Phase I and III of the registration process have a common registration form for all three organisation categories.

Phase II has two different registration forms: one for organisation Category I (Regulators) and one for both Category II (Pharmaceutical Industry and Commercial Sponsors) as well as Category III (Non-Commercial Sponsors).

Below, the various steps that need to be completed in the registration process for each phase, are outlined in detail in line with the registration forms that are available online at the EudraVigilance website.

Depending on the Gateway solution you intend to use, you must take the following into account:

The EudraVigilance External Compliance Testing Environment mirrors the EudraVigilance Production Environment and is intended for the performance of the necessary testing of the EDI process with new partners of the European Medicines Agency.

New organisations of Category II and III should register in the EudraVigilance External Compliance Testing Environment (1) first, in case they are local Gateway users or in case they explicitly request it.

To proceed to registration with EudraVigilance in the Production environment the following is required:

Gateway users: Following successful testing and implementation of the electronic ICSRs transmission in the External Compliance Testing Environment (1) the Agency will inform you to register in the EudraVigilance Production Environment.

Organisations of Category I should register immediately in the Production environment (unless they are Gateway users). This is required to grant the scientific users of Regulators immediate online access to all pharmacovigilance data stored in EudraVigilance.

¹Please note that this environment was formerly known as "Test" and as "Pre-production"

Registration Process Phase I

Phase I - Step 1 - Organisation Information

The registration form is common for all organisation Categories i.e. Regulators, Pharmaceutical Industry and Commercial Sponsors as well as Non-Commercial Sponsors.

Category:
The first field requires you to indicate the organisation Category that is applicable to you. If you choose Category II (Pharmaceutical Company or Commercial Sponsor) you will be also asked to enter the Company's Trademark.

Trademark:
A Trademark is any sign, which can be used to distinguish the goods and services of one trader from another.

The trademark registered in EudraVigilance, should include any letter, word, name, numeral, brand or a combination of these used by the organisation as a marketing tool so that customers can recognize the product of a particular company or firm. It should not include any pictures, signature, signs etc.

The trademark allows grouping of all entities within an organisation (e.g. the headquarter of a Pharmaceutical Company and all registered Affiliates), which is important for query purposes within EudraVigilance, i.e., all entities within an organisation should register with EudraVigilance using the same Trademark. If an organisation doesn't have a Trademark, the name of the organisation can be added in this field.

Organisation ID:
Each organisation must specify a unique Organisation Identifier (Organisation ID), which is used to uniquely identify each organisation in the EDI process. When you choose an Organisation ID, you should use a string formed by upper-case letters (A to Z), a number set (0 to 9) or a combination of both. Special or country-based characters and blank spaces are not allowed. The Organisation ID must consist of a minimum of 3 and a maximum of 10 characters.
The Organisation ID can't be changed once it has been created.
Once approved, the organisation ID of the Headquarter can't be deleted from the system.

If a company registers in both Environments, EudraVigilance External Compliance Testing Environment¹and EudraVigilance Production Environment, each organisation must have two different Organisation Identifiers: one for each Environment. Those two IDs must be different. For example, if your company is called 'Pharmacom' you may choose as your Organisation ID ' PHARMACOMT' for the External Compliance Testing Environment (1) and 'PHARMACOM' for the Production Environment.

You need to provide your External Compliance Testing (1) Organisation Identifier when you register for the EudraVigilance External Compliance Testing Environment (1) and your 'Production' Organisation Identifier when you register for the EudraVigilance Production Environment.

Depending on the Gateway solution you intend to use, you must take the following into account:

• Local Gateway:: If you plan to perform your transmissions using your own local Gateway solution, your Organisation IDs for both the EudraVigilance External Compliance Testing and Production Environment must be identical to your Gateway Identifier.
• WEB Trader:: If you plan to perform your transmissions using the WEB Trader component of EVWEB, your Organisation IDs for both the EudraVigilance Test and Production Environment, also apply accordingly to identify your organisation in the EDI process at the level of the Safety and Acknowledgement Message Sender or Receiver.

The Organisation Identifier is also used to uniquely identify your organisation as the sender of 'Medicinal Product Reports' and Medicinal Product Messages and to assign the ownership of this information for security purposes to your organisation.

