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Due to the potential risks posed to public health, the pharmaceutical sector is a highly regulated industry in Turkey. In recent years, the importation of foreign pharmaceutical product has recorded significant growth in Turkey. Manufacture and handling of pharmaceuticals in the distribution chain are subject to detailed regulations as supervised by national and international authorities. It is essential to monitor product quality standards and prevent illicit trade practices.
Turkish regulations permit three ways to import a pharmaceutical into Turkey:
– Market consumption of licensed products.
– Patient Sales/Named Patient Program.
– Compassionate UseGranting licenses to pharmaceutical products in Turkey.
Importing pharmaceutical products through the licensing method is the most convenient option. The Turkish Pharmaceutical and Medical Device Institution (“Institution”), subordinate to the Ministry of Health (“Ministry”), is responsible for granting license to any pharmaceutical product. This licencing process must respect to the Licensing Regulation on Human Medicinal Products (“Licensing Regulation”), which enlist the documents and information required. Licenses from the Ministry is subject to permission to import the pharmaceutical product into Turkey.
Pharmaceutical Companies Medical Device Manufacturers Biotechnology Firms Clinical Research Org. Healthcare Providers & Hosp. Academic and Research Inst. Regulatory Agencies Health Insurance Companies Public Health Organizations Non-Profit Organizations Healthcare Law Firms Medical Software |
Regulatory Submissions Medical Journals and Research Papers Patient Records and Reports Medical Devices Documents Healthcare Websites and Apps Marketing Materials Training Materials Patient Education Materials Pharmacovigilance Documents Health Insurance Documents |