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

ADMINISTRATIVE REQUIREMENTS OF TRADITIONAL DRUGS EVALUATION 

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.

TECHNICAL REQUIREMENTS OF TRADITIONAL DRUGS REGISTRATION 

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. 

Classification of Medical Devices and Household Appliances


CLASSIFICATION OF MEDICAL DEVICES AND HOUSEHOLD APPLIANCES 

MEDICAL DEVICES 
Class I
Medical devices whose failure or missuse of the product will not cause serious effect. The evaluation of this product merely focused on the quality of product. 
Example : Toothbrush, Dental Flos, Bandage, Ice bag, etc.

Class IIa
Medical devices whose failure or missuse of the product may cause several adverse effect but will not cause a serious accident. These medical devices should comply with the requirements but no need to have a clinical test report.
Example : AC powered dinamometer, reflex hammer, Wheel chair, etc.

Class IIb
Medical Devices whose failure or missuse of the product can cause a significant adverse effect on the patient but will not cause a serious accident. These medical devices should comply with the requirements including the safety assessment but no need of clinical test report. 
Example : Contact lenses, ophthalmic laser, etc.

Class III
Medical Devices whose failure or missuse of the product will cause a serious adverse effect to the patient or physician/operator. These medical devices should comply with the requirements including the safety assessment and clinical test report. 
Example : ventricular by pass device, silicon gel filled breast, prefilled syringe, etc.

Household appliances / PKRT (Perbekalan Kesehatan Rumah Tangga)
Class I (Low risk)
Household appliances whose failure or missuse of the product will not cause serious effect such as iritation, corrosion, carsinogenic. These products should fill out a registration form without any laboratory test report. 
Example : Cotton, Cotton bud, tissue, etc.

Class II (Middle risk)
Household appliances whose failure or missuse of the product may cause iritation, or corrosion but not carsinogenic. these products should fill out a registration form and must comply with the requirements along with the laboratory test report. 
Example : Detergent, Car Freshener, Hand sanitizer, etc.

Class III (High Risk)
Household appliances which contain pesticide where the use of it may cause serious adverse effect such as carsinogenic. These products must fill out a registration form and should comply with safety requirements along with the laboratory test result and approved by the commission of Pesticide usage.
Example : Mosquito reppelent, Anti mosquito coil, Bug spray (insecticide), etc.