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European Commision: Recommendation on “Pharmacovigilance Urgent Measures” procedure under Article 107 of Directive 2001/83/EC

16.02.2009
European Commision:
Recommendation on “Pharmacovigilance Urgent Measures”
procedure under Article 107 of Directive 2001/83/EC. Where, as a result of the evaluation of pharmacovigilance data, a Member State considers that a Marketing Authorisation should be suspended, revoked or varied in accordance with the guidelines referred to in Article 106(1), it shall forthwith inform the Agency, the other Member States and the Marketing Authorisation Holder.