Change/cancel an existing product authorisation

Authorisation holders can request to amend or cancel their national or simplified product / product family authorisations granted under the GB Biocidal Products Regulation (GB BPR) in Great Britain (GB).

Where an issue with the safety or efficacy of a product is identified, HSE may need to impose amendments to the authorisation or cancel it.

Changes - authorisation holder requests

Changes to a biocidal product / biocidal product family authorisation fall into three categories:

Examples

Some administrative changes do not need to be authorised by HSE before they are put into effect by the authorisation holder, such as:

These types of changes should be notified to HSE within 12 months of the change being put into effect.

Most changes will need to be authorised by HSE before they are put into effect by the authorisation holder. The table below gives some examples of the different categories of change and the approximate timeframes for evaluation.

Change to the authorisation Category Approximate timeframe*
Change to biocidal product / biocidal product family name.
Note: The new name cannot be identical to a name used for another biocidal product / biocidal product family.
Administrative 30 days
Transfer of the authorisation to another company established in the UK. Administrative 30 days
Change in the name or address of the authorisation holder. Administrative 30 days
Meeting a post authorisation requirement for storage stability. Minor 90 days
Change in active substance level in formulation. Major 180 days
*It is important to note that these are guideline timeframes and are subject to change if the application is suspended for any reason eg requesting additional information / data

How to apply

The authorisation holder or company acting on their behalf must submit, in English, a completed application form to [email protected] – companies may wish to mark emails as appropriate eg confidential. Please note that your application form may be returned if it is incomplete.

Only the application form should be submitted by email. All other relevant documentation / data must be submitted via the HSE Secure File Sharing Service, including:

All documents/attachments should be included within your IUCLID dossier, where applicable.

Using the HSE Secure File Sharing Service

Things to note

What HSE will do

After receiving your application HSE will:

You may be asked to provide further information at various stages of the process. When such requests are made, the indicative timeframes given above will be suspended. Please noteif the information you provide is not satisfactory, or you fail to provide the information within the specified deadline, your application may be rejected.

If the biocidal product / biocidal product family is supplied in the form of a bait station or other physical device then we may request a sample to inform the risk assessment.

Product authorisation decision

When the evaluation of an application is completed, a decision will be made as to whether the requested change can be authorised.

Successful applications

HSE will:

You should:

Unsuccessful applications

HSE will not issue an amended authorisation where an application does not meet the required standards.

The applicant may have the opportunity to modify / update their application to make it acceptable where that is appropriate.

Rejecting applications

An application can be rejected at any stage if the relevant fees or requested information / data are not submitted or are unacceptable.

Cancellation – authorisation holder requests

A request to cancel an authorisation must be submitted in writing to HSE at [email protected].

In most cases, a fee will not be charged for a cancellation.

Changes and cancellations – HSE imposed

HSE can amend or cancel an authorisation at any time if it considers that:

If HSE intends to cancel or amend an authorisation, the applicant will be notified and given the opportunity to submit comments or additional information within a specific time frame. HSE will consider any additional information that has been submitted when finalising its decision. The authorisation holder will be informed of the final decision and any action they may need to take as a result.

Updated 2020-12-18