College voor de toelating van gewasbeschermingsmiddelen en biociden

3. Ctgb presubmission procedures for PPP renewal applications

3.1 Assignment of Ctgb as ZRMS or as CMS

Ctgb can facilitate applicants for renewals as ZRMS or as CMS; zonal and/or interzonal. Ctgb has reserved ample capacity for ZRMS renewal dossiers, but ultimately this capacity is limited. So applicants that are planning to submit their renewal application to Ctgb as ZRMS are advised to contact the Ctgb account manager as early as possible to reserve the necessary Ctgb capacity.
In case the workload for Ctgb becomes unbalanced, Ctgb may propose a re-division of ZRMS evaluations among member states via the Central Zone Steering Committee (CZSC). The CZSC may also ask Ctgb to take over ZRMS evaluations from other member states within the Central Zone. For AIR-3 and AIR-4 PPP renewals, the division of PPP renewal evaluations among member states will be coordinated by the CZSC through an inventory, and preferably grouped and assigned to the RMS or coRMS for the renewal of  the active substance if member of the zone.
Ctgb does accept to act as ZRMS for renewal of products and uses that do not currently have an authorization in The Netherlands.

3.2 Pre-notification deadline

According to the EU GD Article 43, applicants have to send in pre-notifications (SANCO 12544/2014) for PPP renewals to ZRMS and CMSs around the deadline for the submission of the supplementary dossier for the renewal of the active substance. However, Ctgb prefers to receive a first notification once its role as ZRMS or CMS for the dossier is established but a first notification should not be submitted later than stated under ‘Full notification deadline’ below.

3.3 Full notification deadline

A full notification should be submitted to Ctgb after the publication of the EFSA conclusion, but not later than 6 months before the (expected) DoA for the active substance renewal (= current expiry date of the AS). This full notification should contain:

  1. (updated) Notification form; SANCO 12544/2014
  2. A data matching list with all the references relied on
  3. An indication of which parts of the risk assessment need updating with regard to restrictions in the renewal regulation, new endpoints, new guidance, and/or new data requirements compared to the existing risk assessment.
  4. If applicable, a proposal which new category 4 studies need to be generated for the PPP; see section 3.5 below).
  5. If applicable, a proposal to combine the PPP renewal evaluation with respect to more than 1 AS in a single evaluation and dRR; see also 3.5 B below).
  6. If applicable, an indication which changes to the GAP will need to be made (see below in section 4.5) with a short explanatory note.

Exceptions with regard to the full notification deadline may be accepted for those active substances in AIR2 and AIR3 for which the deadline has already expired before  the release of this communication (March 2016); In those cases, please contact the Ctgb Service Desk on how and when to fulfil the presubmission requirements as soon as possible.

3.4 Presubmission questions and meetings

In the period between the publication of the EFSA conclusion and the submission of the application, the applicant can request an appointment with Ctgb through our Service Desk. For ZRMS dossiers the applicant can opt for an RFM and/or PSM meeting. For CMS dossiers an RFM may be requested. In a PSM (Presubmission meeting) the application can be discussed with experts from all aspects. An RFM (Request for meeting) is more suited when the applicant wants to discuss a limited number of elements for one or a few aspects. Separate questions can also be submitted through the Ctgb Service Desk.

3.5 Extension of submission deadline for the dRR

A - Category 4 studies:

The new list of endpoints or conditions and restrictions confirmed in the active substance renewal regulation may result in requirements for new PPP studies. In that case, applicants may request for extra time for generating these so-called ‘category 4 studies’ (category 4 in section 3.3 in EU GD art 43) and finalizing the dRR. In that case the applicant should submit:

  • A proposal which new category 4 studies have to be generated for the PPP,
  • with the requested time needed for the studies, reporting and making the necessary amendments in the dRR,
  • supported by a sound argumentation.
  • In support of the claim, the applicant should submit the study contract or study plan (financial data may be obscured) with time lines.

Be aware that new endpoints may not always justify new studies. In some cases analysing existing data in a new way may be sufficient. Member states can grant approval to postpone the date of submission for category 4 data up to 2 years (and in exceptional cases even longer) after the DoA stated in the renewal regulation of the active substance. See also in section 2.4.

When Ctgb acts as ZRMS, Ctgb aims to agree on extending submission deadlines for the dRR well in advance of the actual submission deadline for the application, as clarity on this point in an early stage is in the interest of both Ctgb and applicants.

  • The full notification, to be submitted 2 months after publication of EFSA conclusion and not later than 6 months before the DoA of the (first) active substance renewal, should already include the request for the category 4 extensions. This then can be evaluated and/or discussed as part of a Presubmission meeting or Request for meeting. Alternatively, this will be handled through a Service Desk request. Ctgb will invoice the hours needed to evaluate/coordinate these requests, and the outcome will be corresponded to the applicant as concept agreements.
  • As the List of Endpoints is only then formally confirmed, the applicant has to inform Ctgb if any amendments are required in the concept agreement within 2 weeks after the (first) AS renewal (date into force). Ctgb will reconsider and about one month after the AS renewal (date into force) a final agreement for the submission deadline will be sent to the applicant and CMSs.

In case Ctgb is CMS it will generally follow the timelines set by the ZRMS.

B - Renewal for 2 actives:

The EU GD Article 43 states that for products containing more than 1 active substance the renewal for 2 active substances may be done in a single dRR and evaluation, if the expiration dates of the two active substances fall within a period of 12 months. As expiration dates of active substances are subject to change, this situation is not always clear and should be discussed with the ZRMS(s). Member states can grant approval to postpone the date of submission of the dRR until the submission deadline for the second active substance. See also section 2.4.
As it is highly preferable that such decisions are harmonized over all zones, an interzonal coordination is being proposed between member states. So long this is not effective, Ctgb as ZRMS will take the DoA of the first AS as reference date for the 12 month period, compared to the then actual expiry date of the second AS.
•    The full notification, to be submitted between publication of EFSA conclusion and not later than 6 months before the DoA of the (first) active substance renewal, should already include the request to evaluate the PPP renewal for two active substances in one dRR and in one evaluation. This then can be discussed as part of a Presubmission meeting or Request for meeting. Alternatively, this will be handled through a Service Desk request. Ctgb will invoice the hours needed to evaluate/coordinate these requests. Once the DoA for the renewal of the first active substance is officially confirmed, Ctgb will correspond its agreement to the applicant. Ctgb will also inform the CMSs involved.
•    Once agreed that the renewal for the PPP will be combined for two active substances, this agreement stands despite the fact that the expiry date for the second AS might be postponed.

When Ctgb acts as CMS, it will generally follow the extension for submission granted by the ZRMS.



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