EudraVigilance Veterinary User Manual - How to...

Veterinary

How to register with EudraVigilance Veterinary

IN THIS MANUAL

Overview of the registration process

The Registration Process: Step by step

Documents required for registration

Delegation of Registration Process

Annex I: Contact details for submission

Annex II: Forms

SUMMARY

The registration process is necessary to identify the partners of the EMEA in the EEA for the secure electronic transmission of ADRs. Only registered partners are permitted to exchange safety or acknowledgement messages through the EudraVigilance Veterinary Gateway and Database Management System (DBMS). A list of registered parties is maintained by the EMEA and is accessible in the restricted area of the EudraVigilance Veterinary website to all registered partners.

Pharmaceutical companies and national Competent Authorities can register through the EudraVigilance Veterinary webpage with the EMEA, for the purpose of the secure electronic transmission of ADRs and to become part of the EudraVigilance Veterinary user community.

Veterinary

Table of Contents

OVERVIEW OF THE REGISTRATION PROCESS..................................................................3

Test and production environments ..........................................................................3 Specification of the transmission mode ..................................................................4 User rights ...............................................................................................................4

THE REGISTRATION PROCESS: STEP BY STEP ...............................................................6 Registration Form Phase I Step 1 – Organisation Information ...............................6 Registration Form Phase I Step 2 – Responsible Contact for Pharmacovigilance8 Registration Form Phase I Step 3 – Transmission Mode.......................................9 Registration Form Phase I Step 4 – Security Information....................................10 Registration Form Phase I Step 5 – Review, Print and Submit ...........................11 Registration Form Phase II – Affiliate/Subordinate Step 1 – Affiliate/Subordinate Information ............................................................................................................12 Registration Form Phase II – Affiliate/Subordinate Step 2 – Responsible Contact for Pharmacovigilance for an Affiliate....................................................................13 Registration Form Phase II – Affiliate/Subordinate Step 3 – Transmission mode 14 Registration Form Phase II – Affiliate/Subordinate Step 4 – Security information15 Registration Form Phase II – Affiliate/Subordinate Step 5 – Review, Print and Submit ...................................................................................................................15 Registration Form Phase II – Pharmacovigilance Centre Step 1 – Pharmacovigilance Centre Information.................................................................16 Registration Form Phase II – Pharmacovigilance Centre Step 2 – Responsible Person for Pharmacovigilance at Regional Pharmacovigilance Centre level.......17 Registration Form Phase II – Pharmacovigilance Centre Step 3 – Transmission mode .....................................................................................................................17 Registration Form Phase II – Pharmacovigilance Centre Step 4 – Security information ............................................................................................................17 Registration Form Phase II – Pharmacovigilance Centre Step 5 – Review, Print and Submit ............................................................................................................17 Registration Form Phase III – Individual Users Step 1 .........................................18

DOCUMENTS REQUIRED FOR REGISTRATION ................................................................20 DELEGATION OF REGISTRATION PROCESS ..................................................................21 ANNEX I: CONTACT DETAILS FOR SUBMISSION.............................................................22 ANNEX II: FORMS.......................................................................................................23

EudraVigilance Veterinary User Declaration.........................................................24 EudraVigilance Veterinary User Registration Declaration ....................................25 EudraVigilance Veterinary Delegation Declaration ...............................................26

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O v e r v i e w o f t h e r e g i s t r a t i o n p r o c e s s

INDUSTRY REGULATORY BODIES

Phase I

Registration of the Headquarter (at European level) of a pharmaceutical company or a national Competent Authority. Only the respective headquarter of a pharmaceutical company or national Competent Authority will be admitted to this first phase of the registration process. Company Headquarters National Competent Authorities Step 1 - Choose type of organisation - Trademark - Organisation ID - Organisation Name - Organisation address - Responsible Contact for PhV - Contact’s details

Step 1 - Choose type of organisation - Organisation ID - Organisation Name - Organisation address - Responsible Contact for PhV - Contact’s details

