The below shows the steps an OBP takes through On Boarding to the EU Hub via the OBP Portal.
The attached document is available to OBPs in the OBP Portal and gives the steps OBP take to on board. This can be sent to an OBP who is starting the process.
The page then provides the below form to complete. The person who completes this form is then considered to be the Initial Requester (IR):
The IR receives their credentials via email. The email containing the credentials has the name “EMVO OBP Portal: Your new site details” and is sent from the email address noreply@emvs.com.
The IR will initially login to the OBP Portal and set the SPOC (Single Point of Contact) details.
When the SPOC contact details are filled-in on the Portal, the credentials of the IR are revoked. This feature was implemented for security reasons, as the SPOC is the only person responsible for the accuracy of the information provided.
Single Point of Contact (SPOC)
The SPOC also receives their credentials via the email after approval. The credentials are sent from the same address - noreply@emvs.com.
In the event the IR is the same person as the SPOC they will be able to access the OBP Portal with the credential received in the first place, if they clicks on the “I’M SPOC” button.
SPOC Assistant
The SPOC can appoint a SPOC Assistant on the OBP Portal in Step “Single Point of Contact and Assistant Information” by clicking the button “SPOC Assistant” as a back-up. This is optional. The SPOC Assistant will receive his credentials after passing the “Approvals” process.
EMVO recommend that all OBPs have a nominated SPOC Assistant. This is especially important if the SPOC changes or leaves the company, as the SPOC Assistant is able to change the SPOC details in the OBP Portal themselves.
Once the registration request is submitted and the OBP confirms the registration by clicking on the link provided by email, EMVO creates a secured area for the OBP within the OBP Portal.
The Initial Requester will receive two emails. The first email will contain a link to a dedicated area on the OBP Portal, where the
user will be asked to set up their password. The second email will provide the user with a confirmation that his/her account has been properly set up.
If a user logs a ticket concerning a lack of email during their registration to the OBP Portal please use this canned response: OBP Portal - No Email response when Registering
When the user logs in for the first time, they will be directed to the “Create new company” page, where they have to provide the initial company information:
- Name
- Country of Registration
- VAT number
- Company Type
As soon as the account is created on the OBP Portal, the OBP automatically gets an identification number (Contract Partner Number: “CP number”) made of three or four digits. This number will allow for a unique identification of the OBP company and will be reflected in the Participation Agreement which will be concluded with EMVO.
2. On Boarding to the OBP Portal
The OBP Portal URL is https://obp.emvo-medicines.eu/
Once the OBP in given access to the OBP Portal they must start to provide the information to on board, via the below 'Provide Information' section:
General Information Pack
The General Information Pack section consists of EMVO documents that assist the OBP through the On Boarding process and basic EMVS guidelines. This section consists of the below documents:
- EMVO 00038 - EMVO Gateway User Manual
- EMVO 00122 - EMVS Master Data Guide
- EMVO 00127 - EMVO Gateway Templates
- EMVO-00955 - OBP On-boarding Guidelines (this document)
- EMVO-02771 - OBP On-boarding Presentation
- EMVO 02855 - SOP – New OBP Portal On-boarding Process
Contact Information
The Contact Information is where the details for the SPOC and SPOC Assistant are entered
The email address can be a generic email address used by the OBP, however this email address must be accessible for the OBP as any further problems accessing the OBP Portal or resetting the password will utilise this email address.
NOTE: The old OBP Portal had specific EMVO email addresses for the users. The current OBP Portal uses the users own email addresses. in instances of someone trying to access with old email details please use this canned response OBP Portal - Users using old OBP Portal Login
Authorised Representative (AR)
The AR should be a senior officer who is authorized to sign on behalf of the company (for example “Prokurist” in Germany). It may be the person holding the position of CEO, CFO, CIO or a member of the board of Directors depending on each company’s internal signatory policies. Only the named AR is able to sign the Participation Agreement (PA) in the name and on behalf of the OBP company.
The Copy of Proof may take the form of an excerpt form from a National Register, Chamber of Commerce, Trade Register, where the Authorized Representative’s name will be expressly listed as an authorized person.
