求助：关于植物提取物出口用到的DMF 以及 Written Confirmation

欧洲客户回复如下： european drug master file (open and closed part) - it requires additional test - you would he to check it with your quality department * written confirmation (from 2 july 2013, all active substances manufactured outside of the european union (eu) and imported into the eu must be accompanied by a written confirmation from the competent authority of the exporting country which confirms that the standards of good manufacturing practice (gmp) and control of the manufacturing plant are equivalent to those in the eu.) 1. 请问植物提取物产品有dmf文件的吗？可以自己吗？还是需要某机构给工厂，然后工厂才可以用。 2. 需要出口方主管部门出具的written confirmation 是个啥东西。具体啥内容？由谁出具？在座的有人操作过没? 谢过