Experience of the Netherlands Regulatory Agency with EC Concertation Procedures

Abstract

The experience of the Dutch Medicines Evaluation Board as rapporteur in the concertation procedure has been a successful learning experience. We begin with informative discussions with the applicant in the presubmission phase, emphasizing close contact between the company and the authority experts. After the dossier is sent and objections come in from the Member States, we prepare a clear, consolidated list of objections. When the applicant replies, we make an assessment report on that reply. In most cases, agreement is reached on one single summary of product characteristics, and harmonization is achieved.