Turkey’s Medicines and Medical Devices Agency (“TMMDA”) announced the information and documents that should be submitted via “online system” within the scope of “e-transformation in public” for import applications of blood products, human medicinal products containing blood products as well as immunological products starting as of 27 May 2019.
Pursuant to the Communiqué on Import Inspection of Certain Products Inspected by the Ministry of Health published in the 30 December 2018 dated Official Gazette, only the control and proforma invoices will be submitted physically, and the other information and documents requested according to the type of application will be via online system within the scope of e-transformation in public studies.
Within this scope,
- Blood products or human medicinal products containing blood products should be notified of the amount requested to be offered for sale in order to be placed on the market, and the following information and documents (to be submitted physically if requested by the TMMDA) should only be submitted in the electronic application annex;
- Name and content of human medicinal product
- Serial release certificate approved by the National Health Authority (apostilled / approved by the consulate) issued by an accredited national or international laboratory for each batch
- Original copy of the analysis certificate approved by the production center’s technical director, for each batch
- The original copy of the document issued by the licencer for the imported or licensed manufactured products, indicating the country in which each batch is licensed / produced and in which countries it is sold
- The rules for plasma donation, the date of collection of the plasma and the type of donor (voluntary, paid) and, where necessary, the list of donors
- The document given by the above-mentioned laboratory indicating that each donor and plasma pool has been subjected to the tests specified by TMMDA in addition to test results
- The original copy of the document issued by the manufacturer that the donors are safe from the illnesses or diseases suspected by TMMDA (e.g. Creutzfeld-Jacob (CJ) disease) and that there are no donors among these donors, for each batch
- Up-to-date variation undertaking taken from licensing firm and the license owner
- The photocopy of the license issued by TMMDA.
- For immunization medicinal products for human use, the following information and documents (to be submitted physically if requested by TMMDA) should be submitted only in the annex of the electronic application by notifying the amount requested for sale:
- Batch/lot release certificate (apostilled / approved by the consulate) approved by the National Health Authority and issued by an accredited national or international laboratory, for each batch
- Original copy of the analysis certificate approved by the production center’s technical director, for each batch
- Up-to-date variation undertaking by the licensing firm and the license owner
- Photocopy of the license issued by TMMDA.
You may reach TMMDA’s announcement from this link (only available in Turkish).