EU Telematics PIM _
 

eSignatures

_

Home

_

Human eSubmission

_
Veterinary esubmission
_

TIGes

_
CMB Documents
_

Documentation

_

Projects:

_

Common Repository

_
CESP
_

eAF

_

CESSP

_
eASMF
_
ePMF
_

eSubmission Gateway & eSubmission Web Client

_

Delivery file UI

_

eSubmission Gateway

_
PSUR Repository
_

Industry access

_
NCA access
_

eCTD

_

eCTD v4.0

_

EU Module 1

_

eCTD v4.0

_

eSignatures

_
_

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: https://servicedesk.ema.europa.eu

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: https://servicedesk.ema.europa.eu
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:


 

EMA
©1995-2017 European Medicines Agency | Disclaimer | For technical support, please visit the EMA Service Desk portal using your user credentials for a system hosted by EMA (except Eudravigilance). If you do not have an account or have forgotten your credentials, please click here