Thursday, 3 June 2021

Format and validity features of electronic certificates for medicines


 

The European Medicines Agency has issued new guidance, titled “Information note on the format and validity features of electronic certificates for medicines issued by the European Medicines Agency.”

The change is the introduction of an advanced electronic signature that will meet the following requirements: “it is uniquely linked to the signatory; it is capable of identifying the signatory; it is created using electronic signature creation data that the signatory can, with a high level of confidence, use under his sole control; and it is linked to the data signed therewith in such a way that any subsequent change in the data is detectable. By certifying the PDF file, the electronic certificates are being “locked down” to detect unauthorised manipulation.”

 

 

To access, see: https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/information-note-format-validity-features-electronic-certificates-medicines-issued-european_en.pdf

 

 Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (http://www.pharmamicroresources.com/)

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