EU Telematics PIM _
 

Sending Digitally signed documents to 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 EMA to accept digitally signed PDF documents:

 

  1. All electronic document files must conform to the portable document formatted file (PDF) version 1.4 or 1.7 ISO 32000-1:2008 standard.
  2. The EMA will accept digitally signed electronic documents through the EudraLink or by email (only where the contents of the communication do not require confidentiality protection).
  3. The EMA will only accept digital signatures that are supported by Qualified Certificates. The technical specification ETSI TS 101 456 V1.4.3 (2007- 05), issued by European Telecommunications Standards Institute (ETSI), describe the policy requirements for certification authorities issuing qualified certificates. Qualified certificates are issued by Certification Authority Services Providers (CSPs) which are supervised or accredited by an EU State’s supervisory body or trust scheme operator. Supervised and accredited CSPs in the EU may be derived from the European Commission’s list of supervisory bodies (LOTL). The European Commission LOTL is updated as and when required.  Please refer to the Table 1 in the FAQ document for further information .

 

 


 

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