Letter of Access management
KKDIK requires chemical substances that are placed on the Turkish market to be registered with the Turkish Ministry of Environment and Urbanization (MoEU), and pursues the principle "one substance, one registration".
All registrants of the same substance are obliged to the Joint Submission and must use the same data to avoid unnecessary animal testing.
The access rights and costs to the data for the participants of a Joint Submission are regulated via the so-called "Letter of Access" (LoA).
By signing the MBDF / consortium agreement, the co-registrant agrees to contribute to the total cost of registering a particular substance.
These costs consist of the data, dossier and administrative costs and are reflected in the LoA fee. After payment of the LoA fee, the co-registrant receives the agreed files necessary for registration and the token allowing him to access the Joint Submission. The LoA document is certifying the data access rights.
Since the start of KKDIK, we have been supporting MBDFs / consortia and lead registrants in the implementation of an efficient Letter of Access Management system – we are at your disposal as a competent partner with the following services:
- Communication with potential and existing co-registrants
- Set-up and update MBDF agreements
- Calculation of LoA fees
- Issuing LoA documents and exchanging the files required for registration with co-registrants
- Documentation and required data updates
- Management of LoA fees on bank accounts
- Recalculation and processing of reimbursements or additional charges
- Management of MBDFs and consortia
- Letter of Access management
- Study management
- Data management