lexiara

art_46__para_4__text_1

The manufacturer shall inform without delay the approval authority that gave the authorisation of any change affecting the conditions under which it was issued. That approval authority shall decide whether the authorisation has to be reviewed or reissued and whether further tests are necessary.

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Source: EUR-Lex (Cellar) · retrieved 2026-10-12 · Text as adopted (Official Journal); later amendments are not incorporated in this text.