Contingency arrangements in case of failure or unavailability of the Union product database
Article 20
Open ↗1. The Agency shall ensure that in cases within its control the Union product database is not unavailable for periods longer than 3 working days. 2. In case of unavailability of the Union product database, the Agency shall ensure that a clear message to that effect is displayed to all users. 3. The Agency shall ensure that the data and documents stored in the Union product database are recoverable. 4. The Agency, in collaboration with the competent authorities and the Commission and in consultation with marketing authorisation holders, shall develop detailed contingency arrangements to be applied in cases of prolonged failure or unavailability of the Union product database or any of its components or functionalities for reasons outside the Agency’s control. 5. The detailed contingency arrangements shall describe the procedures to be followed to ensure continuity of the regulatory processes supported by the Union product database using appropriate alternative electronic means.