공지/교육
법령
[Chemlinked] Indonesia Consults on the Amendments to Required Documents for Product Information File (PIF)
첨부파일
등록일 2022-11-15
조회수 7947
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
Administrative documents |
Indonesian cosmetics |
Imported cosmetics |
Commissioned produced cosmetics |
1. photocopy of the GMP certificate or the fulfillment certificate for GMP aspects
2. photocopy of the license agreement between the brand owner and the notification applicant (for the notification applicant who is appointed as the trademark licensee)
|
1. photocopy of the agency appointment letter consistent with the one submitted when conducting notification
2. photocopy of the contract cooperation agreement between the notification applicant and overseas cosmetic company that is legalized by a notary public and includes the brand and/or product name and the expiration date of the agreement
3. photocopy of the Certificate of Free Sale (CFS)
4. photocopy of the GMP certificate or the statement of GMP application consistent with the one submitted when conducting notification
|
1. photocopy of
2. photocopy of the contract cooperation agreement between the contractor and the recipient of a production contract consistent with the one submitted when conducting notification
|
|
Cosmetics ingredient’s quality and safety data |
1. Cosmetics ingredient’s quality data
2. Cosmetics ingredient’s safety data
Notes: Safety data can be stored separately from other PIF documents. |
||
Cosmetic product’s quality data |
1. Cosmetics formula which contains
2. Cosmetics manufacturing
3. Cosmetics specifications and analytical methods:
4. Cosmetics stability data
|
||
Safety and efficacy data of cosmetic product |
1. Safety assessment
2. Regularly updated and reported cosmetic adverse reaction monitoring results.
3. Data supporting cosmetic claims
4. Cosmetics labeling and information, at least contain:
|
||
Notes: Added or amended document requirements are marked in red. Deleted document requirements are marked with a |
3. Other noteworthy points
- The draft clarifies the PIF review method that it can be conducted at the notification number owner’s facility and/or online;
- The draft amends the penalties for companies that violate the PIF Guidelines as follows:
1) written warning; 2) temporary closure of online access for notification applications for 1 year at most; 3) temporary closure of online access for import certificate applications for 1 year at most; 4) temporary prohibition to distribute cosmetics for 1 year at most; 5) cosmetics recall; 6) temporary suspension of production and/or importation of cosmetics for of 1 year at most; 7) prohibition of renewing cosmetic notifications; 8) revocation of notification number.
Notes: Added or amended penalties are marked in red. |
- The draft does not modify PIF's language requirements, retention time or retention form.
Further Reading
- Indonesia Implements the Amended Procedure for the Submission of Cosmetics Notification
- Indonesia Amends Labeling Requirements for 2D Barcode on Cosmetics
- Indonesia Implements the Amended Cosmetic Ingredient Use Requirements: 17 Newly Permitted Ingredients and 231 Newly Prohibited Ingredients
- Indonesia Consults on the Draft Regulation for Perfume Refill
Reference Links
[1] Indonesia Releases the Draft of Guidelines for Product Information File
출처 : Chemlinked