- 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.
Information related to investigation is required for the application form, such as the initiation and termination date and duration of the investigation, the number of volunteers in Turkey (that is approved by the MoH/TİTCK) or the maximum allowed dosage. Also it is mandatory to declare the quantity of study products with details in the submission form.
- Proforma invoice for the investigational product (Approved by the company who issued the invoice or approved by the sponsor who made submission to import, wet signed, in two copies, with proforma date/number and page numbers)
- Original Power of Attorney (only for the first submission),
- In case of the use of products obtained from blood in drug clinical investigations, an “apostilled” original document that will be given by the manufacturer company regarding Creutzfeld Jacob (CJ) disease, including that they are safe in terms of disease or suspicion of disease and that no CJ disease is present among donors.
Import license can be received within maximum 2-4 weeks after submission.
Yes, the IL will be valid for one year for the quantity of study products specified in the submission.
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.
Signed Proforma Invoice, the MSDS and the ATR document are required for the shipment.
No, IL is not required for laboratory sets/consumables. Only these materials is necessary customs procedures at the customs Turkey.
The ATR document is required for the shipment.