Introduction
Foreign medicine supply in Turkey is a special legal mechanism that allows certain medicines to be supplied from abroad when they are needed for patient treatment but are not available through the ordinary Turkish pharmaceutical market. This mechanism is known in Turkish as yurt dışından ilaç temini. It is particularly important for oncology medicines, rare disease treatments, biological products, genetic therapies, orphan-like medicines, medicines temporarily unavailable in Turkey, and products that have not yet received Turkish marketing authorization.
Foreign medicine supply is not an ordinary import, not an online medicine purchase, and not a free commercial activity. It is a regulated healthcare process controlled by the Turkish Medicines and Medical Devices Agency, known as TİTCK, and carried out through authorized channels such as the Turkish Pharmacists’ Association, known as TEB, and SGK / İbn-i Sina Social Security Center where reimbursement rules apply. The legal framework is primarily based on the Yurt Dışından İlaç Temini Yönetmeliği and the related TİTCK guide.
The purpose of the foreign medicine supply regulation is to determine the procedures for supplying, on prescription and for personal use, human medicinal products that are not yet licensed in Turkey or are licensed but unavailable for various reasons, while protecting a high level of patient health. The regulation also covers hospital bulk supply from abroad in defined circumstances.
For pharmacies and pharmacists, this topic is legally sensitive. Ordinary community pharmacies are not free to directly import any medicine requested by a patient. Their role is primarily to guide patients correctly, avoid unlawful supply, protect prescription and patient data, comply with medicine tracking and storage duties, and prevent misleading or illegal practices. Where a pharmacy is involved in delivery, counseling, documentation or patient communication, it must act within the formal foreign medicine supply framework.
Legal Framework for Foreign Medicine Supply in Turkey
The main regulatory source is the Yurt Dışından İlaç Temini Yönetmeliği, published in the Official Gazette on 3 February 2023 and later amended. The regulation applies to industrially prepared human medicinal products supplied from abroad for personal use on prescription, as well as hospital bulk supply from abroad and the real or legal persons involved in these processes. It does not cover clinical trial medicines, early access program medicines, or personal luggage-type medicines that are clearly not imported for commercial or professional activity.
The related TİTCK guide explains that the purpose of the system is to ensure the medical, ethical, legal and rational use of medicines supplied from abroad for diagnosis and treatment where products are not licensed in Turkey or are licensed but unavailable for various reasons.
This legal framework must be distinguished from ordinary pharmaceutical market authorization. A medicine supplied from abroad under this system is not necessarily a product generally authorized for free commercial sale in Turkey. It is supplied under a special patient-based or hospital-based mechanism, subject to TİTCK evaluation, prescription requirements, documentation, tracking and authorized supply channels.
Which Medicines Can Be Supplied from Abroad?
Foreign medicine supply may be used for medicines that are necessary for treatment but are either not licensed in Turkey or are licensed but not produced or imported for various reasons. SGK explains that medicines necessary for insured persons’ treatment may be supplied from abroad where they are not licensed in Turkey or, although licensed, are not produced or imported for various reasons.
TEB’s patient information page also states that medicines included in the TİTCK Yurt Dışı Aktif İlaç Listesi may be supplied through its foreign medicine supply system. TEB further notes that, where the active foreign medicine list indicates that approval is mandatory, an off-label or TİTCK approval letter may be requested.
This means that a patient cannot simply choose any foreign product online and request supply. The medicine must fall within the regulatory system, and the patient’s physician must follow the formal route. Where TİTCK approval is required, treatment cannot lawfully begin through the foreign medicine supply mechanism before the relevant approval is obtained, except for narrowly defined medical emergency situations.
Who May Supply Foreign Medicines in Turkey?
Foreign medicines are supplied through authorized channels. SGK states that, for persons whose healthcare expenses are covered by SGK, foreign medicine supply is conducted under the protocol between SGK and TEB, through TEB and the İbn-i Sina Social Security Center within Ankara Social Security Provincial Directorate.
The TİTCK guide defines foreign medicine suppliers as public institutions approved by the Ministry, SGK and TEB, which supply medicines from approved foreign medicine sources and deliver them to hospitals or patients.
