菲律宾化妆品登记法规问题集

Email：mnl4ww@evershinecpa.com
或
菲律宾永辉BPO有限公司
联络人：苏 玉 燕  副总经理
手机：+886-928-486-835
skype: rachelsu8
wechat: r0928486835
电话：+886-2-2717-0515 分机:104

各国化妆品登记法规问答集

HLF-ph-10
请问菲律宾对于化妆品的归类方式为何？它的正式名称为何？不同归类管理强度有何差异?它的政府管辖机构为何？网页？

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：

在菲律宾，化妆品由菲律宾食品药品监督管理局(FDA)负责监督、实施化妆品通知和产品信息文件准备。

化妆品是任何旨在与人体外部或牙齿和口腔粘膜接触的物质或製剂，用以清洁、添香、改变外观和/或纠正体臭和/或保护或维持 人体的健康状况。

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.

【参考连结】

https://www.fda.gov.ph/wp-content/uploads/2021/03/Administrative-Order-No.-2016-0003.pdf

HLF-ph-20
外国公司要到菲律宾销售化妆品，无论设100%子公司或分公司，需要在公司登记时取得营业特许证？
假如要，其必要条件是什麽？所需文件及申请程序为何？网页？

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，在菲律宾从事化妆品的进出口、贸易、零售和分销的企业需要从菲律宾食品药物管理局(FDA)获得经营许可证(LTO)及完成产品註册。

化妆品机构经营许可证

1.申请人：在菲律宾从事化妆品的进出口、贸易、零售和分销的当地企业。

2.申请网页：https://eportal.fda.gov.ph/sysFDA_WorkFlow/en/neoclassic/login/login

申请文件

1. 综合申请表(附有所有者/註册人/总经理和授权人的身份证照片)。

2. 公证秘书证书/特别授权书(如果授权代表不是 DTI 商业登记的所有者或 SEC 的註册人之一)。

3. 商业登记证明

．在贸易和工业部 (DTI) 的有效商业名称註册证书(适用于独资企业)

．在证券交易委员会 (SEC) 和公司或合伙企业章程(对于公司或合伙企业)有效註册。

4. 如果企业名称与公司名称不同，SEC 证书必须以机构名称和风格开展业务。

．合作社发展局 (CDA) 证书适用于合作社。

．如果 DTI 商业登记和 SEC 中的商业地址与申报的办公地址不同，请提供有效的市长许可。

5. 房屋证明(办公室、製造厂和仓库)

．转让产权证书 (TCT) 作为所有权证明。

．经公证的入住证明，如果由其中一家公司所有。

．经公证的有效租赁/转租合同，如果所佔用的空间/建筑物不属于自己。

．房主协会 (HOA)/公寓/建筑管理局的有效许可，如果在住宅区/公寓内。

．第三方物流的有效公证仓储协议。

6. 其他要求

．平面图/以米为单位的佈局和正确识别区域(办公室和仓库)

．製造工厂蓝图

．带有地标的附近/位置图(即谷歌地图，该地区的草图)

7. 授权人(药剂师或任何受过相关培训的联合健康科学专业人员)的相关文件：

． 经公证的联合承诺誓章(附有 2 x 2 授权人身份证照片)

．中国董事会证书

．有效的中华人民共和国身份证

．当前专业税单 (PTR)

．由授权人员和直接主管签署的职责和责任

．CCRR 的行业监管事务合格人员 (QPIRA)出席证明或出席承诺函(附有预定出席日期和付款证明)

．参加13 项东盟化妆品 GMP 模块培训的出席证明或出席的承诺函，附有预定出席日期和付款证明(仅适用于贸易商和製造商)

8.进口商特定要求

．产品清单：来源名称和地址、製造商名称和地址、原产国完整产品清单。

．有效的外国代理协议 (FAA) 或由菲律宾领事馆正式认证的每个来源/供应商的任何形式的授权

．如果来源/供应商已指定另一家物流/开票公司，需提供以下任何一项：外国来源/供应商和製造商之间的有效供应协议、经菲律宾领事馆正式认证的有效三方协议。

．製造商的 GMP 合规性证明(以下任何一项)：原产国政府机构或经认可的商业协会(WHO、ECC/EU、COLIPA)签发的有效製造商GMP证书、如果製造商来自东盟成员国，则自我声明符合 GMP、原产国政府机构(国家监管机构或商会)签发的自由销售证明、符合 GMP 的 ISO 证书、有效的製造商许可证。

9. 效期：LTO 有效期为 1 年(展延需在到期前3个月之前提出)。

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).

