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How do I connect to the EudraVigilance Gateway?
The EudraVigilance Gateway is
providing a single point of contact between MAHs, applicants and sponsors
as well as Competent Authorities in the EEA. By doing so, the EudraVigilance
Gateway is considered a hub and all the connections for the MAH, applicants
as well as sponsors and Competent Authorities in the EEA, are known as
spokes. Safety and acknowledgement messages are routed through the hub
to the desired spoke.
The simplicity of this design allows for the secure
transmission of all safety and acknowledgement messages to every
participant without the expense and complexity that would be needed
to establish a connection between each and every endpoint. The process
of establishing the connection requires several steps:
Step 1: Document Transport Choice
The EudraVigilance
Gateway supports all popular forms of transport. The most popular
form is EDIINT – AS1 or email, followed by AS2 or http and
https and finally FTP.
Step 2: Exchange of Profile Information
In order to use the EudraVigilance Gateway for secure
document exchange you must provide the EMA with the necessary information
in order to create a profile. The EMA in turn will provide the same
information to you so that you can create a profile on your system.
This information consists of name and address, contact person, and
transport details. This information exchange can take place using email.
Step 3: Exchange of Public Keys for Encryption
The EudraVigilance Gateway uses a combination of
public/private key encryption, which is also known as asymmetric encryption
and symmetric key encryption. This hybrid system uses the best characteristics
of each method and minimises the shortcomings of each. It follows the
widely adopted S/MIME standard for securing messages.
The EudraVigilance Gateway uses Triple DES encryption
and requests that you select a 1024 bit or higher key length to provide
enhanced security
Step 4: Testing the connection
When a successful connection has been established,
safety and acknowledgement messages, as well as medicinal product report
messages, can be transferred between each party in the program. This
is accomplished by sending an encrypted safety or acknowledgement message
to the EudraVigilance Gateway, where it is unencrypted, checked for
basic accuracy, then re-encrypted and sent to the ultimate destination.
A list of appropriate registered parties is maintained and distributed
by the EMA. It can be also accessed by registered users in the restricted
area of the EudraVigilance website. Safety, acknowledgement and medicinal
product report message exchange can only take place between registered
parties.
During the testing procedure, a series of XML files
are sent to the EudraVigilance test environment with paper reports
in parallel to assure the correctness of the XML files and compliance
with the requested specifications: syntax, field lengths, minimum
information and data coding against ICH E2B (R2) and ICH M1 and M2
standard terminology. This will also allow comparison of the submitted
data and ensure quality assurance and data consistency. The successful
completion of the testing between the EMA and the EDI Partner will
be certified by the EMA so that the EDI Partner can move into production
pilot. The currently established regulatory reporting mechanism will
remain unaffected during the test phase. Details of the 10-sample
case can be found in annex 5 of the relevant guideline, which can
be downloaded here
This step of the testing is applicable for the testing
of all EDI Partners with the EMA. Other EDI Partners may decide
to follow the same process.
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Last update: Tuesday, 19 June 2012. |
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