先，只能使用符合GMP要求下生产的原料药是生产许可持有人的责任。

法令2001/83/EC第111条（兽药法令2001/82/EC第80条）规定，在活性物质生产商提出特殊申请后，成员国药监局再进行原料药的检查。检查申请应向生产商所在国EEA合法药监机构提出，如果工厂地址位于第三国，则可以向活性物质用作起始物料的制剂生产国合法药监机构提出。如果不属于上述情况，则可以向任何EEA药监机构提出申请。

由于药监机构会优先用风险原则权衡原料药检查，因此不能保证检查申请一定会被接受。所以当原料药生产商自愿申请现场检查时，并不表示药监机构有义务一定进行现场检查。

First, the responsibility for only using active substances that have been manufactured in accordance with GMPs is placed on the holders of a manufacturing authorisation(MA). An inspection of the active substance manufacturer by an EEA authoritydoes not liberate a MA holder from this responsibility.

Article 111 (1f)of Directive 2001/83/EC and Article80(1) of Directive 2001/82/EC , have provision for the competent authority ofthe Member State concerned to carry out inspections of starting material manufacturers at the specific request of the manufacturer. The request for the inspection should be made to the EEA competent authority where the site islocated or, in case of sites located in third countries, to a competent authority where the starting material is used in the manufacture of medicinal products. If this is not the case, any EEA authority can be approached.

There is no guarantee that such a request will be fulfilled since competent authorities primarily use risk-based principles to plan starting material inspections.Thus, when a starting material manufacturer applies for a voluntary inspection,this does not constitute an obligation for the competent authority to triggeran inspection.