Basic information
Outline of the system
The approval of the Ministry of Health, Turkish Medicine and Medical Device Institution is required for importation of goods included in the Communiqué.
Product coverage
Please see Products "Medical Diagnostic Kits"
Nature of licensing
Automatic
If Automatic, administrative purpose
Non-Automatic
If Non-Automatic, description of the notified Non-Automatic Licensing regime
Products under restriction as to the quantity or value of imports
The approval of the Turkish Medicine and Medical Device Institution is not intended to restrict the quantity or the value of importation of the goods. The purpose is to protect public health in country and to ensure product covered by the Communiqué accessibility to the market in safe manner.
Questions for products under restriction as to the quantity or value of imports
Not applicable.
The system applies to products originating from which country?
The system applies to goods imported from all countries.
Expected duration of licensing procedure
Legal requirements
Is the licensing statutorily required?
The procedure is mentioned in the Import Communiqué: (Import Communiqué 2022/19) published in the Official Gazette of 31 December 2021, No. 31706 bis. The Communiqué is available at the https://www.resmigazete.gov.tr/eskiler/2021/12/20211231M3-21.htm website link.
Does the legislation leave designation of products to be subject to licensing to administrative discretion?
Is it possible for the government to abolish the system without legislative approval?
It is possible for the Government to abolish the system without legislative approval.
Eligibility of applicants
Is there a system of registration of persons or firms permitted to engage in importation?
What persons or firms are eligible to apply for a licence?
There is no restriction to apply for a licence for all companies/importer that have completed the Product Tracking System (PTS) registration process and have the Medical Device Sales Center Authorization Certificate.
Is there a registration fee?
PTS registration processes are free of charge.
Is there a published list of authorized importers?
There is no data on the Importer list in the PTS system.
Contact point for information on eligibility
Ministry/Authority
Address
Telephone
Fax
E-mail address
Website
Contact officer
Submission of an application
Administrative body(ies) for submission of an application
Ministry of Health, Turkish Medicine and Medical Device Institution
Documentation requirements
What information is required in applications?
In accordance with the "Communiqué on the Export and Import of Goods Prohibited and Subject to Pre-Permission (Export: 96/31)" dated 29 May 2020, the applications are made electronically through Institution's system.
What documents is the importer required to supply with the application?
Window of submission of an application
How far in advance of importation must application for a licence be made?
Applications for importation of Diagnostic Kits made through institution's Electronic Information System (EIS) are instantly and automatically approved by the system, and the Single Window System (SWS) code is sent to the e-mail addresses defined in the system.
Are there any limitations as to the period of the year during which application for licence can be made? If so, explain
There is no deadline for application. It can be made any time during the year.
Issuing the license
Can a licence be granted immediately on request?
License can be issued immediately and automatically by the EIS if requested information and documents are complete.
Can licences be obtained within a shorter time-limit or for goods arriving at the port without a licence
Which administrative body is responsible for approving application of licences?
In accordance with the "Announcement No. 2020/11 on Products Subject to Pre-Permission" and in line with the "Communiqué on Exports and Imports of Goods whose Export and Imports are Prohibited (Export: 96/31)" dated 29 May 2020, during the pandemic, application for the importation of Covid-19 diagnostic kit is assessed based on the conformity letter to be given by the General Directorate of Public Health of Türkiye.
Must the applications be passed on to other organs for visa, note or approval?
Are there any other conditions attached to the issue of a licence?
There is no other conditions other than specified above.
Fees and other administrative charges
Is there any licensing fee or administrative charge?
Licence is not subject to any fee.
What is the amount of the fee or charge?
Is there any deposit or advance payment required associated with the issue of licences?
Licence is not subject to any fee.
Amount or rate?
Is it refundable?
What is the period of retention?
What is the purpose of this requirement?
Refusal of an application
Under what circumstances may an application for a licence be refused other than failure to meet the ordinary criteria?
Application for approval can be rejected in case information or documents requested by the Institution are incomplete.
In cases where the products used for clinical research purposes are not medical diagnostic kits and require preliminary import permits due to the related HS definitions, if the interested importer/ companies apply to Institution with information/documents regarding the aforementioned products, a preliminary permit is given as a result of the necessary examinations.
Are the reasons for any refusal given to applicants?
The reason for the rejection is notified to the applicant in writing.
Have applicants a right of appeal in the event of refusal to issue a licence?
No appeal procedures are specified in provisions of the legislation in force.
If so, to what bodies and under what procedures?
However, all actions and procedures of the administration is subject to judicial remedy according to constitution.
Importation
Are there any limitations as to the period of year during which importation may be made?
What documents are required upon actual importation?
One copy of the document, which comprises of the approval of the Institute, shall be annexed to the Customs Declaration form.
Are there any other administrative procedures, apart from import licensing and similar administrative procedures, required prior to importation?
There is no other administrative procedure other than import license and similar administrative procedures before import.
Conditions of licensing
What is the period of validity of a licence? Can the validity be extended? How?
There is no specific validity period.
Is there any penalty for the non-utilization of a licence or a portion of a licence?
There is no penalty for non-use or partial use of a license.
Are licences transferable between importers? If so, are any limitations or conditions attached to such transfer?
There is no specific provision in the current legislation regarding the transfer of licenses.
Foreign Exchange
Is foreign exchange automatically provided by the banking authorities for goods to be imported?
Not applicable.
Is a licence required as a condition to obtaining foreign exchange?
Not applicable.
Is foreign exchange always available to cover licences issued?
Not applicable.
What formalities must be fulfilled for obtaining the foreign exchange?
Not applicable.