Adding Marketing Authorisation Holders (MAH)

1. Access VigiUser: https://vigiuseradmin.who-umc.org

2. To add a new MAH, click “Add MAH organisation”.

3. A window will appear where the required information should be entered based on details provided by the MAH. Click the arrow below to see full list of descriptions.

Click here to view field descriptions

a) Short name

A concise identifier that forms part of the worldwide unique case ID (WWUID) and safety report unique identifier (SRUID). Usually an official abbreviation of the company name.

b) Long name

The legal name of the company. This name is displayed in the top left corner of the interface.

c) Sender organisation

The name included in the XML file to indicate which entity is sending the report.

d) Sender identifier

This corresponds to the issuer identifier and is the code used for electronic transmission between databases.

For companies with E2B databases, the relevant fields are:

• E2B (R2): <messagesenderidentifier> (ICH M.1.5: Message Sender Identifier)

• E2B (R3): 2.16.840.1.113883.3.989.2.1.3.11 (ICH N.2.r.2: Message Sender Identifier)

The sender identifier may sometimes be the same as the short name, but not always.

e) Receiver identifier

An abbreviation or code to identify the receiving organisation (the NRA, in the case of VigiFlow eReporting for Industry). The receiver identifier may sometimes be the same as the short name for the receiver.

For companies with E2B databases, the relevant fields are:

• E2B (R2): <messagereceiveridentifier> (ICH M.1.6: Message Receiver Identifier)

• E2B (R3): 2.16.840.1.113883.3.989.2.1.3.12 (ICH N.2.r.3: Message Receiver Identifier)

1. Ensure all information is correct and click Save.

The new MAH will now appear in the list of MAHs.

Sending organisation representing multiple companies

For companies reporting on behalf of multiple MAHs or CROs, the long name should be selected to clearly identify each MAH.

Example: “MAH B (PV Company A)” when PV Company A reports for MAH B.