Turkey: Importing Pharmaceuticals To The Turkish Market

Given the potential risks posed to public health, the pharmaceutical sector is one of the most strictly regulated sectors in many countries, including Turkey. In recent years, the importation of foreign pharmaceutical product has grown immensely in Turkey. Manufacture and handling of pharmaceuticals in the distribution chain must strictly conform with detailed regulations and is controlled by national, as well as international, authorities. It is important to retain control over product quality standards and prevent illicit trade.

Turkish regulations outline three ways to import a pharmaceutical into Turkey:

  • Market consumption of licensed products.
  • Patient Sales/Named Patient Program.
  • Compassionate Use.

The most common approach to importing pharmaceuticals to the Turkish commercial market is through the first method. The other two avenues are not intended for bringing pharmaceuticals to the commercial market.

Market Consumption of Licensed Products

Importing pharmaceutical products through the licensing method is the quickest and most reliable option. The Turkish Pharmaceutical and Medical Device Institution ("Institution"), within the Ministry of Health ("Ministry"), is responsible for granting licenses to pharmaceutical products. These licenses are granted under the Licensing Regulation on Human Medicinal Products ("Licensing Regulation"), which outlines the documents and information required. Licenses from the Ministry include permission to import the pharmaceutical product into Turkey.

Pharmaceutical products cannot be launched on the market in Turkey before obtaining a license from the Ministry (Article 5 of the Licensing Regulation; Article 3 of the Pharmaceuticals and Medical Preparations Act). Since the legislative regime prohibits importation of unapproved new drugs into Turkey, importing drugs which lack this Ministry approval violate the law, whether they are for personal use or otherwise.

Importers of pharmaceutical products and active substances must also obtain a certificate of control from the Ministry, as per the Communiqué on Import of Certain Products that are Audited by the Ministry of Health (Communiqué No: 2012/20).

Named Patient Sales

Some pharmaceuticals, especially those critical for treatment of rare or serious diseases such as cancer, may be quite difficult to access due to problems related to obtaining licenses, pricing, and reimbursement of Social Security Institution ("Institution"). The named patient sales approach allows patients in Turkey to access these medicines, under the responsibility of their physician.

This supply methods has grown enormously in recent years, developing into a market worth approximately TRY 1.2 billion (USD 450 million) annually. The patient must pay for the pharmaceutical themselves if is not deemed to be one which the Institution will reimburse for. In this case, affordability issues can arise for patients with serious diseases who need expensive treatments.

The Ministry published a Guideline ("Guideline"), outlining import principles for pharmaceutical products.1 Accordingly, to import a pharmaceutical product in the way, it must be either:

  • Unlicensed in Turkey, or
  • If the Ministry has granted a license:

    • The product is not produced in Turkey
    • The product could not be found in the Turkish market.

The pharmaceutical product must be necessary for the patient's treatment and be approved by the Ministry. To obtain Ministry approval, the physician must provide a prescription for the patient.

Debate exists about the Turkish Pharmacists Association's exclusive authority to import pharmaceutical products under the patient sales approach. The Guideline states that the Association is the only organization authorized to import products which are registered in the "Imported Pharmaceuticals Provision System". Authorization was later granted to certain pharmaceutical warehouses under a by-law. However, the by-law is currently subject to a cancellation action and the Council of State has granted a preliminary injunction which prevents it being applied during the cancellation action. These proceedings are ongoing and pending a final decision from the Council of State.

Compassionate Use Program

The Ministry's Guideline outlines requirements for the Compassionate Use Program. However, this alternative is quite strict. To date, only around 20 pharmaceuticals have been permitted to enter the Turkish market via this approach.

The Guideline2 states that this alternative aims to provide free of charge pharmaceuticals, which are not registered in Turkey, to patients which meet all of the following criteria:

  • For whom treatment has failed with existing accessible licensed products.
  • Who suffer from a serious or urgent life-threatening disease.
  • Have not been included in the scope of clinical trials.

The program only includes pharmaceuticals which have completed at least Phase II studies and have initiated Phase III studies across the world. However, an exception exists for scientifically justifiable and very rare exceptional cases. Studies are not required to be conducted in Turkey.

The patient's treating physician must make a written commitment taking full responsibility for including the patient in this program and submit this commitment to the Ministry.

The program is not a clinical trial and the physician conducting the program is not allowed to receive any payment, under any name. The program does not aim to collect information about drug efficacy. Even if such information is collected, it cannot be used in the Ministry's license registration procedures.

