菲律賓化妝品登記法規問題集
Email：mnl4ww@evershinecpa.com
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菲律賓永輝BPO有限公司
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HLF-ph-10
請問菲律賓對於化妝品的歸類方式為何？它的正式名稱為何？不同歸類管理強度有何差異?它的政府管轄機構為何？網頁？
What are the categories of cosmetics in Philippines? What is its official name? What is the intensity of management of different categories? What is the governmental authority of cosmetics? Website?
Evershine RD：
在菲律賓，化妝品由菲律賓食品藥品監督管理局(FDA)負責監督、實施化妝品通知和產品信息文件準備。
化妝品是任何旨在與人體外部或牙齒和口腔粘膜接觸的物質或製劑，用以清潔、添香、改變外觀和/或糾正體臭和/或保護或維持 人體的健康狀況。
In Philippines, the Philippine Food and Drug Administration (FDA) is responsible for cosmetic monitoring, implementing cosmetic notification and preparing product information documents.
Cosmetics are any substances or preparations intended to come into contact with the outside of the human body or the mucous membranes of the teeth and oral cavity to cleanse, perfume, alter the appearance and/or correct body odor and/or protect or maintain the health of the human body.
【參考連結】
https://www.fda.gov.ph/wp-content/uploads/2021/03/Administrative-Order-No.-2016-0003.pdf
HLF-ph-20
外國公司要到菲律賓銷售化妝品，無論設100%子公司或分公司，需要在公司登記時取得營業特許證？
假如要，其必要條件是什麼？所需文件及申請程序為何？網頁？
If a foreign company wants to sell cosmetics in Philippines, no matter if it sets up a 100% subsidiary or branch, does it need to obtain an approval from local health bureau before the company’s registration? If so, what are the requests? What are the required documents and application procedures? Website?
Evershine RD：
需要，在菲律賓從事化妝品的進出口、貿易、零售和分銷的企業需要從菲律賓食品藥物管理局(FDA)獲得經營許可證(LTO)及完成產品註冊。
化妝品機構經營許可證
1.申請人：在菲律賓從事化妝品的進出口、貿易、零售和分銷的當地企業。
2.申請網頁：https://eportal.fda.gov.ph/sysFDA_WorkFlow/en/neoclassic/login/login
申請文件
1. 綜合申請表(附有所有者/註冊人/總經理和授權人的身份證照片)。
2. 公證秘書證書/特別授權書(如果授權代表不是 DTI 商業登記的所有者或 SEC 的註冊人之一)。
3. 商業登記證明
．在貿易和工業部 (DTI) 的有效商業名稱註冊證書(適用於獨資企業)
．在證券交易委員會 (SEC) 和公司或合夥企業章程(對於公司或合夥企業)有效註冊。
4. 如果企業名稱與公司名稱不同，SEC 證書必須以機構名稱和風格開展業務。
．合作社發展局 (CDA) 證書適用於合作社。
．如果 DTI 商業登記和 SEC 中的商業地址與申報的辦公地址不同，請提供有效的市長許可。
5. 房屋證明(辦公室、製造廠和倉庫)
．轉讓產權證書 (TCT) 作為所有權證明。
．經公證的入住證明，如果由其中一家公司所有。
．經公證的有效租賃/轉租合同，如果所佔用的空間/建築物不屬於自己。
．房主協會 (HOA)/公寓/建築管理局的有效許可，如果在住宅區/公寓內。
．第三方物流的有效公證倉儲協議。
6. 其他要求
．平面圖/以米為單位的佈局和正確識別區域(辦公室和倉庫)
．製造工廠藍圖
．帶有地標的附近/位置圖(即谷歌地圖，該地區的草圖)
7. 授權人(藥劑師或任何受過相關培訓的聯合健康科學專業人員)的相關文件：
． 經公證的聯合承諾誓章(附有 2 x 2 授權人身份證照片)
．中國董事會證書
．有效的中華人民共和國身份證
．當前專業稅單 (PTR)
．由授權人員和直接主管簽署的職責和責任
．CCRR 的行業監管事務合格人員 (QPIRA)出席證明或出席承諾函(附有預定出席日期和付款證明)
．參加13 項東盟化妝品 GMP 模塊培訓的出席證明或出席的承諾函，附有預定出席日期和付款證明(僅適用於貿易商和製造商)
8.進口商特定要求
．產品清單：來源名稱和地址、製造商名稱和地址、原產國完整產品清單。
．有效的外國代理協議 (FAA) 或由菲律賓領事館正式認證的每個來源/供應商的任何形式的授權
．如果來源/供應商已指定另一家物流/開票公司，需提供以下任何一項：外國來源/供應商和製造商之間的有效供應協議、經菲律賓領事館正式認證的有效三方協議。
．製造商的 GMP 合規性證明(以下任何一項)：原產國政府機構或經認可的商業協會(WHO、ECC/EU、COLIPA)簽發的有效製造商GMP證書、如果製造商來自東盟成員國，則自我聲明符合 GMP、原產國政府機構(國家監管機構或商會)簽發的自由銷售證明、符合 GMP 的 ISO 證書、有效的製造商許可證。
9. 效期：LTO 有效期為 1 年(展延需在到期前3個月之前提出)。
Companies engaged in the import, export, trade, retail and distribution of cosmetics in the Philippines need to obtain a license to operate (LTO) from the Philippine Food and Drug Administration (FDA) and complete product registration.
Cosmetic Institution Business License
1. Applicants: Local businesses engaged in import, export, trade, retail and distribution of cosmetics in the Philippines.
2. Application webpage: https://eportal.fda.gov.ph/sysFDA_WorkFlow/en/neoclassic/login/login
Application documents
1. Consolidated application form (with ID photo of owner/registrant/general manager and authorizer).
2. Notary Secretary Certificate/Special Power of Attorney (if the authorized representative is not the owner of the DTI business register or one of the SEC registrants).
3. Business registration certificate
．Valid business name registration certificate with the Department of Trade and Industry (DTI) (for sole proprietorships)
．Be validly registered with the Securities and Exchange Commission (SEC) and the articles of incorporation (for corporations or partnerships) of the corporation or partnership.
4. If the business name is different from the company name, the SEC certificate must do business in the institutional name and style.
．Cooperative Development Authority (CDA) certificates are available for cooperatives.
．Provide a valid mayor’s permit if the business address on the DTI business register and SEC is different from the reported office address.
5. Proof of housing (office, manufacturing plant and warehouse)
．Certificate of Transferable Title (TCT) as proof of ownership.
．Notarized proof of occupancy, if owned by one of these companies.
．Notarized valid lease/sublease agreement if the space/building occupied is not owned by yourself.
．Valid permit from Home Owners Association (HOA)/Condo/Building Authority, if within a residential complex/condo.
．A valid notary warehousing agreement for a 3PL.
6. Other requirements
．Floor plan / layout in meters and correctly identified areas (offices and warehouses)
．Manufacturing Plant Blueprint
．Nearby/location map with landmarks (i.e. Google Maps, sketches of the area)
7. Relevant documents of the authorized person (pharmacist or any relevant trained allied health science professional):
．Notarized Affidavit of Joint Commitment (with 2 x 2 ID photo of authorizer)
．China board certificate
．Valid PRC ID card
．Current Professional Tax Return (PTR)
．Duties and Responsibilities Signed Off by Authorized Persons and Immediate Supervisors
．CCRR’s Qualified Personnel for Industry Regulatory Affairs (QPIRA) Certificate of Attendance or Letter of Commitment of Attendance (with scheduled attendance date and proof of payment)
．Proof of attendance or letter of commitment to attend 13 ASEAN Cosmetics GMP module trainings with scheduled attendance date and proof of payment (for traders and manufacturers only)
8. Importer specific requirements
．Product list: source name and address, manufacturer’s name and address, complete product list by country of origin.
．A valid Foreign Agent Agreement (FAA) or any form of authorization for each source/supplier duly certified by the Philippine Consulate
．If the source/supplier has designated another logistics/billing company, either: A valid supply agreement between the foreign source/supplier and the manufacturer, a valid tripartite agreement duly certified by the Philippine Consulate.
