Abstract: The Medicines and Medical Devices Agency announced that in case of a breach of the provisions governing the notification of scientific and educational meetings through the online system, the sanctions shall be applied automatically by the system only.
Pursuant to Article 21 of the Regulation on the Sale Advertisement and Promotion of Medical Devices ("Regulation") and its relevant guidelines, for meetings to be organized or supported by the medical device sales centers, including the HCP sponsorships; the sales center is required to make an initial notification at least fifteen days prior to each meeting and a post notification one month after the meetings. The notification are made electronically through the system established by the Turkish Medicines and Medical Devices Agency. Pursuant to Article 28 of the Regulation, in case of a breach of Article 21, the Agency shall issue a warning. The repetition of this breach within one upon the receipt of a sanction, shall cause the prohibition of the company to organize or support any activity mentioned in Article 21 for 3 months. Finally in case a third breach is determined, a third sanction is issued and activities mentioned in Article 21 cannot be performed for 1 whole year.
The Regulation was silent on how the sanctions would be issued and notified to the relevant company. On 5 November 2018, the Agency announced that any sanction issued due to the breach of Article 21 of the Regulation would be notified to the company through the online system and that no further written official letter shall be sent to the company regarding this matter.
Upon this announcement, companies which receive a notification through their online system informing them of a sanction shall not await further official letter from the Agency.
Source: Announcement on the Sanctions to be applied for the Acts Contrary to Procedures of Meeting Notification (Turkish language)
Originally published by Practical Law.
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