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This course, a Thomson Reuters Cortellis Regulatory Online Learning module, covers how to register a pharmaceutical using the centralized procedure. It details the products the procedure applies to and the steps that need to be considered in the pre-submission phase. Participants learn the administrative aspects of a submission and the procedural steps that need to be completed, from day 1 to day 210. The course concludes by reviewing the procedure’s decision-making process and the main post-authorization activities.

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Register a pharmaceutical using the centralized procedure

Who should attend?

Professionals and experts in the pharmaceutical, biotechnology, and medical device fields

Learning objectives

Participants who complete this course should be able to:

  • Identify the legal basis and scope of the centralised procedure
  • Describe the procedural and administrative aspects of a submission
  • Clarify the aspects related to the quality section of the dossier
  • Outline the steps to take before the procedure commences
  • Review the steps and actions taken from Day 1 through Day 210 of the review process
  • Explore the aspects taken in the decision-making process
  • Identify the main post-authorization activities

The course takes an average of two hours to complete.

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