2026 marked a new era for two key types of TİTCK application. GMP inspection applications for sites abroad moved to the Z-Denetim Portal in April, and price applications moved to the Medicines Pricing and Market Analysis System (İFPAS) with the price change period that opened in September. In September, SGK also made reimbursement applications electronic-only. What these changes have in common: getting the data right the first time matters more than ever.
İFPAS: the price calculation is now visible
TİTCK opened İFPAS for testing on 27 August 2026. Together with the Communiqué on the Pricing of Human Medicinal Products of 29 August 2026 and the Pricing Guideline that took effect on 31 August 2026 (EDİT-KLVZ-11, last revised 20 October 2026), applications for the 2026 actual source price change period, which opened on 1 September, are made through İFPAS.
Users log in with their EBS credentials and move to İFPAS from the “New Price” step. The user guide defines these application types: first price assessment and publication in the price list; price list changes requiring reassessment; name/barcode changes and company transfers not requiring reassessment; voluntary price reductions; deactivation in the price list; price certificates for export; and submission of additional information, documents or explanations. Price Assessment Commission applications and the price change period have their own modules.
The key difference is that the calculation is done in the system. Authorisation data is pulled in as registered, the source price and other prices are calculated from the country prices submitted, and the calculation details are visible to the company. If a calculation looks wrong, TİTCK asks companies to check the data they submitted first and, if the difference remains, to report it to yenifiyat@titck.gov.tr. Differences found by TİTCK and requests for explanation are sent through İFPAS as deficiencies; if no explanation is provided, a rejection letter follows.
The status of each application is tracked in the system: In progress, Awaiting accrual, Sent to TİTCK, Incomplete/Incorrect, Rejected and Approved. Applications that carry a fee reach TİTCK once the accrual is completed with a reference code specific to the application. No paper documents are submitted; documents are scanned legibly and uploaded.
The second application window opens in December
The 2026 actual source price change period has two application windows:
| Window | Scope | Dates |
|---|---|---|
| First window | All reference products except biosimilars; reimbursed equivalents with no reference or pharmaceutically similar reference in the price list; products priced with a cost card | 1 September – 23 October (extended from 30 September) |
| Second window | Biosimilars; imported equivalents; reimbursed equivalents with a reference or pharmaceutically similar reference in the price list; non-reimbursed equivalents | 1–21 December |
| Assessment and final list | All applications | 1 September – 15 January; final list on 15 January |
An application is mandatory for every product on the active list, except locally manufactured non-reimbursed products and non-reimbursed traditional herbal medicinal products. Products whose price is not to change also need an application with a price declaration form and price declaration document. For imported products that should have applied but did not, the Ministry determines the actual source price itself: increases are not applied, while decreases are applied ex officio.
TİTCK’s announcement of 15 October 2026 added an important detail: where only prices from countries published by the Ministry are submitted, data for the 10 countries with the lowest ex-factory prices (or for all available countries, if fewer than 10) must be entered in İFPAS together with market shares, and price declaration documents must be prepared accordingly.
Z-Denetim: the GMP inspection application on one screen
The Ministry of Health’s app store listing describes Z-Denetim as a next-generation, AI-supported e-inspection platform developed by TİTCK. Since the company user guide took effect on 30 April 2026, company applications for GMP inspections of sites abroad are made through the Z-Denetim Portal. The portal’s login, overview and inspection management screens were redesigned in October 2026.
The flow described in the guide:
- Login. EBS username and password, then a verification code sent to the email address registered in EBS.
- Form details. The site and at least one product are selected, and the form matching the inspection type is chosen. When products are added, there is a separate field for the priority decision document.
- Authorised person and payment details. The fee is calculated automatically by the system.
- Summary and submission. On submission, a reference number is generated; the bank payment is made with this number and the payment status is updated in the system automatically.
- Tracking. The application status is followed on the “Inspection Management” screen. Fields that the manufacturing site is asked to answer put the process on hold until the site responds.
In practice, this means information gathering at the site is now part of the same process as the importer’s application. A late response from the site holds up the application directly. According to the guide, the site’s answers in the portal are not shown to the company user, so their content should be agreed with the site in advance.
What has changed for companies?
- Data quality is visible. Price calculations in İFPAS and fees in Z-Denetim are generated automatically; incorrect input produces incorrect results.
- Status tracking is routine work. Accrual, deficiency and rejection steps run through the systems, so application statuses need regular monitoring.
- User and authorisation management matters. Both systems use EBS credentials. In SGK’s system, too, proof of the filer’s authority is part of the dossier.
- Every step is charged separately. TİTCK’s fee tariff lists first price assessments, price change period applications, price list changes requiring reassessment and Price Assessment Commission applications as separate items; on the GMP side, even submitting missing documents carries its own application fee.
From price applications in İFPAS to GMP applications in the Z-Denetim Portal, we at Melvin International Consulting would be glad to give you the most professional support as TİTCK procedures go digital. See our Pharmaceutical Market Access and GMP Inspections services or get in touch.
Sources: Communiqué on the Pricing of Human Medicinal Products (OG 29.08.2026, 33355); TİTCK Pricing Guideline (EDİT-KLVZ-11, Rev. 2, 20.10.2026); İFPAS user guide for company applications (Version 4, 2026); TİTCK announcements on İFPAS (27.08.2026), on the 2026 actual source price change period (26.08.2026), extending the first application window (September 2026), to applicant companies (15.10.2026) and on the Z-Denetim interface (October 2026); Z-Denetim Portal application guide for company users (April 2026); TİTCK fee tariff. This article is for general information only; current legislation and TİTCK announcements prevail.
