Recent Development
The Turkish Pharmaceuticals and Medical Devices Authority (“TİTCK“) announced new measures to fight the COVID-19 pandemic. The TİTCK provided detailed explanations on measures concerning readability tests; product certification applications; pharmaceuticals used by patients with chronic diseases; and scientific meetings approvals.
What’s New?
Readability Tests
According to the Regulation on Packaging Information, Instructions for Use and Tracking of Pharmaceuticals, pharmaceuticals’ instructions for use must be easily readable, clear and comprehensible. Pharmaceutical companies must also carry out readability tests with patient groups and submit their results to the TİTCK.
In this regard, considering the risks arising from face-to-face readability tests during the COVID-19 outbreak, the TİTCK announced that pharmaceutical companies can submit readability test results, which are mandatory for license applications, to the TİTCK prior to the sale permit application, instead of being submitted during the initial license application. The TİTCK’s announcement is available online here (in Turkish).
Applications to the Pharmaceutical Product Certification Unit
To reduce the risks arising from submitting physical documents for product certification applications to the Pharmaceutical Product Certification Unit, the TİTCK required applications for certificates subject to payment to be made at the end of the certificate approval evaluation period, which is 10 workdays. Accordingly, pharmaceutical companies should postpone their applications to a suitable date, taking into account the TİTCK’s administrative evaluation and approval periods.
The TİTCK also noted that all assessments on applications will be made electronically, and required pharmaceutical companies to upload copies of their physical documents to the Electronic Process Management system. The TİTCK’s announcement is available online here (in Turkish).
Supply of Pharmaceuticals by Patients with Chronic Diseases
On March 16, 2020, the TİTCK announced temporary measures to facilitate patients’ access to pharmaceuticals used in treating chronic illnesses. In this regard, the TİTCK recently prepared a roadmap document for patients and pharmacies regarding the supply of pharmaceuticals used with a pharmaceutical safety inspection form and limited distribution pharmaceuticals. The TİTCK’s guidance document is available online here (in Turkish).
Scientific Meeting Approvals
With respect to the postponement of organizations and events according to the Presidential Circular No. 2020/3, the TİTCK announced that web-based meetings organized by license/authorization holder pharmaceutical companies are not subject to this regulation. In this respect, pharmaceutical companies must apply to the TİTCK to organize web-based scientific meetings that they wish to organize or sponsor. The TİTCK’s announcement is available here online (in Turkish).
Conclusion
The TİTCK continues to take active steps to protect the public against the COVID-19 pandemic in Turkey. All pharmaceutical companies must comply with the TİTCK’s instructions for regulatory approvals and follow the TİTCK’s announcements in this regard.
Please refer to https://www.esin.av.tr/coronavirus-desk/ for our client alerts regarding the legal consequences of COVID-19 on other areas.
