The Turkish Medicines and Medical Devices Agency (TİTCK) has been founded in charge of regulating drugs, active and excipient ingredients used in the production of pharmaceuticals, agents which are subject to national and international controls, medical devices, extracorporeal diagnosis devices, traditional herbal medicinal products,  cosmetic products, homeopathic medicinal products and special purpose dietary products according to the policy and objectives of the Ministry of Health, in the scope of the Ministry of Health, special budgeted, possessing a public corporate entity and has been published in the official gazette with the 02.11.2011 dated and 28103 numbered decree law. İEGM which is the abbreviation of the General Directorate of Pharmaceutical and Pharmacy in Turkish is the former name of TİTCK. For more information on the Agency you may visit the Web Site of the Agency.

Pharmacovigilance is defined as the gathering of clinical data related to the drug reliability in the daily clinical applications, the tracking of problems which are experienced during the application of drugs, determining the responsible reasons, identification, research, recording, announcing, and taking the necessary precautions.

It also comprises the scientific studies related to the determining of the adverse effects and the other possible problems based on medicinal products for human use, analysis, identification and prevention.

Source: http://farmakovijilansdernegi.org/

The Pharmaceutical Track and Trace System consists of two phases based on its structuring. As it was believed that applying all the rules of the supply chain at one will raise difficulties for the stakeholders, the decision was made to apply the system with a two level transition. These transitions are called Phase 1 and Phase 2.

Phase 2 is the phase of the Pharmaceutical Track and Trace System which is in operation right now. Making the production, importation, dispatch, consumption, dispatch return, deactivation, purchase approval, exportation and dispatch cancellation notifications has been made obligatory with Phase 2.

The starting date of Phase 2 is January 1, 2012. As of this date all the products whose production notification is made are considered as Phase 2 products. The important point here is that, the date that created the distinction between Phase 1 and Phase 2 is not the date of the product’s physical production, it rather is the date of the production notification. All the products whose production notifications have been done after this date will be treated as Phase 2 products in its transactions. For more information you may examine the “Phase 1 – Phase 2” article.

ITS operates on the basis of single drug units. However, commercial transfers are not done by single units; instead they are done using transport units such as bundles, cases and pallets. Thus, the need to share information of the transport units among the stakeholders arose. Therefore, an XML file standard that includes the hierarchical relation between the transportation unit and the drug units has been developed with the contribution of the stakeholders. Furthermore a secondary system, ITS-PTS, operating as web services has been developed to allow stakeholders to share created XML files among each other. 

ITS-PTS uses the ITS authentication system in order to share transfer files among the stakeholders. In addition it also contributes to the stock regulation and tracking since it also contains the hierarchical structure of the transfer units.

For more information, visit the Package Transfer Service page.

Representative pharmaceutical wholesalers have been founded for the purpose of adding a prospectus, labeling, price printing and similar secondary packaging services as well as storing and packaging drugs which have received authentication/permit by the Ministry of Health. Working places receive a permit according to Good Distribution Practices due to its wholesaler character, and according to the Good Manufacturing Practices due to its production site character.