Renewal of authorisation
Tukes can renew an authorisation for a plant protection product, provided that the requirements for safe use are still met. The application for renewal of an authorisation must be submitted within three months from the renewal of the approval of an active substance within the EU and the entry into force of the Commission decision on the approval of the active substance.
The Member State that examines the application must share its work with other Member States within the same zone. The steering committee of the Northern Zone holds regular meetings, where they review the submitted applications and decide which country will prepare the Registration Report. The country completing the evaluation will inform the applicant about the decision.
Applying for renewal of an authorisation in the Northern Zone of EU, i.e. in Finland, Sweden, Denmark, Estonia, Latvia and Lithuania:
- Fill in the application form
- Include in the application the appendices 1–3
- Prepare a draft Registration Report (dRR)
- submit a predicted environmental concentration in soils for plant protection products calculated using the Nordic PECsoil calculator (calculator and user manual) and a risk assessment of the soil organisms prepared on the basis of the calculated results. However, for applications submitted earlier than 1.11.2018 it is allowed to calculate PECsoil using the Finnish PECsoil calculator.
Prepare a comparative assessment if the plant protection product contains an active substance that is a candidate for substitution
Submit complete research material of the product.
Submit the application with relevant documentation to the address ppp (at) tukes.fi.
Send the research material on CD discs (3 pc) by post to Tukes, P.O.Box 66, FI-00521 Helsinki.
In the application remember to propose which Member State will act as zonal Rapporteur Member State, or zRMS, and in which other concerned Member States, or cRMS, you intend to place the product on the market. Guidelines on how to make the application and compile the research material can be found on the EU-level guidelines and the guidelines for the Northern Zone, including the national research requirements. Links to these guidelines provided below.
- Northern Zone work-sharing guidance document ver 6.0_May 2017 PDF; the guidance document is in English
- Northern Zone work-sharing guidance document_ver 5.0_April 2016 PDF; the guidance document is in English
- Guidance on requirements for efficacy data for zonal evaluation of a plant protection product in the Northern Zone can be found on the website of Danish authorities
- EU Guidelines
Processing time: Registration Report prepared by Finland (1 year), authorisation based on mutual recognition 90 days.
|Report prepared by Finland, Art. 28, 36.1, 43||basic fee 45,000 euros||additional evaluation 95 euros/h||maximum fee 85,000 euros|
|Report prepared by another Member State within the zone, Art. 28, 36.2, 43||basic fee 6,000 euros||additional evaluation 95 euros/h||maximum fee 15,000 euros|