Organisations should make sure that adequate business continuity processes and back-up systems are in place to deal with system failures. This will ensure that any system failures can be resolved within a short period of time and submissions made in a timely manner.

In case of a system failure of the Union Product Database requiring resolution by EMA, the organisation will be considered compliant with any submission deadlines if they submit as soon as possible after the Union Product Database becomes available again.

For example, marketing authorisation holders have 30 days after implementing a relevant change to submit a variation not requiring assessment into the Union Product Database. Should the system not be accessible on the day an organisation wishes to submit a variation not requiring assessment, they should submit within 2 business days after the system becomes available again.