Pharmaceutical Law in Turkey regulates the production, licensing, import, distribution, marketing, and sale of pharmaceuticals and medical products. This highly regulated sector is governed by a complex body of national legislation, European Union harmonization rules, and international treaties. At ER&GUN&ER Law Firm, our English Speaking Turkish Lawyers provide full-spectrum legal services to pharmaceutical companies, biotech firms, medical device manufacturers, and healthcare investors.
Key Regulatory Authorities in Turkey
- TİTCK (Turkish Medicines and Medical Devices Agency): Main body regulating drugs and devices
- Ministry of Health: Oversees hospital and healthcare regulation
- Ministry of Agriculture and Forestry: Regulates certain supplements and veterinary pharmaceuticals
Licensing of Pharmaceuticals in Turkey
Before any medicine or medical product can be marketed in Turkey, it must be approved by TİTCK. Our legal services include:
- Preparing marketing authorization (MA) applications
- Reviewing clinical trial documentation
- Translating and verifying regulatory dossiers
- Advising on Good Manufacturing Practices (GMP) compliance
Import and Distribution of Foreign Medicines
Foreign companies can enter the Turkish pharmaceutical market through:
- Direct licensing and MA transfer
- Appointing local authorized representatives
- Establishing a pharmaceutical branch or affiliate company
We assist clients with company formation, commercial agreements, and regulatory filings.
Pharmaceutical Advertising and Promotion Rules
Advertising of prescription drugs is prohibited to the public in Turkey. Legal promotion is restricted to healthcare professionals and must comply with the Regulation on Promotional Activities of Medicinal Products for Human Use. Our services include:
- Pre-approval of promotional materials
- Drafting HCP engagement contracts
- Advising on sponsorship of medical congresses
Compliance, Pharmacovigilance and Data Protection
Pharmaceutical companies must implement compliance programs covering:
- Adverse event reporting (pharmacovigilance)
- KVKK and GDPR-compliant patient data processing
- Anti-bribery and transparency policies
We help our clients build robust internal policies, train their teams, and avoid regulatory fines.
Litigation and Enforcement in the Pharmaceutical Sector
Our litigation services include:
- Disputes over licensing and registration refusals
- IP enforcement (patent and trademark disputes)
- Product liability defense
- Contractual disputes with CROs, suppliers, or distributors
We represent clients before Turkish administrative courts, IP courts, and the Ministry of Health's enforcement units.
Clinical Trials Regulation in Turkey
Clinical trials are regulated by the Regulation on Clinical Trials of Drugs and Biological Products. Legal requirements include:
- Ethics committee approvals
- Informed consent from participants
- Data reporting and registration
We provide end-to-end legal assistance for clinical trial sponsors and CROs.
Internal Resources and Related Guides
- Health Data Law and IT Compliance
- Patent Protection in Pharmaceuticals
- Setting Up a Pharma Company
- Translation of Regulatory Documents
Contact the Best Lawyer in Turkey for Pharmaceutical Law
Whether you are launching a new medicine in Turkey, entering a distribution deal, or responding to a regulatory inquiry, our Turkish Law Firm is ready to support you. Contact our English Speaking Turkish Lawyers for industry-specific legal guidance in pharmaceuticals and medical regulation.
