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Draft guidance on co-packaged drug products: Requirements for drug kits

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General considerations

Drug kits are co-packaged drug products made up of 2 or more components, at least 1 of which is a prescription or non-prescription pharmaceutical or biologic drug subject to the Food and Drug Regulations (FDR), where:

Additional components may be included in a drug kit as a convenience for users and are not intended or recommended to be used in a specific combination with other components to achieve a new or overarching indication.

Health Canada considers a drug kit to be a distinct drug product from its drug components. For this reason, a drug kit requires authorization before it can be marketed in Canada.

Under subsection C.01.014(1) of the FDR, a manufacturer cannot sell a drug in dosage form unless a drug identification number (DIN) has been assigned for that drug and that DIN has not been cancelled. For new drugs that fall under part C, Division 8 of the FDR, market authorization of a drug also requires that a notice of compliance (NOC) be issued.

To market a drug kit, manufacturers must apply for a DIN or an NOC, or both, and provide the required information as set out in the regulations. We will review information submitted as part of an application for a drug kit DIN or an NOC to determine whether the drug and other components in a drug kit meet the safety, efficacy and quality requirements under the recommended conditions of use.

If the information complies with the FDR, we will authorize the drug kit for sale, assign a DIN to the drug kit and issue an NOC if it is a new drug.

Drug kit authorization

Manufacturers of drug kits must file 1 of the following types of applications or submissions:

Individual drug components of a drug kit that are used in combination to achieve a new or overarching indication may have been previously authorized (assigned a DIN) and marketed in Canada as individual drugs before being co-packaged with other components and sold as part of a drug kit. However, these drug components do not have to be individually authorized before an application or submission for a drug kit is filed. Manufacturers can file a submission for a drug kit containing 1 or more drug components that have not been previously authorized and assigned a DIN.

Manufacturers of drug kits must provide specific information on the combined use of the co-packaged components to support the safety, efficacy and quality of the kit. This requirement applies even if Health Canada previously reviewed and approved the components as individual products.

When we review applications or submissions for drug kits, we assess the information including the dosage forms and labelling of drug components proposed for use together with other components. If the information complies with the FDR, we will assign a DIN to the drug kit.

A DIN assigned to a drug kit means users can verify that it is authorized to be marketed in Canada. It also means that manufacturers have adequately addressed possible safety risks for the use of its components together (for example, potential contraindications, drug-drug interactions and risks of overdosing).

A DIN for an entire drug kit (as a whole) means it is authorized for the Canadian market and that the components are intended to be used together. It does not mean that any of the components have been authorized to be sold or used on their own.

To market a drug component of an existing drug kit that has not previously been authorized as a separate and individual drug product, manufacturers must:

The regular drug review process will be followed, including the application of quality and manufacturing requirements in the FDR. If the information complies with the FDR, a new DIN is assigned to the individual drug product.

Manufacturers of drug kits may include previously authorized drug components or other components compliant with applicable regulations in a kit. The application or submission for a drug kit must have enough information on the safety, efficacy and quality of each component when they are used together.

Manufacturers may seek to include drug or other components, including those manufactured by other authorization holders (such as DIN holders for drug components) in a drug kit. Contractual or licensing agreements between implicated manufacturers can help ensure that all required data is available to the manufacturer of the drug kit. These agreements can also be provided to help us examine the safety, efficacy and quality data associated with the product.

For more information on licensing agreements, consult:

Drug-medical device combination products

In some cases, specific drugs that are co-packaged with specific medical devices as part of a combined therapeutic product are subject to the policy for drug-medical device combination products. These co-packaged products are not considered kits or convenience packs under this guidance.

Individual medical devices authorized for sale or otherwise sold in compliance with the Medical Devices Regulations (MDR) as non-specific and substitutable components with a drug kit could be considered a convenience component. The requirements for these medical devices, which are packaged and labelled in accordance with the MDR, are  outlined in this guidance document. For example, a type of general-purpose syringe could be included to help administer an injectable drug.

