Turkey: Parallel Import And Repackaging Of Pharmaceutical Products In Turkey

While the European Union has long determined its approach to trademark issues for parallel imports and repackaging of pharmaceuticals, Turkish courts and legislation lack a unified and established practice on the issue. In fact, the current regulatory regime in Turkey prevents parallel import and repackaging of pharmaceuticals.

Key aspects of trade mark law for pharmaceuticals

Pharmaceutical imports into Turkey are regulated under the Pharmaceutical and Medical Preparations Law numbered 1262 (Law numbered 1262), while parallel imports and the exhaustion of rights principle are regulated by the Decree Law on the Protection of Trade marks numbered 556 (Trade mark Decree Law). These legislative instruments aim to protect public health and intellectual property respectively. However, in practice the differing motivations also lead to contradictory outcomes in interpretation.

One of a company's most important assets is its trade mark portfolio. The key functions from a commercial trade mark portfolio are to:

  • Exclusively identify and guarantee the commercial source or origin of products or services;
  • Distinguish the trade mark owner from other establishments;
  • Enable consumers to be certain that a purchased trade marked product has not been subject to interference by a third party, without the proprietor's authorization; and
  • He or she will enjoy the same quality every time they purchase products from the same brand.

Legal systems generally allow trade mark holders to enjoy these functions by granting the right to prevent third parties from using its trade mark on goods or packaging, as well as prevent the goods being imported or exported. However, limitations apply to this absolute right, including the exhaustion of right principle.

Article 13 of the Trade mark Decree Law explicitly includes the national exhaustion principle as follows. The acts related with a product containing a registered trade mark shall not constitute a breach of the rights of a registered trade mark, where such acts have occurred after the product has been put on the market in Turkey by the proprietor or with his consent. The proprietor has the right, even within the provision of the first paragraph, to oppose further commercialization of the goods, especially where the condition of the goods is changed or impaired after they have been put on the market.

For a right to be exhausted under Article 13, goods must be sold in Turkey either by the trade mark owner, or by third parties with the owner's consent. It is agreed that what becomes exhausted is the right to first sell trade marked goods and not trade mark rights. Therefore, considering the fact that Turkey accepts the national exhaustion principle, the Trade mark Decree Law actually allows trade mark owners to prevent parallel import. If a third party imports goods to Turkey other than the goods in question, which have been already sold in Turkey, the trade mark right is not exhausted for the later goods. Therefore, the trade mark holder can prevent sale of those goods in Turkey.

However, the Court of Appeal interprets the exhaustion of rights in broader terms. In numerous decisions, it has concluded that if goods bearing the registered trade mark are put on the market in Turkey, the exhaustion of rights occurs for all similar goods put on the market in other countries. Therefore, it is not possible to prevent importation or sale of original goods in Turkey, which have been put into the market of the other countries, unless the products are altered or damaged.

Parallel Importing of Pharmaceuticals

Parallel importing involves products being legally made (i.e. not pirated) abroad, but then imported without the intellectual property right-holder's permission. The concept has always been debatable due to the potential advantages which parallel importers gain, as well as possible loss of benefits for trade mark holders and the necessary changes which must be made to original packaging. These issues are particularly relevant for parallel imported pharmaceuticals.

Due to pharmaceutical pricing policies (based on consumer purchasing abilities) and the structures of state health and insurance practices, the same product is often marketed for different prices by different companies. Parallel importers buy original pharmaceuticals from one market at a lower price, then sell them in other markets for a higher price.

Trade mark holders argue that parallel imports harm trade marks' guarantee function. That is, the trade mark holder cannot guarantee the product's quality, since it cannot guarantee that products are kept under the right conditions during parallel importing, nor whether the packaging (including expiry date) has been manipulated.

On the other hand, parallel imports are arguably a strong tool for competition law, enabling international trade to function by preventing the trade mark holder from partitioning markets and allowing goods to move freely.

Parallel Importing in Turkey

Given Turkey's ongoing European Union harmonization process, the CJEU's decisions could potentially serve as valuable guides for Turkish courts and judges in developing a local approach. However, the current regulatory regime in Turkey prevents parallel import and repackaging of pharmaceuticals.

The Turkish Court of Appeal interprets parallel imports widely, failing to take into account the difference between goods which have already been put into the market and later imported goods. However, despite the more liberal judicial approach, pharmaceuticals are strictly regulated in Turkey, with close regulatory control over standards and pricing for manufacture, distribution, sale, promotion, imports and exports.

