Turkish Pharmaceuticals and Medical Devices Agency has recently announced that the sanctions for sales centers provided under the Article 28/5 regarding the breach of Article 21 of the Regulation on Sales, Advertising and Promotion of Medical Devices ("Regulation") shall be applied automatically by the system and no official letter shall be sent to the breaching sales centers as of 9 October 2018 ("Announcement").
Article 21 generally sets forth the conditions for sales centers to organize or sponsor scientific and educational activities, such as national and international meetings, congresses and symposia. In the referenced provision, certain limitations and obligations are determined for sales centers; i.e. to apply for the approval of the Agency at least fifteen days in advance with certain documentation, to notify the Agency within one month following the event, to maintain the respective documents for two years, not to organize events in high seasons, to sponsor the HCPs and medical device technical personnel in certain conditions and limitations.
The administrative sanctions to be applied in case of the breach of the aforementioned rules are provided under Article 28/5 as below;
- In the first breach, the sales center will be warned by the Agency.
- If the breach repeats in a year following the warning, sales center will be banned from the promotional activities under Article 21 for 3 months.
- If the breach repeats in a year as of the application of the 3 months' ban, sales center will be banned from the promotional activities under Article 21 for 1 year.
Before the newly announced procedure, the respective sanctions had been applied by official letters issued by the Agency and served to the relevant sales centers in practice. However, as introduced by the Announcement the sanctions will no longer be notified via official letters but the system shall apply such sanctions automatically. The Announcement do not clarify how the first warning will be notified through the system automatically. However, it is expected that the procedure will be understood soon when practice is seen.
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