Active substance renewal: effect on product authorisation
The renewal of approval of an active substance in Great Britain (GB) impacts product authorisations in GB.
Renewals in the European Union (EU) impact product authorisations in Northern Ireland (NI).
After an active substance is renewed, you must bring all your existing authorisations for plant protection products that contain the substance, in line with the renewal requirements. This applies to substances authorised in NI or GB. If you don't, HSE will withdraw the authorisation in the relevant jurisdiction.
You should apply for renewal of authorisation less than 3 months after the renewal of the active substance. If you submit an appropriate application in time, your product authorisation is ‘frozen’ until HSE makes a final decision. You generally cannot change your product formulation, packaging and uses as part of a renewal application.
HSE will complete your renewal of product authorisation applications within one year of the renewal of the active substance, however delays to parts of the renewal submission means the frozen period can be much longer than one year.
GB and the EU can make active substance renewal decisions at different times. This means the frozen period may start and finish at different times in NI and GB. This can lead to different product authorisation expiry dates in GB and NI. These different dates are carried out with amendment notices which you can find on the Pesticides Register Database.
New and pending authorisations
You generally cannot get authorisations that rely on pre-renewal endpoints after renewal of an active substance in GB or the EU. This includes product authorisations and extensions of authorisation for minor use (EAMUs).
You can submit applications using pre-renewal end-points until GB or the EU makes a decision on active substance renewal. However, there are implications if HSE cannot conclude on the application before renewal of the active substance.
If the active substance renewal is in the EU, HSE can conclude for GB only, but would likely refuse authorisation in NI. To get authorisation in NI you must submit a new application which addresses all of the EU post renewal requirements. In most cases this will be a zonal submission with NI as a concerned territory.
If the active substance renewal is in GB, HSE can conclude for NI only, but would likely refuse authorisation in GB. To get authorisation in GB you must submit a new application which addresses all of the GB post renewal requirements.
Permitted changes during the frozen period
During the frozen period you can only make the following changes:
- Changes to the source of active substance providing all sources are compliant
- Administrative changes like a change in marketing company, product name or new identical 'clone' product
- New EAMUs where no new technical assessment is required
- Non-significant formulation changes
Making new or changed uses available as soon as possible
You can submit a separate application for HSE to assess alongside your product renewal application. If your changes are acceptable, then HSE will implement them at the same time as your renewed product.
If you’re a grower and you need a new EAMU, you should speak to the authorisation holder first. You may be able to support new EAMUs for assessment alongside the product renewal applications. These applications must use the most recent guidance and endpoints and can only be authorised alongside successful renewal.