Data matching check by RMS of the active substance renewal

In the light of equal market participation among producers, the Regulation leaves the opportunity for non-notifying companies to obtain access to the original dossiers supporting approval or renewal of active substances and the EU-agreed endpoints derived thereof, through a data matching process.

The structure of a data matching application is based on the data requirements for active substances, as set out in Regulation (EU) No 283/20132 , with each separate Annex point requiring to be covered by the non-notifying company (or data matching applicant) according to the guidance detailed below. Furthermore, a list of test and study reports necessary for first approval, amendment of approval conditions or renewal of the approval of an active substance prepared by the rapporteur Member State is to be made available to any interested party (Article 60, Regulation (EC) No 1107/2009).

To ensure a harmonized approach and to promote efficiency by work-sharing, the data matching check shall be performed by the active substance Rapporteur Member State (RMS).

In case Ctgb is the RMS of the active substance concerned the following information is needed:

• A data matching table according to the Template for Submission Demonstrating Access to a Complete Package According to Regulation (EU) 283/2013 and for the Data Matching Step, SANTE/2016/11449, 7 December 2016. If relevant, please also fill in the Endpoint concluded from the matching study in the justification column.
• A digital copy of the studies concerned with signed GLP and/or GEP certificates, or signed Letters of Access. Letters of Access should cover the application in all MSs indicated and signed maximum 12 months before the date the application is received.
• All basic information on the relevant GAPs.
• Where the applicant refers to unprotected studies, the applicant shall provide a list of the start date and end date of data protection of the studies in each Member State, including the registration number of the product. Each Member State should verify the list.

Ctgb will check that the studies submitted are GLP/GEP certified, use similar methodology and lead to similar endpoints as the original studies.
Ctgb will communicate the conclusion on the data matching check to the applicant and all Member States.  
In some cases, active substance data may be claimed as Category 4 data, in case applicant could not have foreseen that these studies are required. Category 4 data claims for active substance data should be submitted to and evaluated by the RMS of the active substance and often are part of the matching data. In case Ctgb is the RMS for the active substance, applicants are advised to include the Category 4 data claims for active substance data in the data matching table and provide the necessary details (argumentation, time lines and proof of commitment) as set out in the section about category 4 data.
To request a data matching check and a category 4 active substance study claim please fill in the application form. There will be an advance payment according to the Tariff Decree. The final invoice will be based on the actual costs.

Timelines

• Applicants should submit the data matching request to Ctgb (as RMS of the active substance) before the Date of Application (DoA) as mentioned in the Implementing Regulation of the relevant active substance  However, Ctgb advises to apply for data matching as early as possible.
• Ctgb aims to finalize the first data matching check within approximately 1 month after receipt of the request. However, this depends on the additional information that the applicant may have to supply. There will be a commenting period of 3 weeks for the members states to comment on the finalised data matching table and on the list of studies without data protection before the RMS will draw the final conclusion.

Source specification check

In case the active substance renewal includes a change in the reference specification, applicants should prove that their source for the active substance in a product is equivalent with these new criteria. Applicants should approach the RMS for the active substance with a request for the equivalence check. When Ctgb acts as the active substance RMS, applicants may submit a separate application for the equivalence check. Use application form WI en choose option 1.6 (PWSG application) . Please read also the directions for submission.