Introduction
Bringing medicines from abroad into Turkey, whether for personal use or commercial purposes, is subject to strict legal regulations.
The Ministry of Health oversees the importation and licensing process, while customs and import procedures are regulated under the Ministry of Trade and related legislation.
Any unauthorized or incorrect action can lead to significant administrative fines, seizure or destruction of the products, and even criminal prosecution.
1. Bringing Medicines for Personal Use
1.1 General Rule
- To bring prescription or over-the-counter medicines into Turkey from abroad, approval from the Turkish Medicines and Medical Devices Agency (TİTCK) is required.
- Medicines for personal use are generally limited to a maximum of a 3-month supply.
1.2 Required Permits and Documents
- Doctor’s report or prescription (in Turkish or English, stating the trade name, active ingredient, and dosage).
- TİTCK approval (especially for medicines not licensed in Turkey).
- At customs, the prescription and approval documents must be presented; otherwise, the medicines may be confiscated.
1.3 Unlicensed Medicines
- Medicines not available in Turkey can be brought in under the Guidelines for the Supply of Medicines from Abroad, with TİTCK approval.
- Such medicines are typically listed in the overseas medicines list determined by the Social Security Institution (SGK) and supplied via authorized pharmaceutical warehouses.
2. Importing Medicines for Commercial Purposes
2.1 Licensing
- To import medicines for sale in Turkey, a TİTCK marketing authorization (license) is mandatory.
- The licensing process requires a comprehensive dossier, including product documentation, clinical trial data, quality certificates, and a pharmacovigilance plan.
2.2 Import Permit and Customs Procedures
- Once the license is obtained, an Import Compliance Certificate is issued.
- The import process must comply with the Customs Law, Import Regulation, and Ministry of Health legislation.
- Medical products are subject to pre-import inspection and labelling requirements.
3. Legal Risks
- Unauthorized importation: Medicines may be confiscated, destroyed, and criminal proceedings may be initiated under Law No. 5607 on the Prevention of Smuggling.
- False declaration: Failure to declare medicines at customs can result in both customs penalties and criminal action.
- Counterfeit/illegal medicines: Products infringing brand and marketing authorization rights may also trigger Intellectual and Industrial Property provisions.
4. Practical Recommendations
- Before bringing medicines for personal use, check their licensing status in Turkey.
- Always carry your prescription and doctor’s report.
- Obtain TİTCK approval for unlicensed medicines.
- If planning commercial importation, start the licensing process early.
Conclusion
The process of bringing medicines into Turkey is strictly regulated to protect public health and prevent the entry of counterfeit or illegal medicines. With the correct permits and documents, medicines can be brought in for both personal and commercial purposes. However, unauthorized attempts can lead to serious legal consequences.
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