Instruction for submission
Ctgb can facilitate applicants for renewals as zRMS or as cMS; zonal and/or interzonal. Ctgb has reserved ample capacity for renewal dossiers, but ultimately this capacity is limited.
Coordination zonal applications: Central Zone Steering Committee
Originally a pre-notification process was set out in the first confirmed version of the EU GD art 43 PPP renewals. With the updated version of the EU GD art 43 PPP renewals confirmed in October 2016, this pre-notification process is replaced by an inventory of the zonal Steering Committees. This inventory is implemented by the Central Zone. As a result, applicants do no longer have to submit any pre-notification form to Ctgb in advance of this inventory.
CZSC will invite applicants for subsequent batches of AIR-3 and AIR-4 PPP renewals to submit the necessary information on products in the zone for which renewal applications are foreseen. Likewise the CZSC will ask for the available evaluation capacity of competent authorities in the CZ member states. The CZSC will coordinate assigning the zonal core evaluations grouped by active substance to one or a few member states acting as zRMS, dividing the workload to MS capacity.
For any questions about the option for Ctgb to act as zRMS or more information on the CZ coordination of ZRMS s for product renewals, please contact the Ctgb account manager Mr Geert-Jan Molema.
A full notification should be submitted to Ctgb, about 2 months after the publication of the EFSA conclusion. This notification should contain:
- For non-notifying companies (“generics”), an indicative data matching list for AS data;
- An indication of which sections 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;
- If applicable, a proposal which new category 4 studies need to be generated for the PPP; ‘Extension of submission deadline for the dRR’);
- If applicable, a proposal to combine the evaluation of 2 or more AS in 1 application for the PPP renewal ; (‘Extension of submission deadline for the dRR’);
- If applicable, an indication which forced changes to the GAP are foreseen, with a short motivation.
Dossier preparation - limited supplementary data submission – presubmission support strongly advised
The timelines and procedures set out in the article 43 of regulation 1107/2009 and the Guidance Document on art 43 PPP renewals do not foresee in a stop-the-clock for submission of new data, once the dRR is submitted and the evaluation is started by the zRMS. The first experiences learn that omissions in the dossier can have a huge impact on the authorization. Therefore, Ctgb advises applicants to pay the utmost care in preparing the dossiers.
Within the legal time lines, Ctgb can allow only very limited time for submitting supplementary information and clarifications during the intake and evaluation phase of the application. Time for executing supplementary studies cannot be granted and in principal only additional explanations, calculations and statements can be allowed. While Ctgb will do her best to communicate possible problems as early as possible, applicants are required to react within 1 or 2 weeks. Therefore Ctgb strongly advises applicants to utilize the options Ctgb offers to discuss the dossier with Ctgb experts in a Presubmission meeting or Request for meeting while preparing the dossier.
A Pre Submission Meeting (PSM) is meant to discuss the dRR as a whole with experts from all aspects. The dRR should be nearly complete and the PSM can be seen as the first step in the intake of the dossier. Ctgb experts will give feed-back on points that could be expected to lead to discussion during the evaluation while the applicant is asked to actively indicate any points for which they recognize possible problems. So a PSM is recommended in the months between the vote for renewal of the active substance and the art 43 renewal application deadline of DoA + 3 months. In case an extended deadline for submitting the dRR is agreed, the PSM should be planned in the last months before dossier submission.
When the applicant wants to discuss a few specific issues for one or more aspects (in an earlier stage of the dossier preparation), an Request for meeting (RFM) is more suitable. Separate questions can also be submitted through the our Service Desk and be answered by email.
Application forms and templates
The content and structure of dossiers is precisely and comprehensively defined in several guidance documents. For the general dossier requirements, Ctgb refers to the EU GD art. 43 PPP renewals (SANCO/2010 13170 rev. 14, 7 October 2016 section 3.4 and the application forms and instructions for application for Zonal application Netherlands = ZRMS, or application for Zonal application Netherlands = CMS. The EU GD art 43 PPP renewals also states which data requirements apply for PPP renewals based on AIR 2 or AIR 3 and higher active substances, or combinations of these.
Application forms and addenda
professional and non professional use
LoA (Part A section 1)
GAP (Part A section 2)
Reference list vertebrates
Efficacy NL (Part B section 3)
Environmental Fate NL (Part B section 8)
Ecotoxicology NL (part B section 9)
Additional information is set out below:
- dRR with Core and national addenda must be submitted using the new dRR format, with new data requirements (submission of dRR from 1 January 2016). Exceptions for renewals based on AIR2 substances:
- formally, PPP renewals based on AIR2 active substances are exempted from using the new dRR format. However, as AIR-2 active substance renewals are postponed far beyond their original date of expiry, Ctgb kindly requests applicants to use the new dRR format from January 2017 onwards; the new data requirements may be left open.
