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2019 FSO Announcement

The document announces a new release of the On-boarding Partner Portal that will be available on April 11th. The new release will allow onboarding partners to modify the single point of contact information before approval or after a successful legitimacy check. It will also enable a maintenance step to keep information like company details and affiliated manufacturers up to date. Onboarding partners will be able to appoint a contact assistant with the same permissions. Additionally, the prerequisites for onboarding to the EU Hub test environment have been reduced to passing the first three baseline test dimensions only. The document clarifies that passing all test metrics does not imply certification and that onboarding partners remain responsible for ensuring their system operates correctly and complies with regulations.

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54 views1 page

2019 FSO Announcement

The document announces a new release of the On-boarding Partner Portal that will be available on April 11th. The new release will allow onboarding partners to modify the single point of contact information before approval or after a successful legitimacy check. It will also enable a maintenance step to keep information like company details and affiliated manufacturers up to date. Onboarding partners will be able to appoint a contact assistant with the same permissions. Additionally, the prerequisites for onboarding to the EU Hub test environment have been reduced to passing the first three baseline test dimensions only. The document clarifies that passing all test metrics does not imply certification and that onboarding partners remain responsible for ensuring their system operates correctly and complies with regulations.

Uploaded by

metadimitrios
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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Download as PDF, TXT or read online on Scribd
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LETTER OF ANNOUNCEMENT

OBP Portal – New Release


Wednesday, the 4th of April 2018

Dear On-boarding Partners,

EMVO is glad to inform you that a new release of the On-boarding Partner Portal will be available as of Wednesday
the 11th of April. Among others, the following new features will be made available with this new release:

• The OBP will be able to modify the information related to the Single Point Of Contact (SPOC). This can be
done only before the approval of the Participation Agreement and/or after the legitimacy check has been
reported successful in the portal. The newly appointed SPOC will receive its individual credentials accordingly.
• The Step 5 – “Maintenance” mode is now available. This step in the portal will enable the OBP to keep several
information up to date after the legitimacy check successful completion, such as the Company information
and the list of affiliated MAHs. Also, in addition to the SPOC, the OBP will be able to appoint a SPOC Assistant.
That person will have the same permissions as the SPOC on the OBP Portal (e.g. processing the Technical
On-boarding, updating the information contained in the maintenance mode, etc.).

In addition, please be aware that EMVO has moderated the prerequisites for OBP’s On-boarding to the EU Hub PRD
environment. Currently, only the first three test dimensions of the test metrics are to be passed. We refer to these 3
tests as the baseline tests, which are comprised of the following 3 test dimensions Product Master Data (1), Product
Pack Data (2) and Product Pack Update (3).

EMVO would like to draw your attention on the fact that the IQE Test Status Metrics is a self-awareness tool which
provides the OBP with a means to test dimensions which require interaction with the EU Hub and provide a level of
confidence that the OBP meets certain Software Development Kit requirements. These dimensions are merely
confidence-based. This implies that having all test status metrics marked ‘Passed’ does not mean or imply that the
OBP system has been certified, validated or otherwise checked by EMVO. EMVO does not validate or certify any
Gateway Provider or Connection Provider, the validation and DR compliance therefore remains the sole responsibility
of the OBP in his role as system owner and has to follow the procedures of the OBP’s own Quality Management
System. EMVO does not assume and expressly disclaims any responsibility and/or liability with respect to the
connection of the OBP system and its function in general. The ultimate responsibility for the OBP is to guarantee that
the system operates in a correct, error-free and uninterrupted manner, as well as being in compliance with the
applicable legislation.

In order to assist you in the most efficient way, the updated On-boarding Guideline and On-boarding Presentation will
be available on our Website from the date of the new release.
In the event of any question or uncertainty, please do not hesitate to contact our Helpdesk:
Tel. Helpdesk: +372 611 90 44
E-Mail: [email protected]

EMVO Team
European Medicines Verification Organisation
www.emvo-medicines.eu

Letter of Announcement EMVO


OBP Portal – New Release

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