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- The ASEAN Cosmetic Directive (ACD) requires persons or companies placing a product on the market to keep a product information file “readily accessible to the regulatory authority of the Member State concerned at the address specified on the label in accordance with article 6 of this Directive”.
www.fda.gov.ph/wp-content/uploads/2021/03/Guidelines_Product-Information-File.pdfASEAN Cosmetic Directive Guidelines for Product Information ...
People also ask
What is a product information file (PIF)?
What is the ASEAN Product Information File (PIF) guideline?
What is the purpose of a PIF?
What does PIF stand for?
With the entry of cosmetic products facilitated by the implementation of the electronic notification, the FDA reiterated the responsibilities of the Market Authorization Holder (MAH), pursuant to the ACD, including the maintenance of a Product Information File (PIF).
The Pacific Islands Forum (PIF) is an inter-governmental organisation that aims to enhance cooperation among countries and territories of Oceania, including formation of a trade bloc and regional peacekeeping operations.
The main objective of this ASEAN Product Information File (PIF) Guideline* is to provide companies placing a cosmetic product in the market recommendations on how to organize and compile the PIF based on a recommended PIF format. This document also provides guidance on who is responsible to keep the PIF and some guiding points for PIF audits.
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PIF Audits shall be performed by the FDA in accordance with 48 the Audit Plan and/or other Notices issued by the FDA in order to determine and ensure 49 the compliance of the products with the ACD, following these guidelines:
- FDA Issuance Requiring A Product Information File
- Who Are Required to Maintain A Product Information file?
- Who Are Not Required to Maintain A PIF?
- What Are The Duties of The Marketing Authorization Holder (Mah)?
- What Does Cosmetics Or Cosmetic Product Mean?
- Maintaining A Product Information File
- What Documents Should Be Included in The Product Information file?
- Where Should The Pif Be kept?
- How Long Shall The Pif Be kept?
- What Happens When The Pif Is Incomplete?
With the end in view of ensuring safety, quality and/or efficacy of the cosmetic products that companies are placing in the market, the Food and Drug Administration (FDA) issued FDA Circular No. 2018-001, which requires a Marketing Authorization Holder (MAH) to keep and maintain a Product Information File. A Product Information File (“PIF”) is the ...
All cosmetic establishments who are holders of a valid Certificate of Product Notification or CPNs are required to maintain a Product Information File, pursuant to FDA Circular No. 2018-001. In accordance with the FDA Circular, the PIF must be maintained by the Marketing Authorization Holder (MAH), which is the company or person responsible for pla...
Unlicensed cosmetic establishments and their unnotified cosmetic products, which shall be subjected to appropriate regulatory actions, such as closure and seizure of violative products upon verification of violations committed, are not required to maintain a Product Information File. Obviously, instead of requiring the submission of a PIF, the FDA ...
The MAH who has notified a cosmetic product with FDA must maintain an updated Product Information File. Every cosmetic product duly notified with FDA shall have a corresponding PIF. The MAH shall be updated on the latest amendments of the ASEAN Cosmetic Directive (ACD), its annexes and appendices. The MAH shall preferably keep a file of all FDA iss...
A Cosmetics is any substance or preparation intended to be placed in contact with the various external parts of the human body, or with the teeth and the mucous membranes of the oral cavity, with a view exclusively or mainly to clean them, perfume them, change their appearance and/or correct body odor, and/or protect the body or keep them in good c...
What language shall be used in preparing the Product Information File?
The PIF should be written in English or Filipino. It should be arranged according to the format provided by the ACD Guidelines for Product Information File. In addition, it shall be kept in either electronic and/or hard copies.
What are the necessary documents that must be contained in the PIF?
The PIF is composed of the following documents: PIF Part I – Administrative Documents and Product Summary 1. Administrative Documentation 2. Qualitative and Quantitative formula of the cosmetic product 3. Product pPresentation 4. Manufacturing Statement 5. Summary of the safety assessment of the cosmetic product as per the ASEAN Guidelines for the Safety Assesment of a Cosmetic Product 6. Summary of the Confirmed Undesirable Effects on Human Health 7. On-pack Product Claim Support PIF Part II...
The following are the administrative documentation needed: 1. Copy of the valid License to Operate (LTO) of the MAH 2. Copy of the valid Distribution Agreement 3. Copy of the valid CPN If the MAH is a Cosmetic Distributor (Importer) and the Foreign Supplier is the manufacturer of the cosmetic product, the Foreign Agency Agreement (FAA) or the Lette...
The PIF should be kept and maintained in a per product basis. It should be readily accessible at the address of the MAH, as declared in the CPN, consistent with the address indicated on the immediate or secondary packaging of the cosmetic product as per ACD Appendix II – ASEAN Cosmetic Labeling Requirements.
The PIF should be kept for a minimum of three (3) years after the cosmetic product has last been placed in the market (i.e. date when the inventory reaches 0 at retail level) or according to the company’s Standard Operating Procedure (SOP), whichever provides for a longer retention period.
The MAH with incomplete PIF wille be given sufficient amount of time ranging from fifteen to sixty (15-60) calendar days, depending on the urgency of the audit, to provide their corrective action report (CAR) and other documents required by the auditors. Product Information/documents containing confidential materials that have been required by the ...
Aug 19, 2020 · A Product Information File (PIF) following the format as specified in Annex I shall be prepared and kept by the Marketing Authorization Holder (MAH). HUHS products that have been banned or withdrawn in the country of origin/source or manufacture shall not be allowed to enter the Philippine market.
May 17, 2024 · A PIF is documentation that contains all information related to the product’s identity, quality, safety, and several other significant elements. It must be kept by the designated Responsible Person (RP) for each cosmetic product sold on the European market. PIFs are also required when selling cosmetics in ASEAN countries.