．Manufacturer’s certificate of GMP compliance (any of the following): Valid manufacturer’s GMP certificate issued by a government agency or recognized business association (WHO, ECC/EU, COLIPA) in the country of origin, if the manufacturer is from an ASEAN member state , the self-declaration of compliance with GMP, a certificate of free sale issued by a government agency in the country of origin (national regulatory agency or chamber of commerce), an ISO certificate in compliance with GMP, and a valid manufacturer’s license.
9. Validity period: LTO is valid for 1 year (extensions must be made 3 months before the expiration date).
【參考連結】
https://www.fda.gov.ph/downloadables/
HLF-ph-25
HLF-ph-30
外國公司要到菲律賓銷售化妝品，可以指派菲律賓公司擔任營業代理人銷售嗎? 擔任營業代理人，其必要條件是什麼？
所需文件及申請程序為何？外國公司與營業代理人的產品責任為何?網頁？
If a foreign company wants to sell cosmetics in Philippines, can it assign a Philippines company to act as a business agent?
What are the requests for acting as a business agent? What are the required documents and application procedures?
What is the product liability of foreign companies and the business agents? Website?
Evershine RD：
可以。在菲律賓從事化妝品的進出口、貿易、零售和分銷的企業，需以當地企業名義從菲律賓食品藥物管理局(FDA)獲得經營許可證(LTO)及完成產品註冊。
化妝品機構經營許可證
1.申請人：在菲律賓從事化妝品的進出口、貿易、零售和分銷的當地企業。
2.申請網頁：https://eportal.fda.gov.ph/sysFDA_WorkFlow/en/neoclassic/login/login
申請文件
1. 綜合申請表(附有所有者/註冊人/總經理和授權人的身份證照片)。
2. 公證秘書證書/特別授權書(如果授權代表不是 DTI 商業登記的所有者或 SEC 的註冊人之一)。
3. 商業登記證明
．在貿易和工業部 (DTI) 的有效商業名稱註冊證書(適用於獨資企業)
．在證券交易委員會 (SEC) 和公司或合夥企業章程(對於公司或合夥企業)有效註冊。
4. 如果企業名稱與公司名稱不同，SEC 證書必須以機構名稱和風格開展業務。
．合作社發展局 (CDA) 證書適用於合作社。
．如果 DTI 商業登記和 SEC 中的商業地址與申報的辦公地址不同，請提供有效的市長許可。
5. 房屋證明(辦公室、製造廠和倉庫)
．轉讓產權證書 (TCT) 作為所有權證明。
．經公證的入住證明，如果由其中一家公司所有。
．經公證的有效租賃/轉租合同，如果所佔用的空間/建築物不屬於自己。
．房主協會 (HOA)/公寓/建築管理局的有效許可，如果在住宅區/公寓內。
．第三方物流的有效公證倉儲協議。
6. 其他要求
．平面圖/以米為單位的佈局和正確識別區域(辦公室和倉庫)
．製造工廠藍圖
．帶有地標的附近/位置圖(即谷歌地圖，該地區的草圖)
7. 授權人(藥劑師或任何受過相關培訓的聯合健康科學專業人員)的相關文件：
． 經公證的聯合承諾誓章(附有 2 x 2 授權人身份證照片)
．中國董事會證書
．有效的中華人民共和國身份證
．當前專業稅單 (PTR)
．由授權人員和直接主管簽署的職責和責任
．CCRR 的行業監管事務合格人員 (QPIRA)出席證明或出席承諾函(附有預定出席日期和付款證明)
．參加13 項東盟化妝品 GMP 模塊培訓的出席證明或出席的承諾函，附有預定出席日期和付款證明(僅適用於貿易商和製造商)
8.進口商特定要求
．產品清單：來源名稱和地址、製造商名稱和地址、原產國完整產品清單。
．有效的外國代理協議 (FAA) 或由菲律賓領事館正式認證的每個來源/供應商的任何形式的授權
．如果來源/供應商已指定另一家物流/開票公司，需提供以下任何一項：外國來源/供應商和製造商之間的有效供應協議、經菲律賓領事館正式認證的有效三方協議。
．製造商的 GMP 合規性證明(以下任何一項)：原產國政府機構或經認可的商業協會(WHO、ECC/EU、COLIPA)簽發的有效製造商GMP證書、如果製造商來自東盟成員國，則自我聲明符合 GMP、原產國政府機構(國家監管機構或商會)簽發的自由銷售證明、符合 GMP 的 ISO 證書、有效的製造商許可證。
9. 效期：LTO 有效期為 1 年(展延需在到期前3個月之前提出)。
化妝品不良事件
1.負責將化妝品投放市場的公司應向菲律賓食品藥物管理局(FDA)報告，無論報告的來源(消費者、醫療保健專業人員等)如何。
2. 報告內容
．每例嚴重不良事件：應報告所有嚴重的不良事件。不要求報告非嚴重不良事件。只要合理懷疑化妝品可能是引起反應的原因，就必須報告。
．合理懷疑一詞一般意指有證據表明存在因果關係或關聯。
．在向監管機構報告之前，應對每一種非嚴重、單一嚴重不良反應發生率高的情況進行適當的醫學和科學判斷。
3. 報告時間
．致命或危及生命的不良事件應盡快向監管機構報告(例如通過電話、傳真、電子郵件或書面形式)，但不得遲於 7 個日曆日，然後在另外 8 個日曆日內填寫不良化妝品事件報告表，並提供監管機構可能要求的任何其他信息。
．其他嚴重不良事件：所有其他非致命或不危及生命的嚴重不良事件必須盡快報告，但不得遲於首次發現後 15 個日曆日。
4. 化妝品不良事件報告表
．公司資料：姓名和地址、公司、報告人的姓名和指定電話號碼、 傳真號碼、電子郵件。
．產品詳情：產品名稱(如產品通知)、成分列表和包裝尺寸(請附上單獨的列表)、產品類型/預期用途、製造商名稱和製造國、到期或生產日期、批號。
．不良事件詳情：姓名/姓名首字母、身份證或護照號碼、年齡性別、民族/國籍、不良事件發生日期。
．不良事件描述(如有必要，請使用並附上單獨的報告)：上次使用該產品與出現症狀之間的延遲：產品是如何使用的：該人是否因不良反應住院?是否就醫?結果。
Yes. Companies engaged in the import, export, trade, retail and distribution of cosmetics in the Philippines need to obtain a license to operate (LTO) from the Philippine Food and Drug Administration (FDA) and complete product registration in the name of the local company.
Cosmetic Institution Business License
1. Applicants: Local businesses engaged in import, export, trade, retail and distribution of cosmetics in the Philippines.
2. Application webpage: https://eportal.fda.gov.ph/sysFDA_WorkFlow/en/neoclassic/login/login
Application documents
1. Consolidated application form (with ID photo of owner/registrant/general manager and authorizer).
2. Notary Secretary Certificate/Special Power of Attorney (if the authorized representative is not the owner of the DTI business register or one of the SEC registrants).
3. Business registration certificate
．Valid business name registration certificate with the Department of Trade and Industry (DTI) (for sole proprietorships)
．Be validly registered with the Securities and Exchange Commission (SEC) and the articles of incorporation (for corporations or partnerships) of the corporation or partnership.
4. If the business name is different from the company name, the SEC certificate must do business in the institutional name and style.
．Cooperative Development Authority (CDA) certificates are available for cooperatives.
．Provide a valid mayor’s permit if the business address on the DTI business register and SEC is different from the reported office address.
5. Proof of housing (office, manufacturing plant and warehouse)
．Certificate of Transferable Title (TCT) as proof of ownership.
．Notarized proof of occupancy, if owned by one of these companies.
．Notarized valid lease/sublease agreement if the space/building occupied is not owned by yourself.
．Valid permit from Home Owners Association (HOA)/Condo/Building Authority, if within a residential complex/condo.
．A valid notary warehousing agreement for a 3PL.