NOTE: The AR is the only person who can authorise a change in SPOC or SPOC Assistant in cases where both the SPOC and SPOC Assistant have left the company. In a case where the SPOC, SPOC Assistant and AR have all left the company a new AR will need to provide proof of their position as the AR in order to have a change made.
Company Information
The following data is required:
- Company Name
- Country of Registration
- VAT ISO Code
- VAT Number (if the company has no VAT number, the user can check the box ‘I do not have any VAT Number’)
- Company Registration Number
- Company Type (either ‘Original Pack Manufacturer’, ‘Parallel Distributor’, or ‘Hybrid’)
- Business Phone
- Web Page
- Company Email Address
- Street
- Number
- Box
- Zip Code
- City
- Country
The OBP will need to pay particular attention to the following elements:
- Provide the full name of your (OBP) company, as it is registered in official national registers.
- Make sure to include the full sequence of digits and no typos for your (OBP) company’s registration number. Please do not forget to mention the initial country identification letters in front of the VAT
- Number of your OBP company.
- Make sure the address you share with us is the one appearing in the official national register.
- The permissions given in the EU Hub will depend on the organisation type. Any error in the selection of the organisation type may bring the pursuit of the Technical On-boarding at stake.
MAH and Product Information
The OBP has to provide information about the MAH(s) on behalf of which it will upload data on the EU Hub as well as information about their product(s).
The information on the MAH(s) will be used to check the legitimacy of the OBP as it is required that the OBP and the MAHs are affiliated.
The MAH Information consists of:
- The MAH Company Name, which is the full name of the company as it appears in the relevant official national register.
- The VAT Number, corresponding to the specific MAH company.
- The Country of Registration, which is the country name of the country where the MAH is registered.
- The MAH Active in, which are defined as the target countries/markets, for which the Marketing Authorization Holder of a product/of products, holds a license for and markets a product/products actively, hence the MAH/OBP uploads data/SNs for the product(s) into the referring NMVS(‘) of that target market/country of operation. Please be aware that the drop-down menu of this field consists of and allows a multiple selection of the target countries/markets.
- The Company Registration Number, which is a unique combination of numbers, at times of numbers and letters. A unique company registration number is assigned as the company is registered on a certain register. The issuing entity differs from country to country. The company registration number can be found on the Certificate of Incorporation, on all official documentation received from the issuing entity or on the excerpts of the register.
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Address Information (Street, Number, Box, Zip code, City, Country) as well as Web Page, Company Email Address, Telephone Number and Website Address of OBP.
The Product Information consists of:
- The Marketing Authorization Name, together with the name, please also mention the strength, form and pack size of the product in order to allow EMVO to identify the exact product presentation linked to the Marketing Authorization Number you provided.
- The Marketing Authorization Number, which is the licensed number related to the number of products the MAH received when applying for the Marketing Authorization to the relevant authority (following a decentralized or a centralized procedure).
- The Marketing Authorization Registration, which may refer either to the specific country(ies)/market(s) covered by the marketing authorization or to the entire EU.
OBPs can have multiple MAHs and as such there are two way to add MAHs:
- By clicking the 'Add MAH' button to manually add an MAH
- Using the Export and Import buttons to export the Excel template, complete the template and then import it (further details are in the attached document)
Legitimacy Check
Once the OBP has completed the Information sections in the OBP portal they can launch a Legitimacy check:
The Legitimacy Check ensures that security procedures are in place by the OBP to ensure only users whose identity, role and legitimacy has been verified to allow them to connect to and upload data into EMVS.
In order to trigger the Legitimacy Check the OBP will need to submit the below form:
The Legitimacy Check process is performed by a supplier to EMVO called ETHIKOS.
NOTE: The timeframe from an OBP submitting their Legitimacy Check and this being completed is between 10 and 15 business days. This is also dependent on the OBP submitting their information with Corrections Needed, in which case this process can be extended.
Should there be any incorrect or missing information from the 'Provide Information' section in the OBP Portal the OBP SPOC will be sent an email stating that 'Corrections are needed'
Participation Agreement and Invoice
Once the Legitimacy check is approved a pre-filled Participation Agreement (PA) is available to download. The Authorised Representative must then download the PA, sign it and upload the signed copy.
