Guideline for Working Principles and Procedures of Human Medicinal Products Priority Assessment Commission

Scope

(1) This guideline covers the analysis and finalization of the requests about prioritization of the following applications which are included in the annex of Ministerial Consent dated April 13, 2016 Nr: 2165621 in the Agency’s Assessing Processes;

a) Applications relating to first generic products or products of which generic is authorized but not on the market,

b) Applications relating to biosimilar products,

c) Applications relating to innovative products,

ç) Applications relating to transferring the production of imported medicines to our country,

d) Applications for locally manufactured products for exportation purposes,

e) Applications relating to products which cause serious public health problems in case they are not ready for use including vaccines or those which are included in the Agency’s foreign medicine procurement list on the date of application,

f) Applications relating to products of companies which are benefited from the governmental incentives in the fields of R&D, manufacturing and marketing,

g) Special import permit applications,

ğ) Applications relating to the Good Manufacturing Practices (GMP) audit,

h) Applications relating to products which have strategic importance in terms of country policies.

Basis

(1) This guideline has been prepared on the basis of Article 27 of Decree Law Concerning the Organization and Duties of The Ministry of Health and its Affiliated Institutions Nr:663 and Regulation on the Registration Medicinal Products for Human Use published in the Official Gazette Nr:25705 dated January 19, 2005, referring to the Ministerial Consent Nr: 2165621 dated April 13, 2016.

Definitions

(1) Following terms used in this Guideline shall have the meaning expressly designated to them below;

a) Ministerial Consent: Ministerial Consent Nr:2165621 dated April 13, 2016,

b) Unit: Health Industries Coordination and Tracking Unit within the Department of Economic Assessments and Medicine Procurement Management,

c) First Generic Product: The product only the original of which is available on the market, namely the generic of it is unavailable,

ç) Assessment Process: Product analysis procedures, the GMP audit of manufacturing plants, all the phases of marketing authorization application which starts with pre-assessment and ends in placing on the market,

d) GMP: Good Manufacturing Practices,

e) Commission: Turkish Medicines and Medical Devices Agency Human Medicinal Products Priority Assessment Commission,

f) Agency: Turkish Medicines and Medical Devices Agency,

g) Normal Application: The application for which any prioritization is not requested or of which prioritization request is not approved,

ğ) Original Product: The product which is authorized in order to be put on the market for the first time in the world by proving that it has scientifically acceptable efficiency, quality and reliance in terms of active substance or substances,

h) Prioritization: Assessment of applications within the determined criteria and put them forward in the Agency’s assessment processes by giving priority to applications about medicines which can contribute to the national economy by decrease in import and increase in export and local production; to public finance by decrease in unit medicine price; to public health, preventive and therapeutical health services by using them in health service delivery,

ı) Prioritization Process: All the phases of a prioritization request as of it’s transmitted to the unit till the end of actions and operations about it in the Agency,

i) Priority Application: The application determined as a priority in the assessment process by the Agency,

j) Special import permit: The license given in order to ensure the availability of import licensed medicines in case there is a problem in the supply of them,

k) Marketing authorization application: Marketing authorization applications carried out within the scope of Regulation on the Registration Medicinal Products for Human Use,

l) Request Form: Forms included in the Agency website in order to be used in prioritization request,

m) Innovative Product: The medical product which is the first in or which brings partially or wholly innovation to the diagnosis and treatment of the diseases much faster, much more efficient or with lower costs by aiming at improving the quality of life and health,