Step 2 - Choose transmission mode - Define Visibility Rights

Step 2 - Choose transmission mode - Define Visibility Rights

Phase II Registration of affiliates of pharmaceutical companies and regional pharmacovigilance centres of national Competent Authorities, if necessary. Affiliate Regional PhV Centre Step 1 - Define Affiliate ID - Define Affiliate Name - Define Affiliate Address - Appoint Contact for PhV - Contact’s details

Step 1 - Define Centre ID - Define Centre Name - Define Centre Address - Appoint Contact for PhV - Contact’s details

Step 2 - Choose transmission mode

Step 2 - Choose transmission mode

Phase III Registration of individual users connected to pharmaceutical companies or national Competent Authority or their dependent regional affiliates or pharmacovigilance centres. Individual Users Individual Users

- Define User Name - Define User Address - Define User Rights

- Define User Name - Define User Address - Define User Rights

Test and production environments

EudraVigilance Veterinary has two different environments:

− The test environment is for the testing of electronic transmission of ADRs and to enable users to get used to the system;

− The production environment is for the regular electronic transmission of ADRs.

Each organisation must provide two different Organisation IDs: one for the EudraVigilance Veterinary Test Environment and one for the EudraVigilance Veterinary Production Environment. Those two Organisation IDs must be different.

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Specification of the transmission mode

When you register, you will be asked to specify the transmission mode that your organisation is going to use to send safety and acknowledgement messages.

There are two transmission modes:

Gateway transmission mode

This refers to an organisation that has a pharmacovigilance database available. The database permits the generation and receipt of ADRs as well as a gateway solution that meets the ICH M2 standards and that has been successfully tested and connected with the EudraVigilance Veterinary Gateway.

Webtrader transmission mode

The webtrader is an integrated component of the EudraVigilance Veterinary Gateway to transmit ADRs in a secure way via web access to any registered organisation within the EudraVigilance Veterinary community. The webtrader can be used as part of EVWEB.

Pharmaceutical companies and national Competent Authorities need to specify their transmission mode at all levels: at the level of the headquarters and at the level of the regional pharmacovigilance centers or affiliates, if applicable. Different transmission modes may be used at each level.

User rights

The user rights of each individual user within an organisation must be defined by the Head of the Pharmacovigilance Department of the national Competent Authority or pharmaceutical company with whom the individual is associated.

One of the following access rights can be assigned to an individual user:

− No access right: This does not allow the individual user to access the EudraVigilance Veterinary DBMS. This status should be chosen e.g. if a user is no longer allowed to use the DBMS because he is no longer employed at the organisation or has changed departments.

− Browse: This allows the individual user to access the EudraVigilance Veterinary DBMS to make queries on a “read only” basis. Please note that the access rights of pharmaceutical company users depend on the authorisation given to them by their headquarters (visibility for affiliates section) and that in principle pharmaceutical companies can only access their own submitted data. This status allows the user also to create an ADR and a Medicinal Product Report but not to send it via the webtrader (transmission can only take place via the locally established gateway).

− Send ADR: This applies to individual users of pharmaceutical companies/regional pharmacovigilance centers using the webtrader transmission mode. The user can create and send ADRs using EVWEB.

− Send Medicinal Product Report: This applies to individual users of pharmaceutical companies/regional pharmacovigilance centers using the webtrader transmission mode. The user can create and send a Medicinal Product Report using EVWEB.

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− Browse and send ADRs:

This allows the individual user to access the EudraVigilance Veterinary DBMS to make queries. Please note that the access rights of pharmaceutical company users depend on the authorisation given to them by their headquarters (visibility for affiliates section) and that pharmaceutical companies can only access their own submitted data. This status also allows the user to create and send ADRs via the webtrader.

− Browse and send ADRs and Medicinal Product Reports: This allows the individual user to access the EudraVigilance Veterinary DBMS to make queries. Please note that the access rights of pharmaceutical company users depend on the authorisation given to them by their Headquarters (visibility for affiliates section) and that pharmaceutical companies can only access their own submitted data. This status allows the user also to create and send ADRs and medicinal product reports via the webtrader.

