FDA Issuance Requiring a Product Information File
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 document containing the product’s technical and safety information readily accessible to the FDA representatives during audits.
Who are required to maintain a Product Information File?
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 placing the cosmetic product in the market. The MAH is likewise responsible for all aspects of the product, including quality and compliance with the conditions of the Marketing Authorization (an official document issued by the competent cosmetic regulatory authority for the purpose of marketing or free distribution of a product after evaluation for safety, efficacy, and quality).
The authorized holder must be subjected to legislation in the country that issued the Marketing Authorization, which normally means being physically located in that country. In the Philippines, cosmetic establishments may be a cosmetic manufacturer, trader and/or distributor, duly licensed by the Center for Cosmetics Regulation and Research (CCRR), and holding valid Licenses to Operate.
Who are not required to maintain a PIF?
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 will order their closure and confiscation of unregistered or unnotified cosmetic products, as these are illegal and considered contraband under Philippine law.
What are the duties of the Marketing Authorization Holder (MAH)?
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 issuances disseminating the new rules, regulations and standards for cosmetic products.
For PIF audits, accessibility and availability of information to FDA shall be ensured by the MAH. Routine PIF audits shall be conducted by FDA during the validity of the CPN. The MAH shall be notified through a notice of audit (NOA).
What does cosmetics or cosmetic product mean?
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 condition.
Maintaining a Product Information File
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
- Administrative Documentation
- Qualitative and Quantitative formula of the cosmetic product
- Product pPresentation
- Manufacturing Statement
- Summary of the safety assessment of the cosmetic product as per the ASEAN Guidelines for the Safety Assesment of a Cosmetic Product
- Summary of the Confirmed Undesirable Effects on Human Health
- On-pack Product Claim Support
PIF Part II – Quality Data of Raw Material
- Specifications and test methods of raw materials
- Safety data of the ingredients which are taken from any of the following:
- Ingredient safety data provided by the supplier or Safety Data Sheets
- Published literature and databases (i.e. Toxline, Medline) of ingredients
- Reports from Scientific Committees like the ASEAN Cosmetic Scientific Body (ACSB), the Scientific Committee on Consumer Safety (SCCP) of the European Union (EU) or the United States (US) Cosmetic Ingredient Review Board (CIR).
- In cases when the cosmetic products contain placental protein or any other anial extracts, the following shall be part of PIF Part II.
PIF Part III – Quality Data of Finished Product
- Complete ingredient list of the cosmetic product with their corresponding function and percentage (%) content
- Manufacturing Details
- Technical specifications of the finished cosmetic product and their corresponding test methods
- Product Stability
PIF Part IV – Safety and Efficacy Data
- Safety Assessment
- Record of Confirmed Adverse Events or Undesirable Effects on Human Health
- On-pack product claim support
What documents should be included in the Product Information File?
The following are the administrative documentation needed:
- Copy of the valid License to Operate (LTO) of the MAH
- Copy of the valid Distribution Agreement
- 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 Letter of Authorization from the Foreign Supplier is needed.
If the MAH is a Cosmetic Distributor (Importer) and the Foreign Supllier is not the manufacturer of the cosmetic product, the FAA or the Letter of Authorization from the Foreign Supplier and the Valid Supply Agrrement between the Foreign Supplier and the manufacturer or valid tripartite agreement betwn the MAH, Foreign Supplier and the manufacturer, should be included in the PIF.
Where should the PIF be kept?
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.
How long shall the PIF be kept?
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.
What happens when the PIF is incomplete?
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 FDA representatives during audit may be directly sent to the agency by the foreign supplier.
Apart from the foregoing documents, FDA reserves the right to request for additional product information needed to determine the product’s safety, quality and/or efficacy. MAH will also be given sufficient time, ranging from fifteen to sixty (15-60) calendar days, and depending on the urgency of the audit, to make the necessary arrangements with their suppliers.
What is the consequence of failure to maintain PIF?
Failure of the MAH to present the required PIF Part I or to comply within the agreed timeline may result to the institution of a legal action directed towards the notification of the subject cosmetic product. This may may lead to its cancellation and the corresponding product recall, when circumstances so warrant.
About Nicolas and De Vega Law Offices
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