- Applicants are free to use the new data requirements, but this should be confirmed in the submission letter and is irrevocable.
- In case the ZRMS accepts the old dRR format, Ctgb will also accept this for the CMS application. Applicants should stick to the chosen dRR format for the whole dRR and not mix old and new format within or between Core and National addendum.
- In case of an application including a zonal as well as an interzonal dRR, Ctgb requests that also the parts B of the national addendum are separate for zonal and interzonal uses. Only in case the zRMS evaluating both dossiers is the same, applicants may combine all uses in a single series of part B of the national addendum. Part A should in all cases contain the combined uses.
- The dRR should be updated for the active substance concerned. The data for the other active substance will not be evaluated and therefore do not have to be updated except for those data needed for the combitox assessment.
- The dRR should be drafted in accordance with conditions and restrictions in the renewal regulation of the active substance, new endpoints, and Guidance Documents in force on the date the application is received by Ctgb. New data requirements apply for dossiers of AIR3- and AIR 4-based PPP renewals. An electronic copy of all underlying studies in PDF or MS word file format is required.
- In case existing or new studies are essential for the risk evaluation they should be referred to in the dRR, and a summary should be included. New Guidance may require a new summary of existing studies.
- Specific dossier requirements apply in case of approved extension for category 4 data or combining the renewal for 2 active substances in a single evaluation: see Extension of submission deadline for the dRR.
- Additionally the dossier should contain the following statements (EU GD art 43 PPP renewals):
- A signed statement confirming that the authorized plant protection product, its uses and its active substance sources are in compliance the conditions and restrictions of the renewal of the approval of the active substance.
- A signed statement that the formulation of the product is the same as currently registered and the source of the active substance is equivalent. Any minor changes should be motivated.
- A signed statement that the GAPs applied for (in all countries in case Ctgb = zRMS) are the same as currently registered. Any deviations should be specified and motivated. Ctgb as zRMS will not check current authorizations in CMSs. Therefore there is no need to supply a (translated) copy of the authorizations in CMSs with the dossier. Ctgb as zRMS leaves the check of GAPs applied-for to the individual CMSs.
- If applicable, a statement confirming access to the active substance data, and if applicable a Letter of Access signed by the notifier(s) of the active substance renewal.
Milestones for data submission
- Fill inventory upon request from CZSC;
- Submit the full notification; 2 months after publication of EFSA conclusion;
- Application; In all cases, whether Ctgb acts as CMS or ZMRS, the submission deadline for the application for a PPP renewal to Ctgb is 3 months after the Date of Application (DoA) set in the EC renewal regulation of the (first) active substance (art. 43.2 of Regulation 1107/2009). This deadline is not affected by approved extended deadlines for submitting the dRR because of category 4 data submission or combining the renewal for two active substances in a single evaluation (see LINK). The application should contain:
- In case no postponements were agreed in advance (see LINK) - a complete dossier (see previous section) including all studies and the dRR;
- In case the zRMS agreed to allow extra time for generating category 4 studies (LINK) - a complete dossier (see previous section) minus the new studies, minus the dRR and the CA application. Submission of the dRR and (if applicable) the CA application can be postponed to the date agreed for the submission of new studies.
- In case the ZRMS or Ctgb as ZRMS agreed to combine the renewal for two active substances in a single evaluation (LINK) - a complete dossier (see previous section) for the first active substance minus the dRR and if applicable minus the CA application. Submission of the dRR and if applicable the CA application can be postponed to the submission deadline of the application for the second active substance.
Please also be referred to the appendix III of EU GD art. 43 PPP renewals (SANCO/2010 13170 rev. 14, 7 October 2016) on what to submit when.
EU GD art. 43 PPP renewals (SANCO/2010 13170 rev. 14, 7 October 2016 section 3.5 defines 5 categories of missing data. For any datagaps defined as Confirmatory Data in the renewal regulation of the active substance it is explicitly stated that these should not be reason to delay the PPP renewal authorization. If applicable, Confirmatory Data - Category 2,3 and 5 - should be dealt with once their evaluation proves reason to amend the active substance renewal regulation. In that case, Ctgb will subsequently have to re-evaluate the product authorization on that aspect. Applicants have a duty to bring their authorizations in line with any relevant amendments in the active substance approval.
Category 1 data: Data gaps defined by EFSA, but not set as confirmatory data in the active substance renewal regulation, may in some cases be needed to prove an acceptable risk of the applied for uses of the product.
