Updates from the Northern Zone
Updates from the Northern Zone
Camilla Thorin from the Swedish Chemicals Agency (KEMI) delivered an interesting presentation during our recent PPP Symposium to give updates on the Northern Zone (NZ) in relation to plant protection products.
There is ongoing work in determining unacceptable co-formulants in the NZ phys-chem group. For ongoing product authorisations which will be evaluated and finalised after the 24th of March 2023, the Member States (MS) are supposed to amend or withdraw authorisations as soon as possible (no later than the 24th of March) in regards to these unacceptable co-formulants. The zRMS has prioritised the evaluation of these applications in the NZ.
KEMI concluded that combi-packing basic substances with PPP’s is unacceptable as basic substances cannot be marketed as PPPs, but realistically there is no direct prohibition for this matter. The finalisation of AIR 5 products have been allocated between MS of NZ with Norway leading the work. Finally, for Art. 43 applications that are delayed due to awaiting the assessment of the other a.s, the dossier should be based on the guidance that applies to the second a.s.
Some RMS have concluded that data matching is not considered acceptable on all parts of the dossier, hence some applicants for Art. 43 application did not have a complete dossier. Initially, the different MS had different approaches, some would give a chance to submit lacking data whereas some would revoke the authorisation due to absent data. To resolve divergences, Sweden has made draft flow chart procedures for different cases where it can occur, for example, possible disagreements during evaluations, disagreements from commenting, after final evaluation/decision by zRMS, and procedural disagreements. All these divergences have different procedures which can be resolved in different ways.
Completeness checks and information about inadmissible dossiers is available in the guidance document that the NZ provides, which anyone can view at their own discretion.
If you missed the PPP Symposium, a copy of all the presentations is available on the publications section of the Kerona website at the link https://kerona.ie/product/dublin-ppp-symposium-2022-speakers-presentations/
Please don’t hesitate to contact our regulatory team at info@kerona.ie if you require assistance with applications for PPPs in European Member States.