CH: Swissmedic updates eCTD checklist "Formal Control"

The Swiss Drug Regulatory Agency Swissmedic has released a new version of their national form "Checklist Formal Control". This new version has become necessary due the incorporation of changes introduced with the new version v.1.1 of the Swiss Module 1 eCTD specifications (see our related News Article).

The changes introduced consist of

• The Swiss specific forms "Confirmation Substances from GMO", "DMF for First Authorisation (and Variation)", and "Information on Product Quality (paragraph 13 TPA)" have now been attributed their own entry number (1.2.2.18 - 1.2.2.20 in Module 1 (these forms were previously listed under "1.2.2.99 Other forms").
• The document "Confirmation on GMP Conformity" is now listed under point "1.2.4.4 Annexes - Manufacturing" (previously under "Further information").

The new version of the "Checklist Formal Control" is available for download in MS Word format in English, German, and French language.

[Source: Swissmedic website]

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