In Custodia Legis
Official blog from the Law Library of Congress
Find the Law Library on:
Back to Index of Pharmaceutical Samples
Turkey appears to have in place an extensive national track-and-trace system for pharmaceuticals that involves serialization of all drugs (with certain exceptions) placed in the domestic market and validation of transactions at various points of the supply chain. However, whether or not free samples are subject to serialization within the national tracking system is not clear due to the existence in the current legal framework of certain rules that appear to conflict. Regardless of whether samples are required to be serialized within the national tracking system, Turkish law requires pharmaceutical companies to set their own systems for recording the manufacture, importation, and distribution of free samples and to submit records for administrative auditing when requested.
I. The Serialization of Pharmaceuticals in Turkey
According to the Turkish Pharmaceutical Market 2018 Report, published by the Pharmaceutical Manufacturers Association of Turkey, the volume of the Turkish pharmaceutical market in 2018 was 2.3 billion units (up from 1.62 billion units in 2010), with companies with foreign capital accounting for 66% of the market in value and 69% in volume.[1]
The serialization and tracking of pharmaceuticals is implemented by the Drug Tracking System (Ilac Takip Sistemi, “ITS”),[2] which was first implemented by the amendment in 2008 of the 2005 Regulation on Packaging and Labeling of Medicinal Products for Human Use.[3] Currently, the main framework for the serialization of medicinal products for human use (MPHUs) and the operation of the ITS is provided by the 2017 Regulation on the Packaging Information, Use Instructions, and Tracking of Medicinal Products for Human Use (“2017 Packaging Regulation”).[4]
Details concerning the implementation of the ITS are laid down by a number of binding Guidelines published by the Turkish Medicines and Medical Devices Agency (Agency). In a nutshell, the ITS is a “track-and-trace” system that operates through the validation within a real-time database of each transaction that is made within the supply chain of the product. Stakeholders located at the various points of the supply chain must provide notification of each transaction involving the uniquely serialized product and obtain validation for that transaction. Upon notification, the system validates the transaction if the supply chain data is consistent or declines the transaction if it is not.[5]
MPHUs are serialized by affixing a two-dimensional square-shaped error-correcting matrix barcode, the ECC 200 standard GS1-DataMatrix (“data matrix code”)[6], to the packaging of each manufactured unit. A data matrix code is not required on large-volume parenteral (administered other than by mouth) products, radiopharmaceuticals, and custom-made products for individual patients.[7] The data matrix code includes four types of information:
(1) the Global Trade Item Number (GS1 standard GTIN) that identifies the product,
(2) a serial number (SN) unique for each item of the same type,
(3) the expiration date of the product, and
(4) a batch/lot number identifying the production cycle in which the item was manufactured.[8]
The combination of the GTIN and the SN makes every unit uniquely identifiable.[9]
Each unit is then tracked in the real-time database by scanning the data matrix code accompanied with a coded notification made in the system by the stakeholders at certain transaction points in the supply chain, as determined by the serialization framework. Stakeholders are identified by GS1 standard Global Location Numbers issued for each of their activity locations.[10] The data created is stored by the Ministry of Health for at least three years after the expiration date of the individual unit.[11] According to article 15 of the 2017 Packaging Regulation and article 9 of the Drug Tracking System Operation Guidelines,[12] the transactions requiring notification and validation are as follows:
Stakeholders |
Transaction in supply chain requiring ITS notification |
Drug producer/importer |
Manufacture [first entry of domestically manufactured item into ITS] Importation [first entry of imported item into ITS] Sale [at time of sale to a pharmaceutical warehouse, pharmacy, distributor pharmaceutical company, or hospital] Sales return [if product is returned by the buyer for any reason] Confirmation of receipt [notification made to the system by stakeholders receiving the products to be cross-checked with the corresponding transfer notification] Exportation Deactivation [Removes a serial number from the system, which renders further movement of the serialized item in the supply chain impossible. Deactivation notification is given in cases such as consumption, manufacturing wastage, destruction of recalled or expired products, or removal of serial numbers from the system in other justifiable cases. The reason for deactivation is recorded in the system in code.] |
