Renewal of approval of a plant protection product
Within its expiration period, an active substance will be re-evaluated in the EU. After the approval of the active is renewed, the Norwegian Food Safety Authority will re-evaluate all plant protection products in Norway containing the active substance
To apply for renewal of an approval of a plant protection product, you have to submit an application according to article 43 in the plant protection products Regulation (EC) No. 1107/2009.
What are the requirements to get a plant protection product renewed?
Within three months after an active substance is renewed in the EU, the authorisation holder should apply for renewal of approval of the plant protection products containing the active substance in each member state. The application will be handled as a zonal evaluation. Read more about international cooperation and zonal evaluation.
You will find the requirements as well as description of the procedure in the following guidances from our overview of guidances:
- The latest edition of the Guidance document on work-sharing in the Northern Zone (A1)
- Northern Zone Guidance document - Higher tier risk assessment for birds and mammals, with spreadsheet for birds and mammals (A1.1 and A1.2)
- The latest edition of the EU-guidance SANCO/2010/13170 (Guidance Document on the Renewal of Authorisations according to Article 43 of Regulation (EC) No 1107/2009) (A6)
- The latest edition of Northern Zone guidance paper efficacy version (A2.1)
- Guidance of number of trials in the northern zone (A2.2)
Overview of the application procedure
1. Pre-notify your application
You should pre-notify your application within two months after EFSA have published their conclusion on the active substance. The pre-notification should be submitted to the zonal rapporteur member state and all concerned member states.
You will find more information on pre-notifications in the latest edition of the EU-guidance SANCO/2010/13170 (Guidance Document on the Renewal of Authorisations according to Article 43 of Regulation (EC) No 1107/2009) (A6) and the Guidance document on work-sharing in the Northern Zone (A1) from our overview of guidances.
You may contact us by emailing postmottak@mattilsynet.no if you have any questions or if you need a pre-submission meeting.
2. Submit your application
Use the forms below:
Submit the application to the zonal rapporteur member state and all other concerned member states in the zone.
Submit the application digitally to postmottak@mattilsynet.no
Submit the documentation by post or courier to:
Mattilsynet, national registrations department
Glynitveien 30
1400 Ski
Norway
3. Processing your application
The zonal rapporteur should complete the evaluation within six months.
The zonal rapporteur member state starts by doing a completeness check. Based on the completeness check, the zonal rapporteur member state will decide whether the application is admissible or not.
The zonal rapporteur drafts a registration report (dRR), which will be circulated between the concerned member states and the applicant for comments. After the commenting period, the zonal rapporteur completes the registration report (RR) and makes a national decision whether to approve the product or not.
After the zonal rapporteur has completed the RR, the concerned member states have 90 days to complete their evaluation and make a national decision of approval. The concerned member states may also decide for national risk-reducing measurements.
After you have received a decision from the Norwegian Food Safety Authority
As an authorisation holder or importer of a plant protection product, you have some obligations after the assessment is completed.
Read more about requirements for the authorisation holder and importer after the decision.
If you wish to make an appeal against our decision, you may do so within three weeks after you receive the decision. The appeal should be directed to the Norwegian Food Safety Authority, Greater Oslo Region – postmottak@mattilsynet.no
Fees
We will charge you with a fee for evaluating your application of approval of a plant protection product. You will find the fees for approval of products (“Godkjenning av preparater”) in attachment 1, chapter III, part B in forskrift om betaling av gebyrer for særskilte ytelser fra Mattilsynet (Norwegian).