GB Biocidal Products Regulations – Resubmission deadline approaching

GB Biocidal Products Regulations – Resubmission deadline approaching

Applications for product authorisation and active substance approval need to be resubmitted to the HSE by 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 the 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 changes) and active substance approval (including renewals) need to be resubmitted to the HSE by 29 June 2021.

This includes resubmission of any application where, prior to 1 January 2021, the UK:

1. was a concerned Member State (cMS) for the National/Union product authorisation application (including renewal, mutual recognition);
2. was the reference Member State (rMS) or cMS for the Same Biocidal Products application (National/Union) or any application to change an authorisation; or
3. was not the evaluating eCA for an active substance approval/renewal application (including an application submitted under Article 93)

The HSE website provides details about what information you need to submit and how to submit it.

Fees:

The HSE continues to charge for processing and evaluating applications.

The 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.

However, the HSE will continue to charge fees for processing and evaluating applications. The fee estimates have been updated on the HSE’s website.

In the case of active substances, fees will not be requested until the HSE are ready to start work on your application.