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Impact of active substance renewals on ongoing applications

From the Date of Application (DoA) set in the active substance renewal regulation, Ctgb can no longer grant new authorizations based on the old List of Endpoints – ref. section 3.2 of EU GD art. 43 PPP renewals (SANCO/2010 13170 rev. 14, 7 October 2016). This means that the renewal of the active substance may also have significant consequences for ongoing (and planned) applications based on old Endpoints. In extremis, applications based on old Endpoints cannot be decided on, or have to be denied for procedural reasons.  The facts that the EU renewal programme for active substances is delayed considerably and time lines for the renewal of an individual active substance cannot be foreseen far ahead, are complicating factors for applicants as well as member state authorities.

Submission - all applications for new authorizations, extensions of use and amendments

  • Applicants are advised to submit applications based on old endpoints well ahead of a possible DoA counting with minimum the legal time lines including legal options for stop the clock and a few months extra for realistic delays. In all cases that Ctgb estimates that the expected realistic processing time is longer or close to the time left between submission of the application based on old Endpoints and the expected DoA of the active substance (renewal), Ctgb will contact the applicant. On a case by case basis depending on uncertainty factors, Ctgb may:
    • refuse the application;
    • accept the application under certain conditions;  or
    • accept the application without conditions.

    Conditions will usually include a clause stating that the risk the application based on old Endpoints cannot be finalized before the DoA of the active substance renewal and has to be denied on procedural grounds is for the applicant. This includes the risk that the actual DoA of the active substance renewal will be advanced compared to the estimated date based on the date of expiry. Such applications cannot be advanced.  The Ctgb policy  is:  applications are handled in the order of submission.
  • Applicants may consider submitting an application based on new Endpoints ahead of the DoA of the active substance renewal. Prerequisite is that the EFSA conclusion with the proposed new Endpoints has been published. The risk that the final new List of Endpoints will deviate from the EFSA proposal and the  assessment may have to be adjusted accordingly is for the applicant. Ctgb can issue an authorization based on the new Endpoints once the Renewal regulation confirming the new List of Endpoints has entered into force. In that case no subsequent renewal application is needed.

Ctgb is available for advise on submission plans of applications for new authorizations or amendments around the active substance and subsequent product renewal through a service Desk request.

Ongoing applications

  • In case the application was accepted without conditions but threatens to cross the deadline of DoA because of a delay beyond control of the applicant, Ctgb aims to find a solution on a case by case basis.
  • The deadline for Ctgb as zRMS to decide on the application based on old Endpoints is the DoA of the active substance renewal and should be met on behalf of the CMSs.
  •  Ctgb as CMS is allowed 3 months extra to decide on the application based on old Endpoints (EU GD art. 43 PPP renewals  SANCO/2010 13170 rev. 14, 7 October 2016). Ctgb will not count this as an extended deadline from the start of the application, but rather as a 3 months reserve period in case the zRMS is publishing the final RR within the last 4 months before DoA.
  • For all other applications based on old Endpoints that need an assessment, the deadline to take a decision based on old endpoints is DoA of the active substance renewal. In practice this means that the options for amending existing authorizations are limited for the time it takes to finalize the renewal application for the product. In case extension for submitting the dRR is granted (Category 4 data or second active renewal expected  within 1 year) , this may add up to a considerable period.
  • Purely administrative issues for authorizations based on old Endpoints can be arranged after DoA until renewal of the authorization.

IMPORTANT NOTICE !

Authorization holders should take note that in all cases in which an authorization is granted on old Endpoints before or after DoA, they should make sure that the new/amended uses are included in the Core of the renewal application and in the national addenda where applicable.  If not, these uses will not be included on the label after the product renewal as they are not included in the renewal assessment.