¹Please note that this environment was formerly known as "Test" and as "Pre-production"

Organisation Name:
The Organisation Name is the official full name of the organisation, being either a National Competent Authority, a Marketing Authorisation Holder, Applicant, Commercial or Non Commercial Sponsor.

Please note that you will need two different Organisation Names: one for the EudraVigilance External Compliance Testing Environment¹and another one for the EudraVigilance Production Environment. These two names must be different. For example, if your company is called 'Pharmacom' you may choose as your Organisation Name ' PHARMACOMT' for the External Compliance Testing Environment (1) and 'PHARMACOM' for the Production Environment.

You need to provide your External Compliance Testing (1) Organisation Name when you register for the EudraVigilance External Compliance Testing Environment (1) and your 'Production' Organisation Name when you register for the EudraVigilance Production Environment. For example, you can put the word 'Test' after the official full name of your organisation when you register for the EudraVigilance External Compliance Testing Environment¹.

¹Please note that this environment was formerly known as "Test" and as "Pre-production"

Organisation Address:
The address details such as Street, City, Postcode and Country must be provided for each organisation.

Functional Email:
In the functional email address field please insert a generic email address (e.g. IT@company.com) of the service responsible for IT functions of the organisation. Please note that this field is mandatory at Headquarter level and should not be a personal email address (i.e. firstname.surname@company.com). The "Functional email address" can be provided either from the Headquarter or a CRO.

The "Functional email" will mainly be used for communication relating to technical updates to the EudraVigilance system.

Phase I - Step 2 - Qualified Person Responsible for Pharmacovigilance/Responsible Person for EudraVigilance

As outlined in chapter ‘The Organisation Representative in the EudraVigilance Registration Process’, the role of the ‘Qualified Person Responsible for Pharmacovigilance’ for organisation Category II or the ‘Responsible Person for EudraVigilance’ of organisation Category I, II and III within the framework of the EudraVigilance Registration Process is to co-ordinate the registration at the ‘headquarter level’, the ‘affiliate/subordinate level’ and the ‘individual user level’.

Contact Details
The contact details for the Qualified Person Responsible for Pharmacovigilance/Responsible Person for EudraVigilance include address, direct telephone number, fax number, and e-mail. Please note that for the e-mail address no generic entries such as administration@abc.com’ or info@yahoo.co.uk are accepted.

Phase I - Step 3 - Transmission Mode

Send directly via
Depending on the Gateway solution you intend to use, you must specify, for the Transmission Mode, one of the following two options:

Local Gateway: This is applicable, if you plan to perform your EDI transmissions using your own local Gateway solution.

WEB Trader: This is applicable if you plan to perform your transmissions using the WEB Trader component of EVWEB.

Send Using Third Party Service Provider via
If your organisation intends to use a Third Party Service Provider (for details please refer to chapter ‘Registered Organisations in the EudraVigilance Community’) to perform the EDI transmissions on your 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.

Visibility
Next, you can specify the visibility or access rights at the Affiliate/Subordinate level for your organisation, where applicable. You can choose to allow your Affiliate(s)/Subordinate(s) to be able to view the ICSRs that have been submitted at the 'headquarter level' of your organisation to EudraVigilance. The appropriate option must be selected.

MedDRA
The use of MedDRA is subject to a license fee. Therefore, you must indicate the MedDRA license your organisation has obtained in the framework of the electronic transmission of ICSRs. This is also important since the access to EudraVigilance that is provided to all registered organisations also includes full access to the MedDRA terminology.

All organisations must ensure that they have the necessary MedDRA license in place, before the EDI process and the access to EudraVigilance can be initiated. In the registration form you have to specify the MedDRA license that is applicable to your organisation and the appropriate MedDRA license number.

If you are using a Third Party Service Provider, you have to liaise with this provider with regard to the MedDRA license aspects.

The registration form offers two MedDRA license types:

• Full MedDRA Subscriber License refers to the MedDRA license policy as published at the web site of the MSSO (http://www.meddra.msso.org/)
• EudraVigilance MedDRA Licensing Policy For details please refer to the EudraVigilance web site http://eudravigilance.ema.europa.eu/human/meddra01.asp

In general, Regulators are exempted from a MedDRA subscription. At the registration process Regulators should specify ‘Full MedDRA Subscriber License’. Regulators do not need to specify a MedDRA license number on the form.