Accordingly, pharmaceuticals can only be imported and commercialized by the company which holds marketing authorization from the Ministry of Health. Marketing authorization is granted only to the Turkish subsidiary of the pharmaceutical manufacturer. Therefore, since it is only granted to one company, practically other companies are not allowed to import the pharmaceutical. These restrictions mean that parallel import of pharmaceuticals is not allowed in Turkey.

Labelling is also closely regulated by Law numbered 1262 and the Regulation on Packaging and Labeling of Pharmaceuticals (Regulation). The Regulation explicitly and strictly determines packaging requirements, also requiring packaging changes to be reviewed and approved by the Ministry of Health. Therefore, repackaging of pharmaceuticals is prohibited in Turkey.

When applying for marketing authorization, applicants must prepare sample packaging and submit this to the Ministry of Health for approval, together with other application documents. All information on the packaging and patient leaflets must be in Turkish, including:

  • Name of the marketing authorization holder;
  • Name of the laboratory where the pharmaceutical was manufactured;
  • Marketing authorization number;
  • Instructions for using the pharmaceuticals;
  • Harmful or poisonous ingredients;
  • Whether the pharmaceutical must be sold via a prescription.

Therefore, unless the current regulatory requirements are amended to allow parallel imported pharmaceuticals, the Turkish market will continue to be excluded from the economic benefits provided by parallel imports. For example, preventing division of markets and lowering the risks of companies abusing dominant positions.

Therefore, it seems that for now, Turkey will continue to watch European Union parallel import developments from a distance.

First published in the PTMG newsletter 'Law Lore and Practice', December 2016 (page 10).

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”

Related Topics
Related Articles
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
Registration (you must scroll down to set your data preferences)

Mondaq Ltd requires you to register and provide information that personally identifies you, including your content preferences, for three primary purposes (full details of Mondaq’s use of your personal data can be found in our Privacy and Cookies Notice):

  • To allow you to personalize the Mondaq websites you are visiting to show content ("Content") relevant to your interests.
  • To enable features such as password reminder, news alerts, email a colleague, and linking from Mondaq (and its affiliate sites) to your website.
  • To produce demographic feedback for our content providers ("Contributors") who contribute Content for free for your use.

Mondaq hopes that our registered users will support us in maintaining our free to view business model by consenting to our use of your personal data as described below.

Mondaq has a "free to view" business model. Our services are paid for by Contributors in exchange for Mondaq providing them with access to information about who accesses their content. Once personal data is transferred to our Contributors they become a data controller of this personal data. They use it to measure the response that their articles are receiving, as a form of market research. They may also use it to provide Mondaq users with information about their products and services.

Details of each Contributor to which your personal data will be transferred is clearly stated within the Content that you access. For full details of how this Contributor will use your personal data, you should review the Contributor’s own Privacy Notice.

Please indicate your preference below:

Yes, I am happy to support Mondaq in maintaining its free to view business model by agreeing to allow Mondaq to share my personal data with Contributors whose Content I access
No, I do not want Mondaq to share my personal data with Contributors

Also please let us know whether you are happy to receive communications promoting products and services offered by Mondaq:

Yes, I am happy to received promotional communications from Mondaq
No, please do not send me promotional communications from Mondaq
Terms & Conditions

Mondaq.com (the Website) is owned and managed by Mondaq Ltd (Mondaq). Mondaq grants you a non-exclusive, revocable licence to access the Website and associated services, such as the Mondaq News Alerts (Services), subject to and in consideration of your compliance with the following terms and conditions of use (Terms). Your use of the Website and/or Services constitutes your agreement to the Terms. Mondaq may terminate your use of the Website and Services if you are in breach of these Terms or if Mondaq decides to terminate the licence granted hereunder for any reason whatsoever.

Use of www.mondaq.com

To Use Mondaq.com you must be: eighteen (18) years old or over; legally capable of entering into binding contracts; and not in any way prohibited by the applicable law to enter into these Terms in the jurisdiction which you are currently located.

You may use the Website as an unregistered user, however, you are required to register as a user if you wish to read the full text of the Content or to receive the Services.

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 or with the prior written consent of Mondaq. You may not use electronic or other means to extract details or information from the Content. Nor shall you extract information about users or Contributors in order to offer them any services or products.

