Importing Medicines into Türkiye – Legal Procedures and Requirements

1. Introduction

The importation of medicines into Turkey from abroad is subject to strict regulations in terms of health safety, public health, and control of the pharmaceutical market. Whether by passengers for personal use or imported for commercial purposes , this process the Turkish Medicines and Medical Devices Agency (TİTCK) of the Ministry of Health, the Ministry of Trade , and the Customs Administration .

The purpose of these rules is:

• Protecting public health

• To prevent the entry of unlicensed or counterfeit drugs

• Ensuring drug quality

• To prevent money laundering or illegal trade

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2. Legal Grounds

• Law No. 6197 on Pharmacists and Pharmacies

• Law No. 1262 on Pharmaceutical and Medical Preparations

• Law No. 5549 on the Prevention of Money Laundering (in high-value transactions)

• Turkish Penal Code Articles 186-187 (manufacturing/selling defective or counterfeit drugs)

• Turkish Medicines and Medical Devices Agency (TİTCK) Procedures and Principles for the Procurement of Medicines from Abroad

• Customs Regulations and Circulars on Standardization in Foreign Trade

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3. Bringing Medication for Personal Use

a) Bringing Accompanying Passengers

• For Medical Purposes: The passenger may bring the medication for their own treatment or for a relative accompanying them.

• Documents: Doctor's prescription + report regarding diagnosis and treatment.

• Dosage: Maximum 3-month treatment dose.

• Customs Declaration: The medicine is declared to the customs officer, and the necessary documents are presented.

📌 Note: For medications containing psychotropic or narcotic substances, a special permit is also required under the Regulation on the Control of Narcotic Drugs

b) Supply via Order from Abroad

• Medicines that are not licensed in Turkey can be imported from abroad with the approval of TİTCK (Turkish Medicines and Medical Devices Agency )

• Required Documents:

  • Hospital health board report

  • Doctor's prescription

  • Justification for obtaining the medicine (document showing that there is no licensed equivalent in Türkiye)

• Authorized Supplier: Usually pharmacies authorized by TİTCK (Turkish Medicines and Medical Devices Agency) (e.g., Ankara Oncology Hospital Pharmacy).

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4. Import of Pharmaceuticals for Commercial Purposes

a) Licensing Requirement

• A license issued by TİTCK ( Turkish Medicines and Medical Devices Agency) is required for commercial imports .

• The license application is submitted with a comprehensive file containing data on the drug's efficacy, safety, and quality, as well as its production standards.

b) Pre-import Procedures

• Import License: A document from the Ministry of Trade authorizing the import of the relevant product.

• Health Certificates: Approvals obtained from the health authorities of the country of origin.

• Certificate of Analysis (COA): A quality certificate specific to a production batch.

c) Customs Process

• The goods cannot be cleared from customs without obtaining a certificate of conformity from TİTCK (Turkish Medicines and Medical Devices Agency ).

• Medicines are declared under the code specified in the Customs Tariff Schedule

d) Storage and Distribution

• Imported medicines Good Distribution Practices (GDP) standards.

• Sales can only be made through licensed pharmacies and authorized distribution channels.

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5. Prohibitions and Sanctions

• Importing drugs without a license: According to Article 187 of the Turkish Penal Code, imprisonment of 2 to 5 years and a fine.

• Counterfeit or imitation drugs: Severe prison sentences and confiscation of property.

• Entry without proper documentation: Confiscation at customs and administrative fine.

📌 Supreme Court 10th Criminal Chamber, Case No. 2019/4856 E., Decision No. 2020/2135 K. – In a case of importing unlicensed medicines, the defendant's defense of "personal use" was rejected, and a conviction was issued on the grounds that it was for commercial purposes.

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6. Problems Encountered in Practice

• Delay at customs due to incomplete or incorrectly prepared documents.

• The approval of the Turkish Medicines and Medical Devices Agency (TİTCK) was rejected on the grounds that a licensed equivalent product exists in Türkiye.

• The length of the authorization process for drugs containing narcotics.

• The risk of receiving counterfeit products with online orders.

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7. Suggestions and Practical Advice

1. Obtain Prior Approval: Import attempts should not be initiated without TİTCK (Turkish Medicines and Medical Devices Agency) approval.

2. Prepare all documents completely: Prescriptions, reports, certificates of origin, and other documentation must be complete.

3. Work with authorized pharmacies: Especially when obtaining medicines from abroad for personal use.

4. Customs Consulting: For companies engaged in commercial imports, working with professional customs brokers is essential.

5. Legal Support: Obtain legal assistance from a lawyer in case of a potential dispute or criminal investigation.

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8. Conclusion

The process of importing medicines into Turkey is carried out under strict supervision due to public health and safety requirements . Even for personal use, complete documentation is mandatory. Commercial imports, however, are only possible with the necessary licenses, permits, and compliance with quality standards.

False declarations, missing documents, or attempts at illegal entry can lead to serious penalties. Therefore, the process of experts familiar with TİTCK (Turkish Medicines and Medical Devices Agency) regulations and customs brokers .