Legal Procedures Regarding the Establishment of Foreign Pharmaceutical Companies in Türkiye

     Turkey is one of the most attractive pharmaceutical markets in the region, both for its significant growth potential and its strict regulatory framework. A foreign pharmaceutical company wishing to enter the Turkish market must complete a multi-stage and detailed legal and regulatory process. This process includes establishing a company in Türkiye, obtaining marketing licenses for the products, and securing Good Manufacturing Practices (GMP) certification.

1. Establishing a Company in Türkiye

Foreign companies wishing to register or sell pharmaceuticals directly in Türkiye must first establish a legal entity (company) in the country. The two most common types of companies in Türkiye are:

• Limited Liability Company (Ltd. Co.) – Similar to the LLC structure in America.

• Joint Stock Company (A.Ş.) – A type of company that can be publicly offered, more suitable for corporate structures.

Below is a comparison of these two types of companies:

Main Steps in the Company Formation Process:

1. MERSIS Registration: This is an online system provided by the Ministry of Trade. Basic company information is entered, a company number is assigned, and a draft articles of association are created. The legal process begins with this registration.

2. Articles of Association Preparation: This is a legal document containing the company's purpose, structure, and operating rules. It is notarized and submitted to the Commercial Registry.

3. Tax Registration: The company needs to obtain a tax identification number. This number is essential for operations such as opening bank accounts, issuing invoices, and employing personnel.

4. Commercial Registry Registration: The company is officially established by registering with the relevant Chamber of Commerce.

5. SGK Registration: Every company employing personnel must register with the Social Security Institution (SGK) and provide mandatory health and social insurance.

6. Appointment of Local Representative: Every foreign pharmaceutical company operating in Turkey must appoint a local representative. This representative (individual or company) handles all official correspondence with the Turkish Medicines and Medical Devices Agency (TİTCK). Alternatively, the company may work with a Turkish distributor; however, in this case, the product license belongs to the distributor, not the foreign company.

2. Obtaining a License (Marketing Authorization) for Pharmaceutical Products

    Before a drug can be sold in Türkiye, it must be evaluated and approved by the Turkish Medicines and Medical Devices Agency (TİTCK). This process is called marketing authorization or licensing.

    The license certifies that the product is safe, effective, and complies with quality standards. The application file must be prepared in accordance with the CTD (Common Technical Document) format, and many sections of the file must be translated into Turkish. Labels, packaging, and patient information brochures must also comply with Turkish legislation.

3. Obtaining Good Manufacturing Practices (GMP) Certification

     A GMP certificate demonstrates that a company's production processes meet high quality, hygiene, and safety standards. For all pharmaceuticals to be imported into Türkiye, this certificate is mandatory before the licensing process. Third-party GMP certificates valid in the food or cosmetics sectors are not accepted here. In Türkiye, only GMP certificates issued by the Turkish Medicines and Medical Devices Agency (TİTCK) are valid.

GMP Audit Process:

1. Application: The foreign producer submits a formal application to TİTCK (Turkish Medicines and Medical Devices Agency). Required documents:

   • Full address and description of the production facility

   • Existing GMP certificates from other countries

   • Quality Manual

   • Production procedures, organizational chart, and technical details

2. On-Site Inspection: If deemed necessary, TİTCK (Turkish Medicines and Medical Devices Agency) will send its own inspection team to the production facility abroad. Inspection costs (travel, accommodation, translation, etc.) are covered by the applicant company. Inspections are conducted in Turkish; therefore, a professional translator must be arranged.

3. Issuance of GMP Certificate:

   • If the facility complies with Turkish (EU compliant) GMP rules, it will be issued a GMP Certificate.

   • If irregularities are identified, the company submits a Corrective and Preventive Action Plan.

   • If this plan is approved, a GMP Certificate will be issued.

Legal and Strategic Advice for Foreign Companies

     Drug licensing and regulatory processes in Türkiye can be complex and time-consuming. Companies wishing to successfully manage this process should pay attention to the following practices:

• Work with local lawyers and regulatory consultants who are familiar with Turkish pharmaceutical legislation.

• Ensure that contracts with distributors or representatives comply with the law and clearly define their roles and responsibilities.

• Develop a comprehensive plan in advance for GMP audits, translations, and licensing application preparation.

• Protect your intellectual property rights in Türkiye by registering trademarks and patents.

Conclusion

For companies operating with a strategic approach, Turkey continues to offer significant potential despite strong regulations. Establishing a foreign-owned pharmaceutical company presents both significant opportunities and legal and administrative processes that require careful management. Establishing the company with the correct legal framework, obtaining product licenses, securing GMP certification, and fully complying with local representation arrangements constitute the fundamental building blocks of the process. To navigate this complex structure, working with experts who are well-versed in Turkish pharmaceutical legislation is critically important.