Implications of active substance renewal for ongoing applications, new applications and existing authorised products (transitional arrangements during the frozen period)
Following the renewal of an active substance, all authorisations for products containing that substance must be brought in line with the renewal requirements. This is to ensure continued compliance with Article 29 of Regulation 1107/2009 as it applies in Great Britain/Northern Ireland.
This means that with very few exceptions HSE is unable to issue new or changed authorisations during the period between the renewal of the active substance and the renewal of the product.
If an application which uses pre-renewal criteria cannot be concluded before the date of active substance renewal, the application will be refused. This includes all applications for new products and changes, including new uses/extensions of authorised minor use (EAMUs) of existing products. A new application which upgrades the product authorisation to post-renewal standards must be submitted and assessed before any authorisation can be granted.
Provided that an acceptable Article 43 application is received by the application deadline (3 months after renewal of the active substance), existing product authorisations are ‘frozen’ until the renewal process is complete.
According to 1107/2009 (GB/NI) renewal of products should be within 1 year of the renewal of the active substance. In practice renewal within this timeframe is rarely achievable, especially when considering delays due to category 4 or a second active (further details are in the renewal guidance).
Therefore this ‘frozen period’ can be much longer than that envisaged by the regulation.
Permitted changes during the frozen period
- Changes to the source of active substance (providing all sources remain compliant with the approval)
- Purely administrative changes, for example, change in marketing company. We currently consider that a new product name or new identical ‘clone’ product is an administrative change
- New EAMUs where no new technical assessment is required (in other words, use can be considered purely on extrapolation from existing uses, likely to be a rare occurrence)
Potential approaches for other proposed changes
Any changes to formulation (other than source of active or those which fulfil the non-significant criteria), packaging or use can be submitted as Article 33 applications to be processed in parallel to the Article 43 application. Assuming the risk assessment is acceptable, these changes can only be implemented at the same time or later than the renewed authorisation.
Applications for new products based on extrapolation from existing non-renewed products need to include data and risk assessments to upgrade the assessment to the appropriate standard. This may pose additional difficulties if you do not hold the original data/risk assessment, or the assessment is dependent on category 4 data which are not yet available.
Growers wishing to support new EAMUs are advised to speak to the authorisation holder about their proposed use. It may be possible to submit an application in parallel to the Article 43 application for completion soon after the product renewal.