In order for this to be valid:
- The Authorised Representative named in the Contact Information in the OBP Portal must be the signatory of the PA
- No changes or amendments are allowed on the PA. Any amendment will result in the PA being rejected by EMVO
The OBP will then need to complete the Invoice section which covers an on boarding cost to EMVO that is in line with the number of MAHs for the OBP. The table for the costs is within the attached document, and available to OBPs via the OBP Portal documentation.
Once completed the OBP Portal will state 'Awaiting Payment' on the 'Payment of the Invoice' section. Only when the payment is completed can the OBP progress to Technical On Boarding.
NOTE: The Payment Status is updated once every week.
Technical On Boarding
Following the participation steps an OBP will progress to the Technical On Boarding aspect.
Within the Technical On Boarding section there is a range of Documents available for the OBP to download including the SDK, Guides on EMVS Data and Alerts and Release Notes
An OBP has the option to have 2 Connections, which can be for Direct Connections and Gateway Connections (A Hybrid OBP that is a Manufacturer and Parallel Distributor can have 4 connections)
For Each Connection to the EU Hub the OBP has specific items they need to perform:
- Choose the Environment for the Connection type:
- Choose their Connection Type, being Direct or via a Gateway. For a Gateway connection there is a dropdown for the Gateway providers within EMVS.
- Create the Certificate Signing Request (CSR) file.
- Retrieve the Certificate (CER). In this section the OBP has access to:
- Client certificate (Private Certificate) – downloadable .p7b file
- Hub certificate for the Environment (Public Certificate) – downloadable .cer file
- Once the above items are completed then in order to use the signed certificate to communicate with the EU Hub, a combination of the certificate itself (.cer)and the private key that was generated along with the CSR is needed. A common pattern is to combine the signed certificate and private key into a PFX file and then install that PFX onto machines that need to communicate with the EU Hub. There are a number of tools that can be used to create a PFX file, an example of which can be found in the ‘EMVO-00117 Creating CSR Files’ document.
Session Token Request
On completion of the above steps the OBP can then request a Session Token:
Once a Session Token has been requested the EMVO Helpdesk can see the list of OBPs that have requested a Session Token in the OBP Admin Dashboard:
The EMVO Helpdesk will then perform the generation of the new Session Token using ESTA and copying this token value into the OBP Portal section for the OBPs Session Token (details within Knowledge Article for Session Token Renewals)
NOTE: EMVO Helpdesk check the list twice a day and requests for Session Tokens can take 24 hours to be provided.
NOTE: The validity of a new Session Token can be only 24 hours so once provided the OBP should ensure they check and utilise the token before it expires, otherwise they will need to request a new token.
Once provided the OBP can get their Session Token from the OBP Portal via the 'view' button:
Test Status Metrics
The Test Status Metrics in ITE is a pro-forma self-awareness tool which provides the OBP with a tool to test on dimensions which require interaction with the EU Hub and imparts a level of confidence that the OBP meets certain SDK requirements.
Please find bellow the different dimensions that can be tested in this step:
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Product Master Data [Simply upload more successful master data payloads than failed attempts]
-
Product Pack Data [Simply upload more successful product pack data payloads than failed attempts]
-
Product Pack Update [Successfully amend the status for any given product/batch combination]
- All tests of the test status metrics should use product data which is uploaded in the emulated markets (XX, XY and XZ).
- A 30 minutes timeframe is available to execute and check the test results.
- After the 30 minutes timeframe the status will automatically reset to ‘Failed’.
The Test Status Metrics can often show as failed and therefore there is an Admin Dashboard in the OBP Portal that shows the OBPs that need attention due to failed Test Status Metrics:
Should an OBP be struggling to progress into PRD, due to failed Test Status Metrics then the EMVO Helpdesk will request evidence from the OBP that they have performed the actions successfully. This can be screenshots from there system showing successful uploads being tested.
The EMVO Helpdesk can then use the OBP Portal to manually change the status to Successful.
NOTE: The OBP MUST have successful Test Status Metrics to be allowed to progress into PRD
Once the OBP has completed the above tasks in IQE they can then perform the same steps in PRD in order to fully on board to PRD.