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Draft guidance on co-packaged drug products: Requirements for convenience packs and components

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General considerations

Convenience packs bring together market-authorized therapeutic products (drug and other components), with their individually authorized packaging and labelling. Convenience packs may also include Class I medical devices, cosmetics and consumer products. These packs are sold as a single unit for the convenience of the user.

The co-packaging of authorized products in a convenience pack must not:

The authorized drug components may be co-packaged with auxiliary items, such as sterile syringes that are not specific to the drug. The purpose of the co-packaging may be to streamline the preparation and use of the products, but does not dictate the use of the components together or the specific administration method.

The co-packaged product could meet the definition of a drug kit if:

Visit the section on drug kits.

Establishment and site licensing requirements

Activities such as packaging, labelling, importing and distributing already packaged drugs in a secondary package (for example, a convenience pack) may require an establishment (drug) or site licence (natural health product). Importing and distributing medical devices requires a medical device establishment licence (MDEL). An MDEL is not required for assembling convenience packs, but is required for importing and selling medical devices.

For more information, consult:

Companies engaging in activities that require a licence (for example, packaging, labelling, importing or distributing therapeutic products) must hold the licence before commencing the activities. As licensing requirements may vary depending on the components in the convenience pack, it is the company's responsibility to understand and comply with applicable requirements.

Authorization requirements

Convenience packs do not require additional drug authorization by Health Canada such as another drug identification number (DIN) or notice of compliance (NOC) when all the drug components have been authorized and packaged and labelled in accordance with applicable regulations.

A convenience pack itself does not require separate authorization (assignment of a new DIN) before sale. However, all drug components and other components packaged in a convenience pack must be authorized to be marketed in Canada under the applicable regulations:

A separate authorization and DIN are not required for a convenience pack if the drug and natural health product components in the pack are identified by and labelled with the brand names for which Health Canada has issued a market authorization. A convenience pack must not introduce:

For more information, consult:

Medical device components in convenience packs

Medical devices may also be included as components in convenience packs. For example, they may be included to help administer an injectable drug and diluent by co-packaging a non-specific syringe (medical device). These components must be authorized or licensed, whichever is applicable, and include product packaging and labelling that complies with the MDR.

In general, Class I medical devices that are imported or distributed by licensed establishments and authorized Class II to IV medical devices with the manufacturer’s labelling that complies with the MDR can be added to a convenience pack. Examples include:

The co-packaging must not alter the safety, effectiveness or quality of the device or assign a new purpose. As well, the following applies for all medical devices intended to be sold in a convenience pack:

An MDEL is required for importing and distributing all classes of medical devices.

For more information, consult:

Labelling requirements for convenience packs

Convenience packs must meet all of the packaging and label requirements for their components (Table 5). The drug components and other components (for example, NHPs and Class II to IV medical devices) must be sold with complete packaging and labelling authorized by Health Canada. Class I medical devices must be sold with the original manufacturer’s packaging and labeling. The labelling of all classes of devices must comply with sections 21 to 23 of the MDR.

As outlined in section A.01.017 of the FDR, every label for a drug for human use in dosage form must meet certain requirements. For example, the information on the label must be easily discernible to consumers under normal conditions of sale.  Similar conditions apply to natural health product labels under paragraph 88(b) of the NHPR.

Further, subsection 21(2) of the MDR requires that medical device labels be expressed in a legible, permanent and prominent manner, in terms that the intended user can easily understand. If the medical device is intended to be sold to the general public:

If an outer package obscures any of the information on a component’s outer label that is required by the applicable regulations, it should be displayed on the outer surface of the convenience pack. The information should be visible under normal conditions of sale, purchase and use. The outer surface of convenience packs can also provide additional information about their contents, such as:

These requirements are to ensure consumers have access to essential information so they can make informed decisions about the products they are purchasing and have the information they need to use the products safely.

A convenience pack’s outer surface may have several distinct component labels on or affixed to it. The co-packaging of components in a convenience pack does not require an additional submission or application to Health Canada for the labels of the drug component, authorized natural health product or authorized Class II to IV medical device. However, they must be identical to the labels authorized by Health Canada for the individual products.

For Class I medical device components, labels are not generally submitted to Health Canada. However, for all classes of devices, the packaging and labelling must comply with sections 21 to 23 of the MDR.

