Chapter 4 Documentation-EUGMP-第四章文件管理.docxVIP

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Chapter 4 Documentation-EUGMP-第四章文件管理.docx

EUROPEANCOMMISSION

HEALTHANDCONSUMERSDIRECTORATE-GENERAL

PublicHealthandRiskAssessment

Pharmaceuticals

Brussels,

SANCO/C8/AM/sl/ares(2010)1064587

EudraLex

TheRulesGoverningMedicinalProductsintheEuropeanUnion

Volume4

GoodManufacturingPractice

MedicinalProductsforHumanandVeterinaryUse

Chapter4:Documentation

Legalbasisforpublishingthedetailedguidelines:Article47ofDirective2001/83/EContheCommunitycoderelatingtomedicinalproductsforhumanuseandArticle51ofDirective2001/82/EContheCommunitycoderelatingtoveterinarymedicinalproducts.Thisdoc

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