Non-commercial sponsors and Small and Medium Size Enterprises (SMEs) may qualify for a fee waiver or reduced fee under the EudraVigilance MedDRA Licensing Policy. Please see details on the EudraVigilance website
http://eudravigilance.ema.europa.eu/human/meddra01.asp

Please note that MedDRA versioning is as follows:

• EudraVigilance (production environment) accepts reports using the current version of MedDRA and the one previous to it.
• EudraVigilance (External Compliance Testing Environment ) accepts reports using version 4.0 and higher.
• Backlog reporting, when required, will accept version 4.0 and higher.
• Please note that MedDRA versions are updated every 6 months (normally March and September).

The MedDRA licence number required in the online registration form is the registering organisation’s own, not the MedDRA's licence number of any third party provider, such as a CRO.

Phase I - Step 4 - Security Information

Step 4 is for security purposes

Firstly, contact your Network administrator to determine which IP address/es should be specified here.

The IP address/es you specify here are not those of an individual computer on your Network but refers to the Organisation’s ‘Public’ IP address/es.

Specifying a single public IP number means that all the computers on your Network will be able to access EudraVigilance.

It is allowed to specify up to 3 public IP numbers to provide those organisations with more than one public IP to access EudraVigilance without any problem.

Please note that if you require remote access or access via your home computer, please specify‘all computers’

Phase I - Step - 5 - Review and Print

This last step allows you to review and print the information before proceeding with the submission of your organisation registration information to EudraVigilance.

If you spot any errors, you are able to go back to the completed forms and modify any data you have inserted before finalising the registration by pressing the‘Submit’ button. Please note that you need to print this page first to enable the‘Submit’ button.

You have completed the first part of the registration process (Phase I). Please see chapter ‘Registration Documents’ to complete the registration process. Your submission will be assessed and, if complete, the Qualified Person for Pharmacovigilance/Responsible Person for Eudravigilance will receive a unique user name and password to access EudraVigilance.

¹Please note that this environment was formerly known as "Test" and as "Pre-production"

Registration Process Phase II

Following successful completion of Phase I of the EudraVigilance registration process, the Qualified Person for Pharmacovigilance/Responsible Person for EudraVigilance can now register Affiliates/Subordinates and individual users for their organisation.

Please note that only the Qualified Person for Pharmacovigilance/Responsible Person for Eudravigilance (or the trusted ‘Deputy’) at ‘headquarter level’ will be able to register Affiliate(s)/Subordinate(s) and new users.

For the registration process in Phase II you need to access the restricted area of EudraVigilance via the ‘Registered users’ login link at EudraVigilance homepage. You will be asked to enter your unique username and password.

Following successful login, you will be able to access an alphabetic list of all registered organisations. Clicking on‘Manage your profile’, EudraVigilance will recognise your user credentials and will grant you access to your organisation details. If you choose another organisation, you will have read access but you will not be able to enter new users or Affiliates/Subordinates.

Clicking on the ‘Add Affiliate/Subordinate’ or ‘Add Regional Phv Centre’ button on the menu will grant you access to the Phase II of the EudraVigilance Registration Process. Please note that Affiliate(s)/Subordinate(s) will not be able to register themselves.

Please see chapter "Documentation required" in the ‘Registration Documents’ section to complete the registration process of ‘Affiliates/Subordinates’ and individual users for your organisation.

Affiliate/Subordinate Registration

• Click here for Regional Pharmacovigilance Centre

If your organisation does not have any Affiliates/Subordinates, please move directly to Phase III to register individual users at‘headquarter level’within your organisation.

Phase II - Step 1 - Organisation Information

You will be asked to enter the affiliate Identifier, name and address.

Affiliate/Subordinate Identifier (Affiliate/Subordinate ID)
Each Affiliate/Subordinate must have a unique Affiliate/Subordinate Identifier, which is used to uniquely identify each Affiliate/Subordinate of an organisation. When you choose an Affiliate/Subordinate Identifier, you should use a string formed by upper case letters (A to Z), a number set (0 to 9) or a combination of both. Special or country-based characters and blank spaces are not allowed. The Affiliate/Subordinate Identifier must consist of a minimum of 3 and a maximum of 10 characters.
The Organisation ID can't be changed once it has been created.
Once approved, the organisation ID of the Affiliate can be deleted from the system only under certain circumstances.