Natural health products in drug kits

A manufacturer may wish to market a drug kit consisting of 1 or more drug components, as well as a component that would be classified as a natural health product (NHP), if sold individually, for specific use together to achieve a new or overarching indication. A component may have been previously authorized under the Natural Health Products Regulations (NHPR) and assigned a natural product number (NPN) or DIN-HM (for homeopathic medicines).

These drug kits are classified as a drug and are subject to the requirements under the FDR. If the kit is classified as a drug, persons involved in activities like fabricating and packaging/labelling may require drug establishment licences as outlined in Part C, Division 1A of the FDR.

Cosmetics in drug kits

Similarly, a manufacturer may wish to market a drug kit consisting of 1 or more drug components as well as a component that would be classified as a cosmetic, if sold individually, for specific use together to achieve a new or overarching indication. These drug kits are classified as a drug and are subject to the requirements under the FDR.

Diluents in drug kits

A manufacturer may intend to market a drug kit consisting of 1 or more drug components and a diluent. If the diluent in a drug kit can be sold separately as an individual drug product (used to reconstitute other drug products) and has its own previously assigned DIN, the diluent is considered a drug component of the drug kit. These drug kits are classified as a drug and are subject to the requirements under the FDR.

Recommendations for labelling diluents are provided in Table 4B in the section Labelling requirements for drug kits.

Convenience components in drug kits

Drugs, medical devices, natural health products or cosmetics may also be included as convenience components in drug kits. For example, a non-specific, substitutable syringe (medical device) or alcohol swabs (NHPs) can be included as convenience components to help administer an injectable drug and diluent.

Convenience components may be used together with the drug components of a drug kit as a convenience for the user, but not to achieve a combined or overarching therapeutic effect.

Convenience components must be individually authorized or licensed or notified, as applicable, and include product packaging and labelling that complies with the applicable regulations (for example, MDR, NHPR).

Convenience components usually include licensed NHPs, Class I medical devices imported and distributed by licensed establishments or authorized Class II to IV medical devices. For example:

These general-purpose convenience components must not:

Class I medical device convenience components that are sold in a drug kit must be imported and distributed by licensed establishments (subject to certain exemptions). Class II to IV medical devices that are included as a convenience component in the drug kit must be authorized, and include all the manufacturer’s authorized packaging and labelling. A licensed medical device may include variations of device packaging (such as 10-, 50- or 100-unit medical device packs) under a single medical device licence.

Importing and distributing a medical device as a convenience component in a drug kit requires a medical device establishment licence (MDEL).

For more information, consult:

Labelling requirements for drug kits

Individual drug components intended to be sold in a drug kit do not have to be previously authorized. An application or submission can be filed for a drug kit containing 1 or several new drug components that are specific to the drug kit (not authorized and marketed separately).

However, in some cases, drug components of a drug kit may have been separately authorized, assigned a DIN and marketed as an individual drug. These drugs will have packaging and labelling previously authorized by Health Canada that includes directions for individual use for specific authorized indications. A drug kit may also contain a mix of new and previously authorized drug components.

Drug kits also raise other considerations when they consist of additional layers of packaging. For example, a drug kit may contain several drug components and other components. Each drug component has its own inner and outer labels, in addition to the outer package and overarching labelling for the drug kit.

The FDR outlines labelling rules applicable to drug kits that describe requirements for inner (immediate container) and outer (outside surface of package) labels. In addition, a product monograph is authorized through a notice of compliance (NOC) for new drug submissions, as applicable.

In this guidance, the following terms are used and defined, in line with section A.01.010 of the FDR:

Manufacturers must ensure that all information is presented clearly and effectively on the overall labelling, including any component and kit labels. This includes information that is required by the regulations applicable to each component and other complementary information that help users identify, select and use the product.

For clarity, the information required by the regulations for the outer label of the kit must be displayed on the outer surface of the kit package (drug kit outer label). This helps ensure that Health Canada inspectors can easily verify compliance of the kit upon importation into Canada.

As part of an application or submission for a drug kit, manufacturers should include mock-ups of all packaging and labelling being proposed in and on the drug kit. This includes all previously authorized component labels that the manufacturer intends to reuse, such as:

In most cases, drug kits must have a product monograph and a package insert outlining in detail the recommended use of the specific components in combination to achieve the intended new or overarching indication.

