Module 5 Presentations

05/07/2024

CTIS Application: Product section structure

From R.Pankow, DIA CTR, Nov2020

The Organisation for Professionals in Regulatory Affairs

Regulatory requirements for CTs – EU (Jul2024)

19

Snapshot on important core documents

Document

CTR

Protocol

Reg (EU) 536/2014 Annex I, Section D

IB

Reg (EU) 536/2014 Annex I, Section E

GMP Documents

Reg (EU) 536/2014 Annex I, Section F

IMPD

Reg (EU) 536/2014 Annex I, Section G IMPD guidance: Eudralex Volume 10, Chapter III (CTR)

IMP Labeling

Reg (EU) 536/2014 Annex VI

Documents and their requirements have been transposed from Guidance to Regulation Annex in order to foster harmonization

The Organisation for Professionals in Regulatory Affairs

Regulatory requirements for CTs – EU (Jul2024)

20