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Saatja: Matea Damicevic (Matea Damičević) <[email protected]> Saaja: MSO (Arhiiv), Sanja Vunic (Sanja Vunić), Zahida Drace (Zahida Drače), Sandra Bujas, Josipa Delija, Lucija Bedenikovic (Lucija Bedeniković) Teema: Estonia - Local CT regulations inquiry Tähelepanu! Tegemist on väljastpoolt asutust saabunud kirjaga. Tundmatu saatja korral palume linke ja faile mitte avada. To whom it may concern, I would like to kindly ask for information regarding the local requirements in your country for the investigational medical device. * is there a local requirement to submit USADEs/reportable events to NCA and ethical committee; * is there a local requirement to submit any line listing to NCA? Thank you in advance for your assistance. Kind regards, Matea Matea Damičević MPharm Senior Pharmacovigilance Associate | Medical Reviewer Planinska ulica 13 Zagreb, Croatia Tel: +385 1 558 8297 www.tigermedgrp.com <http://www.tigermedgrp.com/> | www.martifarm.com <http://www.martifarm.com/> We have recently changed our email domain to @tigermedgrp.com. E-mails sent to @martifarm.com will be forwarded to our new domain. NOTE: This e-mail, and any attachments, may contain confidential, and/or legally privileged information, and is intended solely for the use only of the named addressee(s). If you have received this e-mail in error, please notify the sender immediately, and permanently delete the original and any copies of this e-mail, and any attachments, without printing, reading, or copying them. Any use, distribution, or copying of this e-mail other than by the intended recipient is strictly prohibited. MARTI FARM Ltd. accepts no liability for the content of this email, or for the consequences of any actions taken based on the information provided. The recipient should check this e-mail and any attachments. MARTI FARM Ltd. accepts no liability for damage caused by any malicious code potentially transmitted by this e-mail. In line with the provisions of the EU General Data Protection Regulation (GDPR), please ensure that your data is protected, and that the database is never revealed to other parties. You have the right to request deletion of your data from our database pursuant to the principle “the right to be forgotten”. To do so, please contact our Data Protection Officer at [email protected] <mailto:[email protected]> . Thank you! Confidentiality notice: This message and any files transmitted with it are confidential and intended solely for the use of the individual or entity to whom they are addressed. If you have received this message in error, please notify us and remove it from your system and note that you must not copy, distribute or take any action in reliance on it. Any unauthorized use or disclosure of the contents of this message is not permitted and may be unlawful.