EU Telematics PIM _





Human eSubmission
eCTD v3.2
eCTD EU M1 Specification

Veterinary eSubmission
eSubmission expert group

eSubmission expert group documents


External Links



Common Repository



eSubmission Gateway & eSubmission Web Client

Delivery file UI

eSubmission Gateway

PAM submission form

PSUR Repository

Industry access

NCA access


eCTD v4.0


Paediatric submissions




The Agency has introduced capabilities to produce digitally signed electronic documents and to verify incoming digitally signed electronic documents from the areas of Scientific Advice, Orphan Medicines and Paediatric Medicines in portable document format (PDF) .

The Agency provides specific PDF certified electronic application forms that enable the Pharmaceutical industry to digitally sign and submit using a PDF reader application.

These capabilities continue the Agency’s strategy to increase electronic document-only exchanges with the Pharmaceutical industry and regulatory bodies.

The Pharmaceutical industry will benefit by being able to exchange digitally signed documents with the Agency, based upon specific acceptability criteria. Potentially, the exchange of digitally signed electronic documents could bring cost savings to industry by removing the need to print documentation and incur courier charges. Electronic document exchanges also have the potential to increase efficiency and eliminate the requirement for archiving paper documents.

For further information, including specific technical information visit the EMA Service Desk portal:

eSignature Testing Facilities

The EMA Frequently Asked Questions (FAQ) document is digitally signed for you to test your verification of EMA’s digital signatures.

Please email your test PDF electronic documents to the EMA Service Desk portal:
if you require EMA to test the verification of your digital signatures.

Frequently Asked Questions have been designed to assist with general questions about the introduction of these digital signing capabilities.  Criteria for exchanging signed electronic documents with the Agency are provided as follows:


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