UK efficacy trials can be used to support EU product registrations
We have received a number of queries recently relating to the use of UK efficacy trials in support of EU product registrations post Brexit. The question arises due to the UK no longer being an EU member state, and therefore no longer participating in the EU plant protection product registration programme under EU regulation 1107/2009.
Well, you can rest assured - The UK is still geographically part of Europe, and as such remains included in the maritime zone under EPPOs ‘zones of comparable climate’ as described in EPPO guidance PP 1/241 – Guidance on comparable climates.
Under this guidance, when the trial locations and proposed regions of use are within the same defined climatic zone, then the applicant may simply refer to this guidance to establish climate comparability. Therefore, trials based in the UK can indeed be used to support registrations in EU regions covered by the Maritime zone.
It should be noted however that, just as when the UK was a member state, factors other than climate compatibility may also need to be considered for certain products when deciding on trial location such as:
- Crop status
- Edaphic conditions
- Agronomic practices.
It is also worth noting that all relevant EU law in relation to the regulation of plant protection products has been retained in the UK, and it remains a requirement under UK law that efficacy trials must be conducted by 'Officially Recognised' efficacy testing organisations. This means that contract research companies recognised under this scheme in the UK can continue to conduct trials for EU registrations as well as UK registrations.
In the case of using EU based trials in support of UK product registrations the UK guidance is clear – ‘There is no requirement to have data specifically generated in GB & NI (in most circumstances), and typically data may be generated from wide ranging European regional areas. What is important, is to clearly explain and justify the relevance of the data to UK agronomic conditions’.
In summary the UK, with its wealth of officially recognised contract research companies and field agronomists, remains an excellent location for your efficacy trials for both UK and EU registration programmes.
For more advice on placing efficacy trials to ensure you get the results needed to bring your product to market, contact our experts today.