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If you are the holder of an authorisation for a plant protection product and would like to apply for a renewal of the authorisation, new rules apply. You can find the rules in Article 43 of Regulation (EC) 1107/2009.

Article 43 states the deadline for submission of your application, and the time frames for renewal of the authorisation. The article also states which data that shall be submitted with the application.

To clarify the application and evaluation process, a guidance document has been developed at EU level. There is also a guidance document of the Northern zone, which contains information about the agreements made within the Northern Zone. You need to consult both of the documents to get all the information about how to apply.

The European Commission guidance document on the renewal of an authorisation.

Guidance for the northern zone 2017. 

Guidance on requirements for efficacy data for zonal evaluation of a plant protection product in the Northern Zone (engelska).

Conditions

An application for a renewal of an authorisation assume certain prerequisites. This is because the procedure is intended to be simplified to enable it to be finalised within 1 year.

The prerequisites are:

  • the product has been evaluated in accordance with the uniform principles
  • only new data should be evaluated
  • only those uses that are already approved should be evaluated.

Time frames for application and decision

An application for a renewal of an authorisation shall be submitted within 3 months from the entry into force of the renewal of approval of the active substance in the plant protection product.

Member States shall decide on the renewal of an authorisation within 12 months after the renewal of approval of the active substance contained in the plant protection product has entered into force.

Before application a pre-notification is needed

It is necessary to have a dialogue and exchange of information already before your application is submitted in order to keep the time frames. Therefore you need to submit a pre-notification for renewal of an authorisation. The pre-notification need to be submitted to all Member States concerned within 2 months after the publication of the EFSA conclusions on the active substance in your product.

You need to submit a pre-notification for each product that you intend to apply for a renewal of authorisation for, and it shall contain

  • a proposal of a zonal rapporteur
  • new data that is necessary for a renewal of the authorisation of the product
  • information on studies that cannot be produced in time for the application and a time-schedule for each study, so called Category 4 studies
  • information on which parts of the risk assessment that probably need to be updated
  • mutual recognitions planned within the zone.

The Northern Zone Steering Committee appoints the zonal Rapporteur Member State (zRMS) and informs you as applicant which Member State it will be.

No later than 6 months before the decision on the renewal of approval of the active substance enters into force you need to submit an updated pre-notification to all Member States concerned. The updated notification need to contain a compiled GAP-table (Good Agricultural Practice), where all the uses within the zone are stated. You can find more information in the Northern zone guidance document.

Use this notification form for your pre-notification.

As the authorisation holder you are urged to contact the zonal rapporteur to agree on a pre-notification meeting, in order to discuss your application. At the meeting, the zonal rapporteur and the authorisation holder need to reach an agreement on the time-schedules required to develop the studies not yet available. The zonal rapporteur will inform the other Member States concerned about the time-schedules agreed upon.

Description of the different time frames for applications of a renewal of authorisation

Deadlines for the pre-notification relating to the application of a renewal of an authorisation.

The application

The application shall be submitted no later than 3 months after the renewal of the active substance has entered into force to all the Member States, in which you wish to renew your authorisation.

The application shall include the following:

  • a copy of the authorisation of the plant protection product
  • any new information required as a result of changes in data requirements or criteria
  • evidence that the new data are necessary to meet the new requirements and criteria for the authorisation or the renewal of the approval
  • a report on the monitoring information, if the authorisation has been subject to such a requirement
  • a compilation of all intended uses in all Member States concerned (GAP table)
  • a draft assessment report (dRR), in Word, fulfilling the applicable data requirements
  • the complete documentation in accordance with applicable data requirements for the active substance, if not already submitted
  • the complete documentation in accordance with applicable data requirements for plant protection products, if not already submitted.

Use the form MIP-0012-E to apply for renewal of a product authorisation.

Format of a draft Registration Report (dRR) – version 2015

If the zonal rapporteur and you as an applicant have agreed on a time-schedule for studies not yet available, the application does not have to be complete when submitted. The documentation that shall be submitted within the time agreed on is:

  • a draft assessment report (dRR), in Word, fulfilling the applicable data requirements
  • the complete documentation in accordance with applicable data requirements for the active substance, if not already submitted
  • the complete documentation in accordance with applicable data requirements for plant protection products, if not already submitted.
Description of the different time frames for applications of a renewal of authorisation

Deadlines for the application of a renewal of an authorisation.

Evaluation of the application

To be able to make a decision on the renewal of the authorisation within 12 months from the renewal of approval of the active substance, the zonal rapporteur must complete the evaluation of the application within 6 months.

These 6 months include time for:

  • possible need for supplementation of the application within a maximum of 4 weeks
  • commenting on the draft assessment report by the Member States concerned and the applicant during a period of 3 weeks

When the zRMS has finalised the evaluation, taking comments into account, the Member States concerned have 3 months to evaluate any national requirements and make decisions. If the product contains candidates for substitution a comparative assessment should also be made in each member state.

Products with more than one active substance

If the product contains several active substances, and only one of the substances has been renewed, the evaluation will cover the substance that has been renewed. The risk assessment for the product as a whole shall be made according to the guidelines in force at the time of submission. This may result in that you also need to update the parts of the evaluation relating to the active substances that have not been renewed.

If your product contains more than one active substance that has been renewed there are special agreements regarding when you shall submit your application and documentation. You can find the information in Annex II of the EU guidance.