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T h e R e g i s t r a t i o n P r o c e s s : S t e p b y s t e p

Two types of organisations can register with EudraVigilance Veterinary: National Competent Authorities and Pharmaceutical Companies.

Phases I and III of the registration process have a common form for all organisations. Phase II has two different forms: one for National Competent Authorities and another for Pharmaceutical Companies.

Please note that EudraVigilance Veterinary has two different environments: one for testing and another for production (described in section 1: Overview of the registration process).

Registration Form Phase I Step 1 – Organisation Information

This registration form is identical for both Pharmaceutical Companies and Competent Authorities.

The first field requires you to declare the type of organisation about to be registered: Either a Pharmaceutical Company or a National Competent Authority.

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National Competent Authority

In relation to this registration process, a national Competent Authority is defined as an authority within the European Economic Area (EEA) responsible for the granting of marketing authorisations for veterinary medicinal products, and the supervision of marketing of such products, in accordance with the relevant laws and regulations established under Community law.

Pharmaceutical Company

In relation to this registration process, a pharmaceutical company is defined as a marketing authorisation holder or applicant for veterinary medicinal products in the EEA. A marketing authorisation holder is holding a valid marketing authorisation for a veterinary medicinal product in the EEA including any part thereof, independent of the authorisation procedure of this veterinary medicinal product. An applicant is a pharmaceutical company applying for a marketing authorisation for a veterinary medicinal product in the EEA. For transparency purposes the european headquarters of the company will be used as the first point of contact. If you choose ‘Pharmaceutical Company’ you will be asked for the Company’s Trademark.

Pharmaceutical Company Trademark

A Trademark is any sign that can be used to distinguish the goods and services of one trader from another. The trademark for a pharmaceutical company, registered with EudraVigilance Veterinary, should include any letter, word, name, numeral or a combination of these used by the company as a marketing tool for customer recognition. It should not include any pictures, signatures, symbols etc.

The trademark allows grouping of all entities within a company (e.g. the headquarter and all registered affiliates), which is important for query purposes within EudraVigilance Veterinary, therefore all entities within a company should register with EudraVigilance Veterinary using the same Trademark.

Organisation Identifier (ID)

Each pharmaceutical company or national Competent Authority must specify a unique Organisation Identifier (Organisation ID). The organisation ID must comprise between 3 and 10 characters, and should consist of upper case letters (A to Z) and/or numbers (0 to 9), not using spaces or special characters. For easy recognition of the Organisation and the Member State where it is located, it is further recommended to start the Organisation ID with the two-letter country code according to ISO.

Please remember that you will need two different Organisation Identifiers: one for the test environment and another for the production environment. Those two IDs must be different. For example, if the company is called “VetCompany” and is located in the UK you may choose "UKVETCOMPT" for the test environment and "UKVETCOMP” for the production environment.

If your organisation deals with or produces medicines for both humans and animals, you will need different IDs to register with the veterinary and the human EudraVigilance systems.

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Organisation Name

The Organisation Name is the legal name of the company or the exact name of the national Competent Authority.

Organisation Address

The address details of the organisation such as Street, City, Postcode and Country must be provided for each organisation.

Registration Form Phase I Step 2 – Responsible Contact for Pharmacovigilance

Both Pharmaceutical Companies and Competent Authorities will require entering a person responsible for pharmacovigilance to be the EMEA’s contact within that organisation.

Responsible Contact for Pharmacovigilance

The Responsible Contact for Pharmacovigilance in a Pharmaceutical Company is the person responsible for pharmacovigilance as defined in Community legislation1. In a national Competent Authority it is the Head of the Pharmacovigilance department.

1 Directive 2001/82/EC, Art 74

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The role of the responsible contact for pharmacovigilance in the EudraVigilance Veterinary registration process is to register the Headquarter of a Pharmaceutical Company or a national Competent Authority, to register the affiliate(s) or regional pharmacovigilance centres, if applicable, and to register individual users within the organisation including the affiliates or regional centres, if applicable.

