European regulatory authorities must approve any variation to the terms of a drug marketing authorization. This introductory training course, a Zenosis® eLearning module, covers the legislation and classifications to make a variation to a marketing authorization in Europe. Common approaches are adopted within the European Economic Area to variations of licenses approved through centralized, decentralized, or mutual recognition procedures. For national licenses, each country applies its own legislation and guidelines. Participants will learn how to submit variation applications for products authorized through any of the three multinational procedures. The course also describes how to identify the type of application required, the procedures to follow, the timelines, and the data required for a submission.
- Variation of a marketing authorization in Europe
- Types of variations (IA, IB, and II)
- Extensions, consequential variations, and parallel variations
Who Should Attend
- Regulatory affairs and compliance staff
- Those involved in regulatory submissions
Participants who complete this course should be able to:
- Define the concept of variations as applied to post-marketing regulatory activity in the European Union
- Identify which type of variation is appropriate for the change being proposed
- Identify the data required to support the variation being made
- Describe how to prepare and submit variation applications for products authorized through the centralized, decentralized, or mutual recognition procedures
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