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1.1 Table of contents of the application including Module 1 (Module 1 – 5)

Section CONTENT Reference

MODULE 1 - Administrative information and prescribing information
1.0 Cover Letter 1.0
1.1 Comprehensive table of contents 1.1
1.2 Application Information 1.2
1.2.1 Application form 1.2.1
Letter of authorisation for communication on behalf of the
1.2.2 1.2.2
applicant
1.2.3 Electronic copy declaration 1.2.3
Copy of certificate for a Vaccine Antigen Master File
1.2.4 1.2.4
(VAMF)
1.2.5 Copy of certificate for a Plasma Master File (PMF) 1.2.5
Copy of certificate(s) of suitability of the European
1.2.6 1.2.6
Pharmacopoeia (CEP)
Copy of confirmation of API prequalification document
1.2.7 1.2.7
(CPQ)
1.2.8 Letter of access from APIMF, CEP or CPQ holder 1.2.8
1.3 Labelling and packaging 1.3
1.3.1 Package Insert 1.3.1
1.3.2 Summary of Product Characteristics (SmPC) 1.3.2
1.3.3 Patient Information Leaflet (PIL) 1.3.3
1.3.4 Labels 1.3.4
1.3.5 Braille 1.3.5
1.4 Information about the experts 1.4
1.4.1 Quality 1.4.1
1.4.2 Non-clinical 1.4.2
1.4.3 Clinical 1.4.3
1.5 Specific requirements for different types of applications 1.5
1.5.1 Studies and data for generic products 1.5.1
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1.6 Environmental risk assessment 1.6

1.7 Good manufacturing practice 1.7
1.7.1 Date of last inspection of each site 1.7.1
1.7.2 Inspection reports or equivalent document 1.7.2
1.7.3 Latest GMP certificate or a copy of the appropriate licence 1.7.3
Registration of Responsible Pharmacist or Suitably
1.7.4 1.7.4
Qualified Person for local manufacturers
Certified copy of a permit to manufacture specified
1.7.5 1.7.5
controlled substances
1.8 Details of screening
1.9 Individual patient data - statement of availability, if applicable 1.8
1.10 Foreign regulatory status 1.10
List of countries in which an application for the same
1.10.1 product as being applied for has been submitted, approved 1.10.1
rejected or withdrawn
1.10.2 WHO type Certificate of Pharmaceutical Product (COPP) 1.10.2
1.10.3 Registration certificates or marketing authorisation 1.10.3
1.10.4 Foreign prescribing and patient information 1.10.4
1.10.5 Data set similarities 1.10.5
1.11 Regional Summaries 1.11
1.11.1 Summary of the Bioequivalence Studies 1.11.1
Study Title(s) (or brief description giving design,
1.11.1.1 duration, dose and subject population of each 1.11..1.1
study)
1.11.1.2 Protocol and study numbers 1.11..1.2
Investigational products (test and reference)
1.11.1.3 1.11.1.3
details
Confirmation that the test product formulation
1.11.1.4 and manufacturing process is that being applied 1.11.1.4
for
Name and address of the Research
Organisation(s) / Contract Research
1.11.1.5 1.11.1.5
Organisation(s) where the bioequivalence studies
were conducted
Sponsor and responsible sponsor representative:
1.11.1.6 1.11.1.6
name and address, contact details
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Duration of Clinical phase: dates of dosing and

1.11.1.7 1.11.1.7
last clinical procedure
1.11.1.8 Date of final report 1.11.1.8
1.11.2 Biostudy reference product confirmation 1.11.2
1.11.3 Certificates of analysis of the test and reference products 1.11.3
1.11.4 Bioequivalence trial information form (or BTIF) 1.11.4
Biowaiver requests in relation to conducting comparative
1.11.5 1.11.5
bioavailability study
1.11.6 Quality Information Summary (QIS) 1.11.6
1.12 Paediatric development programme 1.12
1.13 Information relating to Pharmacovigilance 1.13
1.13.1 Pharmacovigilance system 1.13.1
1.13.2 Risk management system 1.13.2
Electronic review documents (e.g. product information, BTIF,
1.14 1.14
QOS)
1.15 Sample and Documents (e.g. FPP, device(s), certificates of analysis) 1.15
1.15.1 Confirmation of submission of a sample 1.15.1
1.15.2 Certificate of analysis of the sample 1.15.2
MODULE 2 - CTD Summaries
2.1 CTD Table of Contents (modules 2 to 5) 2.1
2.2 Introduction 2.2
2.3 QUALITY OVERALL SUMMARY - INTRODUCTION 2.3
Drug Substance / Active Pharmaceutical Ingredient 2.3.S
2.3.S.1 General Information 2.3.S.1
2.3.S.2 Manufacture 2.3.S.2
2.3.S.3 Characterization 2.3.S.3
2.3.S
2.3.S.4 Control of the API 2.3.S.4
2.3.S.5 Reference Standards or Materials 2.3.S.5
2.3.S.6 Container Closure System 2.3.S.6
2.3.S.7 Stability 2.3.S.7
2.3.P FINISHED PHARMACEUTICAL PRODUCT 2.3.P
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2.3.P.1 Description and Composition of the FPP 2.3.P.1