The contact details for this person include address, telephone, fax number, and e-mail. It is essential to provide an email address for the responsible contact for pharmacovigilance. Please note that for the e-mail address no generic entries such as ‘[email protected]’ or ‘[email protected]’ are accepted.

Registration Form Phase I Step 3 – Transmission Mode

You will be given the choice of sending your electronic messages directly (via the Gateway or EVWEB). If you are planning to use a third party to send your messages, you need to provide the details of that third party here.

Access Rights for Affiliates/Regional Pharmacovigilance Centres

The Headquarter of a Pharmaceutical Company or the national Competent Authority can choose to allow its affiliate(s)/regional centre(s) to be able to view the ADRs that have been submitted by the Headquarter/national Competent Authority to the EudraVigilance Veterinary DBMS. The appropriate option must be selected.

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Third Party Service Provider

If a Pharmaceutical Company or national Competent Authority chooses to use a third party service provider, that third party will be responsible to undertake the operation of the electronic data interchange (EDI) in accordance with the terms and conditions of the Interchange Agreement on behalf of the pharmaceutical company. In this instance the ‘Third Party’ section in the form needs to be completed. The transmission mode that the third party will be using also needs to be selected.

Registration Form Phase I Step 4 – Security Information

Step 4 is required for security purposes. The requested IP addresses / numbers are public IP numbers used by an organisation to access the internet.

Specifying a single public IP number means that all the computers within the registering organisation will be able to access EudraVigilance Veterinary.

It is allowed to specify up to 3 public IP numbers to provide those organisations with more than one public IP number access to EudraVigilance Veterinary without interferences. Ask your network administrator for the required information.

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Registration Form Phase I Step 5 – Review, Print and Submit

This last step allows you to review and print the information before proceeding with the submission of your organisation registration information to EudraVigilance Veterinary. In case of any errors, you are able to go back to the completed forms and modify any data that 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 refer to the section “Documentation required” (see Section 3) to finalise the registration process by sending the complete documentation to the EudraVigilance Veterinary Contact Person (contact details in Annex I). Your submission will be assessed and, if accepted, the responsible contact for pharmacovigilance identified by you will receive an unique user name and password to enter the EudraVigilance Veterinary system.

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Registration Form Phase II – Affiliate/Subordinate Step 1 – Affiliate/Subordinate Information

The contact responsible for pharmacovigilance of a pharmaceutical company or a national Competent Authority can now register affiliates, pharmacovigilance centers and individual users. If your organisation does not have any affiliates and you want to register individual users, please skip this phase and refer to Section “Registration Form Phase III”.

You must first enter the restricted area of the system via the ‘Login’ link on the EudraVigilance Veterinary homepage http://eudravigilance.emea.eu.int/veterinary/. You will be asked to enter your username and password. Go to <Manage your profile> and EudraVigilance Veterinary will recognise your identity from your login details and will grant you access to your organisation details.

Clicking on the ‘add new affiliate/regional centre’ button in the left-hand side navigation area will start the second phase of the registration process. Please note that affiliates/regional pharmacovigilance centers will not be able to register themselves. The responsible contact for pharmacovigilance at Headquarter/Competent Authority level will be the only person able to add new users to the EudraVigilance Veterinary system.

You will be asked to enter the Affiliate Identifier (ID), name and address.

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Affiliate Identifier (ID)

Please specify a unique Affiliate ID for each affiliate that you register. The ID must comprise between 3 and 10 characters, and should consist of upper case letters (A to Z) and/or numbers (0 to 9), not using spaces or special characters. For easy recognition of the Organisation and the Member State where it is located, it is further recommended to start the Organisation ID with the two-letter country code according to ISO.

Each Affiliate must have two different IDs: one for the EudraVigilance Veterinary test environment and one for the EudraVigilance Veterinary production environment.

Affiliate Name

The Affiliate Name should be the full and precise name of the Pharmaceutical Company’s affiliate. The exact address should be also specified.

