NtA vol. 2.B (Edition 1998)

CTD (Modules)

RO

Full dossier

Full dossier

1⁷²

Additional

Module 1.1

-

Additional Part IA

Module 1.2

2

Additional: IB, SPC, Leaflet, etc.

Module 1.3.1

Module 1.3.2

Module 1.3.3

2

Module 1.3.4

1

Module 1.3.5

3

Additional: IC Expert Reports

Module 1.4

-

Module 1.5

-

Module 1 - Annex

-

Module 2

1

Additional: Part II

Module 3

3

Additional: Part II for Biological/Biotech.

Module 3 for Biological/Biotech.

-

Additional: Part III

Module 4

1

Additional: Part IV

Module 5

-

Written responses

2⁷³

Variations

Application form

2

Type I Documentation

1⁷⁴

Type II Documentation

1⁷⁴

Supplementary info

-

Additional SPC/Leaflet

-

Additional Labels

-

Additional statement on Qualitative & quantitative Composition

-

Written responses

2⁷³