Guidance for post-authorization changes for biocides: What to include

On this page

• Common requirements for all post-authorization changes
• Full review - novel biocide pathway
• Full review pathway
• Major change - quality and risks pathway
• Comparison: administrative application pathway and labelling only pathway
• Use of foreign decisions pathway
• Monograph pathway
• Major change – monograph pathway
• Minor change pathway - product information
• Minor change pathway - company information

Common requirements for all post-authorization changes

All post-authorization changes require:

• an updated biocide application form
  • where applicable, relevant attestation completed
• a cover letter stating:
  • you're seeking a post-authorization change for your biocide
  • a description of the changes

If the change affects the biocide's label, include:

• the reason for the intended change
• annotated label text that clearly highlights all the proposed changes (major and minor changes)
• a clean version of the label text that incorporates the changes

You do not need to submit updated label text if you're proposing changes to:

• product specifications
• package description, if it does not affect the label format or information layout
• stability or shelf life, if the biocide is not required to display an expiry date on its label
• aspects of the biocide that would be classified as a minor change

Contact us if you are unsure of the information to provide in your application or notification.

Full review - novel biocide pathway

When you file an application for a novel change, you must submit safety, efficacy and quality information to support the proposed change, as applicable. If you are unclear on the information required to support your novel change, request a pre-submission meeting.

Full review pathway

When you file an application for a major change, you must submit information to support the proposed change, as applicable. You will need to submit efficacy or confirmatory data in the full review pathway for changes to the biocide's:

• use or purpose (its therapeutic claim)
• directions for use, including method of application
• formulants that are not substitutions for a similar formulant with similar quantities

If any other changes are proposed through this pathway, safety and quality information may also be required.

Which efficacy tests or studies to include to support your proposed changes

Major change - quality and risks pathway

In this pathway, there should not be any impact to the efficacy of the biocide. Do not include efficacy data in the application to support the change. If there is an impact to its efficacy, file the application through the full review pathway.

For the major change – quality and risks pathway, you will need to submit:

• the common requirements for all post-authorization changes
• safety and quality information to support the proposed change, as applicable

The additional safety and quality information needed to support a major change application depends on the proposed change.

You will need to submit safety information for biocide changes affecting the biocide's risks, such as:

• adding a therapeutic use or purpose that increases the biocide's risks (for example, through increased exposure)
• adding a setting for use
• removing or revising risk information
• changing the method of application, if applicable
• changing formulants and their quantities and CAS number, if applicable
• adding new or changing cross-promotion or co-packaging with related products

Which tests and studies to include to support your proposed safety-related changes

You will need to submit stability information for changes that affect the biocide's stability, such as changes to:

• package material
• biocide's stability or shelf life
• formulants (except acceptable formulation variations)

You will need to submit specifications for changes that affect the biocide's specifications, such as changes that affect its:

• purity
• potency
• identity

What to include to support your proposed quality-related changes

Comparison: administrative application pathway and labelling only pathway

When using these pathways to make post-authorization changes for your biocide authorized based on comparison, you must submit certain information.

Unless you are the holder of the market authorization for the comparison biocide, you must submit a letter of confirmation from the licensor. The letter must mention the comparison biocide's identification number and brand names, and confirm that the major change either:

• resulted in an amendment to the master formula for the comparison biocide, and they have provided you with the updated master formula for the biocide or
• did not result in an amendment to the master formula for the comparison biocide

Sample letter of confirmation

You need to also submit the common requirements for all post-authorization changes, including an attestation (through the biocide application form) confirming that the:

• version of the biocide that is affected by the major change will be manufactured in accordance with the updated master formula for the comparison biocide
  • only needed if the major change resulted in an amendment to the master formula for the comparison biocide
• specifications of the version of the biocide that's affected by the major change, other than package description, are the same as the comparison biocide

You must also submit information demonstrating that the version of the biocide affected by the major change and the version of its comparison biocide:

