Exalon: Glossary

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Envelope
The “eu-envelope” element is designed to be used for all types of submissions (initial, variations, renewals, etc.) for a given medicinal product and will mainly be used for the first simple processing at the agency level. The envelope provides meta-data at the submission level. The elements of the "eu-envelope" are defined in the EU Module 1 specification. The “eu-envelope” element should contain a separate “envelope” element for each Member State involved in the procedure that is going to receive that particular eCTD sequence, and each envelope country attribute should be set to the country value of the receiving Member State. For Centralised Procedure submissions, the “eu-envelope” element should contain a single “envelope “element with the country attribute value set to ‘emea’.



See also: eCTD

eCTD Glossary