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02.02.2011
CH: Update - Swissmedic posts translated versions of the checklist "Formal Control Art13 TPA eCTD"
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In their last eCTD-relevant update from December last year (see related News article here), the Swiss Drug Regulatory Agency Swissmedic did release (amongst others) a specific checklist "Formal Control Art13 TPA eCTD" applicable for Applications acc. to article 13 of the Therapeutic Products Act (TPA) that are submitted using eCTD format.
Since then, the checklist was only available in German language. The recent post now complements the German version with the previously announced translations in English and French language.
[Source: Swissmedic website]
- Related News:
CH: Swissmedic updates eCTD guidance documents and eCTD-related forms - 04.12.2010 23:13
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