Confidentiality Principles in the Biocidal Product Authorization Dossier
The Annex II-A active substance data set contains comprehensive information and data on the active substance. Most of this information is classified as confidential. Your active substance supplier may not wish to share Annex II-A dossier requirements due to confidentiality concerns. At this point, CRAD acts as a bridge organization, obtaining the necessary information and documents from your supplier, placing them in the file, and submitting it to the ministry.
This eliminates the active substance supplier's confidentiality concerns. (Another alternative: The supplier can submit the Annex II-A dossier to the Ministry without sharing it directly with the company or consultant. Here, they refer to our petition and share their own information directly with the Ministry.)