Registration Form Phase II – Affiliate/Subordinate Step 2 – Responsible Contact for Pharmacovigilance for an Affiliate

The Responsible Contact for Pharmacovigilance for an affiliate is the person responsible for pharmacovigilance nominated for this affiliate. The form and its field requirements are identical to the one in Phase I Step 2 – the address, direct telephone number, fax number and e-mail address should be provided. Please note that for the e-mail address no generic entries such as ‘[email protected]’ or ‘[email protected]’ are accepted.

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Registration Form Phase II – Affiliate/Subordinate Step 3 – Transmission mode

A new form will be presented to you. You will be asked to choose the transmission mode by which the affiliate will be sending the reports to EudraVigilance Veterinary. Three options are presented:

− Send via Headquarter: If the Pharmaceutical Company has decided that the headquarter undertakes the operation of the electronic data interchange (EDI) on behalf of the affiliate(s), this section should be selected.

− Send directly via: If your organisation has decided that the operation of EDI processes is carried out at Affliliate/Subordinate level, you have to indicate the transmission mode that the Affiliate/Subordinate is going to use:

o Local Gateway; if your Affiliates/Subordinates plan to perform your EDI transmissions using your own local Gateway solution

o WEBtrader; if your Affiliates/Subordinates plan to perform your transmissions using the Webtrader component of EVWEB

− Third Party Service Provider: If your Affiliate/Subordinate chooses 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 also be completed. The transmission mode that the third party service provider will be using, i. e. either the local Gateway or the WEB Trader must also be indicated.

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Registration Form Phase II – Affiliate/Subordinate Step 4 – Security information

This step corresponds to Step 4 of Phase I. Please enter up to 3 public IP numbers for the Affiliate/Subordinate to enable them to access EudraVigilance Veterinary. Contact your network administrator for the required information.

Registration Form Phase II – Affiliate/Subordinate Step 5 – Review, Print and Submit

This step corresponds to Step 5 of Phase I. Please send the documentation identified in Section: Documentation required to the contact person for EudraVigilance Veterinary (contact details in Annex I) to finalise the registration process for your affiliate. After validation, the person responsible for pharmacovigilance at affiliate level will then receive their unique user name and password to access EudraVigilance Veterinary.

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Registration Form Phase II – Pharmacovigilance Centre Step 1 – Pharmacovigilance Centre Information

If your organisation does not have regional pharmacovigilance centres, you can skip this Phase. You can still register individual users (see Phase III).

As in the case of the affiliate registration, you will be asked to enter the regional centre Identifier, name and address.

Regional Pharmacovigilance Centre Identifier (ID)

Please specify a unique Regional Pharmacovigilance Centre ID for each centre that you register. The ID must comprise between 3 and 10 characters, and should consist of upper case letters (A to Z) and/or numbers (0 to 9), not using spaces or special characters. For easy recognition of the Organisation and the Member State where it is located, it is further recommended to start the Organisation ID with the two-letter country code according to ISO.

Each Regional Pharmacovigilance Centre must have two different IDs: one for the EudraVigilance Veterinary test environment and one for the EudraVigilance Veterinary production environment.

Regional Pharmacovigilance Centre Name

The Regional Pharmacovigilance Centre Name should be the full and precise name of the Pharmaceutical Company’s Regional Pharmacovigilance Centre. The exact address should be also specified.

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Registration Form Phase II – Pharmacovigilance Centre Step 2 – Responsible Person for Pharmacovigilance at Regional Pharmacovigilance Centre level

The form and its field requirements are identical to the one in Phase I Step 2 – the address, direct telephone number, fax number and e-mail address should be provided. Please note that for the e-mail address no generic entries such as ‘[email protected]’ or ‘[email protected]’ are accepted.

Registration Form Phase II – Pharmacovigilance Centre Step 3 – Transmission mode

This form and its field requirements correspond to the one in Phase II Step 3 for the registration of affiliates/subordinates.

You will be asked to choose the transmission mode by which the affiliate will be sending the reports to EudraVigilance Veterinary. Three options are presented:

− Send via Headquarter: If the Pharmaceutical Company has decided that the headquarter undertakes the operation of the electronic data interchange (EDI) on behalf of the regional pharmacovigilance centre, this section should be selected.

