EMA eCPP apostille
& legalisation.
Need an electronically issued EMA Certificate of Pharmaceutical Product prepared for use abroad? Apostille Assist assesses the destination requirement and coordinates the required Dutch legalisation and apostille process.
EMA certificates are issued electronically.
Since March 2020, the European Medicines Agency has issued certificates for medicinal products electronically. These certificates are provided as digitally signed PDF documents rather than conventional paper originals.
The electronic signature is used to support verification of the authenticity and integrity of the EMA-issued document. This digital format is now the standard format used by EMA for certificates of medicinal products.
Some receiving authorities may still request an apostille.
Although the EMA certificate is issued electronically and can be authenticated digitally, authorities outside the European Union may still request additional legalisation or an apostille as part of their own regulatory procedure.
The exact requirement depends on the destination country, receiving authority and purpose of the submission. The requested wording should therefore be checked before processing begins.
One managed route for your EMA certificate.
Send us the original electronic EMA certificate and the destination requirement. We assess the document and coordinate the applicable Dutch legalisation and apostille process.
EMA-issued e-certificate
Submit the original digitally signed EMA PDF for assessment together with the destination country and intended use.
Certificate of Pharmaceutical Product
Electronic regulatory certificateDutch legalisation coordination
We assess and coordinate the required Dutch legalisation route for the EMA-issued certificate.
International delivery
The completed physical document can be delivered to your regulatory team, representative or receiving party abroad.
Already have the EMA eCPP?
You can submit the electronic certificate for an initial assessment. We only need a few details to determine the appropriate handling route.
Requirements depend on the receiving authority.
Pharmaceutical-document requirements can differ between countries and regulatory authorities. An apostille, additional legalisation or another form of authentication may be requested depending on the intended submission.
Apostille Assist does not assume that every EMA certificate follows the same route. The destination requirement is reviewed before processing begins.
Have an EMA eCPP that needs an apostille?
Send us the original electronic EMA certificate and the destination-country requirement. We will assess the document and confirm the available handling route.
