- It is necessary to submit to MoH to both import investigational medicinal products and export the biosamples, Import Licence (IL) is required to initiate the import and export licence (EL) is required to initiate the export.
- First of all, the first conformity submission dossier of the clinical trial must be approved by Turkey Pharmaceuticals and Medical Devices Agency (TİTCK) before the IL submission.
- An “Authorization Letter” from the company is required for submissions to the MoH.
- MoH has “Submission Form for Import of Research Products to be Used in Clinical Research”, it is enough to use this form for submission. English translation of the submission form is provided to the sponsor when an agreement is made with the sponsor.
If the sponsor want to send all study products in one shipment, then all total amount have to be written in the submission form. In this situation, import licence that will be given from MoH will be valid for all study products. Otherwise, if the sponsor prefer to send study products in several shipments, the submission dossier must be submitted again to the MoH for each import.