Resubmit pending applications and data to HSE
If you made an application under EU BPR before 1 January 2021 and have not yet had a decision for the UK market you need to resubmit your application to HSE by the deadline if you want to access the market in Great Britain (England, Scotland and Wales).
This applies to applications for:
- product authorisation including renewal or change
- active substance approval including renewal
If you were included on the GB Article 95 List on 1 January 2021, you must resubmit your data or letter of access to HSE by the deadline to remain on the list.
When you must resubmit your pending application or data to HSE
|when you applied for active substance approval or renewal the UK was the evaluating Competent Authority (eCA)
when you applied for product authorisation or renewal the UK was the reference Member State (rMS), with or without mutual recognition – this includes Union applications but excludes applications using the Same Biocidal Product route, or applications to change an authorisation
|31 March 2021|
|when you applied for active substance approval or renewal the UK was not the evaluating Competent Authority (eCA)
when you applied for product authorisation or renewal the UK was a concerned Member State (cMS), with or without mutual recognition – this includes Union applications
you applied for product authorisation in the UK using the Same Biocidal Product route – this includes Union applications
you applied for a change to a UK authorisation – this includes Union authorisations
|29 June 2021|
|you want to remain on the GB Article 95 List||31 December 2022|
Meet the earliest deadline
If you are affected by more than one of the deadlines, you only need to submit the data once and should meet the earliest deadline.
Providing a letter of access
If you issue a letter of access to someone to meet these deadlines, HSE will need your data to be able to process their application. These data only need to be submitted once even if you have issued multiple letters of access.
Confirm your UK location
GB Authorisation holders and GB Article 95 suppliers must be established in the UK (Great Britain or Northern Ireland). There is separate guidance on how to confirm to HSE, by the relevant deadline, that you are established in the UK.
How to resubmit your application
You must resubmit the full original application you made under the EU system, and any additional data gathered or generated since the original submission.
To resubmit your application:
- complete this EU Exit biocides resubmission form
- email the form to [email protected]
- provide additional information and data (outlined in the checklists in Section 6 of the form) using HSE’s Secure File Sharing Service
You can submit the form at the same time as completing another action such as being established in the UK, or you can submit it independently, however you must complete each relevant action by the respective deadline.
Providing additional information
When we process your application form we will send a link to HSEs Secure File Sharing Service. The link will be valid for 5 working days and is specific to your application – please do not use the link to upload files for other applications.
Letter of access
If any part of your application relies on a letter of access, it’s your responsibility to ensure that the data owner submits the relevant data to HSE by the relevant deadline. For product authorisation applications this includes active substance data.
The letter of access must be valid in the UK. HSE accepts EU BPR letters of access providing they are accompanied by a written statement from the issuer confirming that the access extends to GB BPR; however, the data owner may choose to issue GB BPR specific letters of access.
If you’re unsure or are having difficulties with letters of access or data, please resubmit your application by the relevant deadline and describe the issues and/or data gaps - there is no need to contact us in advance of making your resubmission.
You should submit data dossiers in IUCLID format. If you are unable to, you must justify why you cannot.
You must supply reference lists on the GB reference list template.
Using EU versions of supporting documents
HSE accepts EU versions of supporting documents such as the:
- draft Product Assessment Report (PAR)
- Summary of Product Characteristics (SPC) (including meta SPC))
- active substance draft Risk Assessment Report (RAR)
- Safety Data Sheets (SDSs).
HSE will not charge for receiving or handling resubmitted applications or data of pending applications but the normal fees for evaluating data and applications apply.
In the case of active substances, fees will not be requested until HSE is ready to start work on your application.
HSE will not charge for processing data that does not require its own evaluation such as:
- active substance data resubmitted solely in support of a GB Article 95 listing
- approved active substance data resubmitted solely in support of a product application – this excludes new third party dossiers that had not yet been assessed in the EU
- reference product data resubmitted solely in support of a same biocidal product application
For help with resubmissions for active substances, products authorisation and GB Article 95 email [email protected].
For all other biocides enquiries contact us.
There may be other actions you need to take to comply with the transitional arrangements of GB BPR. Further details are available in this Working with biocides after Brexit: actions and deadlines factsheet.