Beşeri Tıbbi Ürünlerin Fiyatlandırılmasına İlişkin Kılavuzda Revizyona Gidilmiştir.

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The Decision on the Pricing of Medicinal Products for Human Use was published on 12 March 2026, followed by the Communiqué on the Pricing of Medicinal Products for Human Use (the “Pricing Communiqué”), which sets out the implementing provisions, on 29 August 2026. Accordingly, revisions have also been made to the Guideline on the Pricing of Medicinal Products for Human Use (the “Guideline”), prepared pursuant to the Pricing Communiqué, which governs the format, content and assessment of applications submitted to the Turkish Medicines and Medical Devices Agency (“TİTCK”). The first revision, dated 11 September 2026, updated calculation terminology, examples and document templates, while the second revision, dated 20 October 2026, updated the explanations concerning the determination of the actual source price and the documents to be submitted with applications.

The recent amendments to the Guideline are outlined below.

First Revision Dated 11 September 2026

Calculation of the Arithmetic Mean Price

In Section 3.4.3.1, the term “unit average” has been replaced with “arithmetic mean price”. The revised text explains that a price may be set at up to 50% of the arithmetic mean price of identical and matching products, while requests for lower prices are subject to assessment by the Commission.

Examples 36, 37 and 44 and Annexes 3, 4 and 8

Examples 36 and 37, concerning voluntary price reductions, and Example 44, concerning cost calculations, have been revised in line with the applicable legislation. The Turkish and English export certificate templates (Annexes 3 and 4) and the cost sheet template (Annex 8) have also been updated. Applications should be prepared using the updated calculation examples and document templates.

Second Revision Dated 20 October 2026

Determination of the Actual Source Price of Imported Reference Products, Domestically Manufactured Reference Products and Imported Generic Products

The following sentence has been added to Sections “3.1.1. Determination of the actual source price of an imported reference product”, “3.1.2. Determination of the actual source price of a domestically manufactured reference product” and “3.1.3. Determination of the actual source price of an imported generic product”:“Further details are provided in Sections 9.1 Price Notification Form and 9.2 Price Declaration Document.”

The framework for determining the actual source price remains unchanged. The revised text clarifies that, where countries listed in Annex 2 are consulted, the detailed requirements concerning the submission of documents and data under Sections 9.1 and 9.2 must be taken into account. The revisions to these three sections clarify the link with the data submission requirements rather than alter the order in which prices are determined.

Changes to the Requirements for the Price Notification Form and the Price Declaration Document

The previous text of Section 9.1, concerning the Price Notification Form, specified the product and price information to be included in the form and the order of priority for selecting the source product. The revision introduces a more detailed data submission requirement for cases in which prices from countries listed in Annex 2 are to be submitted. In such cases, price information for the ten countries in which the product has the lowest ex-factory prices must be submitted, together with market share (%) data for the relevant countries. Where data for ten countries cannot be accessed, data must be submitted for as many countries as are accessible. At this stage, price information may be obtained only from identical products. Accordingly, the ten-country rule should not be construed as an unconditional requirement applicable to all applications.

The previous text of Section 9.2, concerning the Price Declaration Document, specified the product, price, marketing authorisation, market availability and reimbursement information to be included in the declaration. However, it did not contain these specific explanations concerning the submission of data for ten countries and market share data at the Annex 2 stage. The revision expressly extends the requirements under Section 9.1 concerning the ten countries, the number of countries for which data are accessible, market share and identical products to the Price Declaration Document. It also provides that newly prepared declarations must include price information for ten countries or, where data for that number of countries cannot be accessed, information for the countries for which data are accessible. For declarations that have already been prepared, a supplementary price declaration containing prices for ten countries is required. The requirement for a supplementary declaration should therefore be considered separately in respect of existing documents.

Conclusion

While the first revision updates calculation terminology and sample documents, the second revision clarifies the scope of price research involving countries listed in Annex 2 and the supporting documentation. When preparing application dossiers, particular attention should be paid to ensuring consistency between the Price Notification Form and the Price Declaration Document, selecting the relevant prices from identical products, preparing market share data on a country-by-country basis and checking whether supplementary documentation is required for existing declarations.