A New Era in the Procurement of Medicinal Products for Human Use from Abroad by the Social Security Institution: Presidential Decree No. 11190

The Procedures and Principles Regarding the Procurement of Medicinal Products for Human Use from Abroad and the Procurement of Related Services by the Social Security Institution under subparagraph (h) of Article 3 of Public Procurement Law No. 4734 (“Presidential Decree No. 11190”) entered into force upon its publication in the Official Gazette dated 24 April 2026.

With Presidential Decree No. 11190, newly introduced into our legislation, the procedures and principles applicable to the procurement of medicinal products for human use from abroad for personal treatment purposes, as well as the procurement of related services, have been determined.

Through Presidential Decree No. 11190, the processes of the Social Security Institution (“SSI”) for the procurement of medicinal products from abroad are structured around fundamental principles such as transparency, competition, equal treatment, reliability, confidentiality, meeting needs under appropriate conditions and in a timely manner, and efficient use of resources. The Decree aims to ensure that medicinal products for human use procured from abroad for personal treatment purposes are delivered to beneficiaries of the general health insurance scheme without interrupting their treatment.

The key regulations introduced by Presidential Decree No. 11190 are outlined below.

Commission for the Procurement of Medicinal Products from Abroad

One of the most significant innovations introduced by the regulation is the establishment of the Commission for the Procurement of Medicinal Products from Abroad to carry out the procedures and operations related to the procurement of medicinal products for human use from abroad and the procurement of related services.

The Commission will assume a central role in processes such as the establishment and operation of the dynamic purchasing system, the implementation of other procurement methods, the determination of the required quantities, and the selection of the procurement method. The Commission is required to consist of at least five members and an odd number of members, convene fully, adopt decisions by majority vote, and members are not permitted to abstain.

The Commission will determine the quantity of products to be procured or the nature and duration of the service by taking into account criteria such as estimated demand, budgetary constraints, product-specific considerations, and past consumption levels.

In determining the procurement method to be applied for medicinal products for human use to be procured from abroad and for related service procurements, the Commission will consider factors such as the number of suppliers listed in the medicinal product supply source list for the relevant product, the existence of any exclusive rights over the product or service, the required quantity, the urgency of the need, and other criteria stipulated under the relevant legislation. The procurement method determined as a result of this assessment will be submitted for the approval of the contracting authority.

Medicinal Product Supply Source List

The SSI will register real or legal persons who are capable of supplying medicinal products for human use from abroad and who meet the relevant criteria in a medicinal product supply source list on a product-specific basis.

Where more than one supplier is listed for a particular medicinal product for human use, the use of the dynamic purchasing system is envisaged as a rule. However, the Commission may decide to apply a different procurement method by taking into account the characteristics of the specific product and market-specific conditions.

Moreover, in order to identify medicinal products not included in the medicinal product supply source list and alternative products to those listed, market research may be conducted where deemed necessary. This authority is particularly important for identifying alternative treatment options and ensuring supply security.

In order to be admitted to the list, applicants must meet the criteria determined by the Turkish Medicines and Medical Devices Agency regarding the procurement of medicinal products from abroad and must not have had any contracts concluded with the SSI terminated within the last two years due to prohibited acts or conduct.

Dynamic Purchasing System

Pursuant to Presidential Decree No. 11190, a dynamic purchasing system may be established for the procurement of medicinal products for human use from abroad. This system will be open to all potential tenderers and will be based on a pre-qualification assessment conducted in accordance with the criteria specified in the pre-qualification documents. At this stage, candidates will not be required to submit price offers.

After the establishment of the system, real or legal persons meeting the pre-qualification criteria may apply to join the system at any time. Candidates whose applications are rejected will have the opportunity to reapply after remedying the deficiencies. However, candidates whose pre-qualification applications for the same medicinal product for human use are rejected three times within the same calendar year will not be allowed to reapply for the same product within that year.

