CH: Swissmedic adapts national variation legislation document to incorporate eCTD requirements

The Swiss Drug Regulatory Agency Swissmedic has adapted their national variation legislation guide "Verwaltungsverordnung Anleitung Meldepflichtige Änderung" to incorporate the respective requirements for submissions in eCTD format. The document details the requirements to be followed for the submission of variations requiring notification / authorization (human medicinal products).

Respective changes have been introduced in chapter 5.

For the submission of variations in eCTD format the following eCTD-specific requirements have been included:

• For each submission of a variation the form "Meldepflichtige Änderungen" must be completed and signed with a legally valid signature. The original version of the completed form must be submitted together with the eCTD sequence
• The eCTD sequence must be provided in 2 electronic copies
• If the variation affects several individual medicinal products, the documentation must be provided individually in eCTD format for each product

The document is legally binding and is currently available in German and French language only from the Swissmedic website.

[Source: Swissmedic website]

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