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Registering A List B New Chemical Entity via the Concertation Procedure: A Case History

Marion Merrell Dow's (MMD) one experience with the concertation procedure was for a product that did not automatically qualify for the concertation procedure, that is, it is not a List A product but a new chemical entity which met one of the List B criteria. The following aspects are covered: a brief background on the product; why this route was chosen and what was involved in obtaining the List B status; the timetable of events; some of the general issues that arose during the procedure; and finally, some rather limited conclusions from this one experience.