Guidance for post-authorization changes for biocides: Filing pathways
On this page
- Post-authorization change management
- Accepting a post-authorization change
- Refusal of a major change
- Incorrect filing of an application or notification
- Filing multiple changes to a biocide
- Full review - novel biocide pathway
- Full review pathway
- Major change - quality and risks pathway
- Biocides based on comparison
- Use of foreign decisions pathway
- Monograph pathway
- Major change - monograph pathway
- Minor change pathway
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.
- Full review - novel biocide
- Full review (tier i, ii or iii)
- Major change - quality and risks
- Comparison - administrative application
- Comparison - labelling only
- Use of foreign decisions (UFD)
- Monograph
- Major change - monograph
- Minor change
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:
- changing the contact information of the market authorization holder
- adding, replacing or removing an importer or manufacturer of the biocide
- changing the name or contact information of an importer or manufacturer of the biocide
Accepting a post-authorization change
We will approve a major change if:
- the application meets the requirements set out in subsubsection 15(2) of the regulations
- you provide the Minister with any additional information and material requested under subsection 15(7) of the regulations
- the Minister has sufficient evidence to support the conclusion that the benefits associated with the biocide outweigh the risks associated with it, taking into account any uncertainties relating to the benefits and risks
- in the case where the change affects the packaging or labelling of the biocide, the Minister has reasonable grounds to believe that the biocide will be packaged and labelled in accordance with the Food and Drugs Act and these regulations
If we approve a major change, we will:
- issue you a notice of acceptance
- update the product database to reflect the change, as applicable
- update your market authorization with the new information (if that information is captured on the market authorization)
If we do not object to a minor change, we will:
- send you a no objection letter
- update the product database to reflect the change, as applicable
- update your market authorization with the new information (if that information is captured on the market authorization)
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:
- biocide's market authorization to reflect the change
- information published in the market authorization database.
If an application for a notice of acceptance is refused, you must:
- refile the application addressing any deficiencies noted in the notice of refusal
- obtain a notice of acceptance before making the major change to the biocide
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:
- correct filing of your proposed change
- the benefits continue to outweigh the risks for the biocide taking into account any uncertainties
If you have incorrectly filed your proposed changes, we will:
- issue you a screening deficiency notice (SDN) for a major change application
- notify you with a not satisfactory notice (NSN) for a minor change notification
Examples of incorrect filings include:
- filing major changes through the minor change pathway
- submitting changes that create a new biocide using any post-authorization pathway
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:
- pathway to use
- classification of your desired biocide change
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:
- use or purpose
- method of application
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
- Full review
- Comparison - labelling only (if the change deviates from the comparison biocide)
- Comparison - administrative application (if the change deviates from the comparison biocide)
- Use of foreign decisions (UFD) (if the change deviates from the foreign biocide)
- Monograph (if the change is not within the parameters of the monograph)
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:
- your authorized biocide required 30 reports of efficacy tests and studies in its initial application for market authorization and
- you are seeking a change that requires 2 new reports of efficacy tests and studies
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:
- Full review - novel biocide
- Full review
- Comparison - labelling only (if the change deviates from the comparison biocide)
- Comparison - administrative application (if the change deviates from the comparison biocide)
- Use of foreign decisions (UFD) (if the change deviates from the foreign biocide)
- Monograph (if the change is not within the parameters of the monograph)
You may also make these other types of changes through this pathway:
- Major changes that require safety or quality information
- Major changes within the parameters of a monograph
- Minor changes
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:
- major changes within the parameters of a monograph
- minor changes
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:
- Full review - novel biocide
- Full review
- Comparison - labelling only (if the change deviates from the comparison biocide)
- Comparison - administrative application (if the change deviates from the comparison biocide)
- Use of foreign decisions (UFD) (if the change deviates from the foreign biocide)
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:
- the biocide obtained authorization through the UFD pathway and
- the name of the holder of the foreign biocide authorization and the name of the holder of the biocide UFD market authorization are either the same or are affiliated, which means:
- one of them is the subsidiary of the other
- both are subsidiaries of the same entity (parent company)
- each of them is controlled by the same entity (parent company)
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.
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:
- brand names of the biocide
- name of the market authorization holder
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:
- Comparison - administrative application (for major changes if the biocide is remaining identical to the comparison biocide)
- Minor change (for all minor changes)
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:
- Full review - novel biocide (for novel changes)
- Full review (if the change requires efficacy data)
- Major change - quality and risks pathway (if the change requires safety or quality information)
- Use of foreign decisions (UFD) (changing the comparison biocide to a foreign biocide)
- Comparison - labelling only (if the deviation from the comparison biocide is permitted in the comparison - labelling only pathway)
- Minor change (for all minor changes)
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:
- Comparison - labelling only (for all major changes)
- Minor change (for all minor changes)
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:
- Full review - novel biocide (for novel changes)
- Full review (if the change requires efficacy data)
- Major change - quality and risks (if the change requires safety or quality information)
- Use of foreign decisions (UFD) (to change the comparison biocide to a foreign biocide)
- Comparison - administrative application, if:
- you're changing the comparison biocide to a different one and it doesn't result in a change that creates a new biocide
- the biocide meets the conditions of the comparison - administrative application pathway, including that only the brand name and market authorization holder name will differ from the comparison biocide
- Minor change (for all minor changes)
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:
- supporting quality information (specifications)
- applicable confirmatory safety and efficacy information to establish that the benefits continue to outweigh the rights, taking into account related uncertainties
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:
- Full review - novel biocide (for novel types of changes)
- Minor change (for minor changes)
- Major change - quality and risks (the change requires safety or quality information)
- Full review (if the change requires efficacy data)
- Comparison - administrative application (if you are aligning the biocide with a comparison biocide instead of a foreign biocide (as long as the change would not create a new biocide))
- Comparison - labelling only (if you are aligning the biocide with a comparison biocide instead of a foreign biocide (as long as the change would not create a new biocide))
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:
- Use of foreign decisions (UFD) (for major changes)
- Minor change (for minor changes)
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:
- minor changes
- major changes within the parameters of a monograph
The changes not allowed through this pathway include those:
- that create a new biocide
- that are considered novel
- to formulants that would require confirmatory data
- that deviate from the monograph parameters
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:
- Full review - novel biocide (if the change is novel)
- Full review (if efficacy or confirmatory data is required)
- Major change - quality and risks (if the change is related to safety or quality information)
- Minor change (if the change is a minor 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:
- that create a new biocide
- that are considered novel
- to formulants that would require confirmatory data
- that deviate from the monograph parameters
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:
- Full review - novel biocide
- Full review
- Comparison - labelling only
- Comparison - administrative application
- Use of foreign decisions (UFD)
- Monograph
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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