Starting a pharmaceutical and food supplement company in Türkiye requires careful planning, licensing, and compliance with strict regulatory standards. The most suitable company structures for such operations are:
Joint Stock Company (A.Ş.)
Limited Liability Company (Ltd. Şti.)
This guide covers company incorporation, required permits, regulatory approvals, and personnel requirements for both manufacturing and import/export businesses.
1. Company Incorporation Process in Türkiye
To establish a pharmaceutical or food supplement company, the following steps must be completed:
Step 1: Company Type Selection
- Joint Stock Company (A.Ş.) – Recommended for large-scale production and investment.
- Limited Liability Company (Ltd. Şti.) – Suitable for smaller operations and import/export activities.
Step 2: Business Registration & Legal Setup
- Preparation of the Articles of Association
- Trade Registry Registration (at the Chamber of Commerce)
- Tax Registration and Tax Plate Issuance (from the Tax Office)
- Social Security Institution (SGK) Registration
Step 3: Industry-Specific Licensing
- Municipal Licenses (for production facilities)
- Industrial Registry Certificate (from the Ministry of Industry and Technology)
📌 Important: If you only plan to import and distribute pharmaceuticals or supplements, a production license is not required. However, manufacturing businesses must comply with strict food and drug safety standards.
2. Required Licenses for Pharmaceutical Manufacturing in Türkiye
Companies producing medicines in Türkiye must obtain approvals from the Turkish Medicines and Medical Devices Agency (TİTCK) under the Ministry of Health.
📌 Application Authority:
Turkish Medicines and Medical Devices Agency (TİTCK)
Address: Üniversiteler Mah., Dumlupınar Bulvarı 6001. Cad. No: 9, 06800 Çankaya / Ankara
Website: www.titck.gov.tr
Mandatory Permits for Pharmaceutical Production
Pharmaceutical Manufacturing License (Issued by TİTCK)
Good Manufacturing Practices (GMP) Certificate
Environmental Impact Assessment (EIA) Report
ISO 13485 – Medical Device Manufacturing Certification
ISO 9001 – Quality Management System Certification
Workplace Opening & Operating License (From the Municipality)
📌 Important: Each pharmaceutical product requires a separate product license before being sold.
3. Step-by-Step Pharmaceutical Manufacturing License Application
Step 1: Business and Facility Setup
- Company incorporation completed
- Production facility established (GMP-certified)
- Necessary personnel hired
Step 2: Obtain the GMP Certificate
- Apply to TİTCK for a GMP inspection.
- The facility must pass hygiene, safety, and quality control inspections.
Step 3: Pharmaceutical Licensing Application
A separate product license application is required for each drug. The following must be submitted:
- Pharmaceutical formula and composition
- Raw material analysis reports
- Clinical test results (if required)
- Drug labeling and packaging information
📌 Duration: The approval process takes 6-12 months, including GMP certification and inspections.
Step 4: Sales & Distribution Approval
Once production starts, additional permits are needed for sales and distribution:
- Drug Sales & Marketing Authorization (from TİTCK)
- Storage & Logistics Compliance Certificate
- Distribution License (for pharmacies and hospitals)
📌 Regulatory Compliance:
- GMP and ISO certifications must be maintained.
- Regular inspections by TİTCK are mandatory.
- Adverse event reporting (pharmacovigilance) is required.
4. Required Licenses for Supplementary Food Production
📌 Regulating Authority:
Ministry of Agriculture and Forestry – General Directorate of Food and Control
A company producing food supplements must obtain:
– Food Business Registration Certificate (from the Provincial Directorate of Agriculture) – Product License (from the Ministry of Agriculture)
– ISO 22000 – Food Safety Management System Certificate
– GMP Certification for Food Production
📌 Important:
- Food supplements are NOT classified as pharmaceuticals.
- Health claims are strictly regulated – they cannot be marketed as disease treatments.
5. Import & Export Licensing for Pharmaceuticals & Supplements
📌 Companies engaged in import/export must obtain:
Customs Brokerage Authorization (for customs clearance)
Import Permit from TİTCK (for pharmaceuticals)
Import Compliance Certificate from the Ministry of Agriculture (for food supplements)
Ministry of Health & Ministry of Customs Inspections
📌 Export Requirements:
- Compliance with global regulations (EU, FDA, ISO, etc.)
- CE Certificate for exports to Europe
- European Pharmacopoeia Compliance
6. Setting Up a Pharmaceutical or Supplement Manufacturing Facility
Manufacturing facilities must meet legal and environmental requirements:
- GMP Compliance (Good Manufacturing Practices)
- Hygiene & Sterilization Standards
- Environmental Impact Assessment (EIA) Approval
- ISO 9001, ISO 13485 & ISO 22000 Certification
Personnel Requirements
📌 Mandatory personnel for pharmaceutical production:
- Responsible Manager (Pharmacist or Pharmaceutical Chemist)
- Quality Control Manager (Chemist or Biochemist)
- Production Manager (Pharmaceutical Tech or Chemical Engineer)
📌 Personnel for food supplement production:
- Responsible Manager (Food Engineer or Chemist)
- Quality Control Specialist (For GMP & ISO compliance)
📌 SGK (Social Security) registration is mandatory for all employees.
7. Summary: How to Establish a Pharmaceutical or Supplement Company?
– Choose the right company type (A.Ş. or Ltd. Şti.)
– Set up a GMP-certified production facility (if manufacturing)
– Obtain necessary licenses from TİTCK or the Ministry of Agriculture
– Hire mandatory personnel (pharmacist, chemist, or food engineer)
– Apply for import/export permits for international trade
📌 Important Considerations:
- Pharmaceutical manufacturing is highly regulated.
- GMP certification is required before applying for a production license.
- Each pharmaceutical product must have a separate license.
- Selling in pharmacies/hospitals requires Ministry of Health approval.
For expert assistance with company formation, licensing, and regulatory compliance, contact us today!
