The pharmaceutical regulatory environment in Europe has changed dramatically over the past two decades with the establishment of the European Economic Area Agreement and the European Union. The Community has instituted a progressive programme of harmonising medicines legislation with the objective of creating a genuine single market in the pharmaceutical sector, while ensuring a high level of public health protection. This article analyses the Community referral procedures for medicinal products for human use that are used to resolve disagreements between member states. The results are used not only to identify opportunities for improvement in the referral process but also to indicate to the applicant possible improvements in registration strategy.
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