Changes to the Guidance Document Variations TAM HMV4

4 November 2022 – Swissmedic announced an extended reporting time limit of 60 days that applies to variations without assessment.

The reporting time limit for variations without assessment has been extended at the request of marketing authorization holders: instead of the previous 30 days, a reporting time limit of 60 days now applies.

The revised Guidance document Variations TAM HMV4 is valid with effect from 1 November 2022.

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