Guidance for post-authorization changes for biocides: Filing pathways

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Post-authorization change management

There are 9 different post-authorization change pathways. The one you use depends on the type of changes you wish to make and the initial application pathway used to obtain the biocide's market authorization.

If you're making multiple types of changes to your biocide (for example, major and minor changes), use the pathway that applies with the highest fee.

All changes are subject to fees except for:

Accepting a post-authorization change

We will approve a major change if:

If we approve a major change, we will:

If we do not object to a minor change, we will:

Refusal of a major change

If any of the requirements for major change approval are not met, we will refuse the application. We will also not amend the:

If an application for a notice of acceptance is refused, you must:

Incorrect filing of an application or notification

For a minor change, we recommend you wait for a no objection letter before implementing the proposed change, to enable:

If you have incorrectly filed your proposed changes, we will:

Examples of incorrect filings include:

If a change filed as a minor change is not acceptable, we'll send you an NSN outlining why we couldn't process the requested change. For example, it is actually a major change. If an NSN has been issued, you should refile the change through an appropriate pathway.

If you have filed incorrectly and already implemented the change to your biocide, you cannot sell, import or advertise your biocide until your market authorization reflects your biocide's parameters.

Take actions to control any units of your biocide on the market that do not meet its terms of market authorization (for example, stop its sale or issue a recall). This is because a biocide must reflect its terms of market authorization to be sold, imported or advertised. Otherwise, you may be subject to compliance and enforcement action.

Contact us before filing your post-authorization application or notification if you're unsure of the:

Filing multiple changes to a biocide

You may wish to make multiple changes to your biocide at the same time (for example, major and minor changes). To do this, you may submit 1 post-authorization application that captures all proposed changes.

Use the pathway that applies with the highest associated fee. This is because it will capture the type of change with the most evidence required.

Full review - novel biocide pathway

You may file changes that would be considered novel through this pathway, including adding a novel:

You may also include other major or minor changes within your application. You cannot use it to file changes that create a new biocide.

This pathway may be used for biocides that were initially authorized through any of the following pathways:

Full review – novel biocide pathway guidance

Full review pathway

You should file all major changes that require efficacy information through the full review pathway (other than changes that are considered novel). The tier you choose depends on how many reports of tests and studies related to efficacy data are required to support the proposed post-authorization changes.

For example, you would be able to file a change through the full review - tier I pathway if:

This is because the major change requires 25 or fewer reports of efficacy tests and studies.

This pathway can be used for biocides that were initially authorized through any of the following pathways:

You may also make these other types of changes through this pathway:

Major change: quality and risks pathway

You should file major changes that only require safety or quality information through this pathway. In the same application, you may also request:

You will not be able to request a change to your biocide that requires efficacy or confirmatory data through this pathway.

This pathway allows for changes related to a biocide's quality or risks to be made to biocides initially authorized through any of the following pathways:

Biocides based on comparison

To be eligible to file an application through the comparison - administrative application or comparison - labelling only pathways, your application's comparison biocide must not have obtained a market authorization through an application pathway that uses a comparison biocide or foreign biocide, unless it meets certain criteria:

This information can be included in the letter of confirmation from the licensor. The licensor is the holder of the biocide UFD market authorization that's being referenced as the comparison biocide.

Sample letter of confirmation

Comparison - administrative application pathway

During an initial application for a market authorization through this pathway, all aspects of the biocide in the application must be identical to that of the comparison biocide. The only aspects that may be different from the comparison biocide are the:

If the comparison biocide has made changes that affect its safety, efficacy or quality, you should reflect those changes for your biocide within 30 days of the comparison biocide's updates. Changes to align with the comparison biocide's market authorization may be made through these pathways:

If your biocide deviates from its comparison biocide after authorization, you may not file any subsequent changes through this pathway. The exception is if the biocide fully aligns with the current market authorization of the comparison biocide. Changes to the biocide that deviate from the comparison biocide may be filed using these pathways:

Learn about biocide application pathways and general requirements

Comparison - labelling only pathway

During an initial application for a market authorization through this pathway, only certain aspects of the biocide can deviate from those of the comparison biocide.

If your biocide's comparison biocide has made changes that affect its safety, quality or efficacy, you should reflect those changes for your biocide within 30 days of the comparison biocide's updates. Changes to align with the comparison biocide's market authorization may be made through these pathways:

If your biocide deviates from its comparison biocide following its initial authorization in a way this pathway doesn't permit, you will not be able to file any subsequent changes through this pathway. You will only be able to use this pathway when the biocide once again complies with its requirements.

Changes to the biocide that deviate from its comparison biocide and that are not permitted in this pathway may be filed through these pathways:

Learn about biocide application pathways and general requirements

Use of foreign decisions pathway

During an initial application for a market authorization through this pathway, only certain aspects of the biocide can deviate from the foreign biocide.

If you obtained a market authorization for a biocide through this pathway, you attested that the biocide will be manufactured according to the master formula of the foreign biocide. If you wish to deviate from the foreign biocide's formulation post-authorization, then that attestation will no longer be valid. An example would be if you wish to replace 1 formulant with another.

As a result, your application must include:

If your biocide deviates from the foreign biocide following initial authorization, you will not be able to file any subsequent changes through this pathway. The only exception is if it is to match a foreign biocide again in its entirety (with no deviations other than packaging information or shelf life).

Changes that deviate from the foreign biocide may be filed through these pathways:

If the foreign biocide you are relying on has made changes that affect its safety, quality or efficacy after your biocide has received its market authorization, you should also reflect those changes for your biocide within 30 days of the foreign biocide's updates. Changes to align with the foreign biocide's market authorization may be made through these pathways:

Learn about biocide application pathways and general requirements

Monograph pathway

You may use the monograph pathway to make major changes to a biocide that impact its quality or risks if it was initially authorized through the monograph pathway.

If you are already filing major changes related to the biocide's quality or risks through this pathway, you may also make:

The changes not allowed through this pathway include those:

If you obtained a market authorization for a biocide through the monograph pathway and you wish to deviate from the monograph parameters, you must use 1 of the following pathways to make the change:

Major change - monograph pathway

You may file a major change that is within the parameters of a monograph through this pathway if your biocide was initially authorized through the monograph pathway. The biocide must continue to meet the monograph parameters. An example would be a change that's not related to safety or quality, such as adding or revising a claim from the monograph for a biocide that meets the monograph parameters.

You can use this pathway to make major changes to a product that impact efficacy (if initially authorized through the monograph pathway). If you are already filing major changes through this pathway, you may also make minor changes to product or company information.

The changes not allowed through this pathway include those:

Minor change pathway

If you're making minor changes to your biocide, you should file these changes through the minor change pathway. This includes biocides initially authorized through any of the following pathways:

A change to the name of a market authorization holder must be filed through the minor change pathway.

Minor changes also include formulant changes that do not require confirmatory data. An example would be changes to fragrances or dyes that are less than or equal to 1% of the total formulation.

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