The co-packaged drug product could meet the definition of a drug kit or a drug-device combination product if:

For more information, visit the section on drug kits.

Table 5: Labelling requirements for convenience packs
Package inserts for drug component Inner label for other components (for example, swabs, syringe) Inner label for drug component Outer surface of convenience pack for drug and other components (only if individual component labels are obscured)
  • Include previously authorized package insert, if applicable
  • Must use manufacturer’s label that is authorized and/or compliant with the applicable regulations
  • Display NPN, DIN-HM or device identifier that is part of the MDL, as required
  • Must use previously authorized labels of individually authorized component
  • Display DIN of drug component

For drug and natural health product components:

  • Must use previously authorized labels of the individually authorized component
  • Ensure the component’s outer labels are visible to users under normal conditions of sale
  • Ensure that component outer labels reproduced on convenience pack’s outer package are identical to that authorized for the component if the information on the component outer labels is not visible

For medical device components:

  • 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 to be sold to the 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 English or French as a minimum

Refer to the MDR for complete information.

The overall labelling of the convenience pack should reflect the actual contents of the convenience pack. If a manufacturer introduces new packaging or labelling or modifies existing packaging or labelling of convenience pack drug components, an application or submission may be required. This should be filed as a post-authorization change to the DIN of the drug component affected by the modifications.

Similarly, licence holders of natural health products in a convenience pack may need to file post-licence submissions when modifying previously authorized label texts, as appropriate.

Manufacturers of Class II to IV medical devices may have to submit their proposed labelling and packaging changes as part of an amendment or authorization renewal, whichever is applicable. In general, manufacturers of Class I medical devices do not submit labelling or packaging changes to Health Canada.

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

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

For guidance, consult:

Third-party packagers and labellers of convenience packs using marketed products

Whether an application or submission for changes to packaging or labelling a drug within a convenience pack can be filed depends on who assembled the convenience pack: the authorization holder or a third party.

Third parties must not introduce new labels for the drug components or the overall convenience pack that are not identical to the labels authorized by Health Canada and provided by the authorization holder.

Repackaging individual authorized drug components and other components (for example, removing them from their authorized immediate or secondary container, removing or modifying inner or outer labels) could result in the sale of a product that is:

Third parties should ensure that their upstream suppliers sell all authorized drug components and other authorized components (for example, Class II to IV medical devices and natural health products) in authorized packaging and labelling.

If specific labels or product inserts must be included in a convenience pack, the person selling or importing the drug component must ensure that the labels have been authorized by Health Canada.

Third parties should not create a separate label or insert, or modify packages or labels, other than what was authorized for the drug component or other authorized components of the convenience pack. The insert may have been required for the drug or medical device to meet its regulatory requirements. For example, an insert may be required for safety and efficacy reasons, if the individual component labels do not have enough information.

Third-party licensing agreements for drugs

Third-party packagers and labellers of convenience packs wishing to make changes to the packaging and labelling could also consider licensing agreements with the authorization holder of the convenience pack drug components. A licensing agreement is between 2 manufacturers where 1 manufacturer (licensor) supplies a drug product to another manufacturer (licensee) for sale under the second manufacturer's name.

Third-party packagers and labellers of convenience packs who wish to license a drug from another manufacturer to sell under their own name must file a DIN application for Division 1 drugs and an EUNDS, NDS, ANDS or EUANDS for Division 8 drugs.

A letter of authorization (LoA) from the licensor (original DIN holder) is also required as part of the application or submission. The LoA confirms that:

If the application or submission complies with the FDR, Health Canada will authorize the product to be sold under the licensee’s name and issue a new DIN.

After obtaining market authorization for the cross-licensed product, all aspects of the authorization for the licensee's product must be identical to that of the licensor's throughout the product's life cycle. The exception is the manufacturer or product name. Licensees are expected to reflect licensors’ label changes within 30 days and obtain Health Canada’s approval for any label modifications.

Licensees who wish to deviate from the licensor package and labels (for example, changing label content, adding packaging sizes, using novel label formats or private label branding) will require a drug submission or application with supporting data. Licensees should contact the relevant review bureau to determine the type of submission or DIN application that should be filed.

Third-party packagers and labellers of convenience packs should consult:

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