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.
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.
- 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 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 8.0_July 2019, pdf, guidance in English
- Northern Zone work-sharing guidance document_ver 7.0_May 2018, pdf, guidance in English
- Northern Zone work-sharing guidance document_ver 6.0_May 2017, 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.
|Report prepared by Finland, Art. 28, 36.1||basic fee 63,000 euros, charged upon submission of the application||additional evaluation 99 euros/h||
|Report prepared by another Member State within the zone, Art. 28, 36.2||basic fee 6,300 euros||additional evaluation 99 euros/h||