Requirement to get registration number in Indonesia by BPOM

 

ADMINISTRATIVE DOCUMENT

 

I. LOCAL PRODUCT

 

Unlicensed Traditional Medicines (TMs)

·         Certificate of Manufacturer Licensed for TMs or Pharmaceutical Industry

·         Good Manufacturing Practices (GMP) Certificate

 

Licensed Traditional Medicines

Requirements are the same as local product and should attach:

·         Certificate of Manufacturer Licensed for TMs or Pharmaceutical industry of Licensor

·         Certificate of Manufacturer Licensed for TMs or Pharmaceutical industry of licensee

·         Certificate of Free Sale (CFS) issued by government

·         Good Manufacturing Practices (GMP) Certificate

·         Licensed Agreement

 

Toll Manufacturing Traditional Medicines (TMs)

Requirements are the same as local product and should

attach:

·         Certificate of Manufacturer or Pharmaceutical Industry

·         Certificate of Manufacturer Licensed for TMs or Pharmaceutical Industry of Toll Manufacturing industry

·         Good Manufacturing Practices (GMP) Certificate

·         Toll Manufacturing Agreement

 

 

II. IMPORTED PRODUCT

·          Certificate of Manufacturer Licensed for TMs or pharmaceutical Industry or Certificate of Importer Licensed for TMs or Pharmaceutical Products

·          Letter of Authorization

·          Certificate of Free Sale (CFS) issued by government

·          Good Manufacturing Practices (GMP) Certificate

 

  

 

TECHNICAL DOCUMENT

 

 

I. LOCAL / LICENSED PRODUCT

 

Formula

·         Composition: active ingredients, excipient in matrix

·         Direction of use : the direction of use, dosage, warning, precaution, contraindication / recommendation and duration of administration if any

 

Quality and Technology

·           Manufacturing process: started from wheiging of raw material to finished product

·           Specification of formula's ingredients/raw material

·           Finished product evaluation: certificate of Analysis of Finished Product (organoleptics, physical-chemical, microbial and heavy metal contaminant)

·           Method and result of stability study

 

 

II. IMPORTED PRODUCT

 

Requirements are the same as local product and should attach data from manufacturer in original country :

And should be completed with:

·         Certificate of microbial contaminant test result from laboratory which has appointed by NADFC

·         Toxicity test Data for traditional medicines which its safety has not known from laboratory which has appointed by NADFC or from country of origin

 

 

 

 

LABELLING

 

Logo of traditional medicines requires:

·         Word: "JAMU"

 

Logo of Standardized Herbal Medicines requires:

·         Word: "STANDARDIZED HERBAL MEDICINES"

 

Logo of Phytopharmaca requires:

·         Word: "FITOFARMAKA"

·         Product name (Generic or Brand)

·         Net weight or net content

·         Name and address of manufacturer or importer

·         Indication, direction of use and dosage

·         Alcohol substances if available

·         Expiry date production code and the registration number

·         Composition/ingredients

·         Contra indication, side effect and precaution if available

 

Label should be mentioned in Indonesian language

 

 

Duration 1.5 months
Cost Rp 5.000.000,- Rp3.000.000/Produk

Contact Us:
Bambang Widjatmoko
+628158820529
e-mail: myregnumber@gmail.com
 

 

 

 

 

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