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  • On 01 January 2019 the new SWISSmedic update 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.

Correction in eCTD Validation Criteria:

  • 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 should be foart13.

Correction in Swiss M1 Specification:

  • 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.

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