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Swiss Module 1 Specification for ECTD Version 1.3Swiss Module 1 Specification for ECTD Authors:Lead: Ralph Maier, Swiss medic Review team Swiss medic Review team InterpharmaResponsible:Submissions

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What is swiss module 1 specification?

Swiss module 1 specification is a document that contains detailed information about a medicinal product.

Who is required to file swiss module 1 specification?

Marketing authorization holders are required to file swiss module 1 specification.

How to fill out swiss module 1 specification?

Swiss module 1 specification can be filled out electronically using the Swissmedic eSubmissions portal.

What is the purpose of swiss module 1 specification?

The purpose of swiss module 1 specification is to provide comprehensive information about a medicinal product to Swissmedic for evaluation and approval.

What information must be reported on swiss module 1 specification?

Information such as product name, manufacturing process, composition, stability data, and quality control measures must be reported on swiss module 1 specification.

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