Turkish Pharmaceutical Law governs the regulation, production, licensing, and distribution of medical drugs and equipment in Turkey. It ensures product safety, public health, and compliance with national and international standards. At ER&GUN&ER Law Firm, our pharmaceutical lawyers offer legal consultancy for pharmaceutical manufacturers, healthcare providers, and import/export entities.
The Structure of Turkish Pharmaceutical Law
Pharmaceutical Law in Turkey is primarily regulated by:
- Pharmaceutical and Medical Preparations Law No. 1262
- Regulation on Licensing of Human Medicinal Products
- Industrial Property Law (for patents and data protection)
- Turkish Medicines and Medical Devices Agency (TİTCK)
Key Aspects of Turkish Pharmaceutical Law
- Licensing: A license must be obtained before any medical product is introduced to the market.
- Marketing Authorization: Requires submitting detailed product data to the Ministry of Health.
- Compliance Monitoring: Inspections and post-market surveillance are regularly conducted.
- Patent Protection: Inventors are granted exclusive rights for new pharmaceutical products.
- Penalties: Non-compliance can result in revocation of licenses, fines, or legal sanctions.
Online Sales and Dispensing Rules
Online dispensing of medications is tightly regulated. Prescription-only medications require a valid doctor’s prescription and cannot be sold via unauthorized channels. Online platforms must comply with TİTCK guidelines.
Advertising and Promotion Regulations
Pharmaceutical advertising in Turkey is limited. Only non-prescription products may be promoted to the public. Promotional activities must be accurate, scientifically supported, and pre-approved by authorities.
Licensing Process and Legal Representation
Our pharmaceutical lawyers in Turkey provide full legal support for license applications and communication with the Turkish Medicines and Medical Devices Agency. We also assist in managing patent registrations and product approvals.
FAQ About Pharmaceutical Law in Turkey
What law governs pharmaceutical products in Turkey?
The main legislation is Pharmaceutical and Medical Preparations Law No. 1262, supported by TİTCK regulations and international standards.
What is the role of TİTCK?
The Turkish Medicines and Medical Devices Agency (TİTCK) oversees the pharmaceutical market, licensing, inspections, and compliance with pharmaceutical law.
Are there specific rules for prescription-only drugs?
Yes. Prescription medications can only be sold with a valid prescription and must be dispensed by authorized pharmacies.
