2 . 2 Annex Contents

The Q4B annexes will contain the following information at a minimum .Other information might be incorporated ona case-by-case basis .As appropriate, statements that will assist in the use o the referenced pharmacopoeial text by stakeholders .However , FDA might request that a company demonstrate that the chosen method is acceptable and suitable for a specific material or product , irrespective of the origin of the method .Details of implementation requirements will be provided in the notification by MHLW when the specific annex is implemented.