Information Management s1

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.

1 Sponsor :

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

3 Address :

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

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