BABOLNA BIO, as a founding member of the Bromadiolone Task Force has made a major input and contribution to its Bromadiolone Dossier. Bromadiolone, as a second generation anticoagulant has been notifeied under Product Type 14. of Rodenticides. As a result the Swedish Rapporteur has found the content of the Dossier as acceptable and has issued a positive Competent Authority Report (CAR) in July 2009.

The expected EC approval and Annex 1. inclusion is forecasted for 2010.

For the different formulations, BABOLNA BIO has started the preparations of the Product Dossiers. It is expected that authorizations will be made according to the Mutual Recognition (MR) system.

S-methoprene

The second Dossier of BABOLNA BIO has been prepared for S-methoprene insect growth regulator (IGR), under Product Type 18 of Insecticides. Within the European Union, BABOLNA BIO is the only company who has made a Dossier for this highly specific active ingredient. The Irish Rapporteur has forecasted the Competent Authority Report to be ready by August 2010. Annex 1. inclusion is expected in 2011.

S-methoprene is synthetized under Good Manufacturing Practice (GMP) conditions. The accompanying Drug Master File (DMF) is under evaluation for „Certification of Suitability”.

Preparations of formulation Product Dossiers are ongoing.