Documents Required for Eudravigilance Veterinary Registration

CHECK LIST BEFORE SUBMITING DOCUMENTS FOR

EUDRAVIGILANCE VETERINARY REGISTRATION

Documents required for registration of pharmaceutical companies at headquarter level:

A cover letter, signed by the Head of Pharmacovigilance at Headquarter level, indicating that this person is the Pharmacovigilance Responsible Person (main user)

A printed copy of the completed online registration form, Test Environment and /or Production Environment (as applicable). 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, signed by the Pharmacovigilance Responsible Person

A signed and dated copy of the ID card or driver’s license or passport of the Pharmacovigilance Responsible Person

A dated and signed user access security declaration form, signed by thePharmacovigilance Responsible Person

A certified copy of the Trade Register, which proves that the company has been registered in the MemberState in which it has its registered office, according to the law of the respective MemberState.

Documents required for registration of Affiliates / Regional PharmacoVigilance Centres:

A cover letter, signed by the Head of Pharmacovigilance at Headquarter level or by the Trusted Deputy,requesting registration of that affiliate / PharmacoVigilance Centre

A printed copy of the completed online registration form, Test Environment and /or Production (as applicable). This form should be signed and dated by the Responsible Person for Pharmacovigilance of the Headquarters of the Pharmaceutical Company or by the Trusted Deputy

A dated and signed user password security declaration form, signed by the actual person registered in the process

A signed and dated copy of the ID card or driver’s license or passport of the actual person to be registered as Responsible Person for Pharmacovigilance at affiliate level

Documents required for registration of IndividualUsers:

The Responsible Person for Pharmacovigilance or the Trusted Deputy should complete and submit the online individual user registration form in the Test Environment and/or Production Environment under the organisation’s headquarter registration.

The Responsible Person for Pharmacovigilance or the Trusted Deputy should then request to complete the registration of user, by letter or by email,specifying:

• the organisation name and ID
• the Testing Environment and/or Production Environment in the which the user should be registered
• the complete name of the user

Documents required for registration of a Trusted Deputy:

N.B: The Trusted deputy needs to be registered first as an individual user.

A cover letter, signed by the Head of Pharmacovigilance at Headquarter level, indicating that this person wishes to delegate the registration of affiliates/pharmacovigilance centres and/or individual users to a person other than the person registered as Responsible for Pharmacovigilance (main user)

A dated and signed delegation declaration form, signed by the Person Responsible for Pharmacovigilance.

Completed documentation should be sent by registered postal mail or courier service to:

European Medicines Agency (EMEA)
Attn. EudraVigilance Registration Team
7, WestferryCircus
CanaryWharf
London
E14 4HB
United Kingdom