Pharmaceutical Regulatory Affairs: The Mutual Recognition Procedure (MRP)

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Program/Course ID: PRA021 Enrollment Period: 12 months. Average Learning Time: ~. Additional Resources: Supplemental materials & activities. Credit Hours: 3 credits. Method of Training: Online, asynchronous, self-paced eLearning. Accessibility: 24/7 access to all program materials. Demonstration: Four (4) free trial courses are available. Group/Employee Training: Click here to request a quote or invoice. Final Assessment: Multiple choice; unlimited attempts. Certificate: Encrypted PDF with QR validation code.

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Saturday, May 16, 2026 UPDATE:
This program is currently unavailable for enrollment.
It may have been updated or discontinued.
Check for newer version in our catalog.

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Outline: Introduction: This session provides background information. It covers products for which the MRP can be used, the types of Marketing Authorization Application, and characteristics of the application procedure. The MRP process: This session takes you through the entire process from initial national authorization by the RMS to the issuing of national licenses by the CMSs. Referral of issues to the CMD, and the arbitration process, are also covered. Generics and the MRP: This session gives a brief introduction to generics and the special issues that apply to generic products in the MRP.		Objectives: Students completing this course should be able to: Provide an overview of the MRP process. Describe the pre-submission and submission actions in relation to timeline deadlines. Specify the responsibilities of the Reference Member State (RMS), the Concerned Member States (CMSs) and the applicant.

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