Yesterday (16-January-2023) European Medicines Agency (EMA) released an udated guideline "Information note on the format and validity features of electronic certificates for medicines" and "EMA certificates of medicinal products - instructions on how to fill the application form".
In March 2020, EMA implemented a new system to issue electronically signed and authenticated certificates for human and veterinary medicines. Electronic certificates issued by EMA are electronically signed PDF documents that conform to the format recommended by the World Health Organization (WHO).
The purpose of this “Questions and Answers” document is to provide guidance on the format of the electronic certificates issued by EMA, the safety features ensuring their authenticity and integrity, and the agency’s measures to support the regulatory authorities of importing countries when they have questions about their validity.
In order to ensure its integrity and authenticity, 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 using electronic signature creation data that the signatory can, with a high level of confidence, use under his sole control;
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.
Guideline: EMA certificates of medicinal products - instructions on how to fill the application form
This form is intended for requesting EMA certificates of medicinal products only and aims to guide the applicants to complete the form, by point-by-point in these explanatory notes.
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