This course, a Thomson Reuters Cortellis Regulatory Online Learning module, covers how to register a pharmaceutical using the EU’s mutual recognition procedure (MRP). The course reviews the administrative aspects of a submission and aspects relating to the quality section of the submission. The course details the initial steps of the procedure, the application assessment, and the referral to the coordination group level CMD(h). The decision-making process by the Committee on Human Medicinal Products (CHMP) related to arbitration and post-arbitration is also reviewed. The course concludes by describing member states' prerogatives, post-authorization activities, and transparency rules.
- Pharmaceutical registration using the EU’s MRP
- CHMP arbitration and post-arbitration decision-making process
Who should attend?
Professionals and experts in the pharmaceutical, biotechnology, and medical device fields
Participants who complete this course should be able to:
- Identify the legal basis and scope of the MRP
- Provide procedural background information
- Review the administrative aspects of a submission
- Explore the aspects related to the quality section of the dossier
- Describe what occurs during the evaluation process, from the initial steps of the MRP to the decision-making process
- Explain national Member States prerogatives, post-authorisation activities and transparency
The module takes an average of 1.5 hours to complete.