Selasa, 05 Februari 2013

Registration of Traditional Drugs

Who may apply for traditional drugs registration ? 
  1. Traditional drugs Industry
  2. Traditional drugs small Industry 
  3. Company / distributor 
Traditional drugs industry and  Traditional drugs small industry may register Local Traditional drugs, Licensed Traditional drugs, Imported Trasitional drugs.
Company/Distributor may register Imported Traditional drugs. 

What is the procedure to register Traditional drugs ? 
Applicant should fillout the registration form and complete all requirements from the Directorate of Traditional drugs, food supplement, and cosmetics  evaluation, then submit it by : 
  • Direct Submission to registration counter 
  • Post it through Postal package. 
Registration counter of traditional drugs 

Directorate of Traditional drugs, food supplement, and cosmetics evaluation
(Direktorat penilaian Obat tradisional, suplemen makanan, dan kosmetik)
National Agency of drugs and food control
(Badan Pengawas Obat dan Makanan)
Jl. percetakan Negara no. 23 Jakarta 10560
Telepon/Fax: 021-4244819


L o c a l

  • Copy of Traditional drugs and  Traditional drugs small industrial License
  • Copy of diploma and Pharmacist Work License (SIK) of the technical assurer or Pharmacist Letter of assignment (SP).
  • Pharmacist statement letter as responsible person for technical matter. 
  • Sample os product
  • Labelling design 
  • Sample of Simplicia / Raw material (if necessary) 

L i c e n s e d

Same requirements as the local, with addition : 
  • Licensed Appointment Letter. 
  • Free Sale Certificate (asli) from the country of origin, endorsed by the Indonesian embassy. 

I m p o r t e d

Same requirements as local product, with addition : 
  • Appointment Letter from Principal al
  • Free Sale Certificate (asli) from the country of origin, endorsed by the Indonesian embassy. 
  • Lab Test certificate from accredited laboratory (acknowledge by BPOM) 
  • Toxicity test data for traditional drugs with unknown safety assessment.


L o c a l

Formulation/Efficacy :
  • Composition : Name and ammount of raw material 
  • Efficacy/Indication : Efficacy of traditional drugs, supported by efficay of raw material supported by literature
  • Direction of use : Usage and Dosage of traditional drugs (Detailed) : Warning, attention, precaution, usage time. 
Quality and technology : 
  • Manufacturing procedure : Ammount of production and raw material needed in 1 batch, manufacturing flowchart, standard Operating procedure, equipment/machinery used for production. 
  • Raw Material certificate of Origin. 
  • Specification and COA (certificate of Analysis) of raw material. 
  • Specification and COA of finished product, contains : Physical, Chemical, Microbial, and Heavy metal testing. 
  • Stability test method and result. 

I m p o r t e d

Same requirements as local, with attachment of data from the manufacturer (original or copy as required). 

L a b e l l i n g 

On the Label/Etiquette, should at least contain information of : 
  • Name of Traditional Drugs
  • Packaging size (Netto) 
  • Registration number, Nama and address of manufacturer, Name and address of Distributor (At least City name and country) 
  • Composition (Latin Name of raw material) 
  • Efficacy / Usage 
  • Direction of use 
  • Warning and Contra Indication (If any) 
  • Batch/Lot Number 
  • Expiry Date 
For local products, may add the word jamu in the circle (Jamu logo)
For licensed product, add the leaf symbol (Licensed Traditional drugs logo) and name of License owner
For Imported products, add the name of importer/distributor in Indonesia, and Information should be written in latin alphabet in bahasa and original language. 

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