Confirmatory data
A number of active substances (a.s.) are approved with a requirement for confirmatory data in the implementing (approval) regulation.
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on the 'data gaps' listed in the EFSA conclusions ('List of studies to be generated, still ongoing or available but not peer reviewed'), these data gaps should not be considered as confirmatory data as such.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 the approval regulations.
Characteristics
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 approval holder should cross reference the data submitted in both cases, to prevent duplication of assessment by the competent authority(s).
Fees
The fees charged for assessment of the confirmatory data will be based on the hours spend for the assessment. An advance payment will be invoiced (see page on Tariffs). After finalization of the assessment and the peer review extra costs or the surplus will be settled.
Confidentiality
The GFL Regulation as amended by the Transparency Regulation introduced a general principle of proactive disclosure and transparency of information, studies and data submitted to EFSA for scientific evaluation. In light of this principle, and of the related provisions, EFSA will proactively disseminate all information shared by applicants for the purposes of EFSA’s scientific evaluation of regulated products, including confirmatory information.
Please refer to the information on the transparency rules.
Approval process
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 approval holder will be invited to participate in that commenting period.
Timescales for the later stages of the process are not clearly defined, although it is envisaged that the EU Commission will take forward any necessary regulatory action at the next possible Standing Committee on the Food Chain and Animal Health.
Outcome of the assessment of Confirmatory data
The possible outcomes are detailed in SANCO/5634/2009. Where any adverse issues are raised, Ctgb will contact the approval holder (and if necessary other approval holders) at the earliest opportunity.
Instructions for submission
The approval holder (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.
Deadlines for submission
Approval holders must check Part B of the Implementing Regulation of a substance for details. The deadline is usually two years after entry into force of the implementing regulation, 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. Guidance Document SANCO/5634/2009 clarifies that the submission should be sent to the Commission, 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?
The confirmatory information is subject to the study notification obligations. Confirmatory information has to be submitted using the IUCLID software. The approval holders submission must make clear how the data submitted address the outstanding issues (e.g. via a summary document). The assessment should be restricted specifically to the areas required as confirmatory data in the Implementing Regulation.
Documentation
Guidance document on submission and assessment of confirmatory information (rev. 6.1).