6. Other requirements
．Floor plan / layout in meters and correctly identified areas (offices and warehouses)
．Manufacturing Plant Blueprint
．Nearby/location map with landmarks (i.e. Google Maps, sketches of the area)
7. Relevant documents of the authorized person (pharmacist or any relevant trained allied health science professional):
．Notarized Affidavit of Joint Commitment (with 2 x 2 ID photo of authorizer)
．China board certificate
．Valid PRC ID card
．Current Professional Tax Return (PTR)
．Duties and Responsibilities Signed Off by Authorized Persons and Immediate Supervisors
．CCRR’s Qualified Personnel for Industry Regulatory Affairs (QPIRA) Certificate of Attendance or Letter of Commitment of Attendance (with scheduled attendance date and proof of payment)
．Proof of attendance or letter of commitment to attend 13 ASEAN Cosmetics GMP module trainings with scheduled attendance date and proof of payment (for traders and manufacturers only)
8. Importer specific requirements
．Product list: source name and address, manufacturer’s name and address, complete product list by country of origin.
．A valid Foreign Agent Agreement (FAA) or any form of authorization for each source/supplier duly certified by the Philippine Consulate
．If the source/supplier has designated another logistics/billing company, either: A valid supply agreement between the foreign source/supplier and the manufacturer, a valid tripartite agreement duly certified by the Philippine Consulate.
．Manufacturer’s certificate of GMP compliance (any of the following): Valid manufacturer’s GMP certificate issued by a government agency or recognized business association (WHO, ECC/EU, COLIPA) in the country of origin, if the manufacturer is from an ASEAN member state , the self-declaration of compliance with GMP, a certificate of free sale issued by a government agency in the country of origin (national regulatory agency or chamber of commerce), an ISO certificate in compliance with GMP, and a valid manufacturer’s license.
9. Validity period: LTO is valid for 1 year (extensions must be made 3 months before the expiration date).
Cosmetic Adverse Events
1. Companies responsible for placing cosmetic products on the market should report to the Philippine Food and Drug Administration (FDA) regardless of the source of the report (consumers, healthcare professionals, etc.).
2. Report content
．Per Serious Adverse Event: All serious adverse events should be reported. Reports of non-serious adverse events are not required. It must be reported whenever there is a reasonable suspicion that the cosmetic product may have been the cause of the reaction.
．The term reasonable doubt generally means that there is evidence of causation or association.
．Appropriate medical and scientific judgment should be exercised for each condition with a high incidence of non-serious, single serious adverse reactions before reporting to a regulatory agency.
3. Time of reporting
．Fatal or life-threatening adverse events should be reported to the regulatory agency as soon as possible (e.g. by telephone, fax, email, or in writing) but no later than 7 calendar days, followed by an additional 8 calendar days to complete the Adverse Cosmetic Event Reporting Form, and provide any other information that regulators may require.
．Other Serious Adverse Events: All other non-fatal or non-life-threatening serious adverse events must be reported as soon as possible, but no later than 15 calendar days after first discovery.
4. Cosmetic Adverse Event Report Form
．Company information: name and address, company, name and designated telephone number, fax number, e-mail of the reporting person.
．Product Details: Product name (e.g. product notification), ingredient list and package size (please attach a separate list), product type/intended use, manufacturer’s name and country of manufacture, expiry or production date, batch number.
．Adverse event details: name/initial, ID or passport number, age, gender, ethnicity/nationality, date of adverse event.
．Description of adverse events (use and attach a separate report if necessary): Delay between last use of the product and onset of symptoms: How the product was used: Was the person hospitalized for the adverse reaction? Was the person sought medical attention? Results.
【參考連結】
https://www.fda.gov.ph/wp-content/uploads/2021/03/Adverse-Event-Reporting-System.pdf
https://www.fda.gov.ph/downloadables/#
HLF-ph-35
HLF-ph-40
外國公司銷售到菲律賓化妝品本身，進口前需要辦理產品許可嗎？如需要，哪個單位在管理？需要什麼文件？
申請程序為何？化妝品包裝內容及各種標示，需要事先核准嗎？可允許的語文有哪些？網頁？
Do foreign companies need to apply for an approval before importing cosmetics sold to Philippines? If yes, which authority is in charge? What documents are required?
What is the application process? Do cosmetics packaging and labeling require prior approval? Which languages are allowed? Website?
Evershine RD：
負責將化妝品投放市場的當地公司應在於FDA註冊並於產品投放市場前提交通知(化妝品電子通知) 。
化妝品電子通知
1.申請人：負責將化妝品投放市場的當地公司。
2.申請網頁：FDA 電子門戶https://ww2.fda.gov.ph
3.流程
．向info@fda.gov.ph發送請求並提供以下信息：電子郵件地址(最好是公司電子郵件地址)、姓名、聯繫方式、公司名稱、公司地址、產品分類：化妝品。
．登錄FDA 電子門戶。
．選擇新案例並填寫東盟通知表。
．付款。
．如果獲得批准，請下載並列印確認通知。
．獲得通知證書。(初次提交，通知的有效期最長為 1 至 3 年，由申請人選擇。
文件不足的人將收到一份缺陷通知，要求對某些細節進行澄清或進一步解釋，任何宣布虛假或誤導性信息的公司都會收到拒絕信。)
4.申請填寫內容
．公司的有效 LTO 編號。
．製造國、供應商詳細信息(如果適用)。
．確保提供的信息與公司當前有效的 LTO 一致。
．代表公司的人員的姓名和職務。
．產品成分：申請化妝品的完整成分清單、配方中限制成分的作用和百分比。
．在產品通知中聲明的信息：品牌、產品名稱、產品型號、產品類型、預期用途、產品介紹、負責將化妝品投放市場的當地公司、機構信息、當地公司代表、產品成分清單。
．產品信息文件 (PIF)：菲律賓遵守東盟化妝品指令 (ACD)，該指令要求將產品投放市場的個人或公司保持產品信息文件易於相關成員國的監管機構訪問。該文件可以列印或電子化，每次公司決定更改通知產品的任何方面時都應更新。
化妝品標籤
1. 化妝品外包裝或無外包裝的化妝品直接包裝上應標註以下內容：
．化妝品的名稱及其功能，除非從產品的介紹中可以清楚地看出。
．化妝品的使用說明，除非從產品名稱或外觀中明確顯示。
．完整的成分列表，成分必須在添加時按重量降序聲明。香水完整的成分必須在添加時按重量降序聲明，香水和芳香組合物及其原料可以用香水、香精、香氣或香精一詞來替代；濃度小於 1% 的成分可以在濃度大於 1% 的成分之後以任意順序列出；著色劑可以採用顏色索引號或名稱，在其他成分之後以任意順序列出；對於以多種色調銷售的裝飾性化妝品，可以列出該範圍內使用的所有著色劑，前提是添加術語可能包含或+/-。成分應使用最新標準中的命名法來指定；植物藥和植物藥提取物應按其屬和種進行鑑別，屬性可以縮寫，但是，以下不應被視為成分：所用原材料中的雜質、用於製備但不存在於最終產品中的輔助技術材料、用作香料和芳香劑組合物的溶劑或載體的材料，其數量是絕對必要的．製造國。
．負責將產品投放當地市場的公司名稱和地址。
．以公製或公制和英制的重量或體積表示的內容物。
．製造批號。
．產品的製造日期或有效期，以明確的方式表示(例如月/年)，並應按月和年或日月和年的順序組成。最低保質期應為該產品在適當條件下儲存後繼續發揮其初始功能的日期。對於最短保質期少於 30 個月的化妝品，必須註明有效期。
．使用中應遵守的特殊注意事項，尤其是使用條件和警告一欄中的內容必須列在列在附件上，以及化妝品上的任何特殊注意事項。產品標籤上必須有(任何格式的)聲明，表明存在動物源性成分；對於牛或豬來源的成分，必須聲明確切的動物。
．如果容器或包裝的尺寸、形狀或性質不允許展示規定的細節，則使用傳單、小冊子、吊牌、展示板、 應允許使用收縮包裝等。 但是，至少應在小的直接包裝上出現以下細節：化妝品名稱、製造批號。
．細節應易於閱讀、清楚理解和不可磨滅。
．詳細信息應以英語和/或國家語言和/或產品銷售地消費者理解的語言顯示，菲律賓的官方語言是菲語、英語。
．用於化妝品成分命名法的標準參考文件：國際化妝品成分詞典、英國藥典、美國藥典、化學文摘服務。
Local companies responsible for placing cosmetic products on the market should register with the FDA and submit a notification (electronic cosmetic notification) prior to placing the product on the market.
