Guidance on amendments has been revised

The guidance document on amendments to an Active Pharmaceutical Ingredient Master File (APIMF) submitted in support of a Prequalified Pharmaceutical Product (FPP) or Prequalified Active Pharmaceutical Ingredient (API) has been revised to include the following changes:

• Change 2a regarding change in name or address of a manufacturer has been split into two subcategories: 2a.1 if the change refers to a manufacturer of an intermediate or the API and 2a.2 if the changes refers to a manufacturer of a starting material.
   
• Addition of change 11g [AIN] for the submission of the risk assessment for elemental impurities. The document relating to the use of ICHQ3D guideline for APIs has been revised accordingly.
   
• The wording of the declaration regarding the submission of a new APIMF version has been revised to clarify that the 24-month period should be calculated from the date of acceptance of the APIMF or the date of acceptance of the latest APIMF version.