This is a key compliance point for pharmacies. A private pharmacy should not present itself as an independent foreign medicine importer unless it has a lawful role under the authorized system. Direct importation, online ordering, informal courier import, or sale of foreign medicines outside the formal mechanism may create serious regulatory, customs, SGK and criminal-law risks depending on the facts.
Patient-Based Foreign Medicine Use Application
For patient-based use, the application is made by the treating physician, not by the pharmacy. The TİTCK guide states that the foreign medicine use request is submitted by the patient’s treating physician through the Electronic Prescription System by completing the required fields and attaching documents. Required documents include a health board report or medicine use report, informed patient consent form, scientific literature supporting efficacy and safety for the relevant indication and patient characteristics, epikriz showing prior treatments and disease course, and current diagnostic imaging or laboratory reports where relevant.
The guide also provides that, where documents are missing, the application is returned without being evaluated. This makes complete documentation essential. In practice, many delays occur not because the medicine is impossible to supply, but because the report, epikriz, consent form, literature, diagnosis or prescription file is incomplete.
For pharmacies, the practical responsibility is to avoid giving patients incorrect assurances. A pharmacist should not say that a foreign medicine can definitely be obtained before checking whether it is on the relevant list, whether TİTCK approval is required, whether the physician has applied through the correct system, and whether SGK or private payment rules apply.
TİTCK Approval and Use Before Approval
The TİTCK guide states that the relevant human medicinal product may be used only after TİTCK permission and supply under the regulation. If foreign medicine use has begun without TİTCK permission, retrospective applications are not evaluated except for medical emergencies.
This rule is extremely important for liability. A patient may obtain a medicine personally from abroad and begin using it before approval, or a third party may advise immediate use. However, such conduct may create legal and reimbursement problems. If SGK payment or formal recognition is later requested, the absence of prior TİTCK approval may become a major obstacle.
Pharmacists should therefore avoid encouraging patients to start treatment outside the formal approval route. The safer approach is to direct the patient back to the treating physician and TİTCK process.
Continuing Treatment and Renewal Applications
Foreign medicine treatment may require continuation. The TİTCK guide provides that, where a positive response is obtained in terms of efficacy and side effects and continued treatment is desired, a continuation application may be submitted through the Electronic Prescription System during the last month of the authorization period. This continuation application is again made by the physician and must include required fields and the informed patient consent form.
For patients, this means timing is critical. If the application is delayed, treatment interruption may occur. For pharmacists, the responsibility is practical and advisory: patients should be reminded that foreign medicines may require renewed approvals, updated prescriptions and current reports.
TEB’s FAQ states that ordinary prescriptions are valid for 56 days from the date of issue and that patients may apply with a current prescription 28 days before the medicine runs out. These practical timelines should be checked with current TEB and SGK instructions in each case, especially for court decision files, special protocols, or medicine-specific requirements.
Required Documents for SGK-Covered Foreign Medicine Supply
SGK lists the documents required for supply through TEB or İbn-i Sina Social Security Center. These include a prescription issued completely in the patient’s name, a health report or health board report stating the diagnosis, the necessity of the medicine, dose and duration of use, the TİTCK medicine use and import permit, the patient’s identity copy, delivery address and contact information, and additional documents required according to the patient’s insurance status.
Where patients obtain the medicine through their own means and later request payment, SGK requires additional documents, including TİTCK permission, a document showing that TEB could not supply the medicine within the protocol period, the medicine boxes, and the original invoice or equivalent document issued in the patient’s name showing from which country and at what price the medicine was obtained.
This shows that reimbursement is document-heavy. Pharmacies should advise patients that informal purchases without proper documentation may not be reimbursed. The invoice should be in the patient’s name, and the medicine boxes may need to be presented. A simple online receipt, third-party payment record or foreign-language informal document may be insufficient.
TEB Application and Practical Patient Process
TEB’s foreign medicine supply pages describe several practical application routes, including SGK prescription, paid prescription, court decision files and other contracted institution prescriptions. For court decision files, TEB states that the relevant 459 code must first be defined in MEDULA through SGK İbn-i Sina, and the application requires prescription, report and TİTCK approval documents.
