EMA针对小微型和中型药企指南（促进其对药品的理解）.pdf

Userguide

formicro,small

andmedium-sized

enterprises

AnagencyoftheEuropeanUnion

Luxembourg:PublicationsOfficeoftheEuropeanUnion,2024

PrintISBN978-92-9155-076-0doi:10.2809/073053TC-05-23-531-EN-C

PDFISBN978-92-9155-077-7doi:10.2809/18498TC-05-23-531-EN-N

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Userguideformicro,small

andmedium-sizedenterprises

Ontheadministrativeand

proceduralaspectsoftheprovisionslaid

downinRegulation(EC)No726/2004

andRegulation(EU)2019/6,thatare

ofparticularrelevancetoSMEs

EMASMEOffice

Addressingtheneedsofsmall

andmedium-sizedenterprises

Latestrevisedversion–November2023

Update-March2024-Section4.4.Clinicaltrial

applicationsandtheirmanagement-reflecting

changesinClinicalTrialsRegulation

Tableofcontents

Tableofcontents

1.Introduction7

1.1.ObtainingamarketingauthorisationwithintheEuropeanUnion9

1.1.1.Unionmarketingauthorisation–thecentralisedprocedure9

1.1.2.Nationalmarketingauthorisations–national,mutualrecognitiondecentralised

procedures10

1.1.3.Overviewof(data)requirementsforobtainingmarketingauthorisationintheEU...11

1.2.EUlegislativ