Regulatory information - European Medicines Agency introduces digital signatures for selected procedures

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01/08/2013

Regulatory information - European Medicines Agency introduces digital signatures for selected procedures

From September 2013, the European Medicines Agency (EMA) will start to use digital signatures systematically in outgoing documents that currently require a legally binding signature. This will start with documents related to scientific advice for human medicines, to orphan medicines and to paediatric-medicine procedures.

The Agency will also provide certified PDF electronic application forms to allow companies to sign these forms digitally using a PDF reader application, if they wish to do so.

The steps to verify the digital signature of documents issued by the Agency and to send a digitally signed document to the Agency are described in EMA eSignature capabilities: frequently asked questions relating to practical and technical aspects of the implementation, which is available on the Agency’s eSubmission website under eSignatures.

This initiative is part of the Agency’s strategy to increase electronic-document-only exchanges between the Agency and the pharmaceutical industry.

The Agency expects the exchange of digitally signed electronic documents to increase the efficiency of procedures and eliminate the need to archive paper documents. It may also bring about cost savings for companies, by removing the need to print documentation and reducing courier charges.

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