel label.
  • An example of the warning:

As mentioned above, these measures must be put in place no later than 8 weeks after this policy comes into effect, allowing existing stock to be used up. Distribution in Canada of alcohol-based hand sanitizers packaged in beverage containers without these measures must stop after this date.

Over-stickers with the graphic symbol and warning statement will be permitted for 6 months from implementation and up to April 2, 2021, or by the next labelling run, whichever comes sooner. By this date, the warning statements must be incorporated into the packaging and permanent label design. The over-sticker cannot cover other labelling text or information.

The addition of the warning over-sticker should be placed on products before distribution and as soon as possible within the 8-week implementation period. Additionally, product sponsors are expected to make every effort to shift to using traditional hand sanitizer containers.

Health Canada strongly recommends against marketing hand sanitizers to children given the additional heightened risk to this vulnerable subpopulation. For additional information, please see Health Canada’s public advisory on hand sanitizers and children’s safety and the consumer advertising guidelines for marketed health products.

Compliance and Enforcement

Enforcement efforts will focus on compliance monitoring and promotion. Health Canada will consider escalated enforcement if risks to health and safety are identified.

When Health Canada identifies or is notified of potential non-compliance with the Food and Drugs Act and/or its Regulations, the information is assessed. A case may be opened to verify if non-compliance has occurred. Each case is assessed and prioritized, and the appropriate compliance action is taken in proportion to the risk posed to the public. The main goal of Health Canada’s compliance and enforcement approach is to manage the risks to Canadians by using the most appropriate level of intervention.

For more information on Health Canada’s national compliance and enforcement approach for health products regulated under the Act and its regulations, please refer to the compliance and enforcement policy (POL-0001).

As demand for hand sanitizers, disinfectants and medical devices continues to increase to keep the public safe, our team continues to work tirelessly to deliver the compliance and import solutions that are needed.  Our Experts at Quality Smart Solutions continue to support your needs for natural health products, foods, cosmetics, OTC drugs and medical devices for North America. Contact us today to learn more about how we can support your compliance needs during and after licensing!

Resources

https://www.canada.ca/en/health-canada/services/drugs-health-products/disinfectants/covid-19/information-manufacturers/hand-sanitizers-containers-labelling-requirements.html

https://www.canada.ca/en/health-canada/services/drugs-health-products/disinfectants/covid-19/information-manufacturers.html#hand

Categories
Medical Devices

Regulatory Considerations for Non-Medical Masks or Face Coverings

Earlier this summer, Health Canada provided a notice to industry on the regulatory considerations for non-medical masks or face coverings, and the circumstances under which such masks or face coverings would be subject to the regulatory requirements for medical devices during the COVID-19 pandemic.

Generally, non-medical masks or face coverings are made of fabric and come in various shapes, sizes and styles. They are typically sewn and secured with ties or straps around the head or behind the ears. They may be made in a factory, by a home-based small business or hand-made by people for self-use or donation to others. Such masks and face coverings may help reduce the spread of respiratory droplets from the user to others or to the surroundings.

In the context of the COVID-19 pandemic:

  • Masks or face coverings that make medical claims or representations to reduce the risk of or prevent the user from contracting COVID-19 are deemed medical masks. They are regulated as Class I medical devices and require medical device licensing.
  • Masks or face coverings that DO NOT make any medical claims, representations or indicate they will reduce or prevent the user from contracting a disease, do not require any type of licensing.

Examples of medical claims or representations include:

  • to protect the user from contracting COVID-19
  • for anti-viral or anti-bacterial protection (for example, contains a drug or biologic)
  • for use as a medical mask
  • to provide liquid barrier protection
  • designed as a respiratory protective device (for example, used for particulate filtration)
  • for use in high-risk aerosol generating medical procedures

Whereas examples of non-medical claims are:

  • Face coverings can play an important role in situations where physical distancing is not possible or is unpredictable.
  • When worn properly, a person wearing a non-medical mask or face covering may reduce the spread of their respiratory droplets.
  • These non-medical masks or face coverings have not been tested to meet any standards. Although encouraged, wearing a non-medical mask or face covering is not a substitute for physical distancing and hand washing.

All medical masks and face coverings (that make medical claims, as noted above) must meet specific international standards for Class I medical devices, such as ASTM F2100. These standards include requirements for bacterial filtration effectiveness, and may include specifications for particle filtration efficiency, flammability and fluid resistance. Furthermore, the labelling for medical masks must contain clear statements on their intended use and specific performance specifications for their proper use (for example, filtration efficiency and fluid resistance). Medical masks must come with bilingual labelling, either on the packaging or with the device itself.

Medical masks may be authorized for sale or import into Canada through the following routes:

  • interim order authorization to import and sell medical devices related to COVID-19
  • expedited review and issuance of Medical Device Establishment Licences related to COVID-19
  • exceptional importation and sale of certain non-compliant medical devices related to COVID-19

The regulatory pathways outlined above provide Canadians with information about the degree of protection they may expect from a medical vs. non-medical mask or face covering. This will allow them to select a product based on their individual risk profile. For example, people who are at risk of more severe disease if infected with COVID-19 may wish to use a mask with an established higher level of protection.

Companies importing masks/face coverings, medical or non-medical, may be requested by the Canada Border Services Agency (CBSA) to provide proof of a Medical Device Establishment Licence (MDEL). To ensure there are no hold ups at the border and that product is imported smoothly and in a timely fashion, our specialists recommend securing a MDEL for your business to be on the safe side.

As demand for medical devices, disinfectants and hand sanitizers continues to increase to keep the public safe, our team continues to work tirelessly to deliver the compliance and import solutions that are needed.  Our Experts at Quality Smart Solutions continue to support your needs for natural health products, foods, cosmetics, OTC drugs and medical devices for North America. Contact us today to learn more about how we can support your compliance needs during and after licensing!

Resources

https://www.canada.ca/en/health-canada/services/drugs-health-products/covid19-industry/medical-devices/personal-protective-equipment/medical-masks-respirators/face-covering-classifications-notice.html

https://www.canada.ca/en/health-canada/services/drugs-health-products/covid19-industry/medical-devices/personal-protective-equipment/medical-masks-respirators/authorization.html