Turkey: Turkey Introduces A New Regulation On Packaging, Inserts And Tracking Of Pharmaceuticals, In Line With EU Directives

Last Updated: 2 May 2017
Article by Gönenç Gürkaynak Esq, Ceren Yıldız and Ecem Elver

Most Read Contributor in Turkey, March 2019

I - Introduction

On April 25th, 2017, the Ministry of Health ("Ministry") has published the Regulation on Packaging Information, Inserts and Tracking of Medicinal Products for Human Use ("Regulation") on the Official Gazette.

Upon publication of the Regulation, the Regulation on Packaging and Labeling of Human Medicinal Products published on August 12th, 2005 ("Abolished Regulation"), has been abrogated.

The Regulation has been prepared within the scope of "legislative harmonization", in consideration of the Directive 2001/83/EC on the Community code relating to medicinal products for human use and Directive 2011/62/EU, as regards the prevention of the entry into the legal supply chain of falsified medicinal products.

In a nutshell, the Regulation governs principles as to the notifications to be made by sellers/importers for tracking of the distribution chain and includes information required on the packaging and inserts of medicinal products for human use.

II - Interior, Exterior Packaging and Directions for Use

- Articles 5 and 6 of the Regulation list the information required to be added to exterior and interior packaging of human medicinal products.

- As per Article 5 of the Regulation, in case a Turkish version of the exterior packaging cannot be prepared, manufacturers will be allowed to attach a label on the exterior packaging which specifies the required information listed in Article 5.

- Manufacturers/importers are obliged to include the name of pharmaceutical in Braille format, as per Article 13. Packaging of pharmaceuticals should be made complaint with this requirement until 31.12.2018[1].

- Inserts (directions for use) will have to be prepared as per Article 8 of the Regulation, listing the information indicated thereunder and in line with the summary of product characteristics and the relevant guidelines of the Ministry.

- Article 18 lays out the principles on the packaging of radiopharmaceuticals and the additional information for their directions for use, such as special precautions, the parts which are not to be used and the duly disposal of their packages.

III - Marketing Samples

- Principles on the marketing samples of medicinal products for human use are set forth under Article 10 of the Regulation.

- Products to be used for marketing purposes as per the Regulation on Promotional Activities of Human Medicinal Products, should also fulfill the requirements determined by the Regulation.

- Turkish Pharmaceuticals and Medical Devices Institution ("Institution") will determine the products to be excluded from Data Matrix practice applied to marketing products.

- Data Matrix inserted to the marketing samples should indicate that the product is for marketing purposes and not for sale.

IV - Tracking of Human Medicinal Products

- The Regulation, contrary to the Abolished Regulation, brings an in-depth roundup on the Product Tracking System ("System") of the Institution. Mechanism of the System is described as the following:

"The System operates based on the principle of recording of the notifications required to be made by partners who are identified with a Global Location Number in accordance with their identified type, to the central data system and the tracking of these. Data Matrix of human medicinal products is notified to the System by the license/permit holders. System, upon controlling the uniqueness, standards and content of the notified Data Matrix records the Data Matrix to data base or rejects those that are not qualified."[2]

- The Term "partner" used in the foregoing expression has been described in Article 4 of the Regulation as "Real/legal persons, institutions or organizations that can, limited to their field of authorization, conduct any operation under human medicinal products' supply chain such as manufacturing, import, purchasing, sale, usage, consuming, exportation, assignment, loss, refund."

- Article 15 of the Regulation lists the incidents that should be notified to the System by partners as well as pharmaceutical warehouses, such as deactivation process, activities on the registered pharmaceutical and the cancellation of those.

- Principles on recording and protection of the data gathered in the System are regulated under Articles 16 and 17 of the Regulation. Regarding the distribution of human medicinal products, partners will have to comply with rules set forth under Article 17, which in general underlines the transport packaging requirements.

V - Transition Process

The Ministry has granted the following transitional periods for fulfilling the requirements under the Regulation:

(1) Medicinal products for human use that are licensed or permitted or subject to license/permit application before the enforcement of the Regulation will have to be made compliant with packaging and insert requirements of the Regulation until September 30th, 2017.

(2)  Medicinal products for human use manufactured before December 31st, 2017 can be preserved with their current packaging until the expiration of their shelf life.

(3)  For medicinal products for human use manufactured after December 30, 2017, packaging and direction requirements of the Regulation should be fulfilled.

(4) Foods for special medical purposes that are not reimbursed but brought under the scope of the Data Matrix practice as per Article 5 of the Regulation should participate to the Data Matrix practice latest by December 31st, 2018.

(5) Bulky parenteral, radiopharmaceuticals and individualized human medicinal products should participate to the Data Matrix practice (under the scope of guidelines specified in Article 20) latest by December 31st, 2018.

[1] Provisional Article 2 of the Regulation

[2] Article 15 of the Regulation

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.

Similar Articles
Relevancy Powered by MondaqAI
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
Similar Articles
Relevancy Powered by MondaqAI
Related Articles
Up-coming Events Search
Font Size:
Mondaq on Twitter
Mondaq Free Registration
Gain access to Mondaq global archive of over 375,000 articles covering 200 countries with a personalised News Alert and automatic login on this device.
Mondaq News Alert (some suggested topics and region)
Select Topics
Registration (please 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