Our Active Substance Supplier does not want to share the Annex II-A File Requirements due to Confidentiality Reasons, what should we do?

The Annex II-A active substance data set contains comprehensive information and data about the active substance. The majority of this information is classified as confidential information.

At this point, as CRAD, we can recommend that our customers obtain the file under a confidentiality agreement with the suppliers or, if the active substance manufacturer has an authorized company in Turkey, that it submits the file to the Authority in reference to the applicant.