Cosmetics electronic notification
1. Applicant: The local company responsible for placing the cosmetics on the market.
2. Application web page: FDA e-portal https://ww2.fda.gov.ph
3. Process
．Send a request to info@fda.gov.ph with the following information: email address (preferably a company email address), name, contact details, company name, company address, product category: cosmetic.
．Log in to the FDA electronic portal.
．Select a new case and fill out the ASEAN Notification Form.
．Payment.
．If approved, download and print the confirmation notice.
．Get a notification certificate. (Initial submission, notices are valid for up to 1 to 3 years at the applicant’s option. Those with insufficient documentation will receive a notice of deficiencies requesting clarification or further explanation of certain details, any declaration of false or misleading information Companies receive rejection letters.)
4. Application to fill in the content
．A valid LTO number for the company.
．Country of manufacture, supplier details (if applicable).
．Ensure that the information provided is consistent with the company’s current LTO in effect.
．The name and title of the person representing the company.
．Product ingredients: Apply for the complete ingredient list of cosmetic products, the role and percentage of restricted ingredients in the formula.
．Information declared in a product notification: brand, product name, product model, product type, intended use, product description, local company responsible for placing the cosmetic product on the market, agency information, local company representative, list of product ingredients.
．Product Information File (PIF): The Philippines complies with the ASEAN Cosmetics Directive (ACD), which requires individuals or companies placing products on the market to keep product information files easily accessible to regulatory agencies in the relevant member states. This document can be printed or electronic and should be updated every time the company decides to change any aspect of the notification product.
Cosmetic Labels
1. The outer packaging of cosmetics or the direct packaging of cosmetics without outer packaging shall be marked with the following contents:
．The name of the cosmetic and its function, unless it is clear from the description of the product.
．Instructions for use of cosmetic products, unless clearly indicated from the product name or appearance.
．Full ingredient list, ingredients must be declared in descending order of weight when added. Fragrance complete ingredients must be declared in descending order of weight when added, perfumes and fragrance compositions and their raw materials may be replaced by the words perfume, essence, aroma or essence; ingredients with a concentration of less than 1% may be followed by ingredients with a concentration of greater than 1% List in any order; colorants may be listed by color index number or name in any order after other ingredients; for decorative cosmetic products sold in multiple shades, all colorants used in the range may be listed, provided that Added terms may contain or +/-. Ingredients should be specified using the nomenclature in the latest standard; botanicals and botanical extracts should be identified by their genus and species, attributes may be abbreviated, however, the following should not be considered ingredients: impurities in the raw materials used, Auxiliary technical materials that are prepared but not present in the final product, materials used as solvents or carriers for perfume and fragrance compositions, are absolutely necessary in quantities. country of manufacture.
．Name and address of the company responsible for placing the product on the local market.
．Contents expressed in weight or volume in metric or metric and imperial.
．Manufacturing batch number.
．The date of manufacture or expiry date of the product, expressed in an unambiguous manner (eg month/year) and shall consist of month and year or day month and year order. The minimum shelf life should be the date the product will continue to perform its original function after storage under appropriate conditions. For cosmetic products with a minimum shelf life of less than 30 months, an expiration date must be indicated.
．Special precautions to be observed in use, especially those in the columns Conditions of Use and Warnings, must be listed on the attachment, as well as any special precautions on cosmetic products. There must be a statement (in any format) on the product label indicating the presence of ingredients of animal origin; for ingredients of bovine or porcine origin, the exact animal must be declared.
．If the size, shape or nature of the container or packaging does not allow the display of the specified details, use of leaflets, brochures, hang tags, display boards, shrink wrapping etc. shall be permitted. However, at least the following details should appear on the small direct packaging: cosmetic name, manufacturing lot number.
．Details should be easy to read, clearly understood and indelible.
．Details shall be displayed in English and/or the national language and/or language understood by the consumer in the place where the product is sold, the official languages of the Philippines are Filipino, English.
．Standard reference documents for cosmetic ingredient nomenclature: International Cosmetic Ingredient Dictionary, British Pharmacopoeia, United States Pharmacopoeia, Chemical Abstracts Service.
【參考連結】
https://www.fda.gov.ph/wp-content/uploads/2021/07/Appendix-II-Labeling-Requirements.pdf
https://www.fda.gov.ph/downloadables/
HLF-ph-45
HLF-ph-50
外國公司可以用自己名義申請辦理產品許可嗎？如需要，哪個單位在管理？
需要什麼文件？申請程序為何？化妝品包裝內容及各種標示，需要事先核准嗎？可允許的語文有哪些？網頁？
Can a foreign company apply for a product license by its own name? If yes, which authority is in charge? What documents are required? What is the application process? Do cosmetics packaging and labeling require prior approval? Which languages are allowed? Website?
Evershine RD：
在菲律賓從事化妝品的進出口、貿易、零售和分銷的企業，需以當地企業名義從菲律賓食品藥物管理局(FDA)獲得經營許可證(LTO)及完成產品註冊。
化妝品機構經營許可證
1.申請人：在菲律賓從事化妝品的進出口、貿易、零售和分銷的當地企業。
2.申請網頁：https://eportal.fda.gov.ph/sysFDA_WorkFlow/en/neoclassic/login/login
申請文件
1. 綜合申請表(附有所有者/註冊人/總經理和授權人的身份證照片)。
2. 公證秘書證書/特別授權書(如果授權代表不是 DTI 商業登記的所有者或 SEC 的註冊人之一)。
3. 商業登記證明
．在貿易和工業部 (DTI) 的有效商業名稱註冊證書(適用於獨資企業)
．在證券交易委員會 (SEC) 和公司或合夥企業章程(對於公司或合夥企業)有效註冊。
4. 如果企業名稱與公司名稱不同，SEC 證書必須以機構名稱和風格開展業務。
．合作社發展局 (CDA) 證書適用於合作社。
．如果 DTI 商業登記和 SEC 中的商業地址與申報的辦公地址不同，請提供有效的市長許可。
5. 房屋證明(辦公室、製造廠和倉庫)
．轉讓產權證書 (TCT) 作為所有權證明。
．經公證的入住證明，如果由其中一家公司所有。
．經公證的有效租賃/轉租合同，如果所佔用的空間/建築物不屬於自己。
．房主協會 (HOA)/公寓/建築管理局的有效許可，如果在住宅區/公寓內。
．第三方物流的有效公證倉儲協議。
6. 其他要求
．平面圖/以米為單位的佈局和正確識別區域(辦公室和倉庫)
．製造工廠藍圖
．帶有地標的附近/位置圖(即谷歌地圖，該地區的草圖)
7. 授權人(藥劑師或任何受過相關培訓的聯合健康科學專業人員)的相關文件：
． 經公證的聯合承諾誓章(附有 2 x 2 授權人身份證照片)
．中國董事會證書
．有效的中華人民共和國身份證
．當前專業稅單 (PTR)
．由授權人員和直接主管簽署的職責和責任
．CCRR 的行業監管事務合格人員 (QPIRA)出席證明或出席承諾函(附有預定出席日期和付款證明)
．參加13 項東盟化妝品 GMP 模塊培訓的出席證明或出席的承諾函，附有預定出席日期和付款證明(僅適用於貿易商和製造商)
8.進口商特定要求
．產品清單：來源名稱和地址、製造商名稱和地址、原產國完整產品清單。
．有效的外國代理協議 (FAA) 或由菲律賓領事館正式認證的每個來源/供應商的任何形式的授權
．如果來源/供應商已指定另一家物流/開票公司，需提供以下任何一項：外國來源/供應商和製造商之間的有效供應協議、經菲律賓領事館正式認證的有效三方協議。
．製造商的 GMP 合規性證明(以下任何一項)：原產國政府機構或經認可的商業協會(WHO、ECC/EU、COLIPA)簽發的有效製造商GMP證書、如果製造商來自東盟成員國，則自我聲明符合 GMP、原產國政府機構(國家監管機構或商會)簽發的自由銷售證明、符合 GMP 的 ISO 證書、有效的製造商許可證。