Pharmaceutical warehouse (wholesaler) |
Sale [sales allowed only to pharmacies, hospitals, or other pharmaceutical warehouses] Sale return Confirmation of receipt Deactivation |
Pharmacy |
Sale [sales allowed only to patients or other pharmacies] Sale cancellation [only for retail sales in pharmacies] Confirmation of receipt Deactivation |
Hospital pharmacy |
Sale [when product is billed to patient] Consumption notification [indicates consumption of product in a hospital] Confirmation of receipt Deactivation |
Reimbursement agency [public or private] |
Sales confirmation [for products whose costs were reimbursed] |
It appears that by January 1, 2010, all MPHUs in the Turkish market that were not exempted were required to be serialized and carry a data matrix code.[13]
II. The Rules Concerning Free Samples
A. Legal Framework
The general framework that regulates the marketing and promotion of MPHUs is provided by the 2015 Regulation on Promotional Activities for Medicinal Products for Human Use (“2015 Promotion Regulation”).[14] Article 9 of this Regulation lays down the rules for the supply of free samples by a licensed drug manufacturer or distributor or an authorized importer. Article 7 of the 2015 Guidelines on Promotional Activities (2015 Promotion Guidelines),[15] which was published by the Agency on the same day as the 2015 Promotion Regulation to provide guidance on the application of its rules, details certain parts of the procedure provided in Article 9 of the regulation.
B. The Rule Regarding the Serialization of Free Samples Is Not Clear
Although the 2015 Promotion Regulation requires pharmaceutical companies to create their own registration and control system for free samples in accordance with the framework applicable to recalling MPHUs,[16] it is silent on whether sample packages must carry data matrix codes. Nevertheless, article 7(3) of the 2015 Promotion Guidelines states “in principle, promotional samples shall not have affixed a data matrix code / bar code” and adds that the Agency’s written approval is required for free samples to bear a data matrix code (art 7(4)).[17]
On the other hand, article 10 of the 2017 Packaging Regulation establishes a general rule that the framework set by the regulation (thus including serialization within the ITS) also applies to free samples. Nevertheless, the same provision authorizes the Agency to exempt free samples from carrying data matrix codes. The language of the provision is not clear on whether the Agency has the authority to categorically exempt free samples. Rather, it appears to authorize the Agency to determine which samples are to be exempt.
Thus, the serialization rule currently applicable to free samples is unclear. Under Turkish law, a regulation issued by a ministry is higher on the hierarchy of norms than guidelines published by an administrative agency. Therefore, the rule in the 2017 Packaging Regulation may be interpreted as abrogating the rule in the 2015 Promotion Guidelines. On the other hand, the 2015 Promotion Regulation is still in force, and the Guidelines were published based on the authorization provided by article 14 of that regulation. While it might be argued that, according to the Turkish administrative law maxim that a later law repeals an earlier one,[18] the provisions of the 2017 Packaging Regulation regarding the labeling of free samples override the rules regarding the same matter in the 2015 Promotion Regulation, article 10 of the 2017 Packaging Regulation still authorizes the Agency to determine which samples will be exempted from the 2017 serialization requirements.
The Association of Research-Based Pharmaceutical Companies, in the most recent edition of its Code of Good Promotional Practice and Good Communication (Apr. 1, 2017) (Code),[19] states that “[i]t is essential that no commercial barcodes/datamatrixes or price tags are used on the packages of promotional samples,” and that “[i]n case of [the] presence of a barcode/datamatrix on the packages of Free Promotional Samples planned to be distributed, a written permission shall be requested from the Ministry [of Health] along with its justification [ . . . ] sale of samples shall be prevented in the Drug Tracking System of the Ministry,” citing article 9(1) of the 2015 Promotion Regulation.[20] It seems that, without a data matrix code, free samples are not entered into the ITS and are recorded only in a pharmaceutical company’s internal system established according to article 9 of the 2015 Promotion Regulation. However, it is not clear whether, in practice, the standardized unique identifiers are assigned to free samples within the ITS, and subsequently deactivated. It must be noted that the Code is dated April 1, 2017, which is before the date of publication of the 2017 Packaging Regulation on April 25, 2017, and the entry into force of its provisions that appear to require, in principle, the serialization of free samples within the ITS.
