Confirmatory data: active substance approval for plant protection products
An active substance may be approved in Great Britain (GB) for use in a plant protection product subject to the submission of further confirmatory data.
Confirmatory data may be:
- active substance data - for example, plant metabolism study
- product data and associated risk assessments - for example, bird and mammal risk assessment
- required to fully establish the reference technical specification
This procedure refers only to the specific confirmatory data requested in the approval or renewal of approval.
Who submits the data
The applicant for the active substance (who requested the approval or renewal) is responsible for the submission of confirmatory data. Where there was a task force for inclusion/approval, the task force should determine which members are responsible for submission of the data. There is no requirement for alternative applicants to submit confirmatory data.
When to submit the data
Check the approval or renewal of the approval of the active substance for details of when the data should be submitted. The deadline is usually 2 years after entry into force but may alternatively be specified at a particular date. If no specific deadline is set, but submission is 'tied' to the completion of guidance, contact HSE to discuss the submission.
In some cases there may be more than one deadline for different elements of the confirmatory data.
Whilst confirmatory data is often required at the same time as product renewal submissions, do not combine them, as there must be clear separation.
How to submit the data
There is no specific template to use.
Your submission:
- must make it clear how the data addresses the outstanding issues (for example, using a summary document)
- should refer to the uses/GAPs considered in the approval or renewal of approval decision
You must submit the data and summary document electronically, preferably as a DAR addendum.
You should submit the data to HSE who are the assessing competent authority for GB.
Assessment
HSE will aim to prepare and issue a DAR addendum within 6 months of the receipt of the confirmatory data, alongside proposals on the acceptability of the confirmatory data.
HSE will review the approval and undertake any action required once the confirmatory data has been provided and assessed, or if it is not provided by the deadline.