Member States

Article 20 requires the competent authorities of Member States to ensure that all relevant informa tion about suspected adverse reactions to centrally authorised products are brought to the attention of the Agency. Where the suspected adverse reactions are classified as serious, Article 23 requires the competent authorities to record and report them to the Agency and the marketing authorisation holder within 15 days. The Agency is then responsible for informing the competent authorities of the other Member States.

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