- On 01 January 2019 the new Swiss Module 1 Specification for eCTD v1.4 is implemented.
- Both versions (v1.3 and v1.4) will be valid for a half-year period from 01 January 2019 to 30 June 2019.
- As from 01 July 2019 the Swiss Module 1 Specification for eCTD v1.4 must be used for all eCTD submissions.
- Note, due to minor errors in the eCTD M1 Specification and the corresponding eCTD Validation Criteria SWISSmedic updated both the guidelines but the version number 1.4 will be retained.
- The folder name 151-infoaccordappIVguidelinebioequivalence is incorrect and should be 151 infoaccordappivguidelinebioequivalence. IV was wrongly capitalised.
- Incorrect entry in the file folder structure and names. There are differences between the M1 Specification and the Validation Criteria. The fixed component of 1.2.2.20 should be foart13.
- The notation of the new elements in Section 1.12 was incorrect and agency brought into line with the correct notation in the DTD.
- Section 1.8.2 Risk management system, the hyphen (-) was missing between Risk Management and has been reinserted (Risk-Management).
- The hyphen (–) in Section 1.2.1 is different to that in Section 1.2.2 (-). This correction has been noted for the future version 1.5.
- For Section 1.2.2, no fixed component of filename (foadd) and no life cycle operator (New) are necessary.
- In line with HMV4, application types pi and eas are no longer necessary and will be deleted.