That said, the Agency has not issued new guidelines that would shed light on the application of article 10 of the 2017 Packaging Regulation. Thus, taking into consideration the lack of any attempts by the Agency or industry groups to clarify the application of the new rule, we conclude that it is possible that the rule provided by the 2015 Promotion Guidelines is still in force, and free samples are left outside of the ITS serialization system for the time being. Regardless of the rule regarding the ITS, however, the current framework explicitly requires pharmaceutical companies to establish an adequate system to record the manufacture, importation, and distribution of free samples and to provide the Agency these records for auditing.[21]
Kayahan Cantekin
Foreign Law Specialist
September 2019
[1] Pharm. Mfrs. Ass’n of Turkey, Turkish Pharmaceutical Market 2018, 3 (2019), https://perma.cc/EAP5-JTVQ.
[2] ITS website (in English): https://www.its.gov.tr/index.php?run=home.
[3] Regulation on Packaging and Labeling of Medicinal Products for Human Use (repealed) as amended (published on Aug. 12, 2005, in Official Journal No. 25904), https://perma.cc/2UYD-AARY, repealed by Regulation on the Packaging Information, Use Instructions, and Tracking of Medicinal Products for Human Use (published on Apr. 25, 2017, in Official Journal No. 30048, entered into force on date of publication) (“2017 Packaging Regulation”), https://perma.cc/MMU9-4GN6.
[4] 2017 Packaging Regulation, note 3. The objective of the serialization and tracking framework set by the 2017 Packaging Regulation is stated as “the tracking and recording of the supply chain of medicinal products for human use for the creation of more efficient measures against defective and falsified products” (art. 1), medicinal products for human use (MPHUs) being defined as “substance or combination of substances that are (1) presented as having curative or preventative properties with regards to human diseases, and (2) used on or administered to humans for the purposes of restoring, healing, or changing physiological functions through pharmacologic, immunologic, or metabolic effects” (art. 4(1)(b)).
[5] See generally the Drug Tracking System Operation Guidelines, version 1.03 (2009), https://perma.cc/9M2Z-JWUZ.
[6] For technical information on the GS1-DataMatrix, see https://perma.cc/9EQT-ZKYL. GS1 is a not-for-profit organization maintaining global business communication code standards.
[7] 2017 Packaging Regulation, art. 5(n). Article 2(2) of the Medicinal Products for Human Use Barcode and Data Matrix Application Guidelines (date unknown, issued on or after the date of publication of the 2017 Packaging Regulation, https://perma.cc/LR2V-VMZZ) also appears to exempt MPHUs manufactured exclusively for export from the data matrix code affixation requirement. Notably, such an exemption does not appear to be provided in the 2017 Packaging Regulation.
[8] Medicinal Products for Human Use Barcode and Data Matrix Application Guidelines, art. 5, supra note 7.
[9] 2017 Packaging Regulation, art. 16 (2).
[10] 2017 Packaging Regulation, art. 15(1); Medicinal Products for Human Use Barcode and Data Matrix Application Guidelines, art. 12, supra note 7.
[11] Drug Tracking System Operation Guidelines, version 1.03, art. 7, supra note 5.
[12] Drug Tracking System Operation Guidelines, version 1.03 (2009), supra note 5.
[13] Provisional art. 2 of the (repealed) 2005 Regulation on Packaging and Labeling of Medicinal Products for Human Use, note 3; Circular 2009/83 of the (ex) General Directorate of Pharmaceuticals and Pharmacies of Dec. 31, 2009, https://perma.cc/X5KU-WCMS; Carlos Cordon et al., Strategy is Digital, Management for Professionals, 54 (2016).
