Changes to the terms of marketing authorisations for medicinal products, called variations in Europe, must be notified to or approved by the relevant regulatory authorities. Variations include changes to the composition of products, their manufacturing processes, the way they are used, or the indications for which they are authorised. Common approaches are adopted within the European Economic Area to variations to marketing authorisations approved through the Centralised, Decentralised or Mutual Recognition Procedures. Recent legislation has substantially modified the regulatory requirements and extended them to purely national authorisations by member states. This module, which is fully up to date with the new legislation, covers the classification of variations into their several types and the regulatory requirements, guidance and procedures to be followed for each type.
The module takes an average of 3.5 hours to complete. (Note that this is an average time. People learn at different rates, and they explore resources and examples at different paces.)
- Defining variations
- Determining variation types
- General procedural aspects
- Variations via the Centralised Procedure
- Variations via the Mutual Recognition Procedure
- Case study
- The new legislation
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 to marketing authorisations in the EEA.
- Identify which type of variation is appropriate for each kind of change to be made.
- Identify the documentation required to support the variation.
- Describe how to prepare and submit variation notifications or applications appropriate for each type of variation and route of regulatory approval, including options for grouping of variations and for work sharing of assessment.