Category 4 data: Data needed to prove safe use of the product, that the applicant could not have foreseen before publication of the EFSA conclusions. These may lead to category 4 data extension and prove to be reason to postpone the submission of the dRR and the evaluation. Category 4 data extension has to be agreed upon by the RMS/zRMS.
Specific points of attention for aspects
Still to be elaborated for all aspects.
In the standard case that the GAP does not contain major changes, the efficacy section should contain only a well-build update of the resistance paragraph and monitoring data when applicable. No fully filled dRR nor BAD nor underlying studies have to be submitted. For the other sections of the dRR B7 you can refer to previous evaluations. No national addendum part B7 is foreseen.
In the case that GAP changes are accepted, Ctgb as ZRMS and the applicant should discuss if and if yes, how many, new efficacy trials are needed for the changed uses. Such studies may be categorized as category 4 studies for which extension of the submission deadline of the dRR can be agreed on. Applicants are advised to address this subject in the pre submission phase. In this case, a BAD and more efficacy sections in the dRR need to be filled in. In case Ctgb is CMS, applicants may discuss GAP changes and needs for the efficacy evaluation prior to submission via a Request for Meeting.
Minor uses and renewals
Existing minor uses should be included in the renewal Core dossier as far as the applicant has access to the supporting data (owner, via LoA, or data protection has expired). This is usually the case for Dutch minor use authorizations. Minor uses should be included in the GAP table under a separate sub-heading according to the EU GAP format. When a minor use is not part of the GAP and the core assessment used for the renewal application, that use will not be renewed.
In case the data for the minor uses are exclusively owned by a grower association they may be included in the national addenda as long as the corresponding risk assessment is presented in the addenda. These will be evaluated by the individual CMSs.
Third parties holding minor use registrations are advised to closely cooperate with the primary applicant in order to make sure their minor uses are included in the renewal application.
Uses that are on the current label as minor uses, may need to be upgraded to a major use because the crop is no longer considered to be minor according to up-to-date standards. Ctgb does not consider this as a real GAP change as the use was already authorized. However, upgrading to a major use cannot be done without efficacy evaluation. Therefore, Ctgb will accept the upgrading from minor to major use as long as a major use was already authorised in another member state and consequently it is included as such in the EU GAP table and Core dossier prepared by the zRMS or Ctgb as ZRMS. Alternatively, the applicant has to submit an application for use extension with a major use well in advance of the product renewal submission, or after the renewal of the product was concluded. This latter strategy may lead to a gap between the current and the new authorisation for that use.
New minor uses cannot be incorporated in the renewal application. See our page on 'How to apply for new uses ...'.
Renewal of derived authorizations and parallel trade permits
Derived authorizations and parallel trade permits also have to be renewed upon renewal of the active substance. These authorizations do not need a separate renewal evaluation, but the authorization holder that wishes to continue the derived authorization or parallel trade permit has to separately apply for prolongation of the authorization.
In case no renewal application is submitted for the reference product or it was denied, the derived authorizations and parallel trade permits will expire in line with the authorization of the reference product.
- Derived authorizations and parallel trade permits should not be included in any Zonal inventories for PPP renewal applications.
- A notification prior to application is not needed.
- For application use form AG or form PAG from our website; the application is national.
- The application does not necessarily have to be submitted at the deadline for renewal applications of DoA + 3 months, but Ctgb advises to submit it well in advance of the date of expiry of the product authorization; lastly DoA + 9 months. An application is prerequisite in case an administrative extension for the authorization is needed after DoA + 12 months. Non-application may result in termination of the authorization.
- The prolongation is an administrative process. For derived authorizations Ctgb will normally complete this process within a month after the renewal is approved. For parallel trade permits this may take a few months longer;
- The derived authorization or parallel trade permit may have to be adjusted to be in line with the label or reference specification of the renewed reference authorization. E.g. uses that are not renewed in the reference authorization will also be removed from the derived authorization or parallel trade permit. Grace periods may apply.
Fees for zonal PPP renewals
For renewal applications, Ctgb will apply the standard fee structure for zonal applications ZRMS and CMS.
ZRMS applications are invoiced based on hours spent starting with a standard advance payment. In case Ctgb is acting as zRMS and extension of the deadline for submitting the dRR is agreed in advance, the advance payment will be set at Euro 10,000, - instead of the full advance payment. Once the dRR is submitted, this amount largely covers the intake phase, while a second advance payment for the rest of the standard fee will be invoiced after the dRR is submitted.
CMS applications have fixed fees. In case Ctgb acts as cMS for applications with extended dRR submission deadlines, the full application fee has to be payed upon submission. The assessment fee will be invoiced once the assessment is ready to start.
Presubmission meetings, requests for meetings and/or Service Desk questions, Category 4 requests and data matching requests in advance of the product application are invoiced separately.