Procedures for submission and assessment of confirmatory data following approval of an active substance under Regulation (EC) 1107/2009
(previously known as inclusion in Annex I of Council Directive 91/414/EEC)
Introduction & Background
This document outlines the procedures in place for the submission and assessment of confirmatory data. (see Commission guidance document of the same name (SANCO/5634/2009 rev. 3)).
What are confirmatory data?
A number of active substances (a.s.) are approved with a requirement for confirmatory data specified in Part B of the Inclusion Directive/ Implementing Regulation.
Confirmatory data may be either a.s. data (eg mancozeb DNT study), or more commonly product data and associated risk assessments (eg bird and mammal risk assessment). Confirmatory data may also be required to fully establish the reference technical specification.
Whilst confirmatory data are often based on the 'data gaps' listed in the EFSA conclusions ('List of studies to be generated, still ongoing or available but not peer reviewed'), these data gaps should not be considered as confirmatory data as such. These procedures refer only to the specific confirmatory data requested in Part B of the Inclusion Directive.
Who should submit the data?
The notifier (who requested the original inclusion) 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 notifiers to submit confirmatory data.
When should the data be submitted?
Notifiers must check Part B of the Inclusion Directive/ Implementing Regulation for details. The deadline is usually two years after entry into force, but may alternatively be specified at a particular date. Where the confirmatory data relate to establishing the reference technical specification, the submission date may be specified at the entry into force date.
Sometimes no specific deadline is set, but submission is 'tied' to the completion of EU guidance. In this case the notifier should discuss submission with the RMS.
In some cases there may be more than one deadline for different elements of the confirmatory data.
To whom should the notifier send the confirmatory data?
Whilst the Inclusion Directive/ Implementing Regulation specifies that the data should be sent to the Commission, this is not practical. Guidance Document SANCO/5634/2009 rev. 3 clarifies that the submission should be sent to the Commission (who oversee the process), the (Rapporteur Member State (RMS)(who assess the data) and all other MS (to allow them to contribute to the commenting process).
What form should the submission take?
There is no specific template to use. The notifier's submission must make clear how the data submitted address the outstanding issues (eg via a summary document). The notifier should restrict their assessment specifically to the areas required as confirmatory data in Part B of the Inclusion Directive/ Implementing Regulation.
The notifiers submission should refer to the uses/GAPs considered in the approval decision.
The data and summary document must be submitted in electronic format preferably as a DAR addendum (since this is the format that will be used by the RMS).
How does the confirmatory data link with the Step 2 submission?
Whilst the submission of confirmatory data is (in many cases) required at the same time as the administrative deadline for submission of product renewal submissions, notifiers must not combine the two. There must be clear separation between the confirmatory data and product renewal submissions (noting they may reflect different uses/GAPs as they are assessed via two different procedures and charged separately.
However, the notifier should clearly cross reference the data submitted in both cases, to prevent duplication of assessment by the competent authority(s).
Will there be a charge for the assessment of confirmatory data?
The UK will charge a partial dossier fee, calculated on the basis of the amount of data submitted and the type of assessment required.
The confirmatory data submission will be considered by the weekly sift in the usual way. If there is a significant overlap between the confirmatory data submission and re-registration (or new product) submission, it may be possible to avoid duplicate charging of fees if you make this clear in both submissions. You are advised to contact each MS separately to confirm charging of the assessment of confirmatory data.
What are the timescales for assessment?
The RMS will aim to prepare a DAR addendum within 6 months of the deadline for submission of the confirmatory data, alongside proposals on the acceptability of the confirmatory data. There is then a short (6 weeks) commenting period to allow all affected MS and EFSA to comment. The notifier will be invited to participate in that commenting period.
The UK prefer that as RMS (assessing the confirmatory data) we should also be Zonal Rapporteur Member State (ZRMS) for the product renewal/new product assessment, so that we can ensure that the two projects are efficiently co-ordinated, ideally with a single project manager. Where the UK are not both RMS and (ZRMS), we will liaise closely with the other MS to ensure no duplication of assessment and timely delivery.
Timescales for the later stages of the process are less clearly defined, although it is envisaged that the Commission will take forward any necessary regulatory action at the next possible Standing Committee on the Food Chain and Animal Health.
It is important that the assessment of the confirmatory data is conducted in a timely way, since the (later) product renewal assessments may be dependent on its outcome. Where this is the case, it may be necessary to suspend the linked renewal application.
What will the outcome of assessment be?
The possible outcomes are detailed in SANCO/5634/2009. Where any adverse issues are raised we will liaise with notifiers (and if necessary other authorisation holders) at the earliest opportunity.
Do confirmatory data attract protection?
Generally not. See also SANCO 5634/2009. These data are not protected unless the active substance approval is amended as a result of the evaluation of the confirmatory data (or critical end points change as a result). In that case data protection will be 5 years from the date of the amended approval.
1. The ZRMS conducts the core assessment of product submissions on behalf of other MS in the zone - see SANCO Guidance on work sharing SANCO/6896/2009.