[14] Regulation on Promotional Activities for Medicinal Products for Human Use (published on July 3, 2015, in Official Journal No. 29405, relevant provisions entered into force on date of publication) (“2015 Promotion Regulation”), https://perma.cc/32PY-4Y58. The 2015 Promotion Regulation essentially harmonizes the Turkish framework for the supply of free MPHU samples with European Union law set by article 96 of Directive 2001/83/EC, as amended, https://perma.cc/SK53-3WWJ. However, some rules appear not to be harmonized, notably, the rule of article 96(1) of the directive limiting the supply of free samples to “persons qualified to prescribe them” and article 96(1)(b) requiring supply of samples to be “in response to a written request, signed and dated, from the prescribing agent.” Concerning the former rule, the Turkish framework allows the supply of free samples to pharmacists, who are not qualified to prescribe MPHUs under Turkish law. Regarding the latter rule, Turkish law does not include a written request requirement. The Association of Research-Based Pharmaceutical Companies, an industry association composed of some of the largest multinational pharmaceutical companies operating in Turkey, which publishes codes and guidelines for good practices, points out discrepancies between Turkish and EU laws in art. 13 of its Code of Good Promotional Practice and Good Communication (edition 6.01, effective Apr. 1, 2017), https://perma.cc/AQT4-GK56, and requires its members to abide by the EU rules (art. 13.12.1), noting: “In accordance with EU directives and the EFPIA Code [Eur. Fed’n of Pharm. Indus. & Ass’ns, EFPIA Code archived at https://perma.cc/DL7B-28GB], distribution of free reduced samples of prescription-only drugs may only be allowed in special cases to prescribers (physicians and dentists), for a limited period of time and in a limited amount, upon a written, dated and signed request. Although a restriction is imposed on the amount of samples to be distributed by the legislation of the Republic of Turkey, the period of distribution is not restricted, provision of samples to pharmacists is not prevented, and distribution is not bound to the written, dated and signed request of physicians and dentists [ . . . ] In line with EFPIA’s interpretation of the EU Directive, AIFD does not regard [as] suitable the supply of samples of prescription-only drugs to pharmacists [ . . . ] The EFPIA Code indicates that the samples are distributed upon the ‘unsolicited request of physicians.’ Therefore, the relevant physician shall submit his/her sample request in written [sic] and with a date and sign it.” Ass’n of Research-Based Pharm. Cos., Code of Good Promotional Practice and Good Communication (Apr. 1, 2017), at art. 13.12.1 “Article Clarifications and Justifications.”
[15] Guidelines on the Applications for the Distribution of Free Promotional Samples and Press Releases under the Regulation on Promotional Activities for Medicinal Products for Human Use (published on July 3, 2015, in Official Journal No. 29405, entry into force Nov. 16, 2015), https://perma.cc/VPF4-ABDY.
[16] Article 9(1)(a) of the 2015 Promotion Regulation. Recalls and recall systems are regulated in the Recall Regulation (published on Nov. 19, 2015, in Official Journal No. 29537, entered into force on date of publication), https://perma.cc/ZC6Z-BURH.
[17] Notably, article 9(1)(e) of the repealed 2011 Regulation on Promotional Activities for Medicinal Products for Human Use (published on Aug. 26, 2011, in Official Journal No. 28037, repealed by 2015 Promotion Regulation) (https://perma.cc/9GJD-ZD99), had explicitly provided that the samples would, in principle, not have data matrix codes on their packaging. This rule was left out in the 2015 Packaging Regulation, but included in the 2015 Packaging Guidelines.
[18] Kemal Gözler, Yorum İlkeleri, Anayasa Hukukunda Yorum ve Norm Somutaşması, 100 (2012); Kemal Gözler, İdare Hukuku, vol. 1, 1133-1134.
[19] Ass’n of Research-Based Pharm. Cos., Code of Good Promotional Practice and Good Communication (Apr. 1, 2017), supra note 14.
[20] Ass’n of Research-Based Pharm. Cos., Code of Good Promotional Practice and Good Communication, supra note 14, article 13.5. Although the Code cites article 9(1)(e) of the 2015 Promotion Regulation as justification for its rules concerning data matrix codes on packaging, as noted above, such a rule does not exist in article 9 of that regulation. Rather, the relevant rules exist in art. 7 of the 2015 Promotion Guidelines. However, such a rule existed in art. 9(1)(e) of the repealed 2011 Promotion Regulation, supra note 17.
[21] Article 9(1)(a) of the 2015 Promotion Regulation.
Last Updated: 12/30/2020
