Spring Intro 2023

Jenny Lamport

CTD format - Module 1

Administrative information and prescribing information – 1.1 Overall table of contents – 1.2 Application form – 1.3 Product information (SmPC, labelling and leaflets) – 1.4 Information about the experts – 1.5 Specific requirements for different types of application – 1.6 Environmental risk assessment

– 1.7 Information on orphan market exclusivity – 1.8 Information relating to pharmacovigilance - Pharmacovigilance system - Risk Management Plan (RMP) – 1.9 Information relating to clinical trials – 1.10 Information relating to paediatrics

The Organisation for Professionals in Regulatory Affairs

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 Fees, declaration and signature  Type of application  Name of product and active ingredient, ATC code  Pharmaceutical form and strength  Route of administration  Container, pack size, shelf life, storage conditions  Legal status  Names and addresses  Qualitative and quantitative composition  Scientific advice, paediatric development programme  Other MA applications/approvals  Appended documents Application form

The Organisation for Professionals in Regulatory Affairs

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