Each Affiliate/Subordinate must have two different Affiliate/Subordinate Identifiers: one for the EudraVigilance External Compliance Testing Environment¹ and another one for the EudraVigilance Production Environment. Those two IDs must be different. For example, if your company is called 'Pharmacom Affiliate' you may choose as your Affiliate/Subordinate Identifier 'AFFILT' for the External Compliance Testing Environment¹, and 'AFFIL' for the Production Environment.

You need to provide your 'Test' Affiliate/Subordinate Identifier when you register for the EudraVigilance External Compliance Testing Environment¹ and your 'Production' Identifier when you register for the EudraVigilance Production Environment.

The Affiliate/Subordinate Identifier is also used to uniquely identify the sender of 'Medicinal Product Reports' and Medicinal Product Messages and to assign the ownership of this information for security purposes to your organisation or your Affiliates/Subordinates.

Affiliate/Subordinate Name:
The Affiliate/Subordinate Name is the official full name of the Affiliate/Subordinate of a Marketing Authorisation Holder, Applicant, Commercial or Non Commercial Sponsor.

Please note that you will need two different Affiliate/Subordinate Names: one for the EudraVigilance External Compliance Testing Environment¹ and another one for the EudraVigilance Production Environment. These two names must be different.

You need to provide your 'Test' Affiliate/Subordinate Name when you register for the EudraVigilance External Compliance Testing Environment¹ and your 'Production' Affiliate/Subordinate Name when you register for the EudraVigilance Production Environment. For example, you can put the word 'Test' after the official full name of your Affiliate/Subordinate when you register for the EudraVigilance External Compliance Testing Environment¹.

¹Please note that this environment was formerly known as "Test" and as "Pre-production"

Affiliate/Subordinate Address:
The address details such as Street, City, Postcode and Country must be provided for each Affiliate/Subordinate.

Functional Email:
This field is not mandatory at affiliate level.

¹Please note that this environment was formerly known as "Test" and as "Pre-production"

Phase II - Step 2 - Qualified Person Responsible for Pharmacovigilance/Responsible Person for EudraVigilance at Affiliate/Subordinate level

Contact Details
The contact details for the the Qualified Person for Pharmacovigilance/Responsible Person for Eudravigilance at Affiliate/Subordinate level including address, direct telephone number, fax number, and direct e-mail should be provided. Please note that for the e-mail address no generic entries such as administration@abc.com’or info@yahoo.co.uk are accepted.

Phase II - Step 3 - Transmission Mode

Send by Headquarter
If your organisation has decided that the operation of the EDI process is carried out at ‘headquarter level’ including all Affiliate(s)/Subordinate(s), the ‘Send via Headquarter’ section should be selected.

Send directly via
If your organisation has decided that the operation of the EDI process is carried out at ‘Affiliate/Subordinate’ level, you have to indicate the Gateway solution that the Affiliate/Subordinate is going to use. In this case, you must specify for the Transmission Mode one of the following two options:

Local Gateway:This is applicable, if your Affiliates/Subordinates plan to perform your EDI transmissions using your own local Gateway solution.

Web Trader: This is applicable if your Affiliates/Subordinates plan to perform your transmissions using the Web Trader component of EVWEB.

Please note that it is possible to use at 'headquarter level' and 'affiliate/subordinate level' different options for the Transmission Mode (e.g. at 'headquarter level' a local Gateway can be used while at 'affiliate/subordinate level' the use of the Web Trader is chosen).

Send Using Third Party Service Provider via
If your Affiliates/Subordinates intend to use a Third Party Service Provider (for details please refer to chapter‘Registered Organisations in the EudraVigilance Community’) 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.

MedDRA
The use of MedDRA is subject to a license fee. Therefore, you must indicate the MedDRA license your organisation has obtained in the framework of the electronic transmission of ICSRs. This is also important since the access to EudraVigilance that is provided to all registered organisations also includes full access to the MedDRA terminology.

All organisations must ensure that they have the necessary MedDRA license in place, before the EDI process and the access to EudraVigilance can be initiated. In the registration form you have to specify the MedDRA license that is applicable to your organisation and the appropriate MedDRA license number.

If you are using a Third Party Service Provider, you have to liaise with this provider with regard to the MedDRA license aspects.

