News

Health & Beauty Begins in Here!

BPOM Regulation No. 14 of 2024

The newly implemented Regulation Concerning the Control of Drug and Food Online Number 14 of 2014, effective August 5, 2024, allows business actors to distribute cosmetics online using either their own electronic system or one provided by PSE/PPMSE. PSE includes individuals, state organizers, business entities, or communities that provide, manage, or operate electronic systems independently or collectively for their own or others' needs. Conversely, PPMSE refers to business actors who provide electronic communication facilities for trade transactions. Business actors managing online drug distribution must also hold a certificate of good distribution practice for drugs.

Electronic System Requirements

The electronic systems used for the online distribution of drugs and food must comply with the following requirements:

Provide accurate information including:

  • The name, address, or identity of the business actor, clearly and traceably.
  • Data and/or information on product labels or markings, including written descriptions or images, in accordance with regulatory standards.
  • Display the drug and food registration number.
  • Feature a traceable mechanism for recording and documenting electronic transactions, and provide access to all users and regulators as per legal requirements.

Delivery Obligations

Business actors and/or third parties involved in the delivery of drugs, herbal medicines, quasi-drugs, health supplements, cosmetics, processed foods, and/or PKMK must:

  • Ensure that the product packaging remains intact and undamaged throughout the delivery process until it reaches the recipient.
  • Deliver products in sealed containers to maintain integrity.
  • Maintain appropriate delivery conditions based on the characteristics of the product.
  • Confirm that the product reaches its designated destination.
  • Document the transfer of products, including transactions involving third parties, to ensure accurate delivery records to the public.

Prohibited Behaviors for Online Cosmetic Operators

Business operators are prohibited from directly distributing or advertising specific drugs and cosmetics through electronic systems to the public. The prohibited items for direct online distribution are as follows:

Drugs:

  1. Narcotics and psychotropic substances.
  2. Injectable forms, excluding insulin for personal use.
  3. Contraceptive implants.

Cosmetics:

  1. Skin care products containing alpha hydroxy acid (AHA) in concentrations exceeding 10%
  2. Teeth whitening products containing or releasing hydrogen peroxide at concentrations above 6%.
  3. Refillable cosmetics, which are repackaged according to consumer requests at refill facilities.


Reference:

https://jdih.pom.go.id/download/product/1592/14/2024