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Guidance for post-authorization changes for biocides: Overview

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Purpose

A market authorization for a biocide under the Biocides Regulations (the regulations) allows you to import, sell or advertise a biocide according to the parameters it outlines.

After you've obtained market authorization for a biocide, you must use post-authorization change pathways when you want to make a change to:

This guidance provides information on:

The changes listed in this guidance are not exhaustive.

You can request post-authorization changes by filing through an appropriate post-authorization change pathway. We'll review your request and update the market authorization as applicable.

There are 5 categories of changes described in this guidance:

Changes to the information provided in the initial application to obtain a market authorization for a biocide can include:

For information on what types of changes are considered major or minor changes, refer to:

We screen each post-authorization application or notification to confirm:

All changes are subject to fees except for those addressed in subsection 27(1)(c) of the Order Amending the Fees in Respect of Drugs and Medical Devices Order Biocides). Ensure that you select Minor Change – No Fee on the biocide application form when making the following minor changes:

You should contact us if you wish to determine the relevant change pathway for your biocide, or if you wish to deviate from the approaches in this guidance.

For guidance on navigating the biocide application process, consult:

The guidance on management of biocide applications outlines the electronic filing requirements and provides additional resources to help you prepare and file information to Health Canada.

Formulation variations

A market authorization that includes formulation variations means the variations have the same benefits and risks. As indicated in the guidance on biocide application pathways and general requirements, only similar formulations of a biocide can be included in 1 market authorization.

If you want to change a specific formulation variation, you must specify in your post-authorization change application or notification what is changing in that formulation. The change could be major or minor.

A change to the conditions of use must apply to the entire market authorization. However, when marketing a biocide, you can label it with a subset of uses, settings, directions for use and so on as outlined in the market authorization.

Changes to company information

There is a cost recovery fee for a change to:

There is no cost recovery fee for a change to:

You must notify us of these minor changes as soon as feasible.

For changes to an importer name or contact information, including adding or removing an importer, as early as possible (even more than 30 days before making the change). This enables us to capture the updated importer information in the market authorized biocides database, which border agents can verify when a shipment comes into Canada.

Before initiating your import, check the market authorized biocides database to verify that the importer information has been updated to facilitate importation.

You are not required to file changes relating to the packager and labeller information with us. However, you must maintain this information on file and provide it to us, if requested.

Change to other contact information for authorization holder

For changes to update the contact information other than the civic address of the authorization holder, you are not required to submit the common requirements for all post-authorization changes. Instead, you must complete a company amendment by updating the latest Company (CO) template.

Note, the company enrolment/amendment process and the information collected using the CO template are managed independently from the biocide applications filed for review. It can take up to one week to obtain your company ID or amend your company data once you have provided all the necessary information.

For more information on the company enrolment and amendment process, refer to the guidance document on the regulatory enrollment process (REP) for drugs for human/veterinary use, disinfectants, and biocides.

For information on processing company information, contact the Client Information Unit at client.information@hc-sc.gc.ca.

Cross-promotion and co-packaging

You may wish to add a cross-promotion on the label of your biocide or co-package related products (and this co-packaging is not a kit). The addition could be considered a major, minor, or non-notifiable change, depending on the impact to the biocide's:

Learn more about cross promotion and co-packaging.

If you intend on cross promoting or co-packaging a biocide with another product, you should contact us before submitting an application. We will help you verify whether the cross promotion or co-packaging may introduce safety concerns by using the different products together. Depending on the products you will cross promote or co-package, we may need to address unique uncertainties within our review.

Changes that create a new biocide

In some cases, changes to a biocide are so significant that they create a new biocide. These require a new market authorization with a new biocide identification number.

We don't allow changes to an existing market authorization that create a new biocide because they significantly affect the biocide's benefits and risks.

Changes that create a new biocide are changes to the:

Active ingredient

An active ingredient is directly responsible for a biocide's ability to achieve its intended effects. A change to an active ingredient may alter a biocide's benefits and risks.

An active ingredient's CAS number uniquely identifies the substance. When a change to the active ingredient is being proposed, the CAS number would also change. There are a few exceptions when an ingredient has multiple CAS numbers. In those cases, a change to the CAS number is not considered a change to the ingredient, but instead a minor change to the ingredient's unique numeric identifier.

Active ingredient quantity

You cannot change the quantity of an active ingredient in a biocide without obtaining a new market authorization. However, certain changes to widen the tolerance limits of an active ingredient in a biocide's specifications would be a minor change.

Learn more: Table 1: Summary of scope of changes

Physical form

The physical form of the biocide is the form in which it is sold and used. Changes to how a biocide is applied to a surface (its method of application) are not considered changes that create a new biocide. An exception to this is if the physical form of the biocide has also changed (for example, from a solution to a towelette product).

Learn more:

Kits

You will need to apply for a new market authorization if you wish to both:

and

This is because you would be making a change to the biocide's physical form.

When products are packaged and represented for use together, they are considered kits. They require a new market authorization that includes the active ingredients and physical form of all products packaged together.

You may have a kit that has already been authorized and want to add, remove or substitute 1 of the products in the kit with a new product. This type of change is also considered a change that creates a new biocide and requires a new market authorization.

Major changes

A biocide's market authorization must be updated before importing, selling or advertising any version of the biocide affected by a major change.

Major changes are changes to the information provided to us in connection with a biocide that are reasonably expected to have a major impact on the:

As such, you must provide scientific information to support a major change for our review through an application for a notice of acceptance. The options available to file your application for a major change depend on how the biocide was initially authorized and what is changing.

Filing pathways for major change applications

Minor changes to product information

A minor change does not require you to submit data to support the change. Minor changes are changes to the information you provided to us in connection with a biocide that are reasonably expected to have a minor impact on the:

You must submit a notification to us at least 30 days before making a minor change to your biocide if the change is within your control. If the change is not within your control, you must notify us as soon as feasible after you become aware of the change.

Filing pathways for minor change applications

Multiple brand names under a market authorization

All brand names must be unique. To transfer a brand name to a new market authorization from an already authorized biocide, you first need to:

You can remove a brand name from a market authorization using the minor change pathway.

Non-notifiable changes

There are also changes to a biocide that do not meet the definition of a major or minor change. These are non-notifiable changes.

Your biocide label may include information that is not required by the regulations. Changes to this information does not require a post-authorization application or notification to us, unless the change could affect the biocide's:

However, we request that you incorporate these changes into your next post-authorization (major or minor change) filing for the biocide.

If your biocide is a comparison biocide for other biocides authorized based on comparison to it, file all non-notifiable changes through a minor change application. This way we have the most up-to-date information available for when we review any subsequent new or post-authorization change applications for licensees.

Examples of non-notifiable changes include:

Any therapeutic claim on a biocide label requires our authorization before you can sell the biocide.

Editorial changes

Certain editorial changes to statements on a biocide label are non-notifiable provided they don't alter the interpretation or meaning of the authorized statement. They allow you to capture minor variations in the way you present the same information on labels. An example would be changing the storage conditions on the label to indicate that a biocide required to be stored at room temperature to be stored at 15 to 25°C.

Some editorial changes are considered minor changes. For example, changes to the use or purpose of the biocide, as outlined in Table 1: Summary of scope of changes

Contact us

Contact the Natural and Non-prescription Health Products Directorate to:

Email: nnhpd-dpsnso@hc-sc.gc.ca

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