The legal Procedures For Establishing A Foreign Pharmaceutical Company İn Turkey 

Turkey is considered one of the most promising, yet also one of the most strictly regulated, pharmaceutical markets in its region. Any foreign pharmaceutical company that wants to enter the Turkish market must complete a detailed, multi-step legal and regulatory process. This process includes setting up a local company, obtaining marketing authorization for their pharmaceutical products, and receiving Good Manufacturing Practices (GMP) certification.

---

1. Setting Up a Company in Turkey

To do business in Turkey and directly sell or register pharmaceutical products, a foreign company must first set up a legal entity within the country. The two most common types of company structures in Turkey are:

• Limited Liability Company (Ltd. Şirketi) – similar to an LLC
• Joint Stock Company (Anonim Şirket – A.Ş.) – similar to a corporation that can go public

Below is a comparison of the two structures:

Feature	Ltd. Şirketi (LLC)	Anonim Şirket (JSC)
Shareholders	1 to 50 individuals or legal entities	Minimum 1 shareholder
Minimum Capital	10,000 TRY (must be fully paid)	50,000 TRY (25% upfront, rest within 2 years)
Management	Managed by one or more managers	Managed by a Board of Directors
Share Transfer	Requires internal approval	Freely transferable or can be traded
Governance	Fewer formalities, simpler structure	More complex with general assemblies
Best Suited For	Small to medium-sized businesses	Large operations or companies planning to go public

Main Steps in Company Formation:

• MERSIS Registration: This is an online system provided by the Ministry of Trade where companies input their core information. It produces a company ID and draft Articles of Association, starting the legal process.
• Articles of Association: A required legal document that outlines the company’s purpose, structure, and operating rules. This must be notarized and filed with the Trade Registry.
• Tax Office Registration: Every company must be registered with the local tax authority and obtain a tax number. This is necessary for all official transactions such as opening a bank account, issuing invoices, or hiring staff.
• Trade Registry: The company is officially registered with the Chamber of Commerce. This step completes the incorporation process.
• Social Security Institution (SGK) Registration: Any company that plans to employ workers must register with SGK to provide mandatory health and social insurance.
• Appointing a Local Representative: Foreign pharmaceutical companies must appoint a local representative (a person or a company in Turkey). This representative handles all regulatory communications with the Turkish authorities, especially the Turkish Medicines and Medical Devices Agency (TİTCK). Alternatively, a company can work through a Turkish distributor, but in that case, the product license is owned by the distributor, not the foreign company.

---

2. Getting Marketing Authorization for Pharmaceutical Products

Before a pharmaceutical product can be sold in Turkey, it must be evaluated and approved by TİTCK. This process is called marketing authorization or licensing.

The marketing authorization ensures that the product is safe, effective, and meets all quality standards. The application must follow the Common Technical Document (CTD) format, and many parts of the file must be translated into Turkish. Labels, packaging, and patient information leaflets must also comply with Turkish regulations.

---

3. Obtaining Good Manufacturing Practices (GMP) Certification

GMP certification shows that the company’s manufacturing process meets high standards of quality, cleanliness, and safety. This certification is required for all imported medicines before they can be licensed in Turkey.

Unlike in some other sectors (like food or cosmetics), GMP certification for medicines in Turkey must be issued directly by TİTCK — third-party certificates from other countries are not accepted for the licensing process.

Steps in the GMP Inspection Process:

• Application Submission: The foreign manufacturer submits a formal application to TİTCK. The required documents include:
  • Full address and description of the manufacturing facility
  • Any existing GMP certificates from other countries
  • The company’s Quality Manual
  • Production procedures, organizational charts, and technical details
• On-site Inspection: If TİTCK decides an on-site inspection is necessary, it will send a team of inspectors from Turkey to the production facility abroad. The company must cover all costs (including travel, accommodation, translation, and other logistics). Inspections are conducted in Turkish, so a translator should be arranged.
• Issuance of the GMP Certificate:
  • If the facility complies with Turkish (EU-aligned) GMP rules, TİTCK issues a Turkish GMP Certificate.
  • If there are any problems or “non-conformities,” the company must submit a Corrective and Preventive Action (CAPA) Plan.
  • After the CAPA Plan is reviewed and approved, the certificate can be granted.

---

Legal and Strategic Advice for Foreign Companies

The Turkish pharmaceutical regulatory framework can be complex and time-consuming. To successfully navigate it, foreign companies should consider the following best practices:

• Partner with local lawyers and regulatory consultants familiar with pharmaceutical laws in Turkey,
• Make sure any contracts with local distributors or representatives are legally compliant and clearly define responsibilities,
• Plan ahead for GMP inspections, translation requirements, and dossier preparation,
• Register trademarks and patents in Turkey to protect intellectual property rights.

Key Takeaways: