Global Regulatory Intelligence
Log in |  Register

Login to your account

Username *
Password *
Remember Me

Create an account

Registering to our Regulatory Updates easy andis should only
take few minutes. To begin, enter your email enter your email
address below so we can check to see if it is already existing
in our records. Your email address will also be used as your
user name when you log in.

Fields marked with an asterisk (*) are required.
Name *
Username *
Password *
Verify password *
Email *
Verify email *
Captcha *
Reload Captcha
   

Estonia: SAM Changes in Reporting Adverse Drug Reactions to Eudravigilance

Friday, December 08, 2017: The State Agency of Medicines (SAM) of Estonia has changed in reporting adverse drug reactions to Eudravigilance. Marketing Authorisation Holders (MAHs) need to submit electronically to EVPM information on all serious suspected adverse reactions that occur in the Union and in third countries within 15 days following the day on which the MAH concerned gained knowledge of the event.

MAHs need to submit electronically to EVPM information on all non-serious suspected adverse reactions that occur in the Union, within 90 days following the day on which the MAH concerned gained knowledge of the event.

There is no need to additionally notify the State Agency of Medicine.

There will be no changes to the reporting of SUSARs during clinical trials.

 
 
 
 
 
 
More Details
© 2016 MakroCare. All Rights Reserved.
  Privacy policy