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Life science: highly regulated industry

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.

Documentations for Licensing in Turkey

According to Article 5 of the Licensing Regulation, pharmaceutical products may not be introduced to the market before obtaining a license from the Ministry of Health. In order to obtain this license, the applicants resident in Turkey must apply to the Ministry of Health by presenting the documents listed under the Licensing Regulation published in the Official Gazette dated January 19, 2005 and numbered 25705.

The application documents include, without limitation, (i) description of control methods used by the manufacturer; (ii)toxicological and pharmacological tests and clinical trials; and (iii) where a pharmaceutical product is manufactured under a license (granted by a third party owner of intellectual property) or will be imported, a certificate (and a Turkish translation thereof) issued by the licensor or the supplier demonstrating that the manufacturer/importer is the sole representative which is authorized to manufacture and/or sell the product in Turkey, or if any, a certificate illustrating that a real person or legal entity other than the sole authorized representative in Turkey has also been authorized for co-marketing and the written consents of the real persons or legal entities that will be engaged in co-marketing activities.

Granting licenses to pharmaceutical products in Turkey

Importing pharmaceutical products through the licensing method is the 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.

The required documentations for Licensing in Turkey

According to Article 5 of the Licensing Regulation, pharmaceutical products may not be introduced to the market before obtaining a license from the Ministry of Health. In order to obtain this license, the applicants resident in Turkey must apply to the Ministry of Health by presenting the documents listed under the Licensing Regulation published in the Official Gazette dated January 19, 2005 and numbered 25705.

The application documents include, without limitation, (i) description of control methods used by the manufacturer; (ii)toxicological and pharmacological tests and clinical trials; and (iii) where a pharmaceutical product is manufactured under a license (granted by a third party owner of intellectual property) or will be imported, a certificate (and a Turkish translation thereof) issued by the licensor or the supplier demonstrating that the manufacturer/importer is the sole representative which is authorized to manufacture and/or sell the product in Turkey, or if any, a certificate illustrating that a real person or legal entity other than the sole authorized representative in Turkey has also been authorized for co-marketing and the written consents of the real persons or legal entities that will be engaged in co-marketing activities.