Regulatory Support:      Annex I inclusion dossiers      Biocidal Product authorisation      

Annex I Inclusion Dossiers:

Dossiers in support of inclusion in Annex I of Directive 98/8/EC:

  • Product-type specific initial completeness check of data sets

  • Identification of data gaps; evaluation of the validity of existing studies; comprehensive literature searches

  • Preparation of complete dossiers for active substances and biocidal products, according to product-type specific data requirements, including preparation of a comprehensive IUCLID file

  • Performance of product-type specific risk assessments (product safety, human health, environment, efficacy assessment), including highly qualified data management

  • Submission and defence of dossiers in the review process