Costs of plant protection products' registration in Poland.

摘要

This study assessed the costs of registration in Poland of a plant protection product with the following features: the active substances are listed in Annex 1 of Directive 91/414; the active substances are not present in any other plant protection products registered in Poland; and the scope of intended use is 2-3 agricultural crops. The assumption was made that all efficacy studies are performed in Poland and the producer orders and submits only the necessary minimum of efficacy data required by law. In case of price differences, the higher prices were calculated; and no discounts were considered. The prices were calculated according to price lists from January 2009 (without VAT). It was found that the registration costs are as follows: 155,000 PLN for efficacy studies, 10,000 PLN for the registrar fee, and 110,000 PLN for the cost of assessment by responsible authorities, for a total registration cost of 275,000 PLN.