1. REGISTRATION OF PHARMACEUTICAL PRODUCTS
Group 2 :
Ika Isaura Septyanti Suciyati Madeali Yulham Sidar Effan Cahyati Ida Meyda E Ismail Hasan Hikmah Titi Fitry Aprilyanty Rizkie Anugerah P Yandy Efrianna R  

2. INTRODUCTION
DEFINITION
Drugs is substances or mixtures which are used to diagnose, preventive, or reduce eliminate diseases

3. INTRODUCTION
Drug registration is registration procedure and evaluation of the drug to get the permission path
Permission Path is a form of approval of the drug to be released registration in Indonesia

4. Stages of drugs Registration
Pra Registration
Registration

5. Pra Registration
It aims to asess the completeness of the administration
Registration
To Assess whether a drug is worth getting permission path

6. DRUGS REGISTRATION Reg. Number issued Pharmaceutical Industry
Registration Process:
Pharmaceutical Industry
Registration to BPOM
Assessment and Evaluation Drugs
Meet the Requirements
Reg. Number issued

7. Purpose of Registration
Permission path is valid for 5 years The purpose of registration is done is to protect the community medicine of circulation of drugs that don’t meet the requirements of safety, quality and efficacy

8. Registration for Completed Drug is divided to 3 group :
New Drug
New Effect Substances
New Indication
New Supply Form
Biological Product
Copy Drug

10. Registration Requirements
Name Drugs
Generic Name:
Name corresponding to the Pharmacopoeia Indonesia.
2. Trade Nama:
The name given by the registrant to identity drugs
Registration
Domestic Production:
Production under License
2. Imported Drugs:
Drugs manufactured overseas are marketed in the country

11. DRUG CRITERIA
In obtaining drug marketing authorization, a drug should fulfill the below main criteria:
a. Convincing evidence of efficacy, and adequate safety, proven through pre- clinical and clinical trials or other proof in accordance with development in the relevant scientific knowledge.
b. Having quality that fulfils the criteria concerning the production process in accordance with Good Manufacturing Practice of (GMP/CPOB), specifications and method of analysis of all materials used in the finished product with proven documents.
c. Labeling must contains objective and complete information which must ensure, rational and safe use of drugs.

15. Filling Requirements of Drug Registration
A. Domestic Production of Drugs Registrant must have a permit health minister and meets CPOB B. Import Drugs Must have a permit from the pharmaceutical Industry abroad and have a certificate CPOB

16. C. Export Drugs Drugs export have to quality from the country of destination D. Patent Drugs A drug that is manufactured by the pharmaceutical industry patent holders with certificate patents

17. Document of Registration
Part I : Administrative Document, Product Information
Part II :Quality Document
Part III : Non Clinical Document
Part IV : Clinical Document

18. How To Register A Drugs???

19. Pharmaceutical Industry, Food/Drink Industry, OT
The Procedure Of Registration Of Traditional Medicine, food Suplement and Cosmetic
Pharmaceutical Industry, Food/Drink Industry, OT
BPOM and Tradisional assessment directorate food, Suplement and cosmetik
Evaluation
Nomor Registration

20. Number Registration Conventional Drugs
Consist of 15 digit (3 letters and 12 number)
Example: D B L A 1
D: Trade Name
B: Golongan Obat Bebas
L: Import Drug
01: Years List 2001
108: Number sort to the factory 108
037: The approved number sort factory
16: Form of drug preparations
A: The power of drug preparaion (first)
1: Packaging (Primary packaging)

21. B. Traditional Drugs Consist of 12 digit (3 letters and 9 number) Example: T R TR: Traditional Local Drugs 00: Years List : Producen Status (1: Pharmaceutical Factory) 7: Drug Preparations (7: ointment/cream) 0003: Serial number of type of product listed 2: Dose of the drugs (2: 30 ml) 7

22. The Establishment of Traditional Medicine Industry
Traditional medicine industry in Indonesia, there are 2 type of business that require licensing:
Traditional Medicine Industry
Have Assets outside of the land and building more than Rp 600 million
Small Traditional Medicine Industry
Have Assets outside of the land and building less than Rp 600 million

23. The Process of Licensing of traditional Medicine
Consult the building to BBPOM
Petition for approval of the principle industry IOT/IKOT
Submit business license IOT/IKOT
If application letter received by BBPOM
Result of the examination by qualified BBPOM
Ask permission path to BPOM RI

24. STATUTORY OF HEALTH Indonesian Republic of 2005 years bpom
BAB II Requirements and Criteria Pasal 2 Traditional medicine, herbal medicine, standarized and made phytopharm or cirlulated in the region and indonesia are required to have authorization from the head of agency Pasal 3 Pasal 4

25. THANK YOU