Abstract
By the time the concertation procedure became operable in July 1987, Genotropin® was already involved in registration procedures in most EC countries. However, Kabi Pharmacia was able to use the concertation procedure for variations of Genotropin®, with Denmark as rapporteur. Our experience highlights the importance of the rapporteur. Our rapporteur, together with the Member State authorities and the CPMP, worked hard to meet the deadlines. However, national approval times after the. CPMP opinion need to be improved.
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