College voor de toelating van gewasbeschermingsmiddelen en biociden

2 Ctgb procedures for current authorization in relation to PPP renewal submission

2.1 Renewal for each active substance

Article 43 of regulation 1107/2009 states that PPP renewals should be completed within 1 year after the date of application (DoA) stated in the EU renewal regulation of the active substance. In case a PPP contains more than one active substance, each in principle triggers a separate PPP renewal evaluation.

The Guidance Document on PPP renewals makes an exception for PPPs with more than one active substance that expire within a period of 12 months. According to the Guidance Document the re-evaluation of such a PPP may be executed with 1 dossier and 1 evaluation. See below in section 3.5.

2.2 Duration of authorizations

Article 32 of regulation 1107/2009 gives outlines for the duration of PPP authorizations before and after renewal.

Before renewal

Based on article 32 of regulation 1107/2009 and section 3.4 of EU GD art 43, a PPP authorization will expire 1 year after the DoA stated in the renewal regulation of the first active substance in a PPP, even if the PPP authorization was originally issued for a longer time. See below in section 2.3 and 2.4.

After renewal

To be filled in.

2.3 Expiration of the authorization in case no application for renewal was or can be submitted

In case:

  • Ctgb does not receive a notification nor an application for a PPP renewal as ZRMS nor as CMS on time (see sections 3.3 and 4.1 below);
  • The applicant informs Ctgb that he will not support the product renewal;
  • The active substance was not renewed (renewal not applied for or not granted);

The authorization for the plant protection product will:

  • Expire on the national expiration date of the authorization if this date is set before or on the same date as the PPP-URD = the DoA of the renewal regulation for the first active substance plus 1 year (section 3.4 of EU GD art 43).
  • Be revoked by Ctgb on the PPP-URD in case the national expiration date of the authorization is set after the PPP-URD.
  • In case EC denies the renewal of an active substance, the EC may specify expiry dates and grace periods for PPPs containing the active substance. Depending on the exact wording of these regulations, Ctgb may differ from these dates as based on our risk based policy for grace periods for individual PPPs.

Authorization holders may apply for a grace period at expiration/revocation. For this procedure see grace periods.

Timely application for renewal is the responsibility of the authorization holder, and Ctgb does not accept responsibility in case authorizations expire because authorization holders miss deadlines for renewal applications in The Netherlands. Authorization holders are referred to the EU Pesticide database for reference.

2.4 Administrative extension of the current authorization of PPPs

Article 43.6 of regulation 1107/2009 states that member states can issue extensions for the current authorization in case the reason for delay in the evaluation process is beyond control of the authorization holder/applicant.
Reasons that Ctgb considers valid for considering an administrative extension are:

  1. The expiration date of the (first) active substance to expire is postponed by an EU regulation (into force) and therefore the expiration date of the current authorization is no longer in line with PPP-URD, or it was not in line in the first place.
  2. ZRMSs/IZSC agreed on delay for the submission of the dRR on the deadline applicable for the second active substance because the expiration for two active substances within the product falls within 1 year and the renewal for both can be executed in one evaluation.
  3. Confirmed approval of delay of the submission of category 4 studies (see EU GD art 43) and the dRR by the ZRMS or Ctgb as ZRMS.
  4. Delay in the evaluation process caused by the ZRMS or Ctgb (as ZRMS or CMS).

Requirements for administrative extension

In many cases Ctgb will be aware of the expiry dates and the need for administrative extensions of PPPs. Appropriate action will be taken and if needed Ctgb will approach the applicant. However, Ctgb cannot accept the final responsibility. Monitoring the expiry dates and timely action to prevent unwanted expiration is the explicit responsibility of the authorization holder. So in case of doubt, please contact the Ctgb Service Desk or the Ctgb project manager assigned to the specific PPP renewal.

  1. Reason 1: and the active substance renewal is expected (current expiry date of the AS) or effective (DoA in the AS renewal regulation) within 6 months from the current expiry date of the PPP. Ctgb will first check if a notification or application for renewal of the PPP has been received. If yes, an administrative extension until the (new) AS expiry date + 1 year can be proposed without additional documents. If no notification or application has been submitted, the authorization holder should send in a notification as soon as possible if he wishes to continue the authorization. Please contact the Ctgb Service Desk.
  2. Reason 1: and the active substance renewal is expected (current expiry date of the AS) or effective (DoA in the AS renewal regulation) after 6 months from the current expiry date of the PPP. Ctgb can propose an administrative extension until the (new) AS expiry date + 1 year without a notification or application has been received. No further documents are required.
  3. Reason 1: no administrative extension will be issued when the authorization holder has informed Ctgb in advance that he will not support the PPP renewal.
  4. Reasons 2,3,4,5; in these cases a notification or application is already submitted. Ctgb can issue an administrative extension of the current authorization for the period needed to finalize the renewal application without need for further documents.

For further information about the Ctgb policy see administrative extensions.


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