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Receiving Digitally Signed Documents from EMA

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Home

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Human eSubmission
eCTD v3.2
eCTD EU M1 specification

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Veterinary eSubmission
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eSubmission expert group
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eSubmission expert group documents

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External Links

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Systems:

Common Repository

eAF

eASMF
ePMF
CESP

eSubmission Gateway & eSubmission Web Client

Delivery file UI

eSubmission Gateway

PAM submission form

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PSUR Repository

Industry access

NCA access
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Projects:

eCTD v4.0

CESSP

Paediatric submissions

SPOR

eSignatures

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Criteria for the EMA to issue digitally signed PDF documents:

1. The Agency will issue digitally signed electronic documents in the PDF Format. Therefore, it is recommended that you use a suitable PDF Reader Application – e.g. Adobe reader version 9.1 as a minimum.

2. The Agency’s electronic documents will be certified using a certification authority supplier under the Adobe Certified Document Service (CDS). Your PDF Reader Application should already contain the relevant root certification authority certificates. The GlobalSign Root CA certificates may be downloaded directly from GlobalSign

3. The Agency’s digitally signed electronic documents will be supported by Qualified Certificates issued by the Spanish Royal Mint Casa De Moneda - Fábrica Nacional de Moneda y Timbres . Please download these trust anchor FNMT Root Certification Authority Cerificates.

4. The Agency will distribute its digitally signed electronic documents through the EudraLink channel or by email (where the contents do not require confidentiality protection).

 

 

 


 

EMA
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