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Possible amendments to the authorization within renewal applications

EU GD art 43 PPP renewals does not allow for voluntary amendments of the current authorization on a national level. Central Zone MS have confirmed to follow this Guideline. For example, significant formulation changes, label extensions, and voluntary dose changes or other amendments to harmonize the label of PPPs between various EU member states are not allowed. However, for forced and very minor amendments there are some exceptions:

Exceptions for voluntary amendments

  • Restrictions of the GAP (e.g. limitation to certain crop stages or periods, reductions of dose or frequency; increase of intervals or PHI) needed to bring the authorization or a specific use in compliance with new Endpoints and new conditions and restrictions confirmed at the active substance renewal, or with new guidance and data requirements applicable at the date the application is received by Ctgb.
  • Ctgb considers voluntary withdrawal of complete uses (GAP lines) from the label as permissible. However, applicants should consider that this may have consequences for the risk assessment of other uses in case the risk envelope approach was used.
  • Spray volumes: The Dutch national standards for spray volumes have changed in the course of time. Amendments in the spray volume to comply with the current list are permissible, but may have consequences for the risk assessment (especially operator exposure), that should be covered. Changed spray volumes should not lead to dose changes.
  • Non-significant changes in the formulation as defined in GD SANCO/12638/2011 are also permitted.

Applicants are advised to discuss forced GAP amendments in advance during a Presubmission meeting, Request for Meeting, or Service Desk question with Ctgb before the application is submitted. In case Ctgb is zRMS we will not check existing authorizations in other CMSs against the GAP submitted.

However, applicants are advised to identify GAP changes for CMSs other than NL as in such cases efficacy may have to be evaluated. In case changes apply to a use in another cMS,  Ctgb advises to contact the cMS authorities on their specific requirements. GAP amendments should be submitted with a justification which will be evaluated by Ctgb in the intake phase of the application process. In case of CMS applications, Ctgb may need to charge additional fees in case efficacy has to be evaluated as the CMS standard fees for renewals are based on dossiers not including amendments.