CHAPTER IV

POST-MARKETING AUTHORISATION MEASURES
Section 5

Pharmacovigilance

Union pharmacovigilance database
Article 74
1
The Agency shall, in collaboration with Member States, establish and maintain a Union pharmacovigilance database for the reporting and recording of suspected adverse events referred to in Article 73(2) (the ‘pharmacovigilance database’), which shall also include the information on qualified person responsible for pharmacovigilance as referred to in Article 77(8), the reference numbers of the pharmacovigilance system master file, the results and outcomes of the signal management process and results of pharmacovigilance inspections in accordance with Article 126.
2
The pharmacovigilance database shall be interconnected with the product database referred to in Article 55.
3
The Agency shall, in collaboration with the Member States and the Commission, draw up the functional specifications for the pharmacovigilance database.
4
The Agency shall ensure that information reported is uploaded in the pharmacovigilance database and made accessible in accordance with Article 75.
5
The system of the pharmacovigilance database shall be established as a data-processing network allowing transmission of data between Member States, the Commission, the Agency and the marketing authorisation holders to ensure that in the event of an alert related to pharmacovigilance data, options for risk management and any appropriate measures can be considered as referred to in Articles 129, 130 and 134.