Dossier

CTD

RO

Module 1.1

RO/EN

Part IA - Format

Module 1.2

RO/EN

Part IB - SPC

Module 1.3.1

RO/EN¹⁵

Part IB – Leaflets & Labels

Module 1.3.2 – 1.3.4

RO/EN¹⁶

Module 1.4

RO/EN

Module 1.5

RO/EN

Module 1 - Annex

RO/EN

Part IC – Expert Reports

Module 2

RO/EN

Part II

Module 3

RO/EN¹⁷

Part III

Module 4

RO/EN

Part IV

Module 5

RO/EN

Written responses

RO/EN

Variations

Application form

Type I Documentation

RO/EN

Type II Documentation

RO/EN

Written responses

RO/EN

Renewal

RO/EN