The registration form offers two MedDRA license types:

• Full MedDRA Subscriber License refers to the MedDRA license policy as published at the web site of the MSSO (http://www.meddra.msso.org/)
• EudraVigilance MedDRA Licensing Policy For details please refer to the EudraVigilance web site http://eudravigilance.ema.europa.eu/human/meddra01.asp

In general, Regulators are exempted from a MedDRA subscription. At the registration process Regulators should specify ‘Full MedDRA Subscriber License’. Regulators do not need to specify a MedDRA license number on the form.

For details please refer to the document Eudravigilance MedDRA Licensing Policy (http://eudravigilance.ema.europa.eu/human/meddra02.asp)

Phase II - Step 4 - Security Information

Step 4 is for security purposes

Firstly, contact your Network administrator to determine which IP address/es should be specified here.

The IP address/es you specify here are not those of an individual computer on your Network but refers to the Organisation’s‘Public’IP address/es.

Specifying a single public IP number means that all the computers on your Network will be able to access EudraVigilance.

It is allowed to specify up to 3 public IP numbers to provide those organisations with more than one public IP to access EudraVigilance without any problem.

Please note that if you require remote access or access via your home computer, please specify‘all computers’

Phase II – Step 5 - Review and Print

This last step allows you to review and print the information before proceeding with the submission of your Affiliate/Subordinate registration information to EudraVigilance.

If you spot any errors, you will be able to go back to the completed forms and modify any data you have inserted before finalising the registration by pressing the 'Submit' button. Please note that you need to print this page first to enable the 'Submit' button.

You have completed the second part of the registration process (Phase II). Please see chapter 'Registration Documents' to complete the registration process. Your submission will be assessed and, if complete, the Qualified Person for Pharmacovigilance/Responsible Person for EudraVigilance at Affiliate/Subordinate level will receive from the Agency a unique user name and password to access EudraVigilance.

Regional Pharmacovigilance Centre Registration

If your National Competent Authority does not have any Regional Pharmacovigilance Centres, please move directly to Phase III to register individual users at ‘headquarter level’ within your Authority.

Phase II – Step 1 - Regional Pharmacovigilance Centre Information

You will be asked to enter the affiliate Identifier, name and address.

Regional Pharmacovigilance Centre Identifier (Regional Pharmacovigilance Centre ID)
Each Regional Pharmacovigilance Centre must have a unique Regional Pharmacovigilance Centre Identifier, which is used to uniquely identify each Regional Pharmacovigilance Centre of a National Competent Authority. When you choose a Regional Pharmacovigilance Centre Identifier, you should use a string formed by upper-case letters (A to Z) or a number set (0 to 9) only. Special characters are not allowed. The Regional Pharmacovigilance Centre ID must consist of a minimum of 3 and a maximum of 10 characters.
The Organisation ID can't be changed once it has been created.
Once approved, the organisation ID of the Regional Pharmacovigilance Centre can be deleted from the system only under certain circumstances.

Each Regional Pharmacovigilance Centre must have two different Regional Pharmacovigilance Centre Identifiers: one for the EudraVigilance External Compliance Testing Environment¹ and another one for the EudraVigilance Production Environment. Those two IDs must be different. For example, if your Regional Pharmacovigilance Centre is called ' Regional Pharmacovigilance Centre X' you may choose as your Regional Pharmacovigilance Centre Identifier 'RPHCXT' for the External Compliance Testing Environment¹ and 'RPHCX' for the Production Environment.

You need to provide your 'Test' Regional Pharmacovigilance Centre Identifier when you register for the EudraVigilance External Compliance Testing Environment¹ and your 'Production' identifier when you register for the EudraVigilance Production Environment.

Regional Pharmacovigilance Centre Name:
The Regional Pharmacovigilance Centre Name is the official full name of the Regional Pharmacovigilance Centre.

Please note that you will need two different Regional Pharmacovigilance Centre Names: one for the EudraVigilance External Compliance Testing Environment¹ and another one for the EudraVigilance Production Environment. These two names must be different.

You need to provide your 'Test' Regional Pharmacovigilance Centre Name when you register for the EudraVigilance External Compliance Testing Environment¹ and your 'Production' Regional Pharmacovigilance Centre Name when you register for the EudraVigilance Production Environment. For example, you can put the word 'Test' after the official full name of your Regional Pharmacovigilance Centre when you register for the EudraVigilance External Compliance Testing Environment¹.

