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 THE TSGE GROUP D espite 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 a significant challenge to industry. TSGE has invested in and developed a pan-european infrastructure to meet those challenges presented by differing requirements across the Union. The TSGE Group has offices in the UK, Ireland,,, and Poland offering focussed, local registration support. TSGE Deutschland 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 regional offices have the necessary regulatory skills and are experienced, approachable and dependable. If your company requires single EU Member State or country 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. TSGE Iberia TSGE Poland TSGE 1

3 PLANT PROTECTION PRODUCTS T he approval of plant protection products is the responsibility of each EU Member State. The Plant Protection Products Regulation (1107/2009) establishes the rules and procedures with which each Member State must comply to grant or refuse a product approval. Despite ongoing efforts at harmonisation and mutual recognition procedures some Member States maintain different administrative and regulatory or data requirements (some of which are based on differences such as climate or soil type). These requirements and their constant change represent a challenge for companies wishing to place their plant protection products on the market. BIOCIDAL PRODUCTS T he 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 528/2012(EC) 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. TSGE GROUP REGIONAL OFFICES is located in Knaresborough, UK and in Dublin, Ireland. National product authorisation is co-ordinated by Dr Meritxell Guino. also provides scientific expertise in the fields of chemistry, human health and environmental science. We believe 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 industry. DR MERITXELL GUINO Concordia House St James Business Park Grimbald Crag Court Knaresborough North Yorkshire HG5 8QB T +44 (0) F +44 (0) E [email protected] Ireland Sweden Denmark Finland Norway TSGE Deutschland is based in Hildesheim,. The team of registration specialists is headed by Herman Wilhelmy, an experienced and highly regarded regulatory consultant with significant registration experience gained from his time in the industry. On behalf of the TSGE Group, TSGE Deutschland 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. HERMANN WILHELMY TSGE Deutschland GmbH Richthofenstrasse Hildesheim T +49 (0) E [email protected] TSGE Iberia is based in Oviedo,. The team of registration specialists is headed by Maria Fernandez, an experienced and highly regarded regulatory consultant. MARIA JESUS FERNANDEZ VILLAMIL TSGE Iberia, S.L. Avenida de Galicia, 22 5 o Dcha Oviedo Asturias T E [email protected] Austria Belgium Netherlands Luxembourg Switzerland France Portugal Italy Greece Cyprus Malta 2 3

4 TSGE SLOVENIA TSGE is based near Ljubljana. The team of registration specialists is headed by Bojana Zgonec, an experienced and highly regarded, multilingual regulatory consultant. Product Authorisation in Europe: Supported by Our Scientific and Technical Expertise BOJANA ZGONEC TSGE d.o.o. Špruha Trzin T +386 (0) E [email protected] TSGE SLOVENIA Bulgaria Romania Czech Republic Latvia Lithuania Estonia Slovakia Hungary Serbia Croatia Bosnia Montenegro Macedonia With more than 40 scientists consulting across Europe, is a leading regulatory consulting company providing scientific, regulatory and registration services in the animal health, biocide, plant protection, general & speciality chemical and cosmetic sectors of the chemical industry. TSGE POLAND TSGE Poland, based in Warsaw, is managed by Aleksandra Gniado, a registration specialist. ALEKSANDRA GNIADO TSGE d.o.o. sp. z.o.o. ul. Puławska 405a Warszawa Poland T +48 (0) E [email protected] 4

5 CONTACT US GENERAL ENQUIRIES Dr Meritxell Guino Concordia House, St James Business Park Grimbald Crag Court Knaresborough North Yorkshire HG5 8QB T +44 (0) E [email protected] Maria Fernandez Avenida de Galicia, 22, 5º dcha Oviedo Asturias T E [email protected] Herman Wilhelmy Richthofenstrasse Hildesheim T +49 (0) E [email protected] TSGE SLOVENIA Bojana Zgonec Špruha Trzin T E [email protected] TSGE POLAND Aleksandra Gniado TSGE d.o.o. sp. z.o.o. ul. Puławska 405a Warszawa Poland T +48 (0) E [email protected]