The pharmaceutical may be imported to Turkey either by the pharmaceutical company's subsidiary or a clinical research organization ("CRO") with permission from the Ministry. Once the product is brought to Turkey, the Ministry grants another permit to the importer (the CRO or subsidiary) for products to clear customs. For this permit, the Ministry wishes to see an invoice for the product issued in the name of the CRO or subsidiary, issued by the pharmaceutical company.

The critical point for pharmaceutical manufacturers is that they cannot cease to supply the product ex parte. The patient's doctor should file quarterly reports and if these indicate that the patient benefits from the drug, the pharmaceutical manufacturer must continue to send the products, until it obtains a license in Turkey

Since the compassionate use program allows access to drugs which are not yet approved, it naturally involves inherent risks. For instance;

  • The efficacy or side effects of unapproved drugs may not be known yet.
  • Pharmaceutical companies are not obliged to supply unapproved products and there is no tool to require companies to do so.
  • Patients may need to pay for the product personally. Therefore, the pharmaceutical may not be in the Institution's reimbursement list.
  • The procedure is complicated and onerous, so patients may experience long delays in receiving an answer from the Ministry.


1. http://www.titck.gov.tr/Haberler/HaberGetir?id=294

2. http://www.titck.gov.tr/Mevzuat/MevzuatGetir?id=2126

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

To print this article, all you need is to be registered on Mondaq.com.

Click to Login as an existing user or Register so you can print this article.

Merve Altınay
Some comments from our readers…
“The articles are extremely timely and highly applicable”
“I often find critical information not available elsewhere”
“As in-house counsel, Mondaq’s service is of great value”

Up-coming Events Search
Font Size:
Mondaq on Twitter
Register for Access and our Free Biweekly Alert for
This service is completely free. Access 250,000 archived articles from 100+ countries and get a personalised email twice a week covering developments (and yes, our lawyers like to think you’ve read our Disclaimer).
Email Address
Company Name
Confirm Password
Mondaq Topics -- Select your Interests
 Law Performance
 Law Practice
 Media & IT
 Real Estate
 Wealth Mgt
Asia Pacific
European Union
Latin America
Middle East
United States
Worldwide Updates
Check to state you have read and
agree to our Terms and Conditions

Terms & Conditions and Privacy Statement

Mondaq.com (the Website) is owned and managed by Mondaq Ltd and as a user you are granted a non-exclusive, revocable license to access the Website under its terms and conditions of use. Your use of the Website constitutes your agreement to the following terms and conditions of use. Mondaq Ltd may terminate your use of the Website if you are in breach of these terms and conditions or if Mondaq Ltd decides to terminate your license of use for whatever reason.

Use of www.mondaq.com

You may use the Website but are required to register as a user if you wish to read the full text of the content and articles available (the Content). You may not modify, publish, transmit, transfer or sell, reproduce, create derivative works from, distribute, perform, link, display, or in any way exploit any of the Content, in whole or in part, except as expressly permitted in these terms & conditions or with the prior written consent of Mondaq Ltd. You may not use electronic or other means to extract details or information about Mondaq.com’s content, users or contributors in order to offer them any services or products which compete directly or indirectly with Mondaq Ltd’s services and products.


Mondaq Ltd and/or its respective suppliers make no representations about the suitability of the information contained in the documents and related graphics published on this server for any purpose. All such documents and related graphics are provided "as is" without warranty of any kind. Mondaq Ltd and/or its respective suppliers hereby disclaim all warranties and conditions with regard to this information, including all implied warranties and conditions of merchantability, fitness for a particular purpose, title and non-infringement. In no event shall Mondaq Ltd and/or its respective suppliers be liable for any special, indirect or consequential damages or any damages whatsoever resulting from loss of use, data or profits, whether in an action of contract, negligence or other tortious action, arising out of or in connection with the use or performance of information available from this server.

The documents and related graphics published on this server could include technical inaccuracies or typographical errors. Changes are periodically added to the information herein. Mondaq Ltd and/or its respective suppliers may make improvements and/or changes in the product(s) and/or the program(s) described herein at any time.


Mondaq Ltd requires you to register and provide information that personally identifies you, including what sort of information you are interested in, for three primary purposes:

  • To allow you to personalize the Mondaq websites you are visiting.
  • To enable features such as password reminder, newsletter alerts, email a colleague, and linking from Mondaq (and its affiliate sites) to your website.
  • To produce demographic feedback for our information providers who provide information free for your use.

Mondaq (and its affiliate sites) do not sell or provide your details to third parties other than information providers. The reason we provide our information providers with this information is so that they can measure the response their articles are receiving and provide you with information about their products and services.

If you do not want us to provide your name and email address you may opt out by clicking here .

If you do not wish to receive any future announcements of products and services offered by Mondaq by clicking here .

