|
About us
Services
Registration Dossiers
SPC
Preclinical Expert Report
Clinical Expert Report
Package Inserts
Patient Leaflets
Medical Writing
Contact us
|
TABLE OF CONTENTS
PART I SUMMARY OF THE DOSSIER
IA ADMINISTRATIVE DATA
IA 1 Application for Marketing Authorisation
IA 2 Manufacturing Licence
IA 3 Certificate of Pharmaceutical Product
IA 4 Marketing Authorisation particulars for the same product
IA 5 Samples of Finished Product and Reference Standards
IA 6 Proof of Payment of the Fee
IB SUMMARY OF PRODUCT CHARACTERISTICS (SPC)
IB 1 Summary of Product Characteristics (SPC)
IB 2 Proposal for Packing, Labelling and Package Leaflet
IC EXPERT REPORTS
IC 1 Expert Reports on the Chemical, Pharmaceutical and Biological Documentation
IC 2 Expert Report on
Toxico-pharmacological (Pre-clinical) Documentation
IC 3 Expert Report on the Clinical Documentation
PART II CHEMICAL, PHARMACEUTICAL AND BIOLOGICAL DOCUMENTATION
IIA COMPOSITION
IIA 1 Composition of the Medicinal Product
IIA 2 Container
IIA 3 Clinical Trial Formula
IIA 4 Development Pharmaceutics
IIB METHOD OF PREPARATION
IIB1 Manufacturing Formula
IIB 2 Manufacturing Process
IIB 3 Validation of the Manufacturing Process
IIC CONTROL TESTS ON STARTING MATERIALS
IIC 1 Active Substance (s)
IIC 2 Excipients
IIC 3 Packing Material (Immediate Packing)
IID CONTROL TESTS ON INTERMEDIATE PRODUCTS (IF NECESSARY)
IIE CONTROL TESTS ON THE FINISHED PRODUCT
IIE 1 Specifications and Routine Tests
IIE 2 Validation of Analytical Methods
IIF STABILITY TESTS ON THE FINISHED PRODUCT
IIF 1 Stability Tests on active substance(s)
IIF 2 Stability Tests on Finished Product
IIF 3 Ongoing Stability Studies
IIG BIOAVAILABILITY/BIOEQUIVALENCE
IIQ OTHER INFORMATION
|