TEB’s FAQ also clarifies that the medicine must be prescribed in Turkey by physicians approved under the Ministry process and that medicines are supplied from the TİTCK Yurt Dışı Aktif İlaç Listesi. It states that TİTCK approval is obtained through an online application by the requesting physician via the REÇETEM system.
This process differs sharply from ordinary pharmacy dispensing. The patient, physician, TİTCK, TEB and SGK may all have roles. Pharmacists should not simplify the process in a misleading way. A foreign medicine request must be assessed according to the patient’s diagnosis, prescription, approval status, reimbursement position, payment method, delivery conditions and current list status.
Hospital Bulk Supply from Abroad
Foreign medicine supply is not limited to individual patients. Hospitals may apply for bulk supply from abroad in defined circumstances, especially medical emergencies. The TİTCK guide states that hospital bulk supply applications for medical emergency use are evaluated by TİTCK, and applications must include information such as the medical emergency, active substance name and intended supply quantity, signed by the hospital chief physician or responsible manager and submitted through KEP or by post. Applications lacking required information are not evaluated.
The guide further states that bulk supply from abroad for indications other than medical emergency situations is not appropriate, and that applications by institutions other than hospitals are not accepted, except for certain products such as antidotes where the institution’s field of activity requires holding them.
This is important for private healthcare providers, clinics and pharmacies. A clinic or private organization cannot bypass hospital-based rules by directly ordering medicines from abroad. Where bulk supply is needed, the application must fit the regulatory framework.
Quality, Source and Documentation Requirements
Foreign medicines must come from approved sources. The TİTCK guide provides that a foreign medicine source must be the manufacturer or marketing authorization holder, or a pharmacy warehouse licensed by ICH founding or standing member authorities, MHRA or TGA, or an authorized firm connected to the authorization holder or license holder. If these conditions cannot be met, the firm is not evaluated.
The guide also explains that products may require documents such as CPP, short product information, GMP certificate, certificate of origin, certificate of analysis and batch release documents depending on the product category and route.
These requirements protect patients from counterfeit, unsafe, expired, illegally sourced or poor-quality medicines. For pharmacists, the lesson is clear: foreign medicine supply must remain within the authorized chain. A medicine brought from an unknown foreign pharmacy, a social media seller or an online marketplace may not satisfy Turkish regulatory standards and may expose the patient to risk.
Control Certificate and Import Procedures
The TİTCK guide states that control certificate applications for controlled and non-controlled products approved for foreign supply are made only by foreign medicine suppliers. It also requires consistency between the product name in TİTCK’s electronic system, the proforma invoice and other submitted documents.
This confirms that importation is not left to ordinary private actors. The system is designed to keep the medicine traceable and document-based from foreign source to patient or hospital. The supplier must be able to prove where the product came from, which batch was imported and whether quality documents are available.
Barcode, Serialization and İTS Tracking
Foreign medicines supplied under this framework are included in Turkey’s medicine tracking system. The TİTCK guide states that the barcode consists of global trade item number, batch number, serial number and expiry date, and that İTS does not allow registration of the same product with the same global trade item number and serial number more than once. It also states that foreign medicine suppliers must register each unit they supply in İTS through import notification and must notify purchases, sales, returns, sale cancellation and deactivation of products that lose their character due to expiry, theft or deterioration.
The guide further states that the required barcode application and İTS notifications are performed by foreign medicine suppliers through secondary packaging facilities authorized by TİTCK, subject to certain exceptions.
This has direct pharmacy significance. Once a foreign medicine is placed into the Turkish tracking chain, any pharmacy or healthcare actor involved in handling must respect the integrity of that system. TEB also states that medicines are included in the Ministry’s İTS barcode system and that, after exit from the system, returns are not accepted.
Cold Chain and Patient Storage Responsibilities
Many foreign medicines are cold-chain products. TEB’s FAQ states that cold-chain medicines should be kept at +2°C to +8°C on the refrigerator shelf and must never be placed in the freezer.
