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Indonesia Consults on the Amendments to Required Documents for Product Information File (PIF)

The draft of the Guidelines for Product Information File (PIF) clarifies the standards for documents included in PIF, and amends the documents required in PIF.

Background

Before cosmetics are notified in Indonesia, manufacturers or importers shall prepare product information file (PIF) and provide it when the BPOM conducts examination. PIF must be kept in the form of electronic and/or written documents, stored properly for a minimum of 6 years since the latest production or importation of cosmetics, and updated once there are any changes. PIF can either be in English or Indonesian.

On Oct. 31, 2022, Indonesia Food and Drug Supervisory Agency (BPOM) released the draft of the Guidelines for Product Information File (PIF) for public consultation. 1 The draft is divided into 3 chapters and 16 articles with 1 appendix, which stipulates the documents requirements, language requirements, retention time, retention form, PIF review method, etc. The aim of this draft is to guide cosmetic companies in preparing and compiling PIF, and guide BPOM officials to review PIF.

Compared with the current Guidelines for Product Information File, the main amendments in the draft are as follows:

1. Clarifying the standards for documents included in PIF

The documents that should be included in PIF are divided into four types. The draft clarifies the standards that these four types of documents should meet.

No.

Documents Type

Standards

1

Administrative documents

1. Fulfillment of the criteria for safety, efficacy, quality, labeling, and claims stipulated in the Procedure for Submission of Cosmetics Notification;

2. Fulfillment of the requirements stipulated in the Regulation for Cosmetics Adverse Reaction Monitoring in terms of the monitoring results of cosmetic adverse reactions;

3. Scientific or empirical evidence’s compliance with the ingredients’ technical requirements stipulated in Technical Requirements for Cosmetics Ingredients;

4. Fulfillment of contamination requirements stipulated in Limitations for Contamination in Cosmetics.

2

Cosmetic ingredient’s quality and safety data

3

Cosmetic product’s quality data

4

Safety and efficacy data of cosmetic product

2. Amending the documents required in PIF

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