NEWSLETTER-2017

391 MISCELLANEOUS 30 December 2005 15 (“Regulation”). According to the Regulation, a license is defined as “ the document issued by the Ministry indicat- ing that a product can be put into the market in accordance with the accepted product specifications stating its specific formula and phar- maceutical form and dose. ” On the other hand, licensing corresponds to the “analysis and approval process for a product to be placed into the market.” 16 The Regulation aims to “ determine the practice with re- gard to the procedure and principles of the licensing process, and the practices for licensed human medicinal products, in order to provide that the human medicinal products have the required effectiveness, reliability and quality. ” Evaluation of the License Application and Steps of Licensing Before a drug attains its place in the market, it should be licensed upon the completion of all of the steps for licensing specified, below. Preliminary Assessment: Following the receipt of an application filed by the Ministry, the applicant holder is notified of the required assessment within 30 days. If the application has been determined to have deficiencies, the application holder completes the application within 30 days. The second preliminary assessment following the elimination of the deficiencies before the Ministry is completed within 30 days 17 . Licensing Period: The Ministry finalizes a full license applica- tion where the preliminary assessment has been completed, within 210 days following the acceptance of such application assessing whether the licensing conditions have been fulfilled 18 . 15 Union of Pharmaceutical Industry Employers ( İlaç Endüstrisi İşverenler Sendikası )– Licensing http://www.ieis.org.tr/ieis/tr/issues/11/ruhsatlandirma 16 “Ruhsatlama Süreçlerinde Sağlık Bakanlığı Ve İlaç Sanayi İlişkileri” by Yavuz UYAR İstanbul University Cerrahpaşa Medical School, İstanbul, 29.ANKEM Antibiotics and Chemotherapy Congress, Bodrum, 28-31 May 2014 (http://www. ankemdernegi.org.tr/ANKEMJOURNALPDF/ANKEM_28_Ek2_2_6.pdf) . 17 Regulation, Article. 13. 18 Regulation, Article. 15.