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Documentation
The necessary information and regulations for eSubmissions to Swissmedic are provided in the following documents.
Information on the eSubmissions business process
The paper "Questions & Answers of Swissmedic eCTD Implementation" addresses frequent questions from industry on electronic-only submissions with eCTD.
Q&A v1.0 | Q&A v1.1 | |
| status | Applicable until June 30, 2010 | Applicable as of July 1, 2010 |
| document | view | view |
| changes to previous version | view |
The paper "Guidance for Industry on Providing Regulatory Information in eCTD Format" provides guidance for practical aspects related to eCTD submissions to Swissmedic.
Guidance v1.0 | Guidance v1.1 | |
| status | Applicable until June 30, 2010 | Applicable as of July 1, 2010 |
| document | view | view |
| changes to previous version | view |
Information on specifications for the eCTD format for eSubmission
The paper "Swiss Module 1 Specifications for eCTD" describes the requirements a valid Swiss Module 1 in eCTD format has to comply with.
CH M1 v1.0 | CH M1 v.1.0.1 | CH M1 v1.1 | |
| status | Withdrawn | Recommended until June 30, 2010 | Recommended as of July 1, 2010 |
| change protocol | view | view | |
| specification | view | view | |
| dtd | download | download | |
| stylesheet | download | download | |
| examples | download | download | |
| screenshots | download | download | |
| Implementation guidance | view | view | |
| checksums | view | view | |
Changes to previous version | view |
Before an eCTD submission is sent to Swissmedic, its technical validity must be checked. The findings of the validation check must be documented using the form Technical Validation eCTD. Completion of this form for eCTD submissions is mandatory from 1 July 2010 for all eCTD submission.
The following providers offer free-of-charge validation tools for the Swiss eCTD specification:
- EXTEDO GmbH (http://www.extedo.com/) Download link: http://www.extedo.com/register-for-downloads.html
- LORENZ Life Sciences (http://www.lorenz.cc/) Download link: www.lorenz.cc/swiss
(Please note that the use of a validation tool doesn't replace Swissmedic's internal check for technical correctness. Furthermore Swissmedic cannot be held responsible for guaranteeing that the information about technical correctness provided by the validation tools are fully compliant with the Swiss eCTD Validation Criteria.)
Information on the formal requirements for eCTD applications
For eCTD applications a special „check list formal control" has been prepared which has to be used for applications in eCTD format.
For applications for an authorisation of a product already approved abroad (Paragraph 13 TPA) Swissmedic carries out a pilot phase lasting from July until December 2010. Applicants who have signed up for the pilot phase are requested to compile the documentation according to the "Guidance on applications according to Paragraph 13 TPA for eCTD applications".
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