2.3.P.2 Pharmaceutical Development 2.3.P.2
2.3.P.3 Manufacture 2.3.P.3
2.3.P.4 Control of Excipients 2.3.P.4
2.3.P.5 Control of FPP 2.3.P.5
2.3.P.6 Reference Standards or Materials 2.3.P.6
2.3.P.7 Container Closure System 2.3.P.7
2.3.P.8 Stability 2.3.P.8
APPENDICES 2.3.A
2.3.A.1 Facilities and Equipment 2.3.A.1
2.3.A
2.3.A.2 Adventitious Agents Safety Evaluation 2.3.A.2
2.3.A.3 Excipients 2.3.A.3
2.3.R Regional Information 2.3.R
2.4 Non-clinical overview 2.4
2.5 Clinical overview 2.5
2.5.1 Product Development Rationale 2.5.1
2.5.2 Overview of Biopharmaceutics 2.5.2
2.5.3 Overview of Clinical Pharmacology 2.5.3
2.5.4 Overview of Efficacy 2.5.4
2.5.5 Overview of Safety 2.5.5
2.5.6 Benefits and Risks Conclusions 2.5.6
2.5.7 Literature References 2.5.7
2.6 Non-clinical Written and Tabulated Summaries 2.6
2.7 Clinical summary 2.7
MODULE 3 - CHEMICAL-PHARMACEUTICAL DOCUMENTATION
3.1 Table of Contents of Module 3 3.1
3.2 Body of data 3.2
3.2.S Drug Substance / Active Pharmaceutical Ingredient 3.2.S
3.2.S.1 General information 3.2.S.1
3.2.S.1.1 Nomenclature 3.2.S.1.1
3.2.S.1.2 Structure 3.2.S.1.2
3.2.S.1.3 General properties 3.2.S.1.3
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3.2.S.2 Manufacture 3.2.S.2

3.2.S.2.1 Manufacturer(s)(name, physical address) 3.2.S.2.1
Description of Manufacturing Process and
3.2.S.2.2 3.2.S.2.2
Process Controls
3.2.S.2.3 Control of Materials 3.2.S.2.3
3.2.S.2.4 Control of Critical Steps and Intermediates 3.2.S.2.4
3.2.S.2.5 Process Validation and/or Evaluation 3.2.S.2.5
3.2.S.2.6 Manufacturing Process Development 3.2.S.2.6
3.2.S.3 Characterization 3.2.S.3
Elucidation of structure and other
3.2.S.3.1 3.2.S.3.1
characteristics
3.2.S.3.2 Impurities 3.2.S.3.2
3.2.S.4 Control of the API 3.2.S.4
3.2.S.4.1 Specification 3.2.S.4.1
3.2.S.4.2 Analytical Procedures 3.2.S.4.2
3.2.S.4.3 Validation of Analytical Procedures 3.2.S.4.3
3.2.S.4.4 Batch Analyses 3.2.S.4.4
3.2.S.4.5 Justification of Specification 3.2.S.4.5
3.2.S.5 Reference Standards or Materials 3.2.S.5
3.2.S.6 Container Closure System 3.2.S.6
3.2.S.7 Stability 3.2.S.7
3.2.S.7.1 Stability summary and conclusions 3.2.S.7.1
Post-approval stability protocol and stability
3.2.S.7.2 3.2.S.7.2
commitment
3.2.S.7.3 Stability data 3.2.S.7.3
3.2.P Drug Product / Pharmaceutical Product 3.2.P
Description and Composition of the Drug Product /
3.2.P.1 3.2.P.1
pharmaceutical product
3.2.P.2 Pharmaceutical development 3.2.P.2
3.2.P.2.1 Components of the FPP 3.2.P.2.1
Drug Substance / Active
3.2.P.2.1.1 3.2.P.2.1.1
Pharmaceutical Ingredient(s)
3.2.P.2.1.2 Excipients 3.2.P.2.1.2
3.2.P.2.2 Final Drug Product / pharmaceutical product 3.2.P.2.2
3.2.P.2.2.1 Formulation development 3.2.P.2.2.1
3.2.P.2.2.2 Overages 3.2.P.2.2.2
Physicochemical and biological
3.2.P.2.2.3 3.2.P.2.2.3
properties
3.2.P.2.3 Manufacturing process development 3.2.P.2.3
3.2.P.2.4 Container closure system 3.2.P.2.4
3.2.P.2.5 Microbiological attributes 3.2.P.2.5
3.2.P.2.6 Compatibility 3.2.P.2.6
3.2.P.3 Manufacture 3.2.P.3
3.2.P.3.1 Manufacturer(s)(name, physical address) 3.2.P.3.1
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3.2.P.3.2 Batch formula 3.2.P.3.2

