Plant Protection and Biocidal Product Authorisation in Europe

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1 Plant Protection and Biocidal Product Authorisation in Europe

2 The TSGE Group at a Glance

3 The TSGE Group Despite efforts to harmonise legislation and apply the principle of mutual recognition, the process for gaining authorisation for plant protection and biocidal products in Europe remains complex. Member States continue to define their own requirements and procedures to a large extent, presenting significant challenges. TSGE has invested in and developed a pan-european infrastructure to meet those challenges presented by differing requirements across the Union. We have offices in the UK, Ireland, Spain, Germany, Slovenia, Slovakia, Poland, France, Hungary and Romania. Our offices act as regional hubs offering focused, local registration support. Our success has been achieved based on the understanding that no one individual or organisation can manage the authorisation of a plant protection or biocidal product effectively throughout Europe without local knowledge of procedures, culture and language. Our managers and registration professionals in the national offices have the necessary regulatory skills and are experienced, approachable and dependable. If your company requires single Member State authorisation for a plant protection or biocidal product, a portfolio of products or to maintain and/or defend product approvals, then please do not hesitate to contact us. Plant Protection Products The authorisation of plant protection products is the responsibility of each EU Member State. The Plant Protection Products Regulation (EC) 1107/2009 establishes some of the rules and procedures with which each Member State must comply to grant or refuse a product authorisation. This includes a zonal system for assessing product applications. Despite ongoing efforts at harmonisation and mutual recognition procedures, some Member States maintain different administrative and regulatory requirements, which are based on climatic or agronomic differences. Member States may also differ significantly in the risk mitigation measures they will allow. These varied requirements and their constant change represent a challenge for companies wishing to place their plant protection products on the market. Biocidal Products The approval of biocidal products either as an authorisation or a registration (may also be referred to as a notification) is the responsibility of each EU Member State. The Biocidal Products Regulation (EU) 528/2012 establishes the rules and procedures with which each Member State must comply to grant or refuse a product approval. However, Member States have different administrative and, on occasion, regulatory requirements. These requirements are not expected to harmonise as the review programme moves away from the transitional arrangements (those regulatory requirements before the introduction of Directives and Regulations on biocides). These requirements and their constant change represent a challenge for companies wishing to place their biocide products on the market.

4 TSGE Group Regional Offices UK and Ireland Our offices located in Knaresborough, UK and in Dublin, Ireland offer national product authorisations. Co-ordinated by Manda Vince (Plant Protection) and Amy Burrows (Biocides), these offices also provide scientific expertise in the fields of chemistry, human health and environmental science. We believe that the combination of centralised scientific expertise and local product approval services presents a very clear, logical and cost effective service to the chemical and biological products industries. United Kingdom Ireland Sweden Denmark Finland Norway MANDA VINCE Concordia House St James Business Park Grimbald Crag Court Knaresborough North Yorkshire HG5 8QB United Kingdom T +44 (0) E manda.vince@tsgeconsulting.com AMY BURROWS Concordia House St James Business Park Grimbald Crag Court Knaresborough North Yorkshire HG5 8QB United Kingdom T +44 (0) E amy.burrows@tsgeconsulting.com Germany Hermann Wilhelmy heads up the registration specialists based in Hildesheim, Germany. Hermann is an experienced and highly regarded regulatory consultant with significant registration experience gained from his time in the industry. This office also provides expertise in biological efficacy work (data assessment, BADs) for plant protection products. In addition, the German team offers a CADDY dossier service for submission to EU authorities. Germany Austria Belgium Netherlands Luxembourg Switzerland HERMANN WILHELMY Richthofenstrasse Hildesheim Germany T +49 (0) E hermann.wilhelmy@tsgeconsulting.com

5 Spain Based in Oviedo, Spain, the team of registration specialists is headed by Maria Fernandez, an experienced and highly regarded regulatory consultant. MARIA JESUS FERNANDEZ VILLAMIL Avenida de Galicia, 22, 5 Dcha Oviedo Asturias España T +34 (0) E maria.fernandez@tsgeconsulting.com Spain Portugal Italy Greece Cyprus Malta Slovenia Our Slovenian team of registration specialists based near Ljubljana is headed by Bojana Zgonec, an experienced and highly regarded, multilingual regulatory consultant. BOJANA ZGONEC Ljubljanska cesta Domžale Slovenia T +386 (0) E bojana.zgonec@tsgeconsulting.com Slovenia Bulgaria Romania Latvia Lithuania Estonia Serbia Croatia Bosnia Montenegro Macedonia Kosovo Albania Russia Ukraine Poland Our office in Warsaw, is managed by Aleksandra Gniado, a registration specialist. ALEKSANDRA GNIADO Oddział w Polsce ul. Puławska 405 a Warszawa Poland T +48 (0) E aleksandra.gniado@tsgeconsulting.com Poland

6 Slovakia Dr Viktor Prachar, a highly experienced regulatory expert, formally the head of the Biocides Authority in Slovakia leads our Slovakian office based in Bratislava. Slovakia Czech Republic DR VIKTOR PRACHAR Ružová dolina Bratislava Slovakia T +421 (0) E viktor.prachar@tsgeconsulting.com France Séverine Macke, an expert in regulatory affairs with extensive experience working in industry manages our office based near Lyon. France SÉVERINE MACKE Espace Saint Germain Bâtiment «le Saxo» 30 avenue du Général Leclerc BP Vienne Cedex France T +33 (0) E severine.macke@tsgeconsulting.com Hungary Our office in Hegyeshalom is managed by Emília Kotrusz Búriová, a regulatory specialist formally with the Biocides Authority in Slovakia. Hungary EMÍLIA KOTRUSZ BÚRIOVÁ Dózsa Gy Hegyeshalom Hungary T +421 (0) E emilia.buriova@tsgeconsulting.com

7 Romania Our newest office in Bucharest is managed by Mihaela Dragusanu, a regulatory consultant specialising in biocides and plant protection products. MIHAELA DRAGUSANU TSGE svetovanje d.o.o. Domzale Sucursala Bucuresti Soseaua Mihai Bravu Nr Bucharest, Sector 2 Romania T +40 (0) E mihaela.dragusanu@tsgeconsulting.com Romania Moldova Product Authorisation in Europe: Supported by our Scientific and Technical Expertise With more than 40 scientists in UK and Ireland, is a leading regulatory company providing scientific, regulatory and registration services in the biocide, plant protection, general and speciality chemical and cosmetic sectors of the chemical industry. Project Management at TSGE At TSGE, we believe in the value of project management and we recognise that it is a fundamental principle of good client service. Project Managers control cost, manage deadlines and communicate in a professional and timely manner. Our clients appreciate that projects are supported by robust company systems and tools coupled with a tailored approach to their management. From experience, we realise that change is normal whilst a regulatory package is being developed and therefore, we need to be smart and efficient in managing these changes to keep the submission on track. When communicating with government officials, the records of these exchanges and justifications for a particular strategy are valuable assets. Our system ensures that copies of all records are managed and securely held on a client s behalf.

8 With offices in UK Ireland Germany France Spain Slovenia Slovakia Poland Hungary Romania