Regional Pharmacovigilance Centre Address:
The address details such as Street, City, Postcode and Country must be provided for each Regional Pharmacovigilance Centre.

Functional Email:
This field is not mandatory at Regional Pharmacovigilance Centre level.

¹Please note that this environment was formerly known as "Test" and as "Pre-production"

Phase II – Step 2 - Responsible Person for EudraVigilance at the Regional Pharmacovigilance Centre level

Contact Details
The contact details for the Responsible Person for EudraVigilance at the Regional Pharmacovigilance Centre level including address, direct telephone number, fax number, and direct e-mail should be provided. Please note that for the e-mail address no generic entries such as 'administration@abc.com'or info@yahoo.co.uk are accepted.

Phase II – Step 3 - Transmission Mode

Send by Headquarter
If you as National Competent Authority have decided that the operation of the EDI process is carried out at ‘headquarter level’ including all Regional Pharmacovigilance Centre(s), the ‘Send via Headquarter’ section should be selected.

Send directly via
If you as National Competent Authority have decided that the operation of the EDI process is carried out at ‘Regional Pharmacovigilance Centre(s)’ level, you have to indicate the Gateway solution that the Regional Pharmacovigilance Centre is going to use. In this case, you must specify for the Transmission Mode the following option:

Web Trader: This is applicable for your Regional Pharacovigilance Centre(s) to perform the electronic transmissions using the Web Trader component of EVWEB.

Send Using Third Party Service Provider via
If your Regional Pharmacovigilance Centre(s) intend(s) to use a Third Party Service Provider (for details please refer to chapter 'Registered Organisations in the EudraVigilance Community') 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 must use for Regional Pharmacovigilance Centre(s) is Web Trader.

MedDRA
The use of MedDRA is subject to a license fee.

In general, Regulators and their Regional Pharmacovigilance Centres (i.e. Affiliates/Subordinates) are exempted from a MedDRA subscription. At the registration process Regulators should specify 'Full MedDRA Subscriber License'. Regulators do not need to specify a MedDRA license number on the form.

For details please refer to the Eudravigilance web site:
(http://eudravigilance.ema.europa.eu/human/meddra01.asp)

Phase II – Step 4 - Security Information

Step 4 is for security purposes

Firstly, contact your Network administrator to determine which IP address/es should be specified here.

The IP address/es you specify here are not those of an individual computer on your Network but refer to the Organisation's 'Public' IP address/es.

Specifying a single public IP number means that all the computers on your Network will be able to access EudraVigilance.

It is allowed to specify up to 3 public IP numbers to provide those organisations with more than one public IP to access EudraVigilance without any problem.

Please note that if you require remote access or access via your home computer, please specify 'all computers'.

Phase II - Step 5 - Review and Print

This last step allows you to review and print the information before proceeding with the submission of your Regional Pharmacovigilance Centre registration information to EudraVigilance.

If you spot any errors, you are able to go back to the completed forms and modify any data you have inserted before finalising the registration by pressing the‘Submit’button. Please note that you need to print this page first to enable the‘Submit’button.

You have completed the second part of the registration process (Phase II). Please see chapter "Documentation Required" in the ‘Registration Documents’ section to complete the registration process. You submission will be assessed and, if complete, the‘Responsible Person for EudraVigilance’at the Regional Pharmacovigilance Centre level will receive unique user name and password to access EudraVigilance.

Registration Process Phase III

Phase III - Step 1- Registration of Individual Users

Following successful completion of Phase I and/or II of the EudraVigilance registration process, the Qualified Person for Pharmacovigilance/Responsible Person for Eudravigilance can now register individual users at ‘headquarter level’ or ‘affiliate/subordinate level’.

Please note that only the Qualified Person for Pharmacovigilance/Responsible Person for Eudravigilance (or the trusted ‘Deputy’) at ‘headquarter level’ will be able to register new users.

For the registration process in Phase III you need to access the restricted area of EudraVigilance via the ‘Registered users’ login link on the EudraVigilance homepage. You will be asked to enter your unique username and password.

Following successful login, you will be able to access an alphabetic list of all registered organisations and Affiliates/Subordinates. Clicking on‘Manage your profile’, EudraVigilance will recognize your user credentials and will grant you access to your organisation and Affiliate/Subordinate details. If you choose another organisation, you will have read access but you will not be able to enter new users or Affiliates/Subordinates.

