Enhance Quality Assurance in European Union with Electronic Signature Legitimacy

How to eSign a document: electronic signature legitimacy for Quality Assurance in European Union

this short video aims to present how to check the authenticity of a received electronic certificate for human and veterinary medicines issued by the european medicines agency as a reminder since 30th of march 2020 the agency is no longer issuing certificates in paper format but only electronic certificates the format of the electronic certificate is based on an electronically signed pdf document using an electronic signature fully compliant with a high standard set by the european legislation on electronic identification and trust services for electronic transactions electronic certificates follow the same format layouts and contain the same information as printed certificates the certificates are issued in english spanish and french or in portuguese the certificate itself is followed by explanatory notes in the relevant language and annexes that can include the composition and the product information each electronic certificate contains a unique certificate number and request number in the upper right corner of the document as well as the agency's corporate identity features as a watermark in the lower right corner of certain pages to assure the authenticity and integrity of ema electronic certificates each certificate contains an advanced electronic signature from a trusted provider fully compliant with the european regulation the advanced electronic signature meets the following requirements it is uniquely linked to the signatory it is capable of identifying the signatory it is created under the signatory sole control and it is linked to the data signed in such a way that any subsequent change in the data is detectable finally by certifying the pdf file the electronic certificates are being locked down to detect unauthorized manipulation how does an electronic certificate with a valid signature look like first when opening the signed electronic certificate a signature panel ribbon will appear at the top of the document with the message signed and all signatures are valid clicking on the electronic signature itself a pop-up window will appear confirming that the signature is valid it states the name and email address of the signing person that the document has not been modified since it was signed and that the signer's identity is valid when clicking on the signature properties button a pop-up window will confirm that the signature included an embedded timestamp that the signature was validated and that a path from the signer's certificate to the issuer certificate was successfully established this window also confirms the validity of the signer certificate finally the agency provides additional measures to support the authenticity of electronic certificates along with the electronic certificates in each request a signed letter is attached from the executive director of the european medicine agency detailing all authorized signatories the electronic certificates can only be electronically signed by one of the authorized members in the letter on the other hand how does a non-valid electronic certificate with a signature from an untrusted source look like when opening a signed electronic certificate a signature panel ribbon will appear at the top of the document with the message at least one signature has problems clicking on the electronic signature itself a pop-up window will appear alerting that the validity of the signature is unknown in case of any doubt on the authenticity or integrity of electronic certificates issued by ema regulatory authorities of importing countries marketing authorization holders or any interested party can verify their authenticity in the verification system published on ema website this online verification system can be used as an alternative to document legalization in importing countries that still have this requirement to do so you must go in the human regulatory tab on the ema website and select post authorization then under the section certifying medicinal products you can access the online verification tool by clicking on authenticity verification for electronic certificates upon inclusion of the unique numbers for the certificate and the request located in the upper right corner of the document as previously seen the online verification tool will confirm its validity and display some details of the certificate all information on the certification of medicinal products is available on ema's website if there are still questions about authenticity of electronic certificates health authorities can send an email directly to ema to certificate at ema.europa.eu to request for the confirmation of validity of electronic certificates thank you for watching this video