Data matching

Date: 17 April 2020

When a plant protection product (PPP) must be (re-) authorised and the PPP-applicant was not an applicant in the AIR procedure of the active substance, data matching is required, i.e. the PPP-applicant must “show access” (see below) to Annex I (KCA) data of the active substance (a.s.).

To show access to the Annex I data, there are different options:

1) Argumentation why data are not required
2) Referring to non-protected existing data
3) Letter of Access to the study /studies
4) Repeating the study / studies (vertebrate studies are special and must not be repeated)

Although the data matching is necessary for the product (re)-authorisation, the assessment of data matching is to be done by the Rapporteur Member State (RMS) of the active substance. The foreseen deadline for the assessment of the data matching is ideally within a month.

For new products (Article 33 applications; see Academy Article “Zonal approach”), the data matching has to be submitted with the application for authorisation.

In case of product re-authorisations (Article 43), specific deadlines are to be considered. The first step is to be done within 2 months following the publication of the EFSA-conclusion (a.s. AIR procedure). Here an indicative "data matching list" (see SANTE/2016/11449) is to be submitted to the RMS. The studies (or argumentation etc. as outlined above) must be submitted in a second step, within three months from the renewal of the approval of the active substance. Only under specific circumstances (e.g. change of the EU endpoints), it may be possible that some missing data matching studies could be justified as category 4 data (see Article “Category 4 studies”).

Karin Lauber