What is KKDIK SIEF ?
The most important part of the KKDIK TURKREACH registration process is the Substance Information Exchange Forum (SIEF) Management. According to KKDIK Regulation, Substance Information Exchange Forums are held in two stages.
The purpose of each SIEF is to share the information required for registration among potential registrants, to prevent duplication of studies, and to agree on classification and labeling between potential registrants where there is a classification and labeling difference.
SIEF participants share their existing test studies with other SIEF participants according to their needs, and ensure that the test studies carried out have not existed before. Each SIEF continues its activities until 31/12/2025.
How to Share Test Works in Substance Information Exchange Forums?
Before tests are carried out to obtain the necessary information for registration purposes, SIEF participants investigate whether a relevant study is available in their SIEF. If a relevant study including tests on vertebrate animals is available in the SIEF, the SIEF participant requests this study. If a relevant study that does not include tests on vertebrate animals is available in the SIEF, the SIEF participant can request this study. Within one month of the study request, the owner of the study provides evidence regarding the cost of the study to the requesting participant or participants. Participants and the owner of the study make every effort to ensure that the cost of sharing information is distributed fairly, transparently and without discrimination. Calculation of the proportional sharing amount can be facilitated by obtaining the opinion of the Ministry. If the parties do not agree, the cost will be shared equally. The study owner allows the full study report to be referenced for registration purposes within two weeks of receiving the payment. Registrants only share the cost of the information required to meet registration requirements.
How to achieve SIEF Management?
For SIEF Management, first of all, Pre-SIEF registration should be made by the Only Representative or a 3rd party representative. Pre-SIEF participants should be contacted and collaborations should be arranged, and contracts should be prepared. In Substance Information Exchange Forum (SIEF) communication, it is necessary to collect and evaluate a considerable amount of information, especially on data, from pre-SIEF and co-registrants.
Our KKDIK SIEF Management Service
SIEF Management: After pre-SIEF registrations, we provide the following services to the companies we represent.
- Coordination of data sharing
- Joint presentation and financial management of jointly created files
- Management of access letters (communication with relevant parties, distribution of documents, follow-up of payments, etc.)
- Coordination, organization and documentation of telephone conferences and meetings
- Signing contracts within the consortium and with other interested parties (i.e. legal form, letter of access)
- Financial support according to the relevant legal form
- Securing formal requirements in accordance with KKDIK regulation.