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:

administrative - the requested changes to a biocidal product / biocidal product family authorisation do not result in changes to the risk assessment, efficacy or the physical / chemical properties of the product
minor - the requested changes to a biocidal product / biocidal product family authorisation result in limited changes to the risk assessment, efficacy or the physical / chemical properties of the product
major - the requested changes to a biocidal product / biocidal product family authorisation cannot be categorised as administrative or minor changes

Examples

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

removing a manufacturer of the biocidal product / active substance
removal of use against a particular target organism
removal of a specific use
removal of a user category

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:

any data or other documentation necessary to support the change
a draft Summary of Product Characteristics (SPC) for the biocidal product / biocidal product family using the following templates as appropriate:

reference list of studies

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

Using the HSE Secure File Sharing Service

Once we have received and processed your application form, you will be sent a link to upload the files associated with the relevant application – please do not use the link to upload files related to other applications.
Links will be sent out Monday – Friday and are valid for 5 working days – if the link expires before you are able to upload your files, please email [email protected] to request a new link.
Please ensure you comply with the terms and conditions of using the HSE Secure File Sharing Service – these will be included in the email alongside the link.
Please check the spam settings on your email account to ensure our emails are not going to your junk folder.

Things to note

The authorisation holder must be established in the UK.
All biocidal product names must be unique – please check the list of GB authorised products to determine if your proposed product name has already been used.
Letters of Access must relate to data held by HSE – you should talk to your active substance supplier to ensure they have submitted the data to HSE.

What HSE will do

After receiving your application HSE will:

conduct a brief initial check of the information to confirm that it meets the requirements for the application type
estimate how much it may cost (“initial estimated fee”) to process the application based on the information provided
issue an invoice to the applicant which must be paid within 30 days of the date of the invoice – failure to pay the requested fees will result in your application being rejected
accept the application once the initial estimated fee has been paid and check (validate) that you have submitted all of the required information in the correct format – this will take approximately 30 days from the payment of the “initial estimated fee”
evaluate the application according to the approximate time frame for the relevant category of change
make a decision as to whether the requested change can be authorised in GB
issue an invoice for a “top up” fee if the cost of evaluating the application has gone beyond the initial estimated fee, which must be paid within 30 days of the date of the invoice – failure to pay the requested fees will result in your change being rejected

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:

send the applicant a copy of the updated draft authorisation conditions HSE intends to set for the product – these are set out in an updated draft Product Assessment Report (PAR) and updated draft Certificate of Authorisation
take into account the applicant’s comments, where relevant
issue a new signed Certificate of Authorisation that will replace the one previously issued

You should:

examine the draft Product Assessment Report (PAR) and draft Certificate of Authorisation and return them to HSE (with comments if necessary) to indicate your agreement with the updated authorisation conditions
wait until the signed Certificate of Authorisation has been issued and ensure you comply with the conditions and restrictions in the authorisation before making the ‘amended’ product available on the market in GB
ensure you remove from the distribution chain any existing stocks (products already labelled under the old conditions of authorisation) that do not meet the new conditions and restrictions of the authorisation within 180 days of the authorisation being issued
ensure you comply with any deadlines associated with the authorisation, such as for any post authorisation data requirements
note your authorisation expiry date - the authorisation will expire on the date shown unless the authorisation holdersubmits a valid application for renewal at least 550 days before the expiry date
ensure you comply with other requirements of GB BPR which include (but are not limited to):

packaging and labelling requirements (Article 69)
advertising requirements (Article 72)
record keeping requirements (Article 68)
notification of unexpected or adverse effects (Article 47)

ensure you comply with general chemical and product safety law which continues to operate such as:

contact HSE if you intend to make additional amendments or cancel your authorisation

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:

the authorisation was granted based on false or misleading information
the conditions in Article 19 (eg the product is sufficiently effective and has no unacceptable effects on humans, animals or the environment) or, where relevant, Article 25 (eg the product is sufficiently effective does not contain any substances of concern) are not satisfied
the authorisation holder has failed to comply with its obligations under the authorisation or the law

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.