6 135
6 135
6 135
/JFDA
Bio-similar Radiopharmaceuticals
Submission type : (check one)
Complete manufacturing Contract manufacturing Under License
Technology Transfer
Pack Size and Type:
Drug Marketing Authorization Holder (MAH) & Country:
Applicant Name:
Registration File content:-
Volume
Section Module 1: Administrative Documents /Page
1
Form (F1/RDP-3/2011) Registration Drug Dept. /JFDA
1.6.7.4 Prices certificate: (for local products) Suggested Public price\ pharmacist price or
hospital price (for priced drug).
1.6.7.5 JFDA approval certificate for the Manufacturing site/s (for the same production
line)(or copy of the request letter for approval ( date and number))
1.6.7.6 A copy of JFDA committee approval of the B.E or the Comparative Dissolution
Profile should be provided (for generic drugs).
Volume
Section Module 2 CTD Summaries /Page
number
2.1 CTD table of contents (Module 2 5)
2
Form (F1/RDP-3/2011) Registration Drug Dept. /JFDA
3
Form (F1/RDP-3/2011) Registration Drug Dept. /JFDA
4
Form (F1/RDP-3/2011) Registration Drug Dept. /JFDA
Volume
Section Module 4: Non Clinical Study Reports. /Page
number
4.1 Table of Contents of Module 4
4.2.1 Pharmacology
4.2.2 Pharmacokinetics
4.2.3 Toxicology
Volume
Section Module 5: Clinical Study Reports /Page
number
5.1. Table of Contents OF MODULE 5
5.2 Tabular Listing of All Clinical Studies
5.3 Clinical Study Reports:
5.3.1. Reports of Biopharmaceutic Studies:
5
Form (F1/RDP-3/2011) Registration Drug Dept. /JFDA
I declare that all the documents which refer to in this chick list are attached & number of files Submitted for
this application
Name & Sign of responsible Pharmacist: Date:
- (Fees 1500 JD for Originator ) ( Fees200 JD for Generic drugs) (attached the receipt))