Extension of the deadline of dRR submission

Extension of the deadline of dRR submission – general aspects

Any extensions agreed upon of the deadline to submit the dRR, mean that the time lines set in article 43 of PPPR (EC) 1107/2009 cannot be met. Current product authorizations need to be extended beyond the deadline of DoA + 12 months. Ctgb will take a separate decision on administrative extensions about 1-2 months before the current date of expiry of the authorization. Ctgb as zRMS cannot decide on the administrative extension of national authorizations to the individual CMSs and it is the responsibility of the applicant to make sure their applications in CMSs do not expire.
Applicants of CMS applications are advised to indicate clearly in their submission letter that extension of the submission deadlines have been agreed with the zRMS.

Failing submission of missing studies and/or the dRR on the approved extended deadline.

Applicants should be aware that if an extended deadline for submission of missing category 4 data and/or the dRR was approved by the zRMS, the documents should be submitted to both to the zRMS and cMSs before the agreed deadline.
In case the applicant does not submit the missing studies and/or the dRR on the approved extended deadline, Ctgb will terminate the current NL authorization on short term notice, irrespective whether Ctgb is acting as cMS or zRMS for the application. The applicant has the option to request grace periods. In case Ctgb is acting as zRMS, Ctgb will inform the CMSs involved as soon as possible of the applicant failing to submit a dRR and complete dossier on time.

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 studies that could not have beenforeseen by the applicants. New Guidance may add to the need for new studies. In that case, applicants may request extra time for generating these so-called ‘category 4 studies’ (category 4 in section 3.5 in EU GD art. 43 PPP renewals (SANCO/2010 13170 rev. 14) and the dRR . In order to support their request the applicant should submit the following two months after publication of the EFSA conclusion with an update in the final application:

• a proposal which new category 4 studies have to be generated for the PPP,
• with the requested time needed for the studies and finalizing the study report,
• supported by a sound argumentation why the data are needed and the need could not be foreseen,
• in support of the claim, the applicant should submit the study contract or study plan (financial data may be obscured) with time lines.
• applicants should use the template in appendix I of the EU GD art. 43 PPP renewals (SANCO/2010 13170 rev. 14, 7 October 2016.

Be aware that new endpoints or guidance may not always justify new studies. In some cases, analysing existing data in a new way may be sufficient.
ZRMSs 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. A period of 3 months may be added for preparing the final version of the dRR.

The claim for category 4 data extension is evaluated by the zRMS. The EU GD art 43 PPP renewals states that the evaluation should be executed in the first month after submission of the application as the need for studies cannot always be foreseen well ahead of this date. However, when Ctgb acts as ZRMS, Ctgb wishes 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, this is considered an extra service.

• When a claim for cat. 4 studies is submitted and Ctgb is the appointed zRMS, the applicant is encouraged to pre-discuss this request with Ctgb. The claim can be evaluated and/or discussed as part of a Presubmission meeting or Request for meeting or through a separate Service Desk request. Ctgb will invoice the hours needed to evaluate/coordinate these requests, and the outcome will be corresponded to the applicant as a concept agreement.
• As the List of Endpoints is only formally confirmed when the renewal of the active substance is published by the EC, the applicant has to inform Ctgb of any relevant changes and whether any amendments are required in the concept agreement on the cat 4 studies maximum 2 weeks after the AS renewal enters into force. New insight in the risk assessment may also reveal the need for extra studies by that time. If needed , Ctgb will reconsider and approximately one month after the AS renewal (date into force) a final agreement for the extended submission deadline will be sent to the applicant and CMSs. In this way applicants know well in advance what to submit when and Ctgb and CMSs can adjust their work planning to the actual submission deadlines for the dRR.
• Advance evaluation of category 4 claims is on a voluntary basis and will not jeopardize any new claims may the need for additional studies arise during the preparation of the dossier until DoA + 3 months. No category 4 data claim can be submitted after DoA + 3 months.

Ctgb as CMS will generally follow any category 4 extensions set by the ZRMS. (

In case the need could not be foreseen by the applicant, category 4 data extension may also be claimed for active substance data through at the RMS of the active substance. Ctgb in her role as zRMS or CMS will generally follow the agreement of the RMS, but may come to combined conclusions in case category 4 data are claimed on product level as well; see Category 4 data claim for active substance data, under data matching.

Specific dossier requirements in case of an agreement on category 4 data extension:

• The application should be submitted before DoA of the renewal of the first active substance + 3 months. With the application the dossier should be complete minus the dRR, the missing category 4 studies and the CA application (if applicable). All available studies should be submitted with the application.
• The application should contain a signed statement confirming that the authorized plant protection product and uses are in compliance with the restrictions and conditions in the active substance renewal regulation.
• The new studies, the dRR and if applicable the CA application, should be submitted before the agreed extended deadline.
• The dossier should be based on Guidance in place at the date the application was received by Ctgb and not the Guidance in place at the (later) date of submitting the dRR.  
• See also appendix III of the EU GD art 43 PPP renewals.

B - Renewal for 2 actives in a single evaluation:

The EU GD Article 43 PPP renewals states that for products containing more than 1 active substance the renewal for 2 active substances may be done in a single evaluation in case the (expected) renewal dates of the two active substances fall within a period of 12 months. As expiration dates of active substances are subject to change and the Date of Application (DoA) is not set far in advance, such a claim should be discussed with the ZRMS(s). 

• The notification, to be submitted 2 months after publication of EFSA conclusion, should include the request to evaluate the PPP renewal for two active substances in one dRR and in one evaluation.
• Ctgb as ZRMS will decide on such a request once the renewal of the first active substance is published, and the applicant is advised to contact Ctgb at that time. The situation on the date of publication of the first expiring A.I. approval will be leading for determining if the renewals of the 2 actives can be taken care of in one dRR for the product. This is determined by identifying period of time between DoA of the first active substance renewal (known) and the (expected) DoA of the renewal of the second active substance (DoA if known or otherwise the date of expiry of the second active substance approval). Is this a period of 12 months or less, then Ctgb can generally agree to combine the renewals for both active substances in a single dRR and evaluation. If the period is more than 12 months, Ctgb will generally not agree. Ctgb will correspond its (dis)agreement to the applicant and inform the CMSs involved.  
• In case a second zRMS is involved, both zRMSs need to come to a mutual agreement.
• Once agreed that the renewal for the PPP will be combined for two active substances, this agreement stands, irrespective of the fact that the renewal for the second AS might be postponed beyond 12 months after the DoA of the first active substance.
• When Ctgb acts as CMS, it will generally follow the extension for submission granted by the ZRMS(s).

Specific dossier requirements in case of extension to evaluate the renewal for 2 active substances in a single evaluation:

• An application should be submitted before DoA of the renewal of the first active substance + 3 months. The dossier should be complete minus the dRR and (if applicable) minus the CA application. All studies for the first active substance should be submitted with the first application.
• The application should contain a signed statement confirming that the authorized plant protection product and uses are in compliance with the restrictions and conditions in the active substance renewal regulation.
• Before DoA of the second active substance + 3 months, the application has to be submitted for the  second active substance, including a complete dossier, the dRR and if applicable the CA application. Please refer to the first application, so that our administration will add the new application to the original, rather than register 2 separate applications.  
• Note that in this case the dossier should be based on Guidance in place at the submission date of the application for the second active substance.
• See also appendix III of the EU GD art 43 PPP renewals.