Procedural information – EMA goes electronic for PDCO opinions and subsequent EMA decisions

News 06/07/2016

As of 1 August 2016, PDCO opinions and subsequent EMA decisions will be transmitted to applicants electronically only

From 1 August 2016, the European Medicines Agency (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 EudraLink 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”.

EMA decisions, as well as PDCO opinions will no longer contain a signature. For more information, see Regulatory information - Committee chairs' handwritten signatures no longer included in opinion documents from March 2015 (20/2/2015).

Applicants should download and archive the attached documents upon receipt, as Eudralink preserves file attachments only for up to 90 days. EMA will retain a read-only version of the electronic documents in its electronic archives. Further information can be found on Paediatric investigation plans: questions and answers, under the section “Applying for a PIP, waiver or deferral”.

The move from printouts to electronic documents responds to stakeholders' feedback collected over the years. Among the benefits of this change are: accelerated delivery of documents, more convenient receipt of documents as well as a shift towards greener solutions in line with EMA's environmental policy.

Applicants will be offered the possibility to opt-out and receive documents as hard copy instead.

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