30 March 2016

EMA/99666/2016
Information Management

EudraVigilance Form A
Appointment of a 'responsible person for EudraVigilance' by a sponsor
organisation or an organisation acting as the legal representative

I, the undersigned person

Full name:         

confirm that I am (select one):

authorised to act on behalf of the sponsor based in the European Economic Area (EEA);

authorised to act on behalf of the legal representative of the sponsor based outside the EEA.

Sponsor1:      

Name of organisation acting as the legal representative 2 (if applicable):      

Address3:      

Postcode:      

EEA country:      

Telephone number:       Fax number:      

E-mail address:      

I hereby confirm on behalf of the sponsor of a clinical trial conducted in the Community as defined in
Article 2 of the Directive 2001/20/EC that the following person has been appointed as the single
'responsible person for EudraVigilance' of the above sponsor for all clinical trials conducted by the
sponsor in the EEA:

Full name (responsible person):      

Organisation:      

1
This should match the information provided in section B.1 of the Clinical Trial Application provided as part of the
registration.
2
If applicable, this should match the information provided in section B.2 of the Clinical Trial Application provided as part of
the registration.
3
The address should be provided for either the sponsor or in the situation where the sponsor is not located in the EEA the
address of the organisation acting as the legal representative in the EEA

30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom

Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5555
Send a question via our website www.ema.europa.eu/contact An agency of the European Union

© European Medicines Agency, 2021. Reproduction is authorised provided the source is acknowledged.
Address:      

Postcode:      

Country:      

Telephone number:       Fax number:      

E-mail address:      

Date:       Signature:      

Submitted personal data is processed in accordance with Regulation (EC) 45/2001 on the protection of
individuals with regard to the processing of personal data by the Community institutions and bodies
and on the free movement of such data. These personal data are required to manage the
EudraVigilance database, in accordance with art. 57(1) (j) of Regulation (EC) 726/2004, in order to
verify the identity of the users of the system and related pharmacovigilance activities. Your address,
including e-mail address, will be used to send you technical instructions and other pertinent
communications. They are processed by the European Medicines Agency and other national competent
authorities exclusively for the purpose for which they are collected. You are entitled to access, rectify
and block these data in accordance with the provisions of Regulation (EC) 45/2001. You may exercise
these rights by contacting the European Medicines Agency. You have also the right of recourse to the
European Data Protection Supervisor (www.edps.europa.eu) at any time.

EudraVigilance Form A
EMA/99666/2016 Page 2/2