Regulatory approach. To obtain approval the product Alibi Flora must (where appropriate) meet the conditions of EU inclusion and be supported by dossiers satisfying the requirements of Commission Regulation (EU) Nos. 283/2013 and 284/2013, which adopt the requirements of Xxxxx XX and Xxxxx XXX, and the Uniform Principles (Annex VI) to Regulation (EC) 1107/2009. This application was submitted in order to allow the approval of this product in the Netherlands in accordance with the above.
Regulatory approach. To obtain approval the product Ascra Xpro must meet the conditions of Annex I inclusion and be supported by dossiers satisfying the requirements of Xxxxx XX and Xxxxx XXX, with an assessment to Uniform Principles, using Annex I agreed end-points. This application was submitted in order to allow the first approval of this product in the Netherlands in accordance with the above.
Regulatory approach. To obtain re-approval/approval the product XXXXX Xxxxxxxx must meet the conditions of Annex I inclusion and be supported by dossiers satisfying the requirements of Xxxxx XX and Xxxxx XXX, with an assessment to Uniform Principles, using Annex I agreed end-points. New Annex II data were included because they are considered essential for the evaluation (mainly data from open sources) and in this case a full study summary has been provided. The product has been previously evaluated in Germany (Reg. No. 024407-00) and other member states according to Uniform Principles. This application was submitted in order to allow the re-registration in accordance with the above.