Renewal of a product authorisation
Authorisations for plant protection products are time limited and depend on the approval of the active substance within the EU. An application for a renewal of a product authorisation shall be made after the approval of the active substance in the product has been renewed. The application must be made within three months after the renewal of the active substance shall apply.
If you have an authorisation for a plant protection product and the approval of the active substance in the product has been renewed, you need to apply for a renewal of the authorisation in order to keep your product on the Swedish market. It is important to initiate a dialogue with the member state who will evaluate your application, already before you apply for a product renewal.
To clarify the application and evaluation process, there is an EU Guidance document on the renewal of an authorisation. There is also a guidance document for the Northern zone, which contains information regarding the agreements made within the Northern Zone. You need to consult both documents to get all information on the application requirements.
Time frames and conditions
An application for a renewal of a product authorisation shall be submitted within 3 months after the renewed approval of the active substance in the product apply.
Member States shall decide on the renewal of a product authorisation within 12 months after the renewed approval of the active substance in the product apply.
When processing your application, the only information that will be evaluated are the information necessary to demonstrate that new requirements in the renewed approval of the active substance are fulfilled, data arising from new data requirements and data to address new guidance.
Generally, when renewing a product authorisation, it cannot be extended or amended, if it is not necessary as a consequence of new requirements or guidance. However, in Sweden we can admit an amendment of the authorisation if the use is already authorised, in at least on member state in the zone, and if the zonal rapporteur accepts to evaluate the additional documentation required for Sweden.
Before you submit an application
Regarding applications concerning the Northern Zone, the national authorities within the zone will agree on the responsible member state evaluating your application, the so-called zonal Rapporteur Member State (zRMS).
The zonal rapporteur responsible for the evaluation of your product will be allocated approximately three years before the evaluation of the active substance is expected to be finalised. You will be contacted and informed about which member state that will evaluate your application.
Already before you submit your application it is worth-while to exchange information and initiate a dialogue between you and the zonal rapporteur. Preferably, this can be done in the form of a pre-submission meeting. The purpose of the meeting is to discuss potential problems and facilitate the process of the submission and evaluation of the application. For instance, an agreement is needed on when data, which will not be available in time for submission of the application, must be submitted (so called Cat4 data).
When the Swedish Chemicals Agency is zonal rapporteur, we would like you to contact us on mail email@example.com in order to organize a pre-submission meeting. Please, contact us at least three months in advance.
An application shall be submitted to all member states, where you wish to renew your authorisation. The application fee shall be paid in connection with the submission of your application. You need to submit your application and pay the fee, even if you and the zonal rapporteur have agreed that your application will be completed at a later stage.
The application shall include the following:
- a copy of the authorisation of the plant protection product
- any new information required
- a justification that the new data are necessary
- a compilation of monitoring information, if the authorisation has been subject to such a requirement
- a compilation of all intended uses within the zone (GAP table)
- a draft registration report (dRR), in Word format
- the complete documentation for the active substance and the plant protection product, if not already submitted
If the zonal rapporteur and you have agreed that the application does not have to be complete when submitted, you must complete your application within the timeframe agreed on.
Evaluation of the application
The zonal rapporteur must complete their evaluation so that the concerned member states will have at least 3 months in order to complete potential national and comparative assessments and to take their decisions.
The time for evaluation includes a maximum of 4 weeks for potential supplementation of documentation and 3 weeks for commenting on the draft registration report by you and the concerned member states.
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 only the substance that has been renewed. The risk assessment for the product shall be made according to the guidelines in force at the time of application. As a result, you may need to update parts of the risk assessment relating to the active substances not subjected for renewal.
If your product contains more than one active substance that has been renewed there are special agreements regarding when the documentation for your application shall be submitted. You can find the information in Appendix III of the EU guidance.
If your product contains more than one active substance and these shall be evaluated simultaneously, you will not have to pay the full application fee for both applications.