KERONA PPP SYMPOSIUM – SESSION 5: ZONAL AUTHORISATION IN THE SOUTHERN ZONE
On December 1st – 2nd 2020, Kerona Scientific held their first PPP symposium dealing with key regulatory aspects relevant to the registration of products and active substances under Regulation (EC) No 1107/2009. Most of the first day of the symposium was focused on the zonal authorisation processes in the three different zones defined in the Regulation (northern, central and southern).
Ms. Joanne Borg Galea, Assistant Director at the Malta Competition and Consumer Affairs Authority (MCCAA) presented an introduction to the zonal authorisation process in the Southern Zone, describing the most relevant and challenging processes faced by zRMS in the evaluation of dossiers. It was pointed out that the Southern European region is the most demanding area with respect to agricultural pesticides since climatic conditions allow the growing of many fruit and cereal crops with wide extensive cropping fields. However, these conditions are also favourable for the incidence of plagues and diseases in plants.
Ms. Galea started the presentation with a brief description of the zonal authorisation process and core dossier assessment conducted by the Southern Europe zRMS and how the zRMS co-ordinates this assessment with the rest of cMS (if any), including the relevant national addenda. The most difficult points in this process are the dossier harmonization (for the zonal evaluation), the identification of the worst-case scenario, data protection issues and complying with the evaluation deadlines.
Ms Galea also outlined how the Article 43 applications are processed following renewal of active substances, paying particular attention to the re-allocation of Member States, products containing more than one active substance and Category 4 studies. The most challenging situations arising from Article 43 applications are the correct selection of the zRMS, acceptability of studies (Category 4, vertebrate…) and agreement on the data matching list for addressing protected studies.
Finally, Ms Galea summarised future guidance development such as revision and update of the SEU zonal guidance document, guidance on rice crops and the implementation of a guidance document for the Southern zone on ‘generic’ (Article 34) applications.
If you missed the PPP Symposium, a copy of all the presentations is available on the publications section of the Kerona website; https://kerona.es/product/dublin-plant-protection-symposium-2020-speaker-presentations/
If you need assistance with registration of plant protection products in the Southern European region, please do not hesitate to contact one of the plant protection team at Kerona.