9. 效期：LTO 有效期為 1 年(展延需在到期前3個月之前提出)。
化妝品標籤
1. 化妝品外包裝或無外包裝的化妝品直接包裝上應標註以下內容：
．化妝品的名稱及其功能，除非從產品的介紹中可以清楚地看出。
．化妝品的使用說明，除非從產品名稱或外觀中明確顯示。
．完整的成分列表，成分必須在添加時按重量降序聲明。香水完整的成分必須在添加時按重量降序聲明，香水和芳香組合物及其原料可以用香水、香精、香氣或香精一詞來替代；濃度小於 1% 的成分可以在濃度大於 1% 的成分之後以任意順序列出；著色劑可以採用顏色索引號或名稱，在其他成分之後以任意順序列出；對於以多種色調銷售的裝飾性化妝品，可以列出該範圍內使用的所有著色劑，前提是添加術語可能包含或+/-。成分應使用最新標準中的命名法來指定；植物藥和植物藥提取物應按其屬和種進行鑑別，屬性可以縮寫，但是，以下不應被視為成分：所用原材料中的雜質、用於製備但不存在於最終產品中的輔助技術材料、用作香料和芳香劑組合物的溶劑或載體的材料，其數量是絕對必要的．製造國。
．負責將產品投放當地市場的公司名稱和地址。
．以公製或公制和英制的重量或體積表示的內容物。
．製造批號。
．產品的製造日期或有效期，以明確的方式表示(例如月/年)，並應按月和年或日月和年的順序組成。最低保質期應為該產品在適當條件下儲存後繼續發揮其初始功能的日期。對於最短保質期少於 30 個月的化妝品，必須註明有效期。
．使用中應遵守的特殊注意事項，尤其是使用條件和警告一欄中的內容必須列在列在附件上，以及化妝品上的任何特殊注意事項。產品標籤上必須有(任何格式的)聲明，表明存在動物源性成分；對於牛或豬來源的成分，必須聲明確切的動物。
．如果容器或包裝的尺寸、形狀或性質不允許展示規定的細節，則使用傳單、小冊子、吊牌、展示板、 應允許使用收縮包裝等。
但是，至少應在小的直接包裝上出現以下細節：化妝品名稱、製造批號。
．細節應易於閱讀、清楚理解和不可磨滅。
．詳細信息應以英語和/或國家語言和/或產品銷售地消費者理解的語言顯示，菲律賓的官方語言是菲語、英語。
．用於化妝品成分命名法的標準參考文件：國際化妝品成分詞典、英國藥典、美國藥典、化學文摘服務。
Companies engaged in the import, export, trade, retail and distribution of cosmetics in the Philippines need to obtain a license to operate (LTO) from the Philippine Food and Drug Administration (FDA) and complete product registration in the name of the local company.
Cosmetic Institution Business License
1. Applicants: Local businesses engaged in import, export, trade, retail and distribution of cosmetics in the Philippines.
2. Application webpage: https://eportal.fda.gov.ph/sysFDA_WorkFlow/en/neoclassic/login/login
Application documents
1. Consolidated application form (with ID photo of owner/registrant/general manager and authorizer).
2. Notary Secretary Certificate/Special Power of Attorney (if the authorized representative is not the owner of the DTI business register or one of the SEC registrants).
3. Business registration certificate
．Valid business name registration certificate with the Department of Trade and Industry (DTI) (for sole proprietorships)
．Be validly registered with the Securities and Exchange Commission (SEC) and the articles of incorporation (for corporations or partnerships) of the corporation or partnership.
4. If the business name is different from the company name, the SEC certificate must do business in the institutional name and style.
．Cooperative Development Authority (CDA) certificates are available for cooperatives.
．Provide a valid mayor’s permit if the business address on the DTI business register and SEC is different from the reported office address.
5. Proof of housing (office, manufacturing plant and warehouse)
．Certificate of Transferable Title (TCT) as proof of ownership.
．Notarized proof of occupancy, if owned by one of these companies.
．Notarized valid lease/sublease agreement if the space/building occupied is not owned by yourself.
．Valid permit from Home Owners Association (HOA)/Condo/Building Authority, if within a residential complex/condo.
．A valid notary warehousing agreement for a 3PL.
6. Other requirements
．Floor plan / layout in meters and correctly identified areas (offices and warehouses)
．Manufacturing Plant Blueprint
．Nearby/location map with landmarks (i.e. Google Maps, sketches of the area)
7. Relevant documents of the authorized person (pharmacist or any relevant trained allied health science professional):
．Notarized Affidavit of Joint Commitment (with 2 x 2 ID photo of authorizer)
．China board certificate
．Valid PRC ID card
．Current Professional Tax Return (PTR)
．Duties and Responsibilities Signed Off by Authorized Persons and Immediate Supervisors
．CCRR’s Qualified Personnel for Industry Regulatory Affairs (QPIRA) Certificate of Attendance or Letter of Commitment of Attendance (with scheduled attendance date and proof of payment)
．Proof of attendance or letter of commitment to attend 13 ASEAN Cosmetics GMP module trainings with scheduled attendance date and proof of payment (for traders and manufacturers only)
8. Importer specific requirements
．Product list: source name and address, manufacturer’s name and address, complete product list by country of origin.
．A valid Foreign Agent Agreement (FAA) or any form of authorization for each source/supplier duly certified by the Philippine Consulate
．If the source/supplier has designated another logistics/billing company, either: A valid supply agreement between the foreign source/supplier and the manufacturer, a valid tripartite agreement duly certified by the Philippine Consulate.
．Manufacturer’s certificate of GMP compliance (any of the following): Valid manufacturer’s GMP certificate issued by a government agency or recognized business association (WHO, ECC/EU, COLIPA) in the country of origin, if the manufacturer is from an ASEAN member state , the self-declaration of compliance with GMP, a certificate of free sale issued by a government agency in the country of origin (national regulatory agency or chamber of commerce), an ISO certificate in compliance with GMP, and a valid manufacturer’s license.
9. Validity period: LTO is valid for 1 year (extensions must be made 3 months before the expiration date).
Cosmetic Labels
1. The outer packaging of cosmetics or the direct packaging of cosmetics without outer packaging shall be marked with the following contents:
．The name of the cosmetic and its function, unless it is clear from the description of the product.
．Instructions for use of cosmetic products, unless clearly indicated from the product name or appearance.
．Full ingredient list, ingredients must be declared in descending order of weight when added. Fragrance complete ingredients must be declared in descending order of weight when added, perfumes and fragrance compositions and their raw materials may be replaced by the words perfume, essence, aroma or essence; ingredients with a concentration of less than 1% may be followed by ingredients with a concentration of greater than 1% List in any order; colorants may be listed by color index number or name in any order after other ingredients; for decorative cosmetic products sold in multiple shades, all colorants used in the range may be listed, provided that Added terms may contain or +/-. Ingredients should be specified using the nomenclature in the latest standard; botanicals and botanical extracts should be identified by their genus and species, attributes may be abbreviated, however, the following should not be considered ingredients: impurities in the raw materials used, Auxiliary technical materials that are prepared but not present in the final product, materials used as solvents or carriers for perfume and fragrance compositions, are absolutely necessary in quantities. country of manufacture.
．Name and address of the company responsible for placing the product on the local market.
．Contents expressed in weight or volume in metric or metric and imperial.
．Manufacturing batch number.
．The date of manufacture or expiry date of the product, expressed in an unambiguous manner (eg month/year) and shall consist of month and year or day month and year order. The minimum shelf life should be the date the product will continue to perform its original function after storage under appropriate conditions. For cosmetic products with a minimum shelf life of less than 30 months, an expiration date must be indicated.
