Type II Variation

A Type II variation refers to a major change to a marketing authorization for a medicine that has the potential to significantly impact its quality, safety, or efficacy. These changes do not involve alterations to the active substance, its strength, or the route of administration. Unlike minor changes, Type II variations require formal approval from the regulatory authority.

Type II variations encompass a wide range of modifications that can affect different aspects of medicine. Some examples include changes in the manufacturing process, updates to the product information or labeling, modifications to the therapeutic indications or patient population, adjustments to the dosage regimen, or amendments to the specifications for the finished product.

To initiate a Type II variation, the marketing authorization holder (MAH) is required to submit a formal application to the regulatory authority. The application includes comprehensive documentation detailing the proposed changes, supporting data, and a robust scientific justification for the modifications. The regulatory authority evaluates the application, assesses the potential impact of the changes on the medicine’s quality, safety, or efficacy, and makes a decision on whether to approve or reject the variation.

The assessment process for Type II variations involves a thorough review of the submitted data, including preclinical and clinical studies, stability data, and other relevant information. The regulatory authority may also request additional data or clarification from the MAH during the evaluation process. Depending on the complexity of the changes, the evaluation period can vary in duration.