OMC Medical
OMC Medical

 Cosmetics Registration in Indonesia

Regulatory Authority:

The Agency for Drug and Food Control (BADAN POM)

Link for RA:

https://www.pom.go.id/new/home/en

Local regulation:

Regulation about Cosmetics Production Licenses

Who can register :  

  • The manufacturer must obtain a “production license.”

Three types of stakeholders are qualified to apply for the notification:

  • Importers who have Import Identification Numbers (API) and obtain a letter of authorization for the agency from the manufacturer of the country of origin;
  • Individual businesses/business entities that contract with a domestic cosmetic industry that has obtained a production licence; 
  • Importers who have Import Identification Numbers (API) and obtain a letter of authorization for the agency from the manufacturer of the country of origin

Data to be communicated : 

  • Approval of the notification
  • The Certificate of Analysis (CoA) includes product names, testing parameters, testing results, testing methodologies, batch number/production code, manufacturing date and expiration date, and manufacturer name (if the CoA issuer is not the manufacturer)
  • Laboratory testing/invoice sampling (if necessary)
  • Other papers that the relevant authorities may demand
  • Ingredient names, testing parameters, testing results, testing methodologies, batch number/production code, manufacturing date and expiration date, and manufacturer name are all listed on the Certificate of Analysis (COA) (if the CoA issuer is not the manufacturer)
  • Ingredient specifications and safety data sheets
  • Statement about the purpose of usage and distribution
  • Laboratory testing/invoice sampling (if necessary)
  • Other papers that the relevant authorities may demand

Process:  

  1. Registered applicants apply for notification on the BPOM cosmetics notification service official page by filling out and uploading data on another electronic form of Template.
  2. An electronic Pay Order will be sent to the applicant who has successfully submitted the Template. The applicant must make a non-tax state revenue payment within seven working days through an electronic payment method. The system automatically generates a product ID number as a receipt for the notification application.
  3. The notification applicant will receive the cosmetic notification dossier verification result under any of the following conditions within fourteen working days of acquiring the product ID number (for perfume products, three working days).
  4. Within six months of receiving notification, the product must be manufactured or imported and distributed.
  5. Before cosmetics are notified, makers or importers must compile a PIF, which must be supplied when the POM agency conducts an examination.

Timeframe and fees: 

  • The notification is valid for three years.
  • Under priority service, the verification findings for notification dossiers must be issued within three working days.
  • The PIF has to be retained for at least six years.

Additional information:  

Manufacturers who follow GMP guidelines can apply for a certificate online. For five years, the GMP certificate is valid.

In Indonesia, the cosmetic label must list all needed information honestly and accurately. It must be presented so that it cannot be readily removed or separated from the packaging, nor faded or damaged. The above data may be written in Indonesian characters, Latin letters, and Arabic numerals.