For pharmacists, this creates a patient counseling responsibility. If a patient receives a foreign cold-chain medicine, the pharmacist should explain storage, transport, refrigeration, freezing risk and timing. If the patient receives the product through delivery, they must be told to place it in suitable refrigeration immediately and not to leave it in a hot car, exposed to sunlight or near a freezer compartment.
A cold-chain failure may destroy the medicine’s therapeutic value. Where the medicine is expensive or clinically critical, proper counseling and documentation become even more important.
Reimbursement and Alternative Payment Issues
Foreign medicine reimbursement can be complex. Some medicines may be covered through SGK under relevant lists and conditions; others may require court decisions, alternative reimbursement applications, patient co-payment or full private payment. SGK has also published announcements in 2026 concerning alternative reimbursement applications for medicines supplied from abroad for personal treatment.
The TİTCK guide refers to the SUT EK-4/C Foreign Medicine Price List and explains transitional situations where a foreign product is in EK-4/C but an equivalent licensed product is not yet in EK-4/A; to prevent patient hardship, supply of the foreign product may continue until the licensed product enters reimbursement, with additional transition rules.
Pharmacies should avoid making reimbursement promises unless the exact SGK, SUT, EK-4/C, court decision and TİTCK status has been checked. A medicine may be medically necessary but not reimbursed under the current conditions. Conversely, a reimbursed medicine may require strict report, diagnosis, dose and approval conditions.
Pharmacy Responsibilities in Foreign Medicine Supply
The role of the ordinary pharmacy depends on the case. In many patient-based foreign medicine supply files, the actual procurement is conducted by TEB or SGK İbn-i Sina, not by the local pharmacy. However, pharmacists may still be involved in advising patients, checking prescription logic, receiving questions, counseling on storage and use, helping patients understand formal routes, or preventing unlawful supply.
A legally careful pharmacist should:
Explain that foreign medicines are supplied through authorized mechanisms, not ordinary online purchasing.
Refer the patient to the treating physician for REÇETEM / TİTCK application where approval is needed.
Warn that TİTCK approval may be required before treatment begins.
Advise patients to preserve prescription, report, approval, invoice and delivery documents.
Avoid selling or importing foreign medicines through informal routes.
Avoid recommending foreign online sellers, social media suppliers or unlicensed import channels.
Counsel patients on cold-chain storage and expiry.
Protect patient confidentiality.
Document relevant advice where the matter is high-risk.
This approach protects the patient and the pharmacist.
Online Sale and Informal Import Risks
Foreign medicine supply should not be confused with online medicine sales. A patient may find a foreign medicine on a website or through a social media seller, but that does not make the product lawful in Turkey. If the product is not supplied through authorized channels and not supported by TİTCK permission where required, it may create health and legal risks.
The risks include counterfeit medicine, wrong product, wrong dose, expired stock, broken cold chain, customs seizure, lack of reimbursement, lack of Turkish tracking, and liability for anyone facilitating the transaction. Pharmacists should avoid participating in such activity.
Where a patient insists on self-procurement, the pharmacist should explain that SGK requires strict documentation for payment where the patient obtains the medicine by their own means, including TİTCK permission, proof that TEB could not supply within the protocol period, product boxes and original patient-name invoice or equivalent showing country and price.
Court Decision-Based Foreign Medicine Supply
In practice, some patients seek access to foreign medicines through court decisions, especially in urgent or high-cost treatment disputes. TEB’s patient page states that, for court decision-based medicine applications, the patient must first have the 459 code defined in MEDULA through SGK İbn-i Sina; the application requires prescription, report and TİTCK approval documents, and where e-prescription, e-report and TİTCK import approval exist, application can be made through TEB’s online prescription portal.
TEB’s FAQ also states that the prescription validity period for patients receiving medicines through court decisions is 90 days, and that report validity for court decision files may be up to one year for cancer diagnoses and up to two years for other diagnoses.
For lawyers and pharmacists, these details matter. A court decision alone may not be enough if MEDULA code, prescription, report, TİTCK approval and application documents are missing. In foreign medicine cases, legal remedy strategy and administrative process must move together.
