On 25 April 2017, the Regulation on Packaging Information, Directions and Tracking of Human Medicinal Products ("Regulation") was published in the Official Gazette and entered into force as of its publication date. Upon the publication of the Regulation, the previous Regulation on Packaging and Labeling of Human Medicinal Products (published on 12 August 2005) was repealed and abrogated.
The Regulation governs the principles concerning the notifications to be made by sellers/importers for the tracking of the distribution chain, and it also includes information that must be included on packaging and in the directions or instructions for human medicinal products.
- Interior and Exterior Packaging and Directions
Articles 5 and 6 of the Regulation list the information required to be added to the exterior and interior packaging of human medicinal products. As per Article 5 of the Regulation, in cases where a Turkish version of the exterior packaging cannot be prepared, manufacturers will be allowed to attach a label on the packaging specifying the required information listed in Article 5.
Furthermore, for exterior packaging to be prepared subject to the rules of Article 5, manufacturers/importers are obliged to include the name of human medicinal products in Braille format, as per Article 13. As specified in Provisional Article 2 of the Regulation, the packaging of all human medicinal products sold in Turkey should comply with this requirement by 31 December 2018.
Directions for use of human medicinal products, on the other hand, will have to be written and prepared in line with Article 8 of the Regulation.
- Marketing Samples
The principles regarding the marketing samples of human medicinal products are set forth under Article 10 of the Regulation. According to this Article, products to be used for marketing purposes as per the Regulation on Promotional Activities of Human Medicinal Products, must also fulfill the requirements of the Regulation. With that said, the Turkish Pharmaceuticals and Medical Devices Institution ("Institution") is charged with determining the products to be exempted from the data-matrix practice applied to marketing products. Data-matrix inserted into marketing products should clearly indicate that the product is for marketing purposes and not for sale.
- Tracking of Human Medicinal Products
The Regulation, contrary to the previous (now abolished) Regulation, brings a thorough arrangement and provides clarity as to the Product Tracking System ("System") of the Institution. Article 15 of the Regulation describes the mechanism of the System as follows: "The System operates based on the principle of the recording of notifications required to be made by partners, who are identified by a Global Location Number in accordance with their identified nature, to the central data system and the tracking of the same. The data-matrix of human medicinal products is notified to the System by the license/permit holders. The System, upon checking the uniqueness, standards, and content of the notified data-matrix, records the data-matrix to the database or rejects those that are not qualified." The term "partner" used in the foregoing section is 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 related to the human medicinal products' supply chain, such as manufacturing, importation, purchasing, sale, usage, consumption, exportation, assignment, loss, or refund."
In this respect, Article 15 of the Regulation lists incidents that should be disclosed to the System through notification by partners as well as by pharmaceutical warehouses. The principles concerning the recording and protection of the data gathered in the System are regulated under Articles 16 and 17 of the Regulation. As to the distribution of human medicinal products, partners are required to comply with the rules set forth under Article 17, which lays out the general transport packaging requirements.
- Transition Process
The Ministry has specified a transitional period for fulfilling the requirements under the Regulation. Transitional periods, as set forth by Provisional Article 1 of the Regulation, are as follows:
(1) Human medicinal products that were licensed or permitted or subject to a license/permit application before the enforcement of the Regulation will have to be brought into conformity with the packaging and direction requirements of the Regulation by 30 September 2017.
(2) Human medicinal products manufactured before 31 December 2017 can be preserved with their current packaging until the expiration of their shelf lives.
(3) For human medicinal products manufactured after 30 December 2017, the packaging and direction requirements of the Regulation are in effect and must be fulfilled.
(4) Foods for special medicinal purposes that are not reimbursed but brought under the scope of the data-matrix practice as per Article 5 of the Regulation should join and partake in the data-matrix practice by 31 December 2018 at the latest.
(5) Bulky parenteral, radiopharmaceuticals, and individualized human medicinal products should become participants in the data-matrix practice (under the scope of the guidelines specified in Article 20) by 31 December 2018 at the latest.
This article was first published in Legal Insights Quarterly by ELIG, Attorneys-at-Law in June 2017. A link to the full Legal Insight Quarterly may be found here.
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