rec_45
(45) In order to ensure appropriate market surveillance by Member States, it is necessary that manufacturers, importers and distributors operate an appropriate system for monitoring and recording suspected adverse effects and inform the competent authorities about such effects so that appropriate action can be taken. It is warranted to provide for a safeguard clause that would allow Member States to take action to address serious risks to public health.
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Source: EUR-Lex (Cellar) · retrieved 2026-11-06 · Text as adopted (Official Journal); later amendments are not incorporated in this text.