Indonesia Amends Required Documents for Product Information File (PIF)

Background

In Indonesia, PIF shall be prepared by manufacturers or importers before cosmetics are notified and provided when the Indonesia Food and Drug Supervisory Agency (BPOM) conducts an examination. The PIF must be maintained in electronic and/or written form, stored appropriately, and updated whenever changes occur. The language can be either English or Indonesian.

On October 31, 2022, BPOM released a draft of the Guidelines for Product Information File (PIF) for public consultation. ¹ Nine months later, on August 2, 2023, BPOM finalized and implemented the Guidelines. ² For products that received the notification number before August 2, 2023, the notification number owner must update the PIF within six months.

The Guidelines consists of six chapters, sixteen articles, and one appendix, covering requirements for documents, language, retention, storage format, PIF review methods, etc. The purpose of the Guidelines is to assist cosmetic companies in preparing and compiling the PIF and provide guidance to BPOM officials during PIF reviews.

Compared with the previous Guidelines for Product Information File released in 2017, the main amendments are as follows.

1. Clarifying the standards for documents included in PIF

The Guidelines categorizes the documents to be included in the PIF into four types. It provides explicit standards that these four types of documents must adhere to.

No.	Documents Type	Standards
1	Administrative documents	1. Scientific or empirical evidence’s fulfillment of the ingredients’ technical requirements stipulated in Technical Requirements for Cosmetics Ingredients; 2. Fulfillment of contamination requirements stipulated in Limitations for Contamination in Cosmetics; 3. Fulfillment of the requirements stipulated in the Regulation for Cosmetics Adverse Reaction Monitoring in terms of the monitoring results of cosmetic adverse reactions; 4. Fulfillment of the requirements stipulated in the Technical Requirements for Cosmetic Labeling in terms of cosmetic labeling; 5. Fulfillment of the requirements stipulated in the Technical Requirements for Cosmetics Claims in terms of cosmetic claims.
2	Cosmetic ingredient’s quality and safety data
3	Cosmetic product’s quality data
4	Safety and efficacy data of cosmetic product

Indonesia Amends Required Documents for Product Information File (PIF)

Background

1. Clarifying the standards for documents included in PIF

2. Amending the documents required in PIF