Description of manufacturing process and
3.2.P.3.3 3.2.P.3.3
process controls
3.2.P.3.4 Controls of critical steps and intermediates 3.2.P.3.4
3.2.P.3.5 Process validation and/or evaluation 3.2.P.3.5
3.2.P.4 Control of Inactive Pharmaceutical Ingredients 3.2.P.4
3.2.P.4.1 Specifications 3.2.P.4.1
3.2.P.4.2 Analytical procedures 3.2.P.4.2
3.2.P.4.3 Validation of analytical procedures 3.2.P.4.3
3.2.P.4.4 Justification of specifications 3.2.P.4.4
3.2.P.4.5 Excipients of human or animal origin 3.2.P.4.5
3.2.P.4.6 Novel Excipients 3.2.P.4.6
3.2.P.5 Control of Drug Product / pharmaceutical product 3.2.P.5
3.2.P.5.1 Specification(s) 3.2.P.5.1
3.2.P.5.2 Analytical procedures 3.2.P.5.2
3.2.P.5.3 Validation of analytical procedures 3.2.P.5.3
3.2.P.5.4 Batch analyses 3.2.P.5.4
3.2.P.5.5 Characterization of impurities 3.2.P.5.5
3.2.P.5.6 Justification of specification(s) 3.2.P.5.6
3.2.P.6 Reference standards and materials 3.2.P.6
3.2.P.7 Container closure system 3.2.P.7
3.2.P.8 Stability 3.2.P.8
3.2.P.8.1 Stability summary and conclusion 3.2.P.8.1
Post-approval stability protocol and stability
3.2.P.8.2 3.2.P.8.2
commitment
3.2.P.8.3 Stability data 3.2.P.8.3
3.2.A Appendices 3.2.A
3.2.A.1 Facilities and Equipments 3.2.A.1
3.2.A.2 Adventitious agents safety Evaluation 3.2.A.2
3.2.A.3 Excipients 3.2.A.3
3.2 R Regional information 3.2.R
3.2 R.1 Production documentation 3.2 R.1
3.2.R.1.1 Executed production documents 3.2.R.1.1
3.2.R.1.2 Master production documents 3.2.R.1.2
3.2 R.2 Analytical procedures and validation information 3.2 R.2
3.3 Literature references
MODULE 4 - NONCLINICAL STUDY REPORTS (FOR NEW CHEMICAL ENTITIES ONLY)
4.1 Table of Contents of Module 4 4.1
4.2 Study Reports 4.2
4.2.1 Pharmacology 4.2.1
4.2.2 Pharmacokinetics 4.2.2
4.2.3 Toxicology 4.2.3
4.3 Literature References 4.3
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MODULE 5 - CLINICAL STUDY REPORTS

5.1 Table of contents of Module 5 5.1
5.2 Tabular Listing of All Clinical Studies 5.2
5.3 Clinical Study Report 5.3
5.3.1 Reports of Biopharmaceutic Studies 5.3.1
5.3.1.1 Bioavailability (BA) Study Reports 5.3.1.1
5.3.1.2 Comparative BA and Bioequivalence (BE) Study Reports 5.3.1.2
5.3.1.3 In Vitro – In Vivo Correlation Study Reports 5.3.1.3
Reports of Bioanalytical and Analytical Methods for Human
5.3.1.4 5.3.1.4
Studies
Reports of Studies Pertinent to Pharmacokinetics Using Human
5.3.2 5.3.2
Biomaterials
5.3.2.1 Plasma Protein Binding Study Reports 5.3.2.1
5.3.2.2 Reports of Hepatic Metabolism and Drug Interaction Studies 5.3.2.2
5.3.2.3 Reports of Studies Using Other Human Biomaterials 5.3.2.3
5.3.3 Reports of Human Pharmacokinetic (PK) Studies 5.3.3
5.3.3.1 Healthy Subject PK and Initial Tolerability Study Reports 5.3.3.1
5.3.3.2 Patient PK and Initial Tolerability Study Reports 5.3.3.2
5.3.3.3 Intrinsic Factor PK Study Reports 5.3.3.3
5.3.3.4 Extrinsic Factor PK Study Reports 5.3.3.4
5.3.3.5 Population PK Study Reports 5.3.3.5
5.3.4 Reports of Human Pharmacodynamic (PD) Studies 5.3.4
5.3.4.1 Healthy Subject PD and PK/PD Study Reports 5.3.4.1
5.3.4.2 Patient PD and PK/PD Study Reports 5.3.4.2
5.3.5 Reports of Efficacy and Safety Studies 5.3.5
Study Reports of Controlled Clinical Studies Pertinent to the
5.3.5.1 5.3.5.1
Claimed Indication
5.3.5.2 Study Reports of Uncontrolled Clinical Studies 5.3.5.2
5.3.5.3 Reports of Analyses of Data from More than One Study 5.3.5.3
5.3.5.4 Other Study Reports 5.3.5.4
5.3.6 Reports of Post-Marketing Experience 5.3.6
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5.3.7 Case Report Forms and Individual Patient Listings 5.3.7

5.4 Literature References 5.4