For each individual procurement conducted under the dynamic purchasing system, all tenderers registered in the system for the relevant medicinal product for human use will be invited to submit tenders, with sufficient time being granted. Together with this invitation, the procurement documents relating to the individual procurement will also be provided to the tenderers.

The individual procurement documents will include the active substance, pharmaceutical form and other technical characteristics of the products to be procured, as well as the estimated procurement quantities and, where applicable, non-price evaluation criteria.

Tenders submitted will be evaluated not only on the basis of price but also, where specified, taking into account non-price elements. As a result of this evaluation, an individual contract will be concluded with the tenderer determined as having submitted the most economically advantageous tender.

On the other hand, the establishment of a dynamic purchasing system does not create an obligation for the SSI to conduct procurement through this system. Where necessary, the Institution may procure the relevant products by using other procurement methods stipulated under Presidential Decree No. 11190.

Applicable Procurement Procedures

Within the scope of Presidential Decree No. 11190, three main procurement procedures stand out for the procurement of medicinal products for human use and related services:

• Open tender procedure: the classical procurement method in which all tenderers may submit bids.

  
  

• Negotiated procedure: a method in which tenderers invited by the SSI may submit bids without prior publication. It may be used in cases where urgent procurement is required due to sudden and unforeseen events, for cargo and customs brokerage services, and for procurements below certain monetary thresholds.

  
  

• Direct procurement: may be applied in cases where the need can only be met by a single supplier, where there are exclusive rights, for products that are not economically storable, for services that must be procured from abroad, and for procurements below certain monetary thresholds.

In this respect, the regulation provides flexibility specific to situations such as single-source supply, urgency, non-stockability, and exclusive rights, which may arise due to the nature of the procurement of medicinal products from abroad.

Criteria for the Evaluation of Tenders

Pursuant to Presidential Decree No. 11190, the most economically advantageous tender will be determined either solely on the basis of price or by taking into account price together with non-price elements such as operating and maintenance costs, cost-effectiveness, efficiency, quality, and technical value in service procurements related to medicinal products for human use; and, in the case of medicinal products for human use, elements such as expiry date, delivery time, and the quantity of the product offered.

In procurements where the most economically advantageous tender is determined by taking into account non-price elements, the monetary values or relative weights of such elements will be specified in the procurement documents.

Furthermore, procurements may be conducted in foreign currencies. The currency in which tenders will be submitted will be specified in the procurement documents.

Pharmacovigilance, Secondary Packaging and Similar Services

Under the regulation, services such as pharmacovigilance, secondary packaging, and other similar services required for the procurement of medicinal products for human use from abroad and their delivery to beneficiaries of the general health insurance scheme may be procured through service procurement procedures in accordance with the relevant procedures and principles set out in Presidential Decree No. 11190, or such services may be procured from the same contractor together with the procurement of medicinal products for human use.

Notification of Procurement Results and Audit Dimension

The results of procurements of medicinal products for human use and related services carried out under Presidential Decree No. 11190 will be notified to the Public Procurement Authority within a maximum of 15 working days.

In addition, it is stipulated that the relevant provisions of Laws No. 4734 and 4735 regarding exclusion from procurement procedures, prohibited acts and conduct, prohibition, and penal liability will apply.

Conclusion

Presidential Decree No. 11190 aims to place the SSI’s processes for procuring medicinal products from abroad on a more institutional, predictable, and competitive footing. In particular, the Commission for the Procurement of Medicinal Products from Abroad, the medicinal product supply source list, and the dynamic purchasing system indicate that a more structured procurement model will be established in this field. It is expected that, in the upcoming period, the decisions of the Commission for the Procurement of Medicinal Products from Abroad will play a decisive role in practice.

We hope that the procedures and principles introduced by the regulation will facilitate patients’ access to treatment and contribute to the efficient use of public resources.

AUTHORS

Nuri Melih İnce