．Special precautions to be observed in use, especially those in the columns Conditions of Use and Warnings, must be listed on the attachment, as well as any special precautions on cosmetic products. There must be a statement (in any format) on the product label indicating the presence of ingredients of animal origin; for ingredients of bovine or porcine origin, the exact animal must be declared.
．If the size, shape or nature of the container or packaging does not allow the display of the specified details, use of leaflets, brochures, hang tags, display boards, shrink wrapping etc. shall be permitted. However, at least the following details should appear on the small direct packaging: cosmetic name, manufacturing lot number.
．Details should be easy to read, clearly understood and indelible.
．Details shall be displayed in English and/or the national language and/or language understood by the consumer in the place where the product is sold, the official languages of the Philippines are Filipino, English.
．Standard reference documents for cosmetic ingredient nomenclature: International Cosmetic Ingredient Dictionary, British Pharmacopoeia, United States Pharmacopoeia, Chemical Abstracts Service.
【參考連結】
https://www.fda.gov.ph/wp-content/uploads/2021/07/Appendix-II-Labeling-Requirements.pdf
https://www.fda.gov.ph/downloadables/
HLF-ph-55
HLF-ph-60
經過核准登記的化妝品，進口到菲律賓要檢附什麼文件？經過什麼手續？
在銷售時要向各地的衛生福利部相關機構事先或事後準備嗎？網頁？
What documents are required when importing approved cosmetics into Philippines? What is the procedure?
Any preparation is required to submit to the Ministry of Health and Welfare for selling products? Website?
Evershine RD：
海關
1.進口商企業首先需要取得國稅局的進口清關證書，然後進口商在海關局 (BOC) 註冊，並在客戶資料註冊系統 (CPRS) 上開設一個帳戶。
2.進口清關證書有效期為三年，而海關客戶資料認證必須每年更新。CPRS 認證費用為 P1000(20 美元)，通常需要 15 個工作日來處理。
3. 菲律賓海關對進口商品徵收 12% 的增值稅 (VAT)，對價值低於 P10,000(200 美元)的商品不徵收關稅或稅款。
4.進口到菲律賓的企業在貨物到達時必須提供以下文件：
．打包清單。
．發票。
．提貨單。
．進口許可證。
．海關進口申報。
．原產地證書。
．食品和藥物管理局的產品註冊證書。
．經正式公證的估價補充聲明 (SDV) 。
．自由貿易協定 (FTA) 的原產地證明。
．貨物報關單。
．稅收抵免證書 (TCC) 或稅收借記通知單 (TDM)(如果適用) 。
5. 進口文件
．提單/空運提單，或船舶或飛機的承運人或代理人的證明。
．商業發票、信用證或任何其他可證明付款的商業文件。
．表明貨物商業價值的商業文件。
6. 對於信用證 (L/C) 交易，需要正式完成的信用證，包括形式發票和預先海關進口關稅的單一行政文件 (SAD)。
非信用證交易需要形式發票，例如承兌匯票 (D/A)、付款單據 D/P)、開立賬戶 (OA) 或自籌資金文件。
7.文件必須連同報關人和報關行(如有)簽署並公證的 SAD 打印件一起提交給海關正式入境處 (FED) 或其同等辦公室或單位。
Without a sales notification, the local company responsible for placing a cosmetic on the market should register with the FDA and submit a cosmetic electronic notification prior to placing the product on the market.
Customs
1. The importer business first needs to obtain the import clearance certificate from the Internal Revenue Service, and then the importer registers with the Bureau of Customs (BOC) and opens an account on the Customer Data Registration System (CPRS).
2. The import customs clearance certificate is valid for three years, and the customs customer data certification must be updated every year. CPRS certification costs P1000 ($20) and usually takes 15 business days to process.
3. Philippine Customs imposes a 12% Value Added Tax (VAT) on imported goods and no duties or taxes are levied on goods valued below P10,000 (US$200).
4. Enterprises importing into the Philippines must provide the following documents upon arrival of the goods:
．Packing list.
．Bill.
．Bill of lading.
．Import permit.
．Customs Import Declaration.
．Certificate of Origin.
．Product Registration Certificate from FDA.
．Duly notarized Supplemental Statement of Valuation (SDV).
．Free Trade Agreement (FTA) certificate of origin.
．Goods declaration.
．Tax Credit Certificate (TCC) or Tax Debit Notice (TDM) (if applicable).
5. Import Documentation
．Bill of lading/air waybill, or proof of the carrier or agent of the ship or aircraft.
．Commercial Invoice, Letter of Credit or any other commercial document to demonstrate payment.
．Commercial documents indicating the commercial value of the goods.
6. For Letter of Credit (L/C) transactions, a duly completed letter of credit including pro forma invoice and Single Administrative Document (SAD) with pre-customs import duties is required. Non-L/C transactions require pro forma invoices, such as drafts of acceptance (D/A), payment documents (D/P), opening of accounts (OA), or self-funding documents.
7. Documents must be submitted to the Customs Official Entry Division (FED) or its equivalent office or unit together with a signed and notarized SAD printout of the customs broker and the customs broker (if any).
【參考連結】
https://customs.gov.ph/wp-content/uploads/2016/09/Import-Transaction-Overview-Infographic_v1.0.pdf
HLF-ph-70
菲律賓化妝品審核機構，需要附上的實驗室檢驗資料有哪些? 網頁？
What are the laboratory inspection materials that need to be attached for verification? Website?
Evershine RD：
化妝品良好生產規範 (GMP)
1.文件系統應包括每批的完整歷史，從起始材料到成品。系統應記錄維護、儲存、質量控制、初級分銷和其他與 GMP 相關的具體事項的執行活動。
2.應有防止使用任何被取代文件的制度。
3.如果在文件上出現或發現錯誤，應以不丟失原始條目的方式進行更正，並在接近原始條目的地方進行更正，草簽並註明日期。
4.文件中有說明的，應逐級寫明。
5.文件應註明日期和授權。
6.文件應隨時可供相關方使用。
7.所有規格均應由授權人員批准。
8.原包裝材料規格應包括：
．材料名稱
．材料說明
．測試參數和接受限度
．技術圖紙(如適用)
．特殊預防措施，例如：如有必要，存儲和安全條件。
9. 散裝和成品規格應包括：
．產品名稱
．說明
．物理性質