For more information on labelling of drugs, consult:

DIN display requirements

As stated in subsection C.01.005(1) of the FDR, the inner and outer labels of a drug in dosage form must show the DIN assigned to that drug.

In general, the DIN assigned to the drug kit must be displayed on the:

When sold as part of a drug kit, drug and other components may be able to keep much of their previously authorized inner and outer labels. This includes displaying the DIN previously assigned to the drug component in relation to its individual use on the component’s inner and outer labels. However, the packaging and labelling previously authorized for individual use must not:

If both DINs are shown, sponsors should ensure that the DIN assigned to the drug kit is easily identified (for example, including the expression “Kit DIN” preceding the DIN).

This alignment helps provide clear and consistent information on the conditions and authorized use of each component in a drug kit. This helps prevent potential safety issues for users.

Table 3: DIN display requirements
Components DIN display requirements

Drug components that are authorized as individual products and the same conditions of use for the drug kit are maintained

Drug components can generally keep their previously authorized inner and outer labels when sold as part of a drug kit.

The inner and outer component labels:

  • must show the DIN assigned to the drug kit
  • can show the DIN assigned to the drug component in relation to its individual use authorization.
  • when both DINs are shown, recommend preceding the drug kit DIN by the expression “Kit DIN”

Can include reference to authorized conditions of use as part of the drug kit in separate product monographs associated with individual use authorization.

Can include previously authorized package insert of the individual drug components in addition to new drug kit package insert, when applicable.

Drug components that are already authorized as individual products and the same condition(s) of use for the drug kit are not maintained

or

Drug components that are not previously authorized as individual products

Sponsors must submit new component inner labels, component outer labels, as required, as part of the application or submission for the drug kit.

The inner and outer component labels must show the DIN assigned to the drug kit.

A detailed breakdown of specific labelling and display requirements for drug kits under certain circumstances is included in Table 4A. For diluents co-packaged with drug components, specific requirements are listed in Table 4B. Requirements and recommendations for medical device convenience component labelling and packaging are listed in Table 4C.

Table 4: DIN display requirements for drug kits

A drug kit may contain separately and individually authorized drug components and new drug components. For each component, discrete rules within each of the cells of the following tables would apply, if appropriate. The rules in Table 4A also apply to components that would be classified as NHPs if sold individually. When co-packaged for combined use with specific prescription or non-prescription pharmaceuticals or biologics (in a drug kit), these components are regulated as drugs under the FDR.

4A: Drug kits and components
Component authorization Package inserts Inner label (drug component) Outer label (drug component) Outer label (drug kit)

Components that are individually authorized and the same conditions of use for the drug kit is or are maintained (for example, drug A and drug B are individually authorized and are now being packaged together)

Include previously authorized package insert of the individual drug component, where applicable

  • Display drug kit DIN
  • Recommend including DIN or NPN or DIN-HM assigned in relation to individual authorization
  • Can adapt previously authorized label (of the individual component)
  • Display drug kit DIN
  • Recommend including DIN or NPN or DIN-HM assigned in relation to individual authorization
  • Can adapt previously authorized label (of the individual component)
  • New label
  • Display drug kit DIN

Components are previously individually authorized but there is a new condition of use for the drug kit (for example, new indication for previously authorized drug A and drug B to be used in combination)

or

Components that are not individually authorized
  • New label
  • Create separate package insert for the drug kit, where applicable
  • New label
  • Display drug kit’s DIN
  • New label
  • Display drug kit’s DIN
  • New label
  • Display drug kit’s DIN
4B: Diluent component labelling
Inner label of diluent that is individually authorized (DIN assigned) Inner label of diluent that is not individually authorized (no DIN assigned)
  • Can adapt existing authorized diluent labels
  • Display DIN of drug kit
  • Can display diluent DIN on diluent label
  • New label
  • Display “Diluent for [drug kit brand name], [DIN of drug kit]”
4C: Drug kits with medical devices included as convenience components
Component authorization Medical device component package Outer drug kit label

Medical devices:

  • Class I devices sold by medical device establishment licence holders (subject to certain exemptions)
  • Class II to IV medical devices that have been authorized
  • Must meet labelling and packaging requirements under sections 21 to 23 of the MDR for importation or sale, including the requirement that labelling information be legible, permanent, prominently displayed and use terms the user can easily understand
  • Class II to IV device labelling and packaging must be authorized.

