EMA Prefers Electronic Certificate Provision Over Printed Copies

With the prevailing COVID-19 pandemic, the Regulatory bodies are propelled to take quick and flexible Regulatory actions. Accordingly, EMA has called for a new system of issuing electronic certificates for human and veterinary medicines. Proposedly, the Agency will no longer provide printed certificates, but only the electronically signed and authenticated certificates. The EMA’s certification scheme is issued on behalf of the European Commission.

The new certificate format is applicable to all ongoing and future requests and it is based on an electronically signed PDF document. It is said to be fully compliant with the electronic identification and trust services (eIDAS) Regulation (Regulation (EU) No 910/2014). The regulation guarantees the unique link to the signatory and the full authenticity and integrity of the document. The Agency provides certification to products authorized by the Commission through the centralized procedure for which a scientific opinion has been granted by the CHMP.

EMA issues certificates within ten working days (standard procedure) or two working days (urgent procedure) following receipt of a valid application form. Upon request, the Agency can provide printed copies of the certificates, but with the current stringent COVID-19 measures implemented, it is not possible to dispatch the printable. As a part of the Agency’s efforts to digitalize its administrative processes for all documents requiring signature, it is expected that the Agency will consider whether the electronic signature should be implemented as a permanent solution or not.

As with the COVID-19, health authorities worldwide are quickly adapting to new measures to help the applicants streamline their market entry processes. It is important for applicants to keep abreast of all of the evolving regulations and pathways, as they are being devised. Stay informed. Stay compliant.