EMA to only issue electronic medicines certificates during COVID-19 pandemic

30 Mar 2020

The European Medicines Agency (EMA) said Monday it will only issue electronically signed and authenticated certificates for human and veterinary medicines in place of printed ones so it can continue to provide the documents during the COVID-19 pandemic.

The Agency also said it is considering whether to make the electronic signature a permanent solution to digitalise its administrative processes for all documents requiring a signature.

EMA to only issue electronic medicines certificates during COVID-19 pandemic

The new format of the certificates is based on an electronically signed PDF document. It contains an electronic signature fully compliant with the eIDAS (electronic identification and trust services) Regulation (Regulation (EU) No 910/2014) that guarantees the unique link to the signatory and the full authenticity and integrity of the document.

The new format will apply to all ongoing and future requests. The Agency will consider whether the electronic signature should be implemented as a permanent solution as part of its efforts to digitalise its administrative processes for all documents requiring a signature.

The EMA said while it will still be able to provide printed copies of the certificates upon request, due to the current measures implemented in the agency to limit the spread of COVID-19, it is currently not possible to print and dispatch printed certificates at its premises.

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