After an active substance has been included in Annex I of Council Directive 91/414/EEC or approved under Regulation (EC) 1107/2009, if you are a grower or grower group responsible for an (EAMU) 'Extension of authorisation for a minor Use' (formerly known as Specific Off-Label Approval (SOLA)) for a product containing that active substance, we will inform you explaining the impact of the decision and the action you will need to take to support these uses in the future.
At re-registration, we need to confirm that any Extension of authorisation for a minor Use in the UK meet product data requirements and satisfy the Uniform Principles.
Details of deadlines and actions required can be found on our website under Re-registration requirements for existing UK authorisation holders.
You will not need to take any action at Step 1. Providing the product authorisation is maintained, any existing extensions of authorisation for a minor use will be allowed to continue. Occasionally we may need to amend an extension of authorisation for a minor use to comply with the terms of the Annex I inclusion or approval.
If the product does not successfully meet Step 1, its authorisation will be revoked at the compliance deadline. Action will also be taken against any extensions of use. In accordance with the use-up period allowed for on-label uses, the extension of use will continue for a further year after the compliance deadline (or to its current expiry date if this is sooner).
You must submit a new application for consideration of the extension of authorisation for a minor use to meet the Step 2 deadline. This must demonstrate that all relevant product data requirements are met (with the exception of efficacy) for the requested uses and that they satisfy the Uniform Principles and Annex I/ approval agreed endpoints. You should liaise with the product authorisation holder to establish the uses that they will be supporting. If they are making changes, these may have an impact on the extension of authorisation for a minor use. Ideally you should submit your application to re-register any existing extensions of authorisation for a minor use at the same time as the re-registration application for the on-label uses. This will enable us to consider all uses being supported for a product at the same time.
You must submit the following:
Reasoned cases may include extrapolation of relevant recommendations from the product label (providing these are being re-registered) in support of the proposed use. Where read-across is proposed, it is useful to provide a table comparing the following parameters for the proposed use to the on-label use:
You should make a case addressing why the differences do not affect risks to humans or the environment if any of these parameters differ.
You must address any areas highlighted in the Review Report as requiring particular attention (we will identify these in our letter issued following the Annex I Inclusion/approval); and,
Further guidance on making extension of authorisation for a minor use applications can be found in the guidance document for Extensions of Use.
Yes, providing these data and/or information are scientifically valid and address the product data requirements. It would be useful if you could re-submit these data or alternatively provide a clear reference to when they were previously submitted (eg COP number, date submitted). New data and/or information will be required where there are outstanding data gaps that need to be addressed.
Where requirements are met, a new extension of authorisation for a minor use will be issued. This will be subject to the same period of authorisation as for the on-label uses of the product.
Yes, but we will not issue a new extension of authorisation for a minor use until a satisfactory assessment has been carried out.
The main difference is that under national rules (COPR), we will allow a provisional authorisation, with a data submission deadline set for further confirmatory data to address requirements for full authorisation. With the exception of some minor and non-safety related data gaps, we will not be able to issue an authorisation following reregistration unless all product requirements have been addressed.
We will not be able to issue a new extension of authorisation for a minor use. However, in accordance with the use-up period allowed for on-label uses, providing there are no safety concerns, the existing extension of authorisation for a minor use will be allowed to continue for a further year after the final deadline for re-registration (or to the expiry date specified on the extension of use authorisation if this is sooner).
Arrangements will be as detailed in the section above.
Further information is provided on our website.