In your use of the Website and/or Services you shall: comply with all applicable laws, regulations, directives and legislations which apply to your Use of the Website and/or Services in whatever country you are physically located including without limitation any and all consumer law, export control laws and regulations; provide to us true, correct and accurate information and promptly inform us in the event that any information that you have provided to us changes or becomes inaccurate; notify Mondaq immediately of any circumstances where you have reason to believe that any Intellectual Property Rights or any other rights of any third party may have been infringed; co-operate with reasonable security or other checks or requests for information made by Mondaq from time to time; and at all times be fully liable for the breach of any of these Terms by a third party using your login details to access the Website and/or Services

however, you shall not: do anything likely to impair, interfere with or damage or cause harm or distress to any persons, or the network; do anything that will infringe any Intellectual Property Rights or other rights of Mondaq or any third party; or use the Website, Services and/or Content otherwise than in accordance with these Terms; use any trade marks or service marks of Mondaq or the Contributors, or do anything which may be seen to take unfair advantage of the reputation and goodwill of Mondaq or the Contributors, or the Website, Services and/or Content.

Mondaq reserves the right, in its sole discretion, to take any action that it deems necessary and appropriate in the event it considers that there is a breach or threatened breach of the Terms.

Mondaq’s Rights and Obligations

Unless otherwise expressly set out to the contrary, nothing in these Terms shall serve to transfer from Mondaq to you, any Intellectual Property Rights owned by and/or licensed to Mondaq and all rights, title and interest in and to such Intellectual Property Rights will remain exclusively with Mondaq and/or its licensors.

Mondaq shall use its reasonable endeavours to make the Website and Services available to you at all times, but we cannot guarantee an uninterrupted and fault free service.

Mondaq reserves the right to make changes to the services and/or the Website or part thereof, from time to time, and we may add, remove, modify and/or vary any elements of features and functionalities of the Website or the services.

Mondaq also reserves the right from time to time to monitor your Use of the Website and/or services.


The Content is general information only. It is not intended to constitute legal advice or seek to be the complete and comprehensive statement of the law, nor is it intended to address your specific requirements or provide advice on which reliance should be placed. Mondaq and/or its Contributors and other suppliers make no representations about the suitability of the information contained in the Content for any purpose. All Content provided "as is" without warranty of any kind. Mondaq and/or its Contributors and other suppliers hereby exclude and disclaim all representations, warranties or guarantees with regard to the Content, including all implied warranties and conditions of merchantability, fitness for a particular purpose, title and non-infringement. To the maximum extent permitted by law, Mondaq expressly excludes all representations, warranties, obligations, and liabilities arising out of or in connection with all Content. In no event shall Mondaq 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 of the Content or performance of Mondaq’s Services.


Mondaq may alter or amend these Terms by amending them on the Website. By continuing to Use the Services and/or the Website after such amendment, you will be deemed to have accepted any amendment to these Terms.

These Terms shall be governed by and construed in accordance with the laws of England and Wales and you irrevocably submit to the exclusive jurisdiction of the courts of England and Wales to settle any dispute which may arise out of or in connection with these Terms. If you live outside the United Kingdom, English law shall apply only to the extent that English law shall not deprive you of any legal protection accorded in accordance with the law of the place where you are habitually resident ("Local Law"). In the event English law deprives you of any legal protection which is accorded to you under Local Law, then these terms shall be governed by Local Law and any dispute or claim arising out of or in connection with these Terms shall be subject to the non-exclusive jurisdiction of the courts where you are habitually resident.

You may print and keep a copy of these Terms, which form the entire agreement between you and Mondaq and supersede any other communications or advertising in respect of the Service and/or the Website.

No delay in exercising or non-exercise by you and/or Mondaq of any of its rights under or in connection with these Terms shall operate as a waiver or release of each of your or Mondaq’s right. Rather, any such waiver or release must be specifically granted in writing signed by the party granting it.

If any part of these Terms is held unenforceable, that part shall be enforced to the maximum extent permissible so as to give effect to the intent of the parties, and the Terms shall continue in full force and effect.

Mondaq shall not incur any liability to you on account of any loss or damage resulting from any delay or failure to perform all or any part of these Terms if such delay or failure is caused, in whole or in part, by events, occurrences, or causes beyond the control of Mondaq. Such events, occurrences or causes will include, without limitation, acts of God, strikes, lockouts, server and network failure, riots, acts of war, earthquakes, fire and explosions.

By clicking Register you state you have read and agree to our Terms and Conditions