．化學分析和/或微生物分析及其接受限度(如有必要)
．儲存條件和安全預防措施(如有必要)
10生產文件
主配方：應根據要求提供。
．產品名稱和產品代碼/編號
．預期的包裝材料和儲存條件
．使用的原材料清單
．使用的設備清單
．過程控制及其在加工和包裝方面的限制(如適用)
批量生產記錄(BMR)：應為每批產品準備批生產記錄
．產品名稱
．批量公式
．製造工藝簡述
．批號或代碼
．加工和包裝的開始和結束日期
．單個主要設備和使用的線路或位置的標示
．用於加工的設備的清潔記錄(視情況而定)
．過程控制和實驗室結果，例如 pH 和溫度測試記錄
．包裝線清關檢驗記錄
．在處理的各個步驟期間執行的任何採樣
．對特定故障或差異的任何調查
．包裝和標籤產品的檢查結果
質量控制記錄：應保存每次測試、化驗結果以及起始材料、中間體、散裝產品和成品的放行或拒收的記錄。
．測試日期
．材料識別
．供應商名稱
．收貨日期
．原始批號(如有)
．批號
．質控編號
．收貨數量
．取樣日期
．質量控制結果
產品信息文件 (PIF)
1. 東盟化妝品指令 (ACD) 要求將產品投放市場的個人或公司保存產品信息文件。
2. ACD 要求的產品信息
．產品的定性和定量成分，如果是香水成分須包含成分的名稱和代碼以及供應商的身份
．原材料和成品的規格
．符合東盟指南中規定的良好生產規範的生產方法
．評估成品、其成分、化學結構和暴露水平對人體健康的安全性
．使用化妝品對人體健康造成不良影響的現有數據
．化妝品聲稱的益處的支持數據證明其效果的性質、向監管部門提供分析方法信息
．製造商用於檢查與分析證書對應的化妝品成分的可用方法
．用於化妝品微生物控制和化妝品成分化學純度的標準和/或檢查是否符合這些標準的方法
3. 推薦的 PIF 格式：將產品投放市場的公司需要以符合要求並易於當局諮詢的方式組織 PIF，建議將 PIF 分為以下 4 個部分：
．第一部分：行政文件和產品概要
．第二部分：原材料質量數據
．第三部分：成品質量數據
．第四部分：安全性和有效性數據
．4 個部分中的每一個應提供一個目錄
4. 第一部分：行政文件和產品概要
．行政文件：帶有當局確認收據的通知表副本，包括：產品身份、製造商、組裝商、進口商和將產品投放市場的公司的地址、產品所有者的授權書或與產品相關的協議書、其他相關行政文件，例如：營業執照、公司註冊證書
．產品的定性和定量配方(INCI 或其他 ACD 批准的參考名稱和相應的成分濃度)：對於香精，須標示成分的名稱和代碼以及供應商的身份
．產品介紹和標籤：外部和內部標籤(照片和/或圖紙)、消費者信息傳單和使用說明(如果產品的一部分出售給消費者)
．製造聲明：製造商或公司聲明產品是根據東盟 GMP 指南或任何 ACC 批准的等效 GMP 指南製造的、提供產品的批次編碼系統/密鑰
．根據東盟化妝品安全評估指南的安全評估(摘要)：安全聲明(簽署的意見聲明，包括安全評估員的姓名和資格)、已確認對人類健康的不良影響(摘要)
．包裝產品聲明支持(摘要)：基於產品成分或進行的測試的產品功效評估總結報告
5. 第二部分：原材料質量數據
．原料/配料的規格和測試方法：每種成分的規格、每種成分的規格相對應的分析方法、指定香精的名稱和代碼、供應商的名稱和地址、符合最新 IFRA 指南的聲明
．基於供應商數據、已發布數據或科學委員會報告的原材料安全數據，如東盟化妝品科學機構 (ACSB)、歐盟消費品科學委員會 (SCCP) 或美國化妝品成分審查委員會(CIR)
6.第三部分：成品質量數據
．產品的定性和定量配方(INCI 或其他經批准的 ACD 參考名稱和相應的成分濃度)
．配方應說明每種原料/成分的功能
．製造商聯繫方式：製造商、組裝商和包裝商的名稱、國家和地址
．製造過程總結
．製造過程、質量控制和相關製造文件的更多詳細信息
．用於化妝品微生物控制和化妝品成分化學純度的標準
．符合檢查規範的分析方法
．產品穩定性總結報告，產品保質期低於 30 個月者提供支持有效期的穩定性測試數據和報告或穩定性評估
7.第四部分：安全性和有效性數據
．根據其成分、化學結構和暴露水平簽署的成品對人體健康的安全性評估報告
．安全評估員的簡歷
．已確認或記錄的因使用該化妝品而對人體健康造成的不良事件或不良影響的最新彙編報告
．PIF中的不良事件報告預計將由公司定期更新
．基於其成分或進行的測試的產品功效評估的完整簽名報告
．應提供支持數據，包括對化妝品聲稱的益處的文獻審查，以證明其效果的性質
8. 負責將化妝品投放市場的公司或個人應將 PIF 保存在標籤上指定的地址，便於監管機構訪問。無論是進口商、製造商還是分銷商。建議在產品最後一次投放市場後至少保留 PIF 3 年。
化妝品安全評估
1.使用該成分的化妝品類別。
2.使用方法(例如塗抹、噴塗、塗抹和洗掉等)。
3.產品中成分的濃度。
4.用於每個應用的產品數量。
5.應用頻率。
6.皮膚接觸的總面積。
7.接觸部位(例如粘膜、曬傷的皮膚)。
8.接觸時間(例如沖洗型產品、免洗型產品)。
9.可合理預見的可能增加暴露的濫用。
10.消費者類型(例如兒童、皮膚敏感的人)。
11.預計的消費者數量。
12.適用於暴露在陽光下的皮膚區域。
13.可能進入人體的數量。
Good Manufacturing Practices (GMP) for Cosmetics
1. The documentation system should include the full history of each batch, from starting material to finished product. The system shall record the performance of maintenance, storage, quality control, primary distribution and other specific matters related to GMP.
2. There should be a system to prevent the use of any superseded documents.
3. If an error occurs or is found on the document, it should be corrected in a way that does not lose the original entry, as close to the original entry as possible, initialed and dated.
4. If there is an explanation in the document, it should be stated level by level.
5. Documents should be dated and authorised.
6. Documentation shall be readily available to interested parties.
7. All specifications should be approved by an authorized person.
8. Specifications of original packaging materials shall include:
．Material name
．Material Description
．Testing Parameters and Acceptance Limits
．Technical Drawing (if applicable)
．Special precautions, e.g. storage and safety conditions if necessary.
9. Bulk and finished specifications should include:
．Product name
．Description
．Physical properties
．Chemical and/or microbiological analyses and their acceptance limits (if necessary)
．Storage Conditions and Safety Precautions (If Necessary)
10.Production Documents
Master Recipe: Should be available upon request.
．Product name and product code/number
．Expected Packaging Materials and Storage Conditions
．List of raw materials used
．List of equipment used
．Process controls and their limitations on processing and packaging (where applicable)
Batch Manufacturing Record (BMR): A batch manufacturing record should be prepared for each batch of product
．Product name
．Bulk formula
．Brief description of manufacturing process
．Lot number or code
．Start and end dates for processing and packaging
．Indication of a single major device and the line or location used
．Cleaning records of equipment used for processing (as applicable)
．Process controls and laboratory results, such as pH and temperature test records
．Packaging line customs clearance inspection record
．Any sampling performed during various steps of processing
．Any investigation of a specific fault or discrepancy
．Inspection Results of Packaged and Labeled Products
Quality Control Records: Records should be kept of each test, assay results, and release or rejection of starting materials, intermediates, bulk products, and finished products.
．Test date
．Material recognition
．Supplier name
．Received date
．Original lot number (if available)
．Batch number
．QC number
．Quantity received
．Date of sampling
．QC Results
Product Information File (PIF)
1. The ASEAN Cosmetics Directive (ACD) requires individuals or companies placing products on the market to maintain product information documents.