− Send directly via: If your organisation has decided that the operation of EDI processes is carried out at regional pharmacovigilance centre level, you have to indicate the transmission mode that the centre is going to use:

o Local Gateway; if the centre plans to perform your EDI transmissions using your own local Gateway solution

o WEBtrader; if the centre plans to perform your transmissions using the Webtrader component of EVWEB

− Third Party Service Provider: If your regional pharmacovigilance centre chooses 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 also be completed. The transmission mode that the third party service provider will be using, i. e. either the local Gateway or the WEB Trader must also be indicated.

Registration Form Phase II – Pharmacovigilance Centre Step 4 – Security information

This step corresponds to Step 4 of Phase I. Please enter up to 3 public IP numbers for the regional pharmacovigilance centre to enable them to access EudraVigilance Veterinary. Contact your network administrator for the required information.

Registration Form Phase II – Pharmacovigilance Centre Step 5 – Review, Print and Submit

This step corresponds to Step 5 of Phase I. Please send the documentation identified in Section: Documents required to the contact person for Eudravigilance Veterinary (contact details in Annex I) to finalise the registration process for your pharmacovigilance centre. After validation, the person responsible for pharmacovigilance at pharmacovigilance centre level will then receive their unique user name and password to access EudraVigilance Veterinary.

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Registration Form Phase III – Individual Users Step 1

The contact responsible for pharmacovigilance of a pharmaceutical company or a national Competent Authority can also register individual users.

You must first enter the restricted area of the system via the ‘Login’ link on the EudraVigilance Veterinary homepage http://eudravigilance.emea.eu.int/veterinary/. You will be asked to enter your username and password. Go to <Manage your profile> and EudraVigilance Veterinary will recognise your identity from your login details and will grant you access to your organisation details.

Clicking on the ‘add new user’ button in the left-hand side navigation aea will start this phase of the registration process.

The individual user registration form requires the name and contact details for the new user.

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Individual User Name & Contact Details

The contact details for this person including address, telephone, fax number and e-mail must be specified. Please note that for the e-mail address no generic entries such as ‘[email protected]’ or ‘[email protected]’ are accepted.

You will also be asked to specify the user rights for each new user. For further information please refer to Section: User Rights in the Overview chapter.

Please print the form and submit it. Please send the documentation identified in Section: Documents required to the contact person for Eudravigilance Veterinary (contact details in Annex I) to finalise the registration process for the new user. After validation, the new user will receive their unique user name and password to access EudraVigilance Veterinary.

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D o c u m e n ts r e q u i r e d f o r r e g i s t r a t i o n

To successfully complete the registration process you need to post several documents to the EMEA. Among those are the printed forms obtained during the electronic registration.

Documents required for every registration: − A cover letter:

o For registering the pharmacovigilance responsible person (main user): indicating that this person is the pharmacovigilance responsible person, signed by the Head of Pharmacovigilance at Headquarter level

o For registering a further user/affiliate: requesting registration of that person/affiliate, signed by pharmacovigilance responsible person (main user)

− A printed copy of the completed online registration form. This form should be

signed and dated by the responsible person for pharmacovigilance of the Headquarters of the Pharmaceutical Company, and the following declaration should be hand-written at the bottom: “The undersigned party declares that the information provided in this form is accurate and correct”.

− A dated and signed user password security declaration form. This form is to

be signed by the actual person registered in the process (new user or pharmacovigilance responsible person). You can download the template for the User Password Security declaration form on our website http://eudravigilance.emea.eu.int/veterinary/docs/EudraVigilance Veterinary User Password Security Declaration.doc or use the template in Annex II.

− A signed and dated copy of the ID card/drivers license or passport of the person to be registered. This is refering to the actual person to be registered. This information is used to verify the identity of the registered person. If will be treated confidentially and will not be published or included in any user list.

Additionally for the person to be registered as the person responsible for pharmacovigilance: − A dated and signed user access security declaration form. You can download

the template for the Access Security declaration form on our website http://eudravigilance.emea.eu.int/veterinary/docs/EudraVigilance Veterinary Access Security Declaration.doc or use the template in Annex II.

