The central competent health authority may announce or approve drugs of a specific type or composition and demand that the pharmaceutical dealer prepares the Risk Assessment and Control Plan (See Appendix 3) within three months following the date of announcement of approval and submit it to the central competent health authority for approval before it may be enforced.The Plan in the preceding paragraph shall cover the methods of risk assessment and control, the deadline for submitting the report, and other matters to be implemented.Changes to the Plan indicated in the preceding paragraph, if any, shall be submitted to and approved by the central competent health authority before they may be enforced, except for the following changes:1. Name, address, correspondence site, telephone, or fax number of the pharmaceutical dealer or manufacturer.2. Name or address of the distributor.Appendix 3 Items to be specified in the Drug Risk Assessment and Control Plan.pdfAppendix 3 Items to be specified in the Drug Risk Assessment and Control Plan.doc