NEWSLETTER-2017

392 NEWSLETTER 2017 Licensing Criteria: Conditions to be taken into consideration regarding the products by the Ministry for the licensing of human medicinal products: • Proof of the effectiveness of the envisaged usage conditions, • Proof of reliability, • Suitable technical and pharmaceutical characteristics 19 . Validity Period of the License: The license holder shall present all the information with regard to quality, reliability and effectiveness, including all the changes since the grant of the license along with the required pharmacovigilence data at least 3 months before the expira- tion of the first five years following the license date 20 . It is aimed that the extension of the validity period of the license is to be completed within 6 months at the latest 21 . Liability of the License Holder: The license holder is liable to the Ministry with regard to the product subject to the license, in those matters such as the following: • Production of the product in accordance with the specifica- tions stated under the annex of the application and accepted by the Ministry; • Update of the short product information and instructions for use in order to provide correct and secure usage; and • Providing availability of the product subject to the license 22 . Also, the Ministry requires proof of bio-equivalence to grant li- cense to generic drugs since 2000. As per those drugs produced before 2000 without bioequivalence certification, it has been requested that their bioequivalence is proven in a certain period of time 23 . 19 Regulation, Article. 16. 20 Regulation, Article. 21. 21 Ministry of Health, General Directorate of Pharmaceutics and Pharmacy, Public Service Standards Chart, https://sgb.saglik.gov.tr/content/files/hizmetstandart/ iegm_kamu_hizmet_standartlari.pdf. 22 Regulation, Article. 24. 23 “Biyoeşdeğerlilik ve Jenerik İlaçlar”, Prof Dr. Öner Süzer, Cerrahpaşa MedicaL