For a medicine to be paid for by the Social Security Institution (SGK), it has to be included on SGK’s reimbursement list. This is a separate application with its own calendar, following marketing authorisation and price approval. Since 15 September 2026, applications for listing and for changes to listed products can be made only through SGK’s Drug Reimbursement Application System; physical filing is possible only if SGK determines a technical failure. The last deadline of 2026 is 30 November.
Who decides?
Under the SGK Drug Reimbursement Regulation, applications are assessed by two commissions. The Medical and Economic Evaluation Commission (TEDK) reviews the literature, clinical and economic data and pharmacoeconomic studies in the dossier. The Drug Reimbursement Commission (İGK) decides on listing, reimbursement rules and delisting. Applications proposing an alternative reimbursement model are also assessed under the Alternative Reimbursement Regulation.
Some applications, such as name or barcode changes, MA transfers and increased discounts, are processed by the Secretariat without waiting for a commission meeting.
Timeline: March, July and November
The İGK holds at least three ordinary meetings a year. Since the amendment of 28 November 2024, the application deadlines for each working period are the last working day of March, July and November. Under SGK’s procedures, the sales authorisation must also be uploaded to the system by the 15th of the month following the deadline at the latest (inclusive).
| Period | Application deadline | Sales authorisation by |
|---|---|---|
| November 2026 | 30 November 2026 | 15 December 2026 |
| March 2027 | 31 March 2027 | 15 April 2027 |
| July 2027 | 30 July 2027 | 15 August 2027 |
| November 2027 | 30 November 2027 | 15 December 2027 |
Once the meetings are concluded, decisions are sent to the SGK President within 15 working days, and the President reviews them within 10 working days. Applications that are not accepted or are still under assessment are notified to the company in writing, with reasons, within 10 working days of the President’s approval.
The SGK application is the last link in a chain: marketing authorisation, TİTCK price and sales authorisation. A sales authorisation is granted for a product whose price has been approved, and price applications are now made through TİTCK’s İFPAS system. The price and sales authorisation steps should be planned backwards from the target deadline.
Application categories
SGK’s procedures of 15 September 2026 group applications in two sets:
- Listing (Annex 1A, Listing Applications Form): reference products, biosimilars, products with no equivalent on the list and new molecules entering the list for the first time; equivalent products with an equivalent already listed; foods for special medical purposes.
- Changes to listed medicines (Annex 1B, Drug Information Changes Form): changes of company, barcode or name; changes of indication, SmPC/PIL or reimbursement rules; discount changes and delisting.
Reapplications after a rejection are no longer a separate category; they are filed with the documents of the relevant category.
What goes into the dossier?
A listing dossier has three parts:
- General: cover letter, undertaking and proof of signing authority, product information card, marketing authorisation, sales authorisation, barcode approval, approved SmPC/PIL and the TİTCK price list. For reference products, biosimilars and new molecules, also the FDA marketing authorisation/NDA number and/or EMA marketing authorisation, where available (not required for new molecules developed and authorised in Türkiye), and a table of the product’s authorisation and reimbursement status in OECD, reference and source countries. A distribution document showing that the product is on the market: submitted with the application for applications under Article 12 of the Regulation, and within the periods set in the Regulation for other listing applications; it is not required in listed exceptions such as medicines with a special distribution model or those listed by TEDK decision.
- Clinical data: ATC 4 and ICD-10 codes, treatment regimens, efficacy and safety tables, comparison with alternative treatments, epidemiology and the estimated prevalence in Türkiye. All studies with evidence level I or II are provided in full, and abstracts of other sources, with sworn Turkish translations.
- Pharmacoeconomic evaluation: for equivalent products with an equivalent already listed, a unit price comparison table is enough. Other products need a cost-minimisation or cost-effectiveness analysis with sensitivity analysis and the “New Treatment Balance” tables. Alternative reimbursement applications add the Drug Offer Form (Annex 11).
Format rules can also cause delays. A separate dossier is needed for each strength, pack size and pharmaceutical form. Documents must be copyable, unencrypted PDF or DOCX files, and all content must be in Turkish. Proof that the person filing the application is authorised to act for the company is part of the dossier.
Incomplete files and rejections: a lost period
- If a dossier for commission review is found incomplete, it is not placed on the agenda. It is placed on the agenda only if the missing items are completed by the next period’s deadline; otherwise the application must be made again.
- When additional information is requested during the assessment, the review stops until it is provided. If it is not provided by the end of the review, the decision is based on the information available.
- A company whose application is rejected can reapply within 2 months with its response to the grounds for rejection and any supporting documents, without preparing a new dossier. After 2 months, a new dossier is needed.
In practice, a single missing document can push a product’s listing to the next period.
The October 2026 amendment: from market share to drug market ratio
The 1% threshold has applied since the amendment of 28 November 2024. Under that amendment, a newly listed medicine with the lowest unit price in its group was left out of the band calculation until it reached a 1% market share, and the lowest-priced medicines that had not reached 1% in any of the last five months were removed from it. The amendment published in the Official Gazette of 3 October 2026 (No. 33389) rewrote this rule: “market share” was replaced by the “drug market ratio”, still based on the number of packs reimbursed by SGK, and “band” by the “payable unit price range”. The rule now covers internal reference and equivalent groups, and the relevant provisions refer to Medula data instead of “market shares”. The amendment also expressly requires a distribution document at the time of application for applications under Article 12.
What works in practice
- A calendar planned backwards from the target period: price approval, sales authorisation and, where required, the distribution document
- Early selection of the clinical literature by evidence level, with sworn translations planned from the start
- A well-justified comparator in the pharmacoeconomic analysis, adapted to Turkish data
- The system user and authorisation documents ready before the deadline
From the price application and sales authorisation to preparing the SGK dossier and following the commission process, we at Melvin International Consulting would be glad to give you the most professional support at every step. See our Pharmaceutical Market Access service or get in touch.
Sources: SGK Drug Reimbursement Regulation (OG 25.08.2022, 31934 bis), Art. 4–7, 12, 14 and 15; amendments OG 28.11.2024, 32736 and OG 03.10.2026, 33389; SGK Procedures and Principles for Drug Reimbursement Applications (15.09.2026), Art. 4–6; Regulation on the Marketing Authorisation of Human Medicinal Products, Art. 28. This article is for general information only; current legislation and SGK announcements prevail.
