Vastuskiri

Dear Dr. Podolak,

According to the Regulation (EU) 2017/746 Article 73, the sponsor shall notify each Member State in which the performance study was being conducted within 15 days of the end of the performance study in said Member State. A notification via e-mail is sufficient.

Please be aware that a performance study report must be submitted within one year of the end of the study to the Member State.

All the best,

Dear Health Board Team,

Could you please tell me what is required for study completion information? Is an email notification sufficient or cover letter will be required? Also, will there be any AoR once end of study is submitted?

I would appreciate your response on this matter.

Kind regards,

Amira Podolak, Ph.D.

Sr. Regulatory & Start-Up Specialist

IQVIA MedTech, Clinical Operations

Learn more about IQVIA MedTech

Home Based (Gdynia, Poland)

tel. +48 22 430 31 34

Upcoming ooo: 05-16Aug (both included)

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