Küsimused

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

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