The undersigned Qualified person responsible for pharmacovigilance (QPPV)/responsible person (RP) declares that he/she:
• will keep the username and password provided by the European Medicines Agency (EMA) for the access to the EudraVigilance database under an adequate regime of security measures; access to the EudraVigilance database refers to access using the EudraVigilance Data Analysis System (EVDAS) and/or the EudraVigilance web application (EVWEB);
• may propose third parties within his/her organisation to have access to the EudraVigilance database for the purpose of pharmacovigilance activities; to that effect, the undersigned must take responsibility to verify the identity of the authorised third parties and communicate their contact details to the responsible EMA Service;
• is responsible for the access and use of the EudraVigilance database system made by the authorised users within his/her organisation;
• remains strictly responsible for any unlawful use or security breaches that may occur to the data stored with EudraVigilance as a result of his/her negligence or the negligence of the authorised third parties within his/her organisation;
• will inform the EMA immediately of any potential compromise to the integrity and confidentiality of password details and other logical security. EMA administrators can be contacted during normal office hours. In such case, the compromised password will be disabled immediately;
• will inform the EMA immediately in writing of any changes in his/her contact details as specified in the online user registration form;
• will inform the EMA 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 user in relation to the organisation as indicated
below;
• will inform the EMA immediately in writing about any changes of his/her access rights (e.g. end of employment with the registered organisation, change of department within the registered organisation, etc.).