Type IA Variation

A Type IA variation is a minor change that has minimal or no impact on the quality, safety, or efficacy of the medicine. This type of variation typically does not require prior approval from the regulatory authority before implementation by the marketing authorization holder (MAH).

Type IA variations are typically limited to administrative changes or corrections that do not affect the essential characteristics of the medicine. These changes are considered low-risk and do not require a comprehensive review by the regulatory authority. Instead, the MAH is responsible for ensuring compliance with the relevant regulations and guidelines and is permitted to implement the variation directly without prior approval.

Examples of Type IA variations may include changes to the medicine’s packaging materials, labeling, product information leaflet, manufacturing site, or changes to the name or contact details of the MAH. These variations are typically straightforward, well-defined, and pose minimal risk to patient safety or the overall quality of the medicine.

Despite not requiring prior approval, MAHs are generally required to notify the regulatory authority of the Type IA variation and provide relevant documentation and supporting information. This allows the regulatory authority to maintain oversight and ensures that any changes made comply with applicable regulations and guidelines.