2. Product information required by ACD
．Qualitative and quantitative ingredients of the product, in the case of fragrance ingredients, the name and code of the ingredient and the identity of the supplier
．Specifications of raw materials and finished products
．Production methods that comply with the Good Manufacturing Practices set out in the ASEAN Guidelines
．Assess the safety of the finished product, its composition, chemical structure, and exposure levels to human health
．Existing data on adverse effects of cosmetic use on human health
．Supporting data on the claimed benefit of a cosmetic product to demonstrate the nature of the effect, providing information on analytical methods to regulatory authorities
．Available methods for manufacturers to check cosmetic ingredients against certificates of analysis
．Standards and/or methods for checking compliance with these standards for cosmetic microbiological control and chemical purity of cosmetic ingredients
3. Recommended PIF Format: Companies placing products on the market need to organize the PIF in a way that is compliant and easy to consult with the authorities, it is recommended that the PIF be divided into the following 4 parts:
．Part 1: Administrative Documents and Product Summary
．Part 2: Raw material quality data
．Part 3: Finished Product Quality Data
．Part 4: Safety and Efficacy Data
．Each of the 4 sections should provide a table of contents
4. Part 1: Administrative Documents and Product Summary
．Administrative documents: A copy of the notification form with the confirmation receipt from the authorities, including: the identity of the product, the address of the manufacturer, assembler, importer and the company placing the product on the market, a letter of authorization from the owner of the product or a letter of agreement related to the product, Other relevant administrative documents, such as: business license, company registration certificate
．Qualitative and quantitative formulation of the product (INCI or other ACD approved reference name and corresponding ingredient concentration): For fragrances, the name and code of the ingredient and the identity of the supplier must be declared
．Product descriptions and labels: external and internal labels (photos and/or drawings), consumer information leaflets and instructions for use (if part of the product is sold to consumers)
．Manufacturing Declaration: The manufacturer or company declares that the product is manufactured in accordance with the ASEAN GMP Guidelines or any ACC-approved equivalent GMP guidelines, providing the batch coding system/key of the product
．Safety Assessment (Summary) according to ASEAN Guidelines on Cosmetics Safety Assessment: Safety Statement (Signed Statement of Opinion, including Name and Qualifications of Safety Assessor), Adverse Human Health Effects Confirmed (Summary)
．Packaged Product Claim Support (Summary): Summary Report of Product Efficacy Evaluation Based on Product Composition or Testing Conducted
5. Part 2: Raw material quality data
．Specifications and test methods for raw materials/ingredients: Specifications for each ingredient, method of analysis corresponding to the specification for each ingredient, name and code of the specified fragrance, name and address of the supplier, statement of compliance with the latest IFRA guidelines
．Raw material safety data based on supplier data, published data, or reports from scientific committees such as the ASEAN Cosmetic Science Body (ACSB), the European Union’s Scientific Committee on Consumer Products (SCCP) or the US Cosmetic Ingredient Review (CIR)
6. Part 3: Finished Product Quality Data
．Qualitative and quantitative formulation of the product (INCI or other approved ACD reference name and corresponding ingredient concentration)
．The recipe should describe the function of each ingredient/ingredient
．Manufacturer contact details: name, country and address of manufacturer, assembler and packer
．Manufacturing Process Summary
．Further details of the manufacturing process, quality control and related manufacturing documents
．Standard for cosmetic microbiological control and chemical purity of cosmetic ingredients
．Analytical methods for compliance with inspection specifications
．Product stability summary report, product shelf life less than 30 months to provide stability test data and report or stability evaluation supporting the validity period
7. Part 4: Safety and Effectiveness Data
．Signed safety assessment report for human health of finished products based on their composition, chemical structure and exposure levels
．Safety Assessor Resume
．The latest compiled report of confirmed or documented adverse events or adverse effects on human health resulting from the use of the cosmetic
．Adverse event reports in PIF are expected to be regularly updated by the company
．Full signed report of product efficacy evaluation based on its ingredients or tests conducted
．Supporting data, including a literature review of the cosmetic’s claimed benefit, should be provided to demonstrate the nature of its effect
8. The company or individual responsible for placing the cosmetic product on the market should keep the PIF at the address specified on the label for easy access by the regulatory authorities. Be it an importer, manufacturer or distributor. It is recommended to retain PIF for a minimum of 3 years after the product was last placed on the market.
Cosmetic Safety Assessment
1. The cosmetic category that uses the ingredient.
2. Method of use (eg smear, spray, smear and wash off, etc.).
3. Concentration of ingredients in the product.
4. The number of products used for each application.
5. Frequency of application.
6. Total area of skin contact.
7. Contact sites (eg mucous membranes, sunburned skin).
8. Contact time (eg, rinse-off products, leave-on products).
9. Reasonably foreseeable abuse that may increase exposure.
10. Type of consumer (eg children, people with sensitive skin).
11. Estimated number of consumers.
12. Apply to sun-exposed skin areas.
13. Quantity that may enter the human body.
【參考連結】
https://www.fda.gov.ph/wp-content/uploads/2021/03/Guidelines-for-the-Safety-Assessment.pdf
https://www.fda.gov.ph/downloadables/
HLF-ph-75
HLF-ph-77
HLF-ph-80
外國子公司進口化妝品後，如果委託菲律賓的經銷商銷售，經銷商需要化妝品營業許可證嗎？
假如化妝品有品質瑕疵的話，外國子公司和經銷商各自的責任為何？是連帶責任嗎？還是可以規範由外國子公司負責？
After a foreign subsidiary imports cosmetics and entrusts a distributor in Philippines to sell it, does the distributor need a cosmetics business license?
What are the respective responsibilities of foreign subsidiaries and distributors if cosmetic products have quality defects? Is it joint liability? Or can the responsibility of the foreign subsidiary be regulated?
Evershine RD：
在菲律賓從事化妝品的進出口、貿易、零售和分銷的企業需要從菲律賓食品藥物管理局(FDA)獲得經營許可證(LTO)及完成產品註冊。
化妝品不良事件
1.負責將化妝品投放市場的公司應向菲律賓食品藥物管理局(FDA)報告，無論報告的來源(消費者、醫療保健專業人員等)如何。
2. 報告內容
．每例嚴重不良事件：應報告所有嚴重的不良事件。不要求報告非嚴重不良事件。
只要合理懷疑化妝品可能是引起反應的原因，就必須報告。
．合理懷疑一詞一般意指有證據表明存在因果關係或關聯。
．在向監管機構報告之前，應對每一種非嚴重、單一嚴重不良反應發生率高的情況進行適當的醫學和科學判斷。
3. 報告時間
．致命或危及生命的不良事件應盡快向監管機構報告(例如通過電話、傳真、電子郵件或書面形式)，但不得遲於 7 個日曆日，然後在另外 8 個日曆日內填寫不良化妝品事件報告表，並提供監管機構可能要求的任何其他信息。
．其他嚴重不良事件：所有其他非致命或不危及生命的嚴重不良事件必須盡快報告，但不得遲於首次發現後 15 個日曆日。
4. 化妝品不良事件報告表
．公司資料：姓名和地址、公司、報告人的姓名和指定電話號碼、 傳真號碼、電子郵件。
．產品詳情：產品名稱(如產品通知)、成分列表和包裝尺寸(請附上單獨的列表)、產品類型/預期用途、製造商名稱和製造國、到期或生產日期、批號。
．不良事件詳情：姓名/姓名首字母、身份證或護照號碼、年齡性別、民族/國籍、不良事件發生日期。
．不良事件描述(如有必要，請使用並附上單獨的報告)：上次使用該產品與出現症狀之間的延遲：產品是如何使用的：該人是否因不良反應住院?是否就醫?結果。
Companies engaged in the import, export, trade, retail and distribution of cosmetics in the Philippines need to obtain a license to operate (LTO) from the Philippine Food and Drug Administration (FDA) and complete product registration.
Cosmetic Adverse Events
1. Companies responsible for placing cosmetic products on the market should report to the Philippine Food and Drug Administration (FDA) regardless of the source of the report (consumers, healthcare professionals, etc.).
2. Report content
．Per Serious Adverse Event: All serious adverse events should be reported. Reports of non-serious adverse events are not required. It must be reported whenever there is a reasonable suspicion that the cosmetic product may have been the cause of the reaction.
．The term reasonable doubt generally means that there is evidence of causation or association.
．Appropriate medical and scientific judgment should be exercised for each condition with a high incidence of non-serious, single serious adverse reactions before reporting to a regulatory agency.
3. Time of reporting
．Fatal or life-threatening adverse events should be reported to the regulatory agency as soon as possible (e.g. by telephone, fax, email, or in writing) but no later than 7 calendar days, followed by an additional 8 calendar days to complete the Adverse Cosmetic Event Reporting Form, and provide any other information that regulators may require.
．Other Serious Adverse Events: All other non-fatal or non-life-threatening serious adverse events must be reported as soon as possible, but no later than 15 calendar days after first discovery.
4. Cosmetic Adverse Event Report Form
．Company information: name and address, company, name and designated telephone number, fax number, e-mail of the reporting person.
．Product Details: Product name (e.g. product notification), ingredient list and package size (please attach a separate list), product type/intended use, manufacturer’s name and country of manufacture, expiry or production date, batch number.
．Adverse event details: name/initial, ID or passport number, age, gender, ethnicity/nationality, date of adverse event.
．Description of adverse events (use and attach a separate report if necessary): Delay between last use of the product and onset of symptoms: How the product was used: Was the person hospitalized for the adverse reaction? Was the person sought medical attention? Results.
URL:
https://www.fda.gov.ph/wp-content/uploads/2021/03/Adverse-Event-Reporting-System.pdf
【參考連結】
https://www.fda.gov.ph/downloadables/
https://www.fda.gov.ph/downloadables/#
HLF-ph-85
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