【参考连结】

https://www.fda.gov.ph/downloadables/

HLF-ph-25

HLF-ph-30
外国公司要到菲律宾销售化妆品，可以指派菲律宾公司担任营业代理人销售吗? 担任营业代理人，其必要条件是什麽？
所需文件及申请程序为何？外国公司与营业代理人的产品责任为何?网页？

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。在菲律宾从事化妆品的进出口、贸易、零售和分销的企业，需以当地企业名义从菲律宾食品药物管理局(FDA)获得经营许可证(LTO)及完成产品註册。

化妆品机构经营许可证

1.申请人：在菲律宾从事化妆品的进出口、贸易、零售和分销的当地企业。

2.申请网页：https://eportal.fda.gov.ph/sysFDA_WorkFlow/en/neoclassic/login/login

申请文件

1. 综合申请表(附有所有者/註册人/总经理和授权人的身份证照片)。

2. 公证秘书证书/特别授权书(如果授权代表不是 DTI 商业登记的所有者或 SEC 的註册人之一)。

3. 商业登记证明

．在贸易和工业部 (DTI) 的有效商业名称註册证书(适用于独资企业)

．在证券交易委员会 (SEC) 和公司或合伙企业章程(对于公司或合伙企业)有效註册。

4. 如果企业名称与公司名称不同，SEC 证书必须以机构名称和风格开展业务。

．合作社发展局 (CDA) 证书适用于合作社。

．如果 DTI 商业登记和 SEC 中的商业地址与申报的办公地址不同，请提供有效的市长许可。

5. 房屋证明(办公室、製造厂和仓库)

．转让产权证书 (TCT) 作为所有权证明。

．经公证的入住证明，如果由其中一家公司所有。

．经公证的有效租赁/转租合同，如果所佔用的空间/建筑物不属于自己。

．房主协会 (HOA)/公寓/建筑管理局的有效许可，如果在住宅区/公寓内。

．第三方物流的有效公证仓储协议。

6. 其他要求

．平面图/以米为单位的佈局和正确识别区域(办公室和仓库)

．製造工厂蓝图

．带有地标的附近/位置图(即谷歌地图，该地区的草图)

7. 授权人(药剂师或任何受过相关培训的联合健康科学专业人员)的相关文件：

． 经公证的联合承诺誓章(附有 2 x 2 授权人身份证照片)

．中国董事会证书

．有效的中华人民共和国身份证

．当前专业税单 (PTR)

．由授权人员和直接主管签署的职责和责任

．CCRR 的行业监管事务合格人员 (QPIRA)出席证明或出席承诺函(附有预定出席日期和付款证明)

．参加13 项东盟化妆品 GMP 模块培训的出席证明或出席的承诺函，附有预定出席日期和付款证明(仅适用于贸易商和製造商)

8.进口商特定要求

．产品清单：来源名称和地址、製造商名称和地址、原产国完整产品清单。

．有效的外国代理协议 (FAA) 或由菲律宾领事馆正式认证的每个来源/供应商的任何形式的授权

．如果来源/供应商已指定另一家物流/开票公司，需提供以下任何一项：外国来源/供应商和製造商之间的有效供应协议、经菲律宾领事馆正式认证的有效三方协议。

．製造商的 GMP 合规性证明(以下任何一项)：原产国政府机构或经认可的商业协会(WHO、ECC/EU、COLIPA)签发的有效製造商GMP证书、如果製造商来自东盟成员国，则自我声明符合 GMP、原产国政府机构(国家监管机构或商会)签发的自由销售证明、符合 GMP 的 ISO 证书、有效的製造商许可证。

9. 效期：LTO 有效期为 1 年(展延需在到期前3个月之前提出)。

化妆品不良事件

1.负责将化妆品投放市场的公司应向菲律宾食品药物管理局(FDA)报告，无论报告的来源(消费者、医疗保健专业人员等)如何。

2. 报告内容

．每例严重不良事件：应报告所有严重的不良事件。不要求报告非严重不良事件。只要合理怀疑化妆品可能是引起反应的原因，就必须报告。

．合理怀疑一词一般意指有证据表明存在因果关係或关联。

．在向监管机构报告之前，应对每一种非严重、单一严重不良反应发生率高的情况进行适当的医学和科学判断。

3. 报告时间

．致命或危及生命的不良事件应尽快向监管机构报告(例如通过电话、传真、电子邮件或书面形式)，但不得迟于 7 个日曆日，然后在另外 8 个日曆日内填写不良化妆品事件报告表，并提供监管机构可能要求的任何其他信息。

