Abstract
In 1990, F. Hoffman-LaRoche used the multi-state procedure for moclobemide, with Denmark as rapporteur. Our experience demonstrated the importance of planning. We developed a custom focused document in reply to questions, which enabled the authorities to evaluate answers easily, and made reference documents available, but not part of the main answers. From our experience, we've seen a trend toward harmonization of the summary of product characteristics and noted the importance of the efficacy working party in facilitating harmonization and shortening approval time.
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