Importing medicine to Turkey is subject to stringent regulations and legal requirements to ensure the safety, quality, and efficacy of pharmaceutical products. The Turkish Medicines and Medical Devices Agency (TİTCK) governs the importation, distribution, and sale of medicines in Turkey. In this comprehensive article, we will explore the crucial legal points that individuals or organizations should consider when importing medicine to Turkey.
Before importing medicine to Turkey, it is essential to obtain the necessary licenses and authorizations from the TİTCK. The TİTCK regulates and oversees all activities related to pharmaceutical products, including importation. Familiarize yourself with the specific licensing requirements, such as the Wholesale Distribution Authorization, which is mandatory for importing and distributing pharmaceuticals.
All medical products intended for sale in Turkey must be licensed by the TİTCK. The procedures and evaluation process for obtaining a license for a medical product are outlined in the "Regulation on the Licensing of Human Medicinal Products." It is primarily determined by the "Law on Cosmetics and Medical Products No.1262" whether a product intended for trade is considered as "any herbal or chemical substance with therapeutic properties" or "materials, devices, tools, or equipment used for medical purposes." It can also be said that this law serves as a pharmacy law. If blood, blood components, and products are to be used in the products, a separate licensing process exists, and this special condition is regulated by the “Law on Blood and Blood Products No. 5624”.
The TİTCK classifies imported medicines into three categories: licensed medicines, unlicensed medicines, and clinical trial medicines. Each category has its own set of requirements and procedures. Licensed medicines are those already approved by the TİTCK, while unlicensed medicines require additional documentation and compliance with certain conditions. Clinical trial medicines are imported for research purposes and must adhere to specific regulations.
Companies or individuals wishing to import medicines to Turkey must appoint an authorized representative who is a Turkish citizen or legal entity. The authorized representative is responsible for ensuring compliance with regulations and acting as a liaison between the importing entity and the TİTCK. This representative must possess the necessary knowledge and expertise in pharmaceutical regulations.
Adhering to Good Distribution Practices is crucial when importing medicine to Turkey. GDP sets quality standards for the storage, transportation, and distribution of pharmaceutical products and aims to ensure that the distribution is conducted in accordance with relevant national and internationally recognized standards. Importers must establish and maintain proper storage conditions, including temperature control and suitable facilities, to ensure the integrity of the imported medicines. The TİTCK conducts inspections to ensure compliance with GDP guidelines. A “Good Distribution Practices Guide” has been published by the TİTCK regarding pharmacy establishments that have been opened or will be opened in relation to this matter, as well as for individuals involved in distribution.
If a pharmacy is to be opened for the sale of medicines, for how it will be opened and the conditions, primarily, the Law No.984 specific to Pharmacy Establishments should be consulted. Additionally, the "Regulation on Pharmacies and Products Held in Pharmacies" ,which is based on the Law No.984 previously mentioned, regulates the entire legal supply chain in parallel with GDP guidelines.
Accurate and complete documentation is vital when importing medicine to Turkey. Ensure that all required documents are prepared and available for customs authorities and the TİTCK. Essential documents include the commercial invoice, bill of lading, packing list, certificate of analysis, manufacturer's authorization, and a detailed product description. The TİTCK may request additional documentation based on the specific requirements of the imported medicine.
Imported medicines must meet international quality standards and comply with the TİTCK's regulations. Ensure that the medicines are manufactured by reputable pharmaceutical companies that adhere to Good Manufacturing Practices (GMP). Verify that the medicines have the necessary marketing authorizations from their country of origin and that the labeling and packaging meet Turkish regulatory requirements.
According to Article 13 of the "Regulation on Packaging Information, Package Leaflets, and Tracking of Medicinal Products” all imported medicine packaging and labeling must include a Turkish translation or be provided with a separate Turkish leaflet containing essential information. One of the languages used, other than Turkish, must be one of the official languages of the European Union member states, and it can be used with official approval, provided that the same provisions are included in all languages used. The Article 8 of the same regulation provides that the leaflet should include the medicine's name, active ingredients, dosage instructions, potential side effects, contraindications, and the manufacturer's contact information. Ensuring compliance with language requirements is crucial for patient safety and understanding.
Importing counterfeit or substandard medicines is strictly prohibited in Turkey. Such products pose significant risks to public health and may result in legal consequences. Please be sure to source medicines from reliable suppliers and ensure their authenticity. We also recommend doing due diligence on the supplier, verifying credentials and requesting supporting documents to verify the legitimacy and quality of medicines.
Certain medicines containing controlled substances, such as narcotics and psychotropic drugs, require special permits and strict compliance with regulations. Importing these substances without the appropriate permits is illegal and can lead to severe penalties. Familiarize yourself with the regulations governing controlled substances and ensure full compliance when importing such medicines.
Importers have a responsibility to report any adverse events associated with imported medicines to the TİTCK. Adverse events include unexpected side effects, medication errors, and any other adverse reactions observed in patients. Timely reporting of adverse events helps the TİTCK monitor and ensure the safety of medicines in the market.
Importing medicine to Turkey involves navigating a complex legal landscape governed by the TİTCK. Compliance with licensing requirements, proper documentation, adherence to quality standards, and awareness of the regulations surrounding language, counterfeit medicines, controlled substances, and adverse event reporting are essential. It is strongly advised to seek legal counsel and consult with professionals experienced in pharmaceutical importation to ensure a smooth and legally compliant process. By considering these legal points, importers can help ensure the safety, quality, and efficacy of imported medicines in Turkey.
Under the previous regulations, medicines that are not licensed or not available in the market could only be sourced from abroad through a special importation process based on a doctor's request and special permission. Previously, "Guideline for Procurement of Medicines from Abroad" regulated this method of medicine procurement. However, a new regulation has been published regarding the procurement of medicines from abroad, and the corresponding guideline has been updated accordingly. The Regulation on Supply of Medicines from Abroad entered into force on February 3, 2023, in Turkey.
The Regulation has been prepared in parallel with the Guidelines for Medicine Supply and Use from Abroad . The regulation includes various regulations on medicine supply. These include the expansion of definitions, the obligation to have a representative, traceability measures, product safety decisions, data matrix application and ban on promotion. According to this new regulation, the individual or legal entity residing abroad who will procure the medicine is defined as the "Source", while the authorized individual or legal entity located in Turkey, who acts on behalf of the Source and is duly authorized in writing, is referred to as the "Representative”.In addition, issues such as the first drug application, collective procurement arrangements and the responsibilities of representatives are also included in the regulation. The regulation also regulates administrative sanctions.
From now on, the suppliers will be obliged to provide the requested information and documents in accordance with the guidelines published by the TİTCK regarding the medicine they supply, and to present the foreign drug sourcing entity, the representative, and the authorization document. They will also be responsible for keeping these documents up to date. In compliance with the regulations, a "QR code" application will be implemented for the procured pharmaceutical products, and as part of this, the notifications of these products will be provided to the Drug Tracking System (İTS).
Sinan KÜLEKÇİ |