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Guidelines on Distribution of Free Drug Samples Amended


On 3 September 2021, the Turkish Medicines and Medical Devices Agency's (the Agency) amended Guidelines on the Distribution of Free Drug Samples within the Scope of the Regulation on Promotional Activities of Medicinal Products for Human Use (Guidelines) entered into force. The most important amendments concern the registration of the free promotional samples in the Product Tracking System.

Pursuant to the Guidelines, the marketing authorisation holder is obliged to notify using the Product Tracking System the production and distribution of free samples of the medicinal products for which it has a marketing authorisation (MA). In addition, the products produced/imported as free samples and the products produced/imported for sale but subsequently converted into free samples are not permitted to be sold through the Product Tracking System. If a company wishes to distribute as a free sample a medicinal product that was originally intended for sale (and therefore contains a barcode), the MA holder should obtain written approval from the Agency. Also pursuant to the Guidelines, the Agency will publish a "List of Products for which Free Sample Production and Distribution is not Mandatory". However, there is no information on when this list will be published and how often it will be renewed.

First published by Practical Law, in 04.10.2021

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