Turkish Medicines and Medical Devices Agency (“TITCK”) has published an updated Guideline on Distribution of Free Promotional Samples and Press Announcements of Medicinal Products for Human Use (“Guideline”) with the purpose to provide supplementary guidance to the relevant Turkish legislations on promotion, packaging, and instruction manuals of medicinal products for human use. With the Guideline, free promotional sample, demo device, and the Pharmaceutical Track and Trace System (“ITS”) are defined and additional principles for distribution of free promotional samples are stipulated.
Accordingly, permit owners are now required to make separate production and distribution notifications regarding free promotional samples. The notifications concerning production and distribution of the free promotional samples are required to be made through ITS and the time restrictions that depend on production or importation status of the medicinal products for human use are not applicable for products that are produced or imported as free promotional samples. The distribution notification for the free promotional samples is required to be made within 60 days after a free promotional sample is given to a physician, dentist, or apothecary by the promotion representative of the product.
Products produced or imported as free promotional samples and products that are later converted to free promotional samples cannot be sold through ITS. Products produced or imported as free promotional samples may not bear a barcode and must bear a QR code, for a medicinal product for human use that bears a barcode or commercial QR code to be distributed as a free promotional sample, the permit owner is required to acquire a written permission from TITCK. Conversion to free promotional sample for products that received such permission is done by permit owners through ITS. The barcode included in the QR code of the products produced or imported as free promotional samples needs to be the same as the barcode on the medicinal product for human use.
As a rule, free promotional samples are required by the relevant legislation to be of a smaller quantity than the commercial products, for the products that cannot be reduced in quantity because of technical reasons, the permit owner is required to acquire a written permission from TITCK.
If a change has been made to the short product information, instruction manual, and/or the packaging of the medicinal product for human use, the medicinal products that have been produced or imported prior to such change cannot be converted to and distributed as free promotional samples by the permit owner.
Additionally, “List of Products Exempt from Free Promotional Sample Production and Distribution Notifications” (“List of Exempted Products”) has been published by TITCK. Accordingly, production and distribution notifications on ITS is required for products that are on the List of Exempted Products that has been produced or imported as free promotional samples and products that has been produced or imported as free promotional samples before the publishing date of the Guideline. However, the permit owners are still required to complete conversion processes through ITS for products on the List of Exempted Products that are planned to be converted to and distributed as free promotional samples if the production notification has already been made.
Moreover, pursuant to the Guideline, permit owners are required to establish a system for internal records, tracking and control processes other than the notification and distribution notification processes of free promotional samples, and to share these records with TITCK upon request.
In addition to the previous documentation required for free promotion sample applications to TITCK, a written confirmation for any possible change in permit owner’s address and/or address of its production facilities, written undertakings stating that the conversion to free promotional sample process will be completed through ITS for products bearing commercial QR codes, and that the packaging for the free promotional sample is exactly the same as the most current packaging for the medicinal product for human use that is approved by TITCK is required pursuant to the Guideline.