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Procedural renewal / suspension of the expiration of an authorisation

As part of an application for renewal/re-registration of an authorisation, the assessment/decision-making may not be completed on time for various reasons. As a result, an authorisation may not be renewed until some after the expiration date; this could lead to a period without authorisation. To avoid this, there is a possibility to renew the authorisation for procedural reasons. The Ctgb then has the opportunity to complete the assessment without penalising the authorisation holder and users.

The Ctgb has adopted a policy concerning all procedural renewals for which decision-making is required about the suspension of the expiration dates of plant protection products until or after the deadline for renewal or re-registration. You can read more about this below.

Procedure

If renewal/re-registration is not yet possible because the applicant/authorisation holder is unable to submit a complete re-registration dossier since they are waiting for the approval (or renewed approval) of the active substance, then the procedure for suspending the expiration date of a product until the renewal or re-registration deadline is as follows:

  1. An application (for renewal/ re-registration) or - in cases where an application is not yet possible - a declaration of intent for such an application must be submitted to the Ctgb 1.5 years (78 weeks) before the expiry date of the authorised product.
  2. The suspension decision does not contain any substantive aspects regarding the risk assessment.

If the reassessment cannot be completed on time due to a delay which has been incurred outside the control of the applicant/authorisation holder, then the procedure is to suspend the expiration date of a product until after the renewal or re-registration deadline. This takes place as follows:

  1. The suspension will be issued for the shortest possible – but still realistic– time period that the Ctgb believes is necessary to complete the assessment procedure. If it is immediately clear that supplementary questions will have to be asked during the initial assessment, then the suspension period includes the time that is required to submit the supplementary data and to implement the second assessment and decision-making.
  2. When the decision to suspend the expiration is made, if it is not yet clear whether supplementary questions will be asked, then a procedural renewal will be issued based on the time that is expected to be required to complete the first assessment and decision-making. If supplementary questions must still be asked, a second suspension will be considered.
  3. The proposal with the suspension period will be communicated to the applicants/authorisation holders before the decision-making takes place.
  4. The suspension decision does not contain any substantive aspects regarding the risk assessment.

More information

If you have any questions on this topic, please contact the Service Desk of the Ctgb.