．其他严重不良事件：所有其他非致命或不危及生命的严重不良事件必须尽快报告，但不得迟于首次发现后 15 个日曆日。

4. 化妆品不良事件报告表

．公司资料：姓名和地址、公司、报告人的姓名和指定电话号码、 传真号码、电子邮件。

．产品详情：产品名称(如产品通知)、成分列表和包装尺寸(请附上单独的列表)、产品类型/预期用途、製造商名称和製造国、到期或生产日期、批号。

．不良事件详情：姓名/姓名首字母、身份证或护照号码、年龄性别、民族/国籍、不良事件发生日期。

．不良事件描述(如有必要，请使用并附上单独的报告)：上次使用该产品与出现症状之间的延迟：产品是如何使用的：该人是否因不良反应住院?是否就医?结果。

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.

【参考连结】

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
外国公司销售到菲律宾化妆品本身，进口前需要办理产品许可吗？如需要，哪个单位在管理？需要什麽文件？
申请程序为何？化妆品包装内容及各种标示，需要事先核准吗？可允许的语文有哪些？网页？

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：

负责将化妆品投放市场的当地公司应在于FDA註册并于产品投放市场前提交通知(化妆品电子通知) 。

化妆品电子通知

1.申请人：负责将化妆品投放市场的当地公司。

2.申请网页：FDA 电子门户https://ww2.fda.gov.ph

3.流程

．向info@fda.gov.ph发送请求并提供以下信息：电子邮件地址(最好是公司电子邮件地址)、姓名、联繫方式、公司名称、公司地址、产品分类：化妆品。

．登录FDA 电子门户。

．选择新案例并填写东盟通知表。

．付款。

．如果获得批准，请下载并列印确认通知。

．获得通知证书。(初次提交，通知的有效期最长为 1 至 3 年，由申请人选择。
文件不足的人将收到一份缺陷通知，要求对某些细节进行澄清或进一步解释，任何宣布虚假或误导性信息的公司都会收到拒绝信。)

4.申请填写内容

．公司的有效 LTO 编号。

．製造国、供应商详细信息(如果适用)。

．确保提供的信息与公司当前有效的 LTO 一致。

．代表公司的人员的姓名和职务。

．产品成分：申请化妆品的完整成分清单、配方中限制成分的作用和百分比。

．在产品通知中声明的信息：品牌、产品名称、产品型号、产品类型、预期用途、产品介绍、负责将化妆品投放市场的当地公司、机构信息、当地公司代表、产品成分清单。

．产品信息文件 (PIF)：菲律宾遵守东盟化妆品指令 (ACD)，该指令要求将产品投放市场的个人或公司保持产品信息文件易于相关成员国的监管机构访问。该文件可以列印或电子化，每次公司决定更改通知产品的任何方面时都应更新。

化妆品标籤

1. 化妆品外包装或无外包装的化妆品直接包装上应标註以下内容：

．化妆品的名称及其功能，除非从产品的介绍中可以清楚地看出。

．化妆品的使用说明，除非从产品名称或外观中明确显示。

．完整的成分列表，成分必须在添加时按重量降序声明。香水完整的成分必须在添加时按重量降序声明，香水和芳香组合物及其原料可以用香水、香精、香气或香精一词来替代；浓度小于 1% 的成分可以在浓度大于 1% 的成分之后以任意顺序列出；着色剂可以採用颜色索引号或名称，在其他成分之后以任意顺序列出；对于以多种色调销售的装饰性化妆品，可以列出该范围内使用的所有着色剂，前提是添加术语可能包含或+/-。成分应使用最新标准中的命名法来指定；植物药和植物药提取物应按其属和种进行鑑别，属性可以缩写，但是，以下不应被视为成分：所用原材料中的杂质、用于製备但不存在于最终产品中的辅助技术材料、用作香料和芳香剂组合物的溶剂或载体的材料，其数量是绝对必要的．製造国。

．负责将产品投放当地市场的公司名称和地址。

．以公製或公制和英制的重量或体积表示的内容物。

．製造批号。

．产品的製造日期或有效期，以明确的方式表示(例如月/年)，并应按月和年或日月和年的顺序组成。最低保质期应为该产品在适当条件下储存后继续发挥其初始功能的日期。对于最短保质期少于 30 个月的化妆品，必须註明有效期。

．使用中应遵守的特殊注意事项，尤其是使用条件和警告一栏中的内容必须列在列在附件上，以及化妆品上的任何特殊注意事项。产品标籤上必须有(任何格式的)声明，表明存在动物源性成分；对于牛或猪来源的成分，必须声明确切的动物。

．如果容器或包装的尺寸、形状或性质不允许展示规定的细节，则使用传单、小册子、吊牌、展示板、 应允许使用收缩包装等。 但是，至少应在小的直接包装上出现以下细节：化妆品名称、製造批号。

．细节应易于阅读、清楚理解和不可磨灭。

．详细信息应以英语和/或国家语言和/或产品销售地消费者理解的语言显示，菲律宾的官方语言是菲语、英语。

．用于化妆品成分命名法的标准参考文件：国际化妆品成分词典、英国药典、美国药典、化学文摘服务。

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.

