MLIT report raising concerns over the way approval numbers reflect the supplements covered. The draft Revision 3 of the 1958 Agreement requires that each approval number include the applicable supplement number; however, the application for a change of the supplement number does not constitute application for an extension of the approval. As a result, the approval number will not be changed even if a different supplement comes into force, resulting in a product having a supplement number that is different from the actual number of the supplement in force.
| SGR0-19-12/Rev.1 |