• have the same active ingredients in the same quantities (for a given quantity of biocide)
• contain formulants that are among the formulants under the comparison biocide's market authorization
• contain the same quantity of each formulant under the comparison biocide's market authorization (for a given quantity of biocide)
• fall within the same conditions of use
  • exceptions are risk information and directions for storage, which must be the same as the comparison biocide

These application pathways rely on this information and the change having been authorized already for the comparison biocide. As such, applications for a major change filed through these pathways do not need to include:

• product specifications
• information on the benefits and risks of the biocide and associated uncertainties, or a summary of that information

Use of foreign decisions pathway

For post-authorization changes filed through this pathway, you need to submit the common requirements for all post-authorization changes. These include an attestation (through the biocide application form) confirming that:

• you possess or have immediate access to the information that was submitted to the foreign regulatory authority to obtain the authorization for the change
• either the major change:
  • resulted in an amendment to the master formula for the foreign biocide, and the version of the biocide affected by the major change will be manufactured in accordance with this updated master formula for the foreign biocide, or
  • did not result in an amendment to the master formula for the foreign biocide
• the specifications of the version of the biocide that's affected by the major change, other than package description, are the same as those of the foreign biocide

You will also need to include evidence that the foreign regulatory authority named in the biocide's market authorization authorized the change for the foreign biocide through an acceptable pathway. They cannot have authorized it through a type of application that is set out in the List of Foreign Regulatory Authorities.

If the change affects the biocide's label, you must also include a copy of the text approved by the foreign regulatory authority for every label to be used in connection with the foreign biocide.

Using this pathway for a major change to match the foreign biocide allows you to rely on the approval of that change by the foreign regulatory authority. Your application would not need to include:

• product specifications
• information on the benefits and risks or associated uncertainties, or a summary of that information

However, the Minister may request this information to determine if the benefits outweigh the risks of the biocide before issuing a revised market authorization.

Monograph pathway

When you file an application for changes to a product previously approved through this pathway, you must submit information to support the proposed change, as applicable.

You will need to submit quality information (including stability information, as applicable) for changes to:

• package material
• revisions to the biocide's stability or shelf life
• formulants (except acceptable formulation variations)

What to include to support your proposed quality-related change

You will need to submit safety information for biocide changes relating to:

• adding a therapeutic use or purpose that increases the biocide's risks (for example, through increased exposure)
• adding a setting for use
• removing or revising risk information
• changing the method of application, if applicable
• changing formulants and their quantities and CAS number, if applicable

Which tests and studies to include to support your proposed safety-related change

Major change - monograph pathway

In this pathway, there should not be any impact to the risks or quality of the biocide. As such, safety or quality information is not required in this pathway. If there is, the application should be filed through either the:

• full review pathway (if the biocide does not meet the parameters of the monograph)
• monograph pathway (if the biocide meets the parameters of the monograph)

For this pathway, you will need to:

• reference the appropriate monograph
• submit the common requirements for all post-authorization changes, including the monograph attestation within the application form

Minor change pathway - product information

For minor changes to product information, you will need to submit the common requirements for all post-authorization changes.

You are not required to submit label text when filing a notification for minor changes to specifications, unless requested during screening or review.

Minor change pathway - company information

For changes to company information other than a change to the market authorization holder name, you do not need to:

• pay fees
• provide label text, unless requested by us

Change to name of market authorization holder

If the name of the market authorization holder is changing, you must file a biocide minor change notification (with a fee associated). The notification must use the new company name for all affected biocides in situations where you are changing the name of your company (including mergers or buyouts). You must do this for all marketed, dormant and approved biocides that are impacted by the name change.

Contact us to discuss filing strategies if you are acquiring or transferring the authorizations for a large number of biocides.

Contact information

In the application for a change to market authorization holder name, include:

• common requirements for all post-authorization pathways
• a certificate of amendment (optional)
• written confirmation that states there is a changed business circumstance from the original market authorization
• a letter of authorization for a change in product ownership, merger or buyout, indicating that the current market authorization holder is transferring ownership of the biocide to the new holder

Instead of a letter of authorization, companies who have completed a merger or buyout can provide:

• proof of incorporation or
• a certificate of amalgamation

Letter of authorization – change in product ownership, merger or buyout