【参考连结】

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
外国公司可以用自己名义申请办理产品许可吗？如需要，哪个单位在管理？
需要什麽文件？申请程序为何？化妆品包装内容及各种标示，需要事先核准吗？可允许的语文有哪些？网页？

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：

在菲律宾从事化妆品的进出口、贸易、零售和分销的企业，需以当地企业名义从菲律宾食品药物管理局(FDA)获得经营许可证(LTO)及完成产品註册。

化妆品机构经营许可证

1.申请人：在菲律宾从事化妆品的进出口、贸易、零售和分销的当地企业。

2.申请网页：https://eportal.fda.gov.ph/sysFDA_WorkFlow/en/neoclassic/login/login

申请文件

1. 综合申请表(附有所有者/註册人/总经理和授权人的身份证照片)。

2. 公证秘书证书/特别授权书(如果授权代表不是 DTI 商业登记的所有者或 SEC 的註册人之一)。

3. 商业登记证明

．在贸易和工业部 (DTI) 的有效商业名称註册证书(适用于独资企业)

．在证券交易委员会 (SEC) 和公司或合伙企业章程(对于公司或合伙企业)有效註册。

4. 如果企业名称与公司名称不同，SEC 证书必须以机构名称和风格开展业务。

．合作社发展局 (CDA) 证书适用于合作社。

．如果 DTI 商业登记和 SEC 中的商业地址与申报的办公地址不同，请提供有效的市长许可。

5. 房屋证明(办公室、製造厂和仓库)

．转让产权证书 (TCT) 作为所有权证明。

．经公证的入住证明，如果由其中一家公司所有。

．经公证的有效租赁/转租合同，如果所佔用的空间/建筑物不属于自己。

．房主协会 (HOA)/公寓/建筑管理局的有效许可，如果在住宅区/公寓内。

．第三方物流的有效公证仓储协议。

6. 其他要求

．平面图/以米为单位的佈局和正确识别区域(办公室和仓库)

．製造工厂蓝图

．带有地标的附近/位置图(即谷歌地图，该地区的草图)

7. 授权人(药剂师或任何受过相关培训的联合健康科学专业人员)的相关文件：

． 经公证的联合承诺誓章(附有 2 x 2 授权人身份证照片)

．中国董事会证书

．有效的中华人民共和国身份证

．当前专业税单 (PTR)

．由授权人员和直接主管签署的职责和责任

．CCRR 的行业监管事务合格人员 (QPIRA)出席证明或出席承诺函(附有预定出席日期和付款证明)

．参加13 项东盟化妆品 GMP 模块培训的出席证明或出席的承诺函，附有预定出席日期和付款证明(仅适用于贸易商和製造商)

8.进口商特定要求

．产品清单：来源名称和地址、製造商名称和地址、原产国完整产品清单。

．有效的外国代理协议 (FAA) 或由菲律宾领事馆正式认证的每个来源/供应商的任何形式的授权

．如果来源/供应商已指定另一家物流/开票公司，需提供以下任何一项：外国来源/供应商和製造商之间的有效供应协议、经菲律宾领事馆正式认证的有效三方协议。

．製造商的 GMP 合规性证明(以下任何一项)：原产国政府机构或经认可的商业协会(WHO、ECC/EU、COLIPA)签发的有效製造商GMP证书、如果製造商来自东盟成员国，则自我声明符合 GMP、原产国政府机构(国家监管机构或商会)签发的自由销售证明、符合 GMP 的 ISO 证书、有效的製造商许可证。

