London, 29 June 2007

Doc. Ref. EMEA/290696/2007

Eudravigilance Veterinary

Guidance for Marketing authorisation holders on:

registration options

reporting / transmission options

Access to data

This document provides an overview of the different registration options for MAHs to EVVet. The various routes of communication, which depend on the type of registration, are further explained as well as the different levels of access to the data.

A Marketing Authorisation Holder (MAH) in the EEA being a company or a firm, can have a headquarter (HQ) which is the highest level in the organisation (‘headquarter level’) and linked to it one or several affiliates in the different Member States (‘affiliate level’). If a MAH has no affiliates it should register itself HQ.

For MAHs the organisation representative in the EudraVigilance Registration Process must be the ‘Qualified Person Responsible for Pharmacovigilance’ (QP) (as defined in Community legislation) of the headquarters in the EEA.

Please note that for the e-mail address of the QP no generic entries such as ’or are accepted.

Please also note that only the QP at ‘headquarter level’ will be able to register new users (see arrows in Annex 1 from QP to all users). New users can be located at the level of the HQ, the nominated affiliates and/or the nominated third party service providers, when relevant.

The QP can delegate the functions related to registration of new users with EudraVigilance to a trusted ‘Deputy’ within the same organization. The QP should register the trusted 'Deputy' with EudraVigilance as a user in the first instance. The delegation and the registration of the deputy can be performed simultaneously.

Clinical Research Organisations (CROs), which do not qualify as a MAH, as well as IT vendors, can not become a registered organisation in the EudraVigilance Community. However, CROs or IT vendors may be registered by a MAH as ‘Third Party Service Providers’ acting on behalf of these organisations by providing services related to EudraVigilance.

Choice of transmission mode

During the registration process the MAH needs to identify for the Transmission Mode for the Headquarter, one of the following two options:

The MAH will send directly via

  • Local Gateway: This is applicable, if Electronic Data Interchange (EDI) transmissions will be done via a Gateway solution.

or

  • WEB Trader: This is applicable if EDI transmissions will occur via the WEB Trader component of EVWEB.

If the MAH intends to use a Third Party Service Provider to perform the EDI transmissions on their behalf, a contact name and the contact details for the Third Party Service Provider must be also completed. The Transmission Mode that the Third Party Service Provider will be using i.e. either the Local Gateway or the WEB Trader, must be also indicated.

The SARs created within the HQ or by its Third Party Service Provider will all carry the same sender ID (organisation ID) and the name of the QP. It will not be possible to distinct the different HQ users or its Third Party Service Provider’s users from the xml of the safety message.

In addition, the MAH may choose to allow for EDI transmission via affiliate organisations who at their level also may choose to allow for EDI transmission via a Third Party Service Provider (see Annex 1.) The affiliate organisations will receive their separate organisation ID, so that safety messages created by the affiliate’s users or its Third Party Service Provider user’s will carry the organisation ID of the affiliate and the sender name oflocal QP of the affiliate.

Please note that it is possible to use different options for the transmission mode at HQ level and affiliate level (e.g. at HQ level a local Gateway while at affiliate level a Webtrader.) However all users within one profile will use the same transmission mode chosen for the organisation.

Access rights[1]

Access rights are set in two ways by the QP of the MAH:

1) The MAH must first decide whether visibility or access rights would be provided to the affiliates or the Third Party Service providers for the EDI information being submitted by the HQ to EVVet. Please note that different affiliates will not be able to access each others SARs via EVWEBwhen the HQ visibility is set to No.

The QP will have full access to all SARs sent by HQ and/or its affiliate organisations. At present this access to the SARs in EVVet is however only limited to the messages being sent by the particular MAH to EVVet. All other messages in EVVet involving medicinal products from a MAH will not be accessible if these messages did not originate from the particular MAH. Also, when a SAR is being sent by a MAH to a Competent Authority (CA), and this CA forwards the message to the EVVet central database (after including its causality assessment), this SAR will not be available to the MAH. When a SAR is being sent by a MAH directly to the EVVet central database[2] and to the CA, the follow-up message from the CA to the EVVet central database will still not be visible to the MAH.

Access on the basis of product ownership is being planned and would address this current limited access facility of MAHs to data concerning its products in the EVVet central database. However, already now, when the legal reporting requirements are being followed, the MAH should also have received all SARs in its pharmacovigilance system by CAs copying the information to the MAHs.

2) The QP will also decide for all individual users for their specific additional access rights:

1. Browse EudraVigilance Veterinary:
This allows the individual user to access EVVet through EVWEB and to perform queries on a read only basis.
2.Create and Send SARs:
This applies to individual users of organisations at ‘headquarter level’ or ‘affiliate/subordinate level’ that are using the WEB Trader transmission mode for the EDI process. The user can create and send SARs using EVWEB. In addition, the user can receive Safety Messages with one or several SARs, store the Safety Messages locally and generate Acknowledgement Messages.

3. Send Medicinal Product Report:
This applies to individual users of organisations at ‘headquarter level’ or ‘affiliate/subordinate level’ independently if they are using the WEB Trader or Local Gateway Transmission Mode. The user can create and send a Medicinal Product Reports and Medicinal Product Messages using EVWEB.

4. Browse and Send SARs:
This allows the individual user to access EudraVigilance to perform queries. The ‘Browse and Send SARs’ status allows the user also to create and send SARs via the WEB Trader. In addition, the user can receive Safety Messages with one or several SARs, store the Safety Messages locally and generate Acknowledgement Messages.

5. Browse and Send SARs and Medicinal Product Reports:
This allows the individual user to access EudraVigilance to perform queries.
This status allows the user also to create and send SARs and Medicinal Product Reports via the WEB Trader. In addition, the user can receive Safety Messages with one or several SARs, store the Safety Messages locally and generate Acknowledgement Messages.

Choice of RECEIVER for the EDI process

For communication from a Competent Authority (CA) to a MAH, the CA will choose as Receiver ID the organisation ID considered being owned by the MAH of the product(s) involved in the SAR(s). If a MAH wishes for SARs for certain products being sent directly to the HQ or a different affiliate, this should be communicated and agreed with the CA.

The qualified person of the MAH is responsible for the follow-up of the SARs in line with the Guideline on the Electronic Data Interchange (EDI) of Suspected Adverse Reaction Reports (SARs) in Pharmacovigilance in the European Economic Area (EEA) (EMEA/89569/2004).

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[1] With access is being meant access to the data via EVWEB

[2] Please note that when messages are created in EVWEB and more than 1 message receiver is entered, EVWEB will create one message per receiver.