Recommend indicating the regulatory authorization status of the device inside (for example, this package contains the licensed medical device [insert device name])

If a medical device is intended to be sold to the general public, specific labelling requirements under sections 22 and 23 of the MDR must be met, including:

  • labelling information from 21(1) MDR that is visible under normal conditions of sale and
  • specific labelling information in both English and French as a minimum

Refer to the MDR for complete information.

Consult the following guidance documents to ensure all packaging and labels comply with the FDR:

Brand names of drug kits

Health Canada assesses the brand names of drugs to make sure they are not misleading or easily confused with other products. This assessment is done to prevent medication errors, maintain patient safety and support the effective use of medications.

Sponsors are responsible for providing information to support the safety of a proposed brand name for their drug kit. For example, they should consider whether the proposed brand name of a drug kit could be confused with any individually authorized drug components.

For more information, consult:

Notification of 12 months without sale

A drug that is authorized for sale both individually and separately as a component of a drug kit should be considered marketed (not dormant) when sold individually or as part of the kit.

Once a drug (pharmaceutical or biologic) or other component has been marketed, there may be times when the manufacturer has not made any sales. If any of these periods extends to 12 consecutive months, manufacturers are required to report the period of no sales to us. Such a drug is considered to be “dormant”. The requirements to report are outlined in section C.01.014.71 and subparagraph C.01.014.5(1)(a)(ii) of the FDR.

Medical device discontinuation

Authorization holders of a Class II to IV medical device who discontinue the sale of the medical device must inform us within 30 days. The authorization will then be cancelled.

Drug kit manufacturers, importers and distributors must ensure that Class II to IV medical devices added as a convenience component are authorized at the time of sale.

Post-authorization changes

Authorization holders are responsible for ensuring that post-authorization changes or amendments that may affect 1 or more of their authorized products are filed correctly with Health Canada.

Swapping drug components in a drug kit

In some cases, manufacturers may wish to replace 1 of the drug components in a drug kit that are part of the combined treatment regimen. For example, they may wish to swap a diluent for another equivalent diluent or a drug component from a different supplier. These may include components that may or may not be separately and individually authorized.

Manufacturers must file a DIN application for Division 1 drugs or a supplement to an NDS, ANDS or (A)EUNDS for Division 8 drugs. The application must contain information to support the safety, efficacy and quality of the newly introduced or modified equivalent components. If the information complies with the FDR, we will authorize the sale of the drug kit containing the newly introduced or modified components.

For information on filing post-authorization changes to Health Canada, consult:

In other cases, manufacturers may wish to introduce new drug components that are different from the original components of the kit. An example would be to include a drug component with a different strength. The overall drug kit is considered a new and distinct product. Manufacturers must file a DIN application for Division 1 drugs or an NDS, ANDS or (A)EUNDS for Division 8 drugs, whichever is applicable.

Swapping a convenience component for another in a drug kit

Drug kit manufacturers may also choose to make changes to the drug kit by introducing or swapping separately authorized or licensed convenience components, such as:

A new authorization for the drug kit (new DIN) is not required as long as the convenience components contain all the original manufacturer’s packaging and labelling that is compliant with the applicable regulations. However, the overall labelling of the drug kit should reflect the actual contents of the drug kit, including any information related to the convenience component.

Visit the section on label changes.

The co-packaging of convenience components cannot affect their individual intended use, safety, efficacy or quality. Also, the individual convenience components cannot be used together for a new purpose or intended use not previously authorized.

Labelling changes to drug kit or drug components

A post-authorization labelling change may or may not require a submission to Health Canada. This will depend on the nature of the product and the nature of the change to the packaging and labelling.

Sponsors are responsible for filing appropriate regulatory submissions for post-authorization changes that affect the labelling of 1 or more of their authorized products.

For example:

For more information on the type of submission required for a labelling change, consult:

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