Posted by Michael Wonder on 06 Jul 2016
EMA goes electronic for PDCO opinions and subsequent EMA decisions
6 July 2016 - As of 1 August 2016, PDCO opinions and subsequent EMA decisions will be transmitted to applicants electronically only.
From 1 August 2016, the EMA will transmit the opinions of the Paediatric Committee (PDCO) and subsequent EMA decisions to applicants in electronic format only. Applicants will no longer receive paper versions.
PDCO opinions and subsequent EMA decisions will be sent to applicants as a PDF via EudraLink - the European medicines regulatory network’s secure file-transfer system.
The date when the message is opened by applicants for the first time will be considered as the day of the receipt of the document attached to the EudraLink message, for the purpose of calculating procedural timelines in accordance with Regulation (EC) No. 1901/2006. EudraLink automatically records this date as “access by”.