Liability Risks for Pharmacists
Pharmacist liability may arise if the pharmacist:
Supplies a foreign medicine outside the formal system.
Misleads the patient about approval or reimbursement.
Encourages use before TİTCK approval where approval is required.
Handles a cold-chain product improperly.
Participates in informal import, online sale or unlicensed supply.
Fails to protect patient health data.
Provides incorrect counseling on dose, storage or substitution.
Claims that a foreign product is equivalent without medical or regulatory basis.
Civil liability may arise if the patient suffers harm. Administrative and professional liability may arise if pharmacy rules are violated. Criminal or customs-related risk may arise in more serious cases involving counterfeit products, unlicensed imports, controlled medicines or fraudulent documentation.
Practical Checklist for Foreign Medicine Supply in Turkey
A pharmacy or pharmacist dealing with a foreign medicine inquiry should use the following checklist:
Identify the medicine, active substance, dosage form and indication.
Check whether the medicine is licensed and available in Turkey.
Determine whether it appears on TİTCK / TEB foreign medicine lists.
Ask whether the treating physician has made a REÇETEM / TİTCK application.
Check whether TİTCK approval or off-label approval is required.
Confirm whether SGK, TEB, İbn-i Sina or paid route applies.
Advise the patient to preserve prescription, report, approval and communication documents.
Warn against online or informal purchase.
Check cold-chain requirements.
Explain that reimbursement depends on SGK rules, not only medical need.
Document advice in high-risk cases.
Refer court decision files to SGK İbn-i Sina and TEB process where applicable.
Frequently Asked Questions
What is foreign medicine supply in Turkey?
Foreign medicine supply is the regulated supply of human medicinal products from abroad for diagnosis or treatment where the product is not licensed in Turkey or is licensed but unavailable, usually for personal use on prescription or hospital bulk supply in defined cases.
Can a patient obtain foreign medicine without a prescription?
No. TEB states that a prescription issued in Turkey by Ministry-approved physicians is mandatory for obtaining foreign medicines.
Who applies for TİTCK foreign medicine approval?
The treating physician applies through the REÇETEM / Electronic Prescription System by completing the required fields and attaching supporting documents.
Who supplies foreign medicines for SGK-covered patients?
SGK states that supply is conducted under the SGK–TEB protocol through TEB and SGK Ankara Provincial Directorate’s İbn-i Sina Social Security Center.
Are foreign medicines included in İTS?
Yes. TİTCK’s guide states that foreign medicine suppliers must register each supplied unit in İTS and notify transactions such as purchase, sale, return, cancellation and deactivation due to expiry, theft or deterioration.
Can foreign medicines be returned?
TEB states that because all medicines are included in the Ministry’s İTS barcode system, returns are not accepted once the medicine has exited the system.
Conclusion
Foreign medicine supply in Turkey is a tightly regulated healthcare mechanism designed to protect patients while allowing access to medicines that are not licensed in Turkey or are licensed but unavailable. The system is based on TİTCK approval, physician application, prescription and report documentation, authorized suppliers, İTS tracking, SGK/TEB procedures and strict quality controls.
For patients, the most important point is that foreign medicine access must follow the official route. The treating physician must make the required application, and where approval is mandatory, the medicine should not be used before TİTCK permission except for narrowly defined medical emergency situations.
For pharmacists, the most important responsibility is lawful guidance and risk prevention. Ordinary pharmacies should not create informal foreign medicine supply channels, recommend unlicensed online sellers or promise reimbursement without checking SGK and TİTCK status. They should guide patients toward the physician, TİTCK, TEB and SGK/İbn-i Sina process; protect patient documents; advise on cold-chain storage; and avoid any conduct that may be interpreted as unauthorized import or medicine sale.
For hospitals, bulk foreign medicine supply is possible only within the formal TİTCK framework, mainly for medical emergency situations and with proper institutional application.
In Turkish pharmacy law, foreign medicine supply is not a shortcut around authorization rules. It is an exceptional patient-protection mechanism. A legally compliant process protects patients, physicians, pharmacists, suppliers and public reimbursement systems by ensuring that foreign medicines are medically justified, officially approved, traceable, properly sourced and safely delivered.
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