Registration Procedure for Completed Drug in indonesia (BPOM) National Agency of Drug and Food Control

Registration for Completed Drug

Registration for Completed Drug is divided to 3 group :

1. New Drug
• New Effect Substances
• New Indication
• New Supply Form
2. Biological Product
3. Copy Drug
Drug which has the same effect as the Registered Drug

Registration Procedure for Completed Drug
There are two steps for Drug Registration, which are :

• Pre Registration
  Consideration for evaluation path and completion of registration document
• New Drug (Path I: 100 HK, Path II: 150 HK, Path III: 300 HK)
• Copy Drug (Path I: 100 HK, Path III: 80 HK or 150 HK)
Consultation for terms/criterias and completeness of registration document
• Registration
  Submission of registration document has the following terms/criterias:
• Fill request form diskette according to the Pre Registration result or application form
• Pay evaluation fee
• Fill diskette
• Submit completed document according to the registration purpose

Who may Submit Registration ?
Pharmaceutical Industry for :

• Contract and Local Completed Drug
• Licensed Completed Drug
• Imported Completed Drug

Large Pharmaceutical Company for:

• Imported Completed Drug

Registration place/booth for Completed Drug

Directorate for Drug and Biological Product Evaluation
National Agency of Drug and Food Control
Building D Lt.1 - Jl. percetakan Negara no. 23 Jakarta 10560
Telephone/Fax: 4245459 ext. 105 and 110, Email : regobpom@indo.net.id

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ADMINISTRATION DATA FOR DRUG REGISTRATION
Local Product
PhotoCopy of pharmaceutical industry license
PhotoCopy of CPOB Certificate
C o n t r a c t
PhotoCopy of pharmaceutical industry license from registrar and contract recipient
PhotoCopy of contract agreement
PhotoCopy of CPOB certificate from contract recipient and registrar
L i c e n s e
Terms/Criterias are the same as local product with addition of:
License Agreement
I m p o r t
PhotoCopy of Pharmaceutical Industry license
Selection Letter from abroad product owner
Certificate of Pharmaceutical Product /Free sale certificate (original) from manufacturer country
Site master file :: manufacturer which product that has not owned distribution license in Indonesia or certain condition

Technical Data
Form A
Form B
Form C1 (Quality and technology Data)
Form C2,C3,C4,C5,D2,D3,D4,D5 (Effective and Secured Data )
Packet
Completeness Technical Data which must be submitted :
New Drug : A,B,C,D,E
Copy Drug and Biological Product : A,B,C,E
Changes :
Adding/changing packaging :
Different packaging type : A, C, E
Different packaging size : A, E
Changing packaging design / logo : A, E
Changing reductional brochure (without testing of preclinic/clinic)
Circulation License number which has expired : A, B, C, E
Circulation License number which has not expired : A, B (which has changed), E
Changing from Local to Import or the other way round : A, B, C, E
Changing manufacturer : A, B, C, E
Changing manufacturer name/ license authority : A, E
Changing Importer : A, E
Changing drug classification : A, B, C, E, supporting data
Changing formulae : A, B, C, E
Changing supply form (With Exception of new supply form) : A,B,C,E
All the above form can be obtained at registration place/booth