Notification of Sponsor S 'Legal Representative'

30 March 2016 EMA/99667/2016 Information Management

EudraVigilance Form B Notification of sponsor’s 'legal representative'

I, the undersigned person

Full name: confirm that I am authorised to act on behalf of the sponsor:

1 Sponsor :

2 Address :

Postcode:

Non-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 the appointment of the following person/organisation as the sponsor’s legal representative as defined in Article 19 of Directive 2001/20/EC:

Name of organisation acting as legal representative:

Full name of person representing organisation:

Full name of the legal representative:

3 Address :

Postcode:

Country:

1 This should match the information provided in section B.1 of the Clinical Trial Application provided as part of the registration. 2 This should be the address of the sponsor located outside of the European Economic Area (EEA) that is required to have a legal representative in the EEA. If the sponsor is located in the EEA then this form should not be completed, in such cases only Form A should be provided. 3 This should match the information provided in section B.2 of the Clinical Trial Application included with the registration.

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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 B EMA/99667/2016 Page 2/2