FantasticSearch

Transitional measures concerning active substances evaluated under Directive 98/8/EC 1. The Agency shall be responsible for coordinating the process of evaluation of dossiers submitted after 1 September 2012 and shall facilitate the evaluation by providing organisational and technical support to the Member States and the Commission.

2. Applications submitted for the purposes of Directive 98/8/EC for which the Member States’ evaluation in accordance with Article 11(2) of Directive 98/8/EC has not been completed by 1 September 2013 shall be evaluated by the competent authorities in accordance with the provisions of this Regulation and, where relevant, Regulation (EC) No 1451/2007. That evaluation shall be carried out on the basis of the information provided in the dossier submitted under Directive 98/8/EC. Where the evaluation identifies concerns arising from the application of provisions of this Regulation which were not included in Directive 98/8/EC, the applicant shall be given the opportunity to provide additional information.

Every effort shall be made to avoid additional testing on vertebrates and to avoid causing delays to the review programme laid down in Regulation (EC) No 1451/2007 as a result of these transitional arrangements. Notwithstanding paragraph 1, the Agency shall also be responsible for coordinating the evaluation process of dossiers submitted for the purposes of Directive 98/8/EC for which the evaluation has not been completed by 1 September 2013 and shall facilitate the preparation of the evaluation by providing organisational and technical support to the Member States and the Commission from 1 January 2014.