EU GMP 附录21：进口医药产品-2022年-英文.pdf

EUROPEAN

COMMISSION

Brussels,16.2.2022

C(2022)843final

GUIDELINES

TheRulesGoverningMedicinalProductsintheEuropeanUnion

Volume4EUGuidelinesforGoodManufacturingPracticeforMedicinalProductsfor

HumanandVeterinaryUse

ENEN

EudraLex

TheRulesGoverningMedicinalProductsintheEuropeanUnion

Volume4EUGuidelinesforGoodManufacturingPracticeforMedicinalProducts

forHumanandVeterinaryUse

Annex21:Importationofmedicinalproducts

Legalbasisforpublishingthedetailedguidelines:Article47ofDirective2001/83/EC

ontheCommunitycoderelatingtomedicinalproductsforhumanuseandArticle51of

Directive2001/82/EContheCommunitycoderelatingtoveterinarymedicinalproducts.

Thisdocumentprovidesguidancefortheinterpretationoftheprinciplesandguidelines

ofgoodmanufacturingpractice(GMP)formedicinalproductsaslaiddowninDirective

2003/94/ECformedicinalproductsforhumanuseandDirective91/412/EECfor

veterinaryuse,andRegulation(EU)No536/2014onclinicaltrialsonmedicinalproducts

forhumanuse,andCommissionDelegatedRegulation(EU)2017/1569supplementing

it.

Statusofthedocument:Newannex.

Reasonsforchanges:Notapplicableatthisoccasion.

Deadlineforcomingintooperation:21August2022(6monthsafterpublication].

Page1of5

1.Scope

ThisAnnexsummarizestheGMPrequirementsapplicabletoaManufacturing

ImportAuthorisation(MIA)hold