Authorisation based on zonal assessment
Authorisation based on zonal assessment means that one of the Member States in the Northern Zones, the rapporteur Member State, carries out the assessment of the product. Other Member States grant or refuse an authorisation based on the zonal assessment.
Applying for an authorisation for a product in the Northern Zone of the EU:
- Six months prior to submitting the actual application send a notification to Tukes about the intended application.
- Fill in the application form
- Include in the application the appendices 1–3:
- Prepare a draft Registration Report (dRR). See the draft Registration Report template.
Make a comparative assessment of the product if the product contains an active substance that is a candidate for substitution.
- Submit complete research material of the product.
- Submit the composition data of the co formulants contained in the plant protection product or ask the manufacturer of the co formulants to provide the composition information of the co formulants contained in the plant protection product using this form. Compositional information must also be submitted for alternative co formulants. If the name of the plant protection product cannot be told to the co formulant manufacturer, ask Tukes for the code number for the plant protection product in order to supply the compositions of the co formulants.
- Submit the application with relevant documentation to the address ppp (at) tukes.fi.
You can submit research material through the applicant's own cloud service or alternatively send the material on CD disc (1 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 11.1_Sept 2023, (pdf 1,70 Mt), guidance in English
- Northern Zone work-sharing guidance document ver 10.0_June 2021, (pdf 2,18), guidance in English
- Northern Zone work-sharing guidance document ver 9.0_June 2020, pdf, guidance 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
- 1 year if the Registration Report is prepared by Finland
- 120 days if the authorisation is based on mutual recognition.