Additionally for registrations of pharmaceutical companies: − A certified copy of the Trade Register. Document which proves that the

company has been registered in the Member State in which it has its registered office, according to the law of the respective Member State.

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D e l e g a t i o n o f R e g i s t r a t i o n P r o c e s s

The person responsible for pharmacovigilance at headquarter level can delegate the functions related to the registration of new users with EudraVigilance Veterinary to a trusted “Deputy” within the same organisation.

The person responsible for pharmacovigilance at headquarter level should register the trusted “Deputy” with EudraVigilance Veterinary as an individual user (see section on Phase III of Registration process). The delegation and the registration of a deputy can be performed simultaneously.

In addition to the usual documents required for the registration of the new user (see section on required documentation), the person responsible for pharmacovigilance should then send the following documents to the EudraVigilance Veterinary team (contact details in Annex I):

− A cover letter indicating that he/she wishes to delegate the functions related to EudraVigilance Veterinary Registrations of individual users and/or affiliates in the organisation to the named trusted Deputy.

− A completed EudraVigilance Veterinary Registration Delegation Form, which is available for download on the website http://eudravigilance.emea.eu.int/veterinary/docs/EudraVigilance Veterinary Delegation Declaration.doc and in Annex II of this document.

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A n n e x I : C o n t a c t d e ta i l s f o r s u b m i s s i o n

The complete documentation should be sent by registered postal mail or courier service to

European Medicines Agency (EMEA) Attn. Jos Olaerts 7, Westferry Circus Canary Wharf London E14 4HB United Kingdom

If you have questions regarding the registration process, please contact us via the helpdesk on the EudraVigilance Veterinary webpage http://eudravigilance.emea.eu.int/veterinary/ or by sending an email directly to [email protected].

You can also contact us directly by tel +44 (0) 207 418 86 24.

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A n n e x I I : F o r m s

EudraVigilance Veterinary User Password Security Declaration

The undersigned user declares that he/she will

− Keep the password provided by the EMEA for the access to EudraVigilance Veterinary a secret, remember the password and destroy the e-mail/slip on which it is printed; not write the password down in any way that it could be understood by anyone else; never tell anyone the password or allow anyone else to use it. If it happens, the user is responsible for any security breaches that may occur to the data stored with EudraVigilance Veterinary;

− Inform the EMEA immediately if the user suspects that anyone knows the password. The EMEA administrators can be contacted during normal office hours. In such case, the user must request a new password immediately from the EMEA;

− Inform the EMEA immediately in writing about any changes in their contact details as specified in the user registration form;

− Inform the EMEA immediately in writing about any changes of their access rights (e. g. end of employment with the registered organisation, change of department within the registered organisation, etc.)

Access to EudraVigilance Veterinary will be denied if the user enters the incorrect password in the login process of EudraVigilance Veterinary three times in a row on the same day.

The EMEA can refuse the registration of a user for any valid reason.

Organisation:

Address:

Postcode:

City:

Country:

User Name:

User Telephone Number:

User Fax number:

User E-mail address:

Date:

Signature:

EudraVigilance Veterinary Access Security Declaration1

The undersigned party declares that it will inform the EMEA immediately in writing about any changes affecting the access rights (e. g. end of employment with the registered organisation, change of department within the registered organisation, etc.) of any registered EudraVigilance Veterinary users of the organisation as indicated below.

Organisation:

Address:

Postcode:

City:

Country:

User Name:


User Fax number:


Date:

Signature:

1 To be completed, signed and submitted by Responsible Person for Pharmacovigilance, when registering a new organisation.

EudraVigilance Veterinary Delegation Declaration

The Qualified Person Responsible for Pharmacovigilance / Responsible Person for EudraVigilance Veterinary declares that he/she will delegate the registration functions for EudraVigilance Veterinary to the person indicated below. The roles and responsibilities signed in the User Declaration form and the Change of User Status Declaration form remain unaffected.

Name:

E-mail address:

Organisation:

Address:

Postcode:

City:

Country:

User Name:


User Fax number:


Date:

Signature:

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