Information Collection and Use

We require site users to register with Mondaq (and its affiliate sites) to view the free information on the site. We also collect information from our users at several different points on the websites: this is so that we can customise the sites according to individual usage, provide 'session-aware' functionality, and ensure that content is acquired and developed appropriately. This gives us an overall picture of our user profiles, which in turn shows to our Editorial Contributors the type of person they are reaching by posting articles on Mondaq (and its affiliate sites) – meaning more free content for registered users.

We are only able to provide the material on the Mondaq (and its affiliate sites) site free to site visitors because we can pass on information about the pages that users are viewing and the personal information users provide to us (e.g. email addresses) to reputable contributing firms such as law firms who author those pages. We do not sell or rent information to anyone else other than the authors of those pages, who may change from time to time. Should you wish us not to disclose your details to any of these parties, please tick the box above or tick the box marked "Opt out of Registration Information Disclosure" on the Your Profile page. We and our author organisations may only contact you via email or other means if you allow us to do so. Users can opt out of contact when they register on the site, or send an email to unsubscribe@mondaq.com with “no disclosure” in the subject heading

Mondaq News Alerts

In order to receive Mondaq News Alerts, users have to complete a separate registration form. This is a personalised service where users choose regions and topics of interest and we send it only to those users who have requested it. Users can stop receiving these Alerts by going to the Mondaq News Alerts page and deselecting all interest areas. In the same way users can amend their personal preferences to add or remove subject areas.


A cookie is a small text file written to a user’s hard drive that contains an identifying user number. The cookies do not contain any personal information about users. We use the cookie so users do not have to log in every time they use the service and the cookie will automatically expire if you do not visit the Mondaq website (or its affiliate sites) for 12 months. We also use the cookie to personalise a user's experience of the site (for example to show information specific to a user's region). As the Mondaq sites are fully personalised and cookies are essential to its core technology the site will function unpredictably with browsers that do not support cookies - or where cookies are disabled (in these circumstances we advise you to attempt to locate the information you require elsewhere on the web). However if you are concerned about the presence of a Mondaq cookie on your machine you can also choose to expire the cookie immediately (remove it) by selecting the 'Log Off' menu option as the last thing you do when you use the site.

Some of our business partners may use cookies on our site (for example, advertisers). However, we have no access to or control over these cookies and we are not aware of any at present that do so.

Log Files

We use IP addresses to analyse trends, administer the site, track movement, and gather broad demographic information for aggregate use. IP addresses are not linked to personally identifiable information.


This web site contains links to other sites. Please be aware that Mondaq (or its affiliate sites) are not responsible for the privacy practices of such other sites. We encourage our users to be aware when they leave our site and to read the privacy statements of these third party sites. This privacy statement applies solely to information collected by this Web site.

Surveys & Contests

From time-to-time our site requests information from users via surveys or contests. Participation in these surveys or contests is completely voluntary and the user therefore has a choice whether or not to disclose any information requested. Information requested may include contact information (such as name and delivery address), and demographic information (such as postcode, age level). Contact information will be used to notify the winners and award prizes. Survey information will be used for purposes of monitoring or improving the functionality of the site.


If a user elects to use our referral service for informing a friend about our site, we ask them for the friend’s name and email address. Mondaq stores this information and may contact the friend to invite them to register with Mondaq, but they will not be contacted more than once. The friend may contact Mondaq to request the removal of this information from our database.


This website takes every reasonable precaution to protect our users’ information. When users submit sensitive information via the website, your information is protected using firewalls and other security technology. If you have any questions about the security at our website, you can send an email to webmaster@mondaq.com.

Correcting/Updating Personal Information

If a user’s personally identifiable information changes (such as postcode), or if a user no longer desires our service, we will endeavour to provide a way to correct, update or remove that user’s personal data provided to us. This can usually be done at the “Your Profile” page or by sending an email to EditorialAdvisor@mondaq.com.

Notification of Changes

If we decide to change our Terms & Conditions or Privacy Policy, we will post those changes on our site so our users are always aware of what information we collect, how we use it, and under what circumstances, if any, we disclose it. If at any point we decide to use personally identifiable information in a manner different from that stated at the time it was collected, we will notify users by way of an email. Users will have a choice as to whether or not we use their information in this different manner. We will use information in accordance with the privacy policy under which the information was collected.

How to contact Mondaq

You can contact us with comments or queries at enquiries@mondaq.com.

If for some reason you believe Mondaq Ltd. has not adhered to these principles, please notify us by e-mail at problems@mondaq.com and we will use commercially reasonable efforts to determine and correct the problem promptly.