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Active substance and product suppliers that were on the EU Article 95 List on 31 December 2020 have been included on the GB Article 95 List.
To remain on the GB Article 95 list after 31 December 2022 you must:
- resubmit your active substance dossier / data or letter of access to HSE; and
- confirm you are Established in the UK
Suppliers can complete both actions at the same time or independently, however both actions must be completed by 31 December 2022.
If you submit your active substance dossier by either the March 2021 or June 2021 deadlines for pending applications for active substance approval, you do not need to resubmit your dossier again for the Article 95 deadline. You must still complete the UK establishment action.
If you submit your active substance dossier in advance of the Article 95 deadline to support Letters of Access e.g. to product authorisation applicants and authorisation holders or new Article 95 suppliers, you do not need to resubmit your dossier again. You must still complete the UK establishment action.
What information do suppliers need to resubmit?
You must resubmit your full original EU application, and any data gathered or generated since the original submission.
If any part of your application relies on a letter of access, you must ensure that the data owner submits the relevant data to HSE by the relevant deadline.
Data dossiers should be submitted in IUCLID format. If you are unable to provide in IUCLID format you must provide a justification.
In all cases reference lists must be supplied on the GB reference list template.
If you’re having difficulties obtaining letter of access or data, please resubmit your application by the deadline stating any issues/data gaps; there is no need to contact us in advance of making your resubmission.
Further details including a link to the application form can be found on our website.
Confirmation of UK establishment
GB Article 95 suppliers must be established in the UK. You must tell HSE that you are established in the UK by the deadline to maintain access to the GB market.
Further details, including a link to the form suppliers should submit to HSE and the definition of Established in the UK, can be found on our website.
Fees
HSE will not charge for receiving and handling the resubmission of Article 95 data.
Letters of Access
Data owners can still grant access to their data in GB via a letter of access. However, HSE also needs the relevant data.
Some companies may need data owners to submit their data / dossier sooner than 31 December 2022 e.g. GB product authorisation applicants / authorisation holders or a new GB Article 95 supplier using a letter of access to support their application.
HSE cannot process companies’ product authorisation / Article 95 applications without the data referred to in the letter of access.
The data only need to be submitted once even if you have issued multiple letters of access.
Letters of access must be valid in the UK. HSE accepts EU 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.
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