Re-submitting marketing authorisation and active substance approval dossiers to remain compliant
Following Brexit, Britain had to establish its own system for regulating biocides. For example, a UK version of the EU list of approved suppliers has been established. If a company was already on the EU list before 31st December 2020, it can be included in the UK list.
However, as the Health & Safety Executive (HSE) no longer has access to EU IT systems, it is not possible to access data relating to active substance applications and authorisation dossiers previously submitted under the EU system. Companies wishing to transfer their applications to the UK must therefore submit supporting information to the HSE.
This information on applications for product authorisation and approval of active substances must therefore be submitted to HSE by 29th June 2021 if, before 1st January 2021, the UK:
- was a Member State concerned for the application for national product authorisation (including renewals, mutual recognition)
- was the reference Member State or the Member State concerned for the application for authorisation of the same biocidal products or any application for amendment of an authorisation
- was not the Competent Assessment Authority for an application for approval or renewal of an active substance
The GB BPR post-Brexit
Following the UK's withdrawal from the European Union and the end of the Brexit transition period, a separate UK Biocides Regulation was introduced on 1st January 2021. This new GB BPR is identical to the EU BPR.
Among the changes brought about by this regulation, it is worth noting, for example, that the UK will make all its own decisions and will no longer participate in the EU decision-making process or in the work-sharing between Member States. Besides, the UK will develop its own review programme for existing active substances and will no longer participate in the EU review programme.
Namely, as procedures have changed, in order to transmit the information required by the HSE, companies must:
- Fill in the EU Exit Biocides Resubmission Form
- Send the form by email to biocidesapplications@hse.gov.uk
- Provide additional information and data using the HSE's secure file sharing service
Wish to know more about the biocidal products regulation?
For more information, do not hesitate to contact Cornelia Garaudel or one of our experts!
Re-submitting marketing authorisation and active substance approval dossiers to remain compliant
Following Brexit, Britain had to establish its own system for regulating biocides. For example, a UK version of the EU list of approved suppliers has been established. If a company was already on the EU list before 31st December 2020, it can be included in the UK list.
However, as the Health & Safety Executive (HSE) no longer has access to EU IT systems, it is not possible to access data relating to active substance applications and authorisation dossiers previously submitted under the EU system. Companies wishing to transfer their applications to the UK must therefore submit supporting information to the HSE.
This information on applications for product authorisation and approval of active substances must therefore be submitted to HSE by 29th June 2021 if, before 1st January 2021, the UK:
- was a Member State concerned for the application for national product authorisation (including renewals, mutual recognition)
- was the reference Member State or the Member State concerned for the application for authorisation of the same biocidal products or any application for amendment of an authorisation
- was not the Competent Assessment Authority for an application for approval or renewal of an active substance
The GB BPR post-Brexit
Following the UK's withdrawal from the European Union and the end of the Brexit transition period, a separate UK Biocides Regulation was introduced on 1st January 2021. This new GB BPR is identical to the EU BPR.
Among the changes brought about by this regulation, it is worth noting, for example, that the UK will make all its own decisions and will no longer participate in the EU decision-making process or in the work-sharing between Member States. Besides, the UK will develop its own review programme for existing active substances and will no longer participate in the EU review programme.
Namely, as procedures have changed, in order to transmit the information required by the HSE, companies must:
- Fill in the EU Exit Biocides Resubmission Form
- Send the form by email to biocidesapplications@hse.gov.uk
- Provide additional information and data using the HSE's secure file sharing service
Wish to know more about the biocidal products regulation?
For more information, do not hesitate to contact Cornelia Garaudel or one of our experts!