To add a new user to the headquarters level, click on ‘Manage your own profile’. You will be given the choice of ‘Add User’. By clicking on the ‘Add User’ button, the Qualified Person for Pharmacovigilance/Responsible Person for Eudravigilance (or his/her deputy) at ‘headquarter level’ will be able to register new users.

To add a new user at an Affiliate/Subordinate/Centre level, you need to follow a different process. Click on ‘Manage your own profile’ to see details of your Affiliates/Subordinates/Centres and users registered with your organisation.

Click on the Organisation ID of the Affiliate/Subordinate/Centre to which you whish to add a new user. A new window with the details of that Affiliate/Subordinate/Centre will appear. At the top of that new window you will find an ‘add user’ button. By clicking on that button you will reach the registration form required to add a new user to that Affiliate/Subordinate/Centre.

Please see chapter "Documentation Required" in the ‘Registration Documents’ section to complete the registration process of individual users.

Add Individual User Name and Contact Details
The user registration form will ask you to enter the full name and contact details for that new user, including address, telephone number, fax number, and e-mail address.

Individual User Rights
The individual user rights depend on the overall access policies in EudraVigilance for the various registered partners.

Currently National Competent Authorities have full access to all ICSRs stored in EudraVigilance. During the registration process National Competent Authorities can decide what level of access they will grant to Regional Pharmacovigilance Centres, where this is applicable.

Marketing Authorisation Holders/Applicants have restricted access to all ICSRs, they have submitted to EudraVigilance. Marketing Authorisation Holders/Applicants can decide what level of access they will grant to their Affiliates, where this is applicable.

Commercial and Non-Commercial sponsors currently do not have access to any ICSRs that qualify as suspected serious unexpected adverse reactions (SUSARs) that occur in Clinical Trials and that qualify for reporting to the EudraVigilance Clinical Trial Module (EVCTM) in accordance with the appropriate note for guidance as published by the European Commission.

Taking into account the overall EudraVigilance access policy, one of the following access rights can be assigned to an individual user:

• Browse EudraVigilance:
  This allows the individual user to access EudraVigilance and to perform queries on a read only basis. Please note that the access rights of Affiliate/Subordinate users depend on the authorization granted by the organisation Headquarter (visibility for Affiliates/Subordinates).
  The ‘Browse EudraVigilance’ status allows the individual user also to create ICSRs and Medicinal Product Reports, but not to send it via the Web Trader (transmission can only take place via the locally established gateway).
• Create and Send ICSRs:
  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 ICSRs using EVWEB. In addition, the user can receive Safety Messages with one or several ICSRs, store the Safety Messages locally and generate Acknowledgement Messages.
• 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.
• Browse and Send ICSRs:
  This allows the individual user to access EudraVigilance to perform queries. Please note that the access rights of Affiliate/Subordinate users depend on the authorization granted by the organisation headquarter (visibility for Affiliates/Subordinates). The ‘Browse and Send ICSRs’ status allows the user also to create and send ICSRs via the Web Trader. In addition, the user can receive Safety Messages with one or several ICSRs, store the Safety Messages locally and generate Acknowledgement Messages.
• Browse and Send ICSRs and Medicinal Product Reports:
  This allows the individual user to access EudraVigilance to perform queries. Please note that the access rights of Affiliate/Subordinate users depend on the authorization granted by the organisation headquarter (visibility for Affiliates/Subordinates).
  This status allows the user also to create and send ICSRs and Medicinal Product Reports via the Web Trader. In addition, the user can receive Safety Messages with one or several ICSRs, store the Safety Messages locally and generate Acknowledgement Messages.
• No Access Right:
  The ‘No Access Right’ status does not allow the individual user to access EudraVigilance. This status will be assigned to a user by the Agency following a request to do so by an organisation (e.g. if a user is no longer allowed to access EudraVigilance because he/she is no longer employed by the organisation or has changed departments).
  

Phase III – Step 2 - Review and print

This last step allows you to review and print the information before proceeding with the submission of your Individual user to EudraVigilance.

If you spot any errors, you are able to go back to the completed form and modify any data you have inserted before finalising the registration by pressing the ‘Submit’ button. Please note that you need to print this page first to enable the ‘Submit’ button.

¹Please note that this environment was formerly known as "Test" and as "Pre-production"

up |go back

Last update: Wednesday, 6 July 2016.