EMA to issue electronic certificates for medicines

News 30/03/2020

EMA has implemented a new system to issue electronic certificates for human and veterinary medicines. As of today, the Agency will no longer provide printed certificates but only electronically signed and authenticated certificates to maintain EMA’s ability to provide these documents during the COVID-19 pandemic.

EMA issues certificates on behalf of the European Commission to confirm the marketing authorisation status of products either authorised by the Commission through the centralised procedure or medicinal products for which a scientific opinion pursuant to Article 58 of Regulation 726/2004/EC has been granted by the CHMP.

The new format of the certificates is based on an electronically signed PDF document. It contains an electronic signature fully compliant with the eIDAS 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 signature.

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

Questions on the new electronic certificates can be sent by email to: certificate@ema.europa.eu. More information on the certification of medicinal products is available on EMA’s website.

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