Type IB Variation

A Type IB variation refers to a minor change to a marketing authorization for a medicine that the marketing authorization holder (MAH) must notify the regulatory authority before implementing the change. However, this type of variation does not require formal approval from the regulatory authority.

Type IB variations typically involve straightforward changes that have minimal impact on the quality, safety, or efficacy of the medicine. They may include modifications such as updates to the product labeling, changes in the manufacturing process, or adjustments to the packaging materials.

While Type IB variations do not require formal approval, the MAH is obligated to inform the regulatory authority of the proposed changes and provide all necessary documentation and relevant information. This allows the regulatory authority to maintain oversight and ensure compliance with regulatory requirements.

Upon receiving the notification, the regulatory authority reviews the proposed changes and assesses their compliance with applicable regulations and guidelines. If the authority determines that the variation is acceptable, it acknowledges receipt of the notification. The MAH can then proceed with implementing the change in accordance with the regulatory requirements.