This information alerts businesses to upcoming deadlines and the need to take action
Resubmitting applications - 31 March 2021 and 29 June 2021 deadlines
Applications for product authorisation and active substance approval need to be resubmitted to HSE by 31 March 2021 or 29 June 2021
From 1 January 2021 applications for product authorisation and active substance approval are being evaluated under the GB Biocidal Products Regulations. As HSE no longer has access to EU IT systems, it is not possible to access applications (including the data dossiers) previously submitted under those systems.
Applications for GB product authorisation (including renewals) and active substance approval (including renewals) need to be resubmitted to HSE, by the following deadlines:
By 31 March 2021:
- Resubmission of any application where the UK was, at any time prior to 1 January 2021:
- evaluating the Union or National (with or without mutual recognition in EU Member States) product authorisation application (including renewal) as the reference Member State (rMS); or
- the evaluating Competent Authority (eCA) for an active substance approval/renewal application.
This deadline does not apply to applications for authorisation via the Same Biocidal Products route or any applications to change an authorisation.
By 29 June 2021:
- Resubmission of any application where, prior to 1 January 2021, the UK:
- was a concerned Member State (cMS) for the National/Union product authorisation application (including renewal, mutual recognition);
- was the rMS or cMS for the Same Biocidal Products application (National/Union) or any application to change an authorisation; or
- was not the evaluating eCA for an active substance approval/renewal application.
HSE's fact sheets will help you determine which deadline is relevant to your applications:
What information do applicants need to resubmit?
The full original application must be resubmitted to HSE by the applicable deadline (31 March 2021 or 29 June 2021).
The applicant should resubmit the full original application and any additional data gathered or generated since the original submission.
If the application (or any part of your application) relies on a letter of access, applicants must ensure that the data owner submits the relevant data to HSE. For product authorisation applications this includes active substance data.
It is the applicant’s responsibility to arrange for the data owner to submit data by the relevant deadline.
If you’re having difficulties obtaining the letter of access or data, please resubmit your application by the relevant deadline stating any issues/data gaps; there is no need to contact us in advance of making your resubmission.
Please note the letter of access must be valid in the UK.
HSE will accept the EU version of supporting documents e.g. the draft Product Assessment Report (PAR), Summary of Product Characteristics (SPC) (including meta SPC)) and active substance draft Risk Assessment Report (RAR).
Data dossiers should be submitted in IUCLID format. If you are unable to provide in IUCLID format you must provide a justification.
Reference lists must be supplied on the GB reference list template:
If you want to remove products or uses from your original application this can be done once HSE has accepted your resubmitted application.
How to submit your application
Applicants should use HSE’s application forms and systems.
A new resubmission application form will be available on the website. Until then please complete “the resubmission of a pending application” sections of our application forms:
- product application form (including data submission to support product applications) - Word format - www.hse.gov.uk
- active substance application form (Word format) - www.hse.gov.uk
Completed forms should be emailed to firstname.lastname@example.org.
Please indicate any changes you wish to make in the email accompanying your application form.
Only the application form should be submitted by email.
Once HSE has received and processed your application form, you will be sent a link to HSEs Secure File Sharing Service.
Links will be sent out Monday – Friday and are valid for 5 working days.
The link is application specific – please do not use the link to upload files related to other applications.
HSE continues to charge for processing and evaluating applications.
HSE will not charge for receiving and handling the resubmission of data or applications due to loss of access to EU databases and IT systems.
Fees to evaluate the resubmitted data or application will be applied as normal. The fee estimates have been updated on HSE's website.
In the case of active substances, fees will not be requested until we are ready to start work on your application.
HSE's website provides details of the application processes and answers many common questions.
If you have a specific question(s) that has not been answered, you can contact a helpdesk:
- Active and product application specific questions should be sent to Biocides@hse.gov.uk
- Scope and general biocides questions should be sent to email@example.com
Please be aware that all our helpdesks are receiving unprecedented numbers of enquiries. You can help us by only contacting one helpdesk per enquiry and by not chasing up enquiries, which will help to speed up response times.
Please be assured that enquiries will be answered as soon as possible.
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