9. 效期：LTO 有效期为 1 年(展延需在到期前3个月之前提出)。

化妆品标籤

1. 化妆品外包装或无外包装的化妆品直接包装上应标註以下内容：

．化妆品的名称及其功能，除非从产品的介绍中可以清楚地看出。

．化妆品的使用说明，除非从产品名称或外观中明确显示。

．完整的成分列表，成分必须在添加时按重量降序声明。香水完整的成分必须在添加时按重量降序声明，香水和芳香组合物及其原料可以用香水、香精、香气或香精一词来替代；浓度小于 1% 的成分可以在浓度大于 1% 的成分之后以任意顺序列出；着色剂可以採用颜色索引号或名称，在其他成分之后以任意顺序列出；对于以多种色调销售的装饰性化妆品，可以列出该范围内使用的所有着色剂，前提是添加术语可能包含或+/-。成分应使用最新标准中的命名法来指定；植物药和植物药提取物应按其属和种进行鑑别，属性可以缩写，但是，以下不应被视为成分：所用原材料中的杂质、用于製备但不存在于最终产品中的辅助技术材料、用作香料和芳香剂组合物的溶剂或载体的材料，其数量是绝对必要的．製造国。

．负责将产品投放当地市场的公司名称和地址。

．以公製或公制和英制的重量或体积表示的内容物。

．製造批号。

．产品的製造日期或有效期，以明确的方式表示(例如月/年)，并应按月和年或日月和年的顺序组成。最低保质期应为该产品在适当条件下储存后继续发挥其初始功能的日期。对于最短保质期少于 30 个月的化妆品，必须註明有效期。

．使用中应遵守的特殊注意事项，尤其是使用条件和警告一栏中的内容必须列在列在附件上，以及化妆品上的任何特殊注意事项。产品标籤上必须有(任何格式的)声明，表明存在动物源性成分；对于牛或猪来源的成分，必须声明确切的动物。

．如果容器或包装的尺寸、形状或性质不允许展示规定的细节，则使用传单、小册子、吊牌、展示板、 应允许使用收缩包装等。
但是，至少应在小的直接包装上出现以下细节：化妆品名称、製造批号。

．细节应易于阅读、清楚理解和不可磨灭。

．详细信息应以英语和/或国家语言和/或产品销售地消费者理解的语言显示，菲律宾的官方语言是菲语、英语。

．用于化妆品成分命名法的标准参考文件：国际化妆品成分词典、英国药典、美国药典、化学文摘服务。

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.

【参考连结】

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
经过核准登记的化妆品，进口到菲律宾要检附什麽文件？经过什麽手续？
在销售时要向各地的卫生福利部相关机构事先或事后准备吗？网页？

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：

海关

1.进口商企业首先需要取得国税局的进口清关证书，然后进口商在海关局 (BOC) 註册，并在客户资料註册系统 (CPRS) 上开设一个帐户。

2.进口清关证书有效期为三年，而海关客户资料认证必须每年更新。CPRS 认证费用为 P1000(20 美元)，通常需要 15 个工作日来处理。

3. 菲律宾海关对进口商品徵收 12% 的增值税 (VAT)，对价值低于 P10,000(200 美元)的商品不徵收关税或税款。

4.进口到菲律宾的企业在货物到达时必须提供以下文件：

．打包清单。

．发票。

．提货单。

．进口许可证。

．海关进口申报。

．原产地证书。

．食品和药物管理局的产品註册证书。

．经正式公证的估价补充声明 (SDV) 。

．自由贸易协定 (FTA) 的原产地证明。

．货物报关单。

．税收抵免证书 (TCC) 或税收借记通知单 (TDM)(如果适用) 。

5. 进口文件

．提单/空运提单，或船舶或飞机的承运人或代理人的证明。

．商业发票、信用证或任何其他可证明付款的商业文件。

．表明货物商业价值的商业文件。

6. 对于信用证 (L/C) 交易，需要正式完成的信用证，包括形式发票和预先海关进口关税的单一行政文件 (SAD)。
非信用证交易需要形式发票，例如承兑汇票 (D/A)、付款单据 D/P)、开立账户 (OA) 或自筹资金文件。

7.文件必须连同报关人和报关行(如有)签署并公证的 SAD 打印件一起提交给海关正式入境处 (FED) 或其同等办公室或单位。

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).

【参考连结】

https://customs.gov.ph/

https://customs.gov.ph/wp-content/uploads/2016/09/Import-Transaction-Overview-Infographic_v1.0.pdf

HLF-ph-70
菲律宾化妆品审核机构，需要附上的实验室检验资料有哪些? 网页？

What are the laboratory inspection materials that need to be attached for verification? Website?

Evershine RD：

化妆品良好生产规范 (GMP)

1.文件系统应包括每批的完整历史，从起始材料到成品。系统应记录维护、储存、质量控制、初级分销和其他与 GMP 相关的具体事项的执行活动。

2.应有防止使用任何被取代文件的制度。

3.如果在文件上出现或发现错误，应以不丢失原始条目的方式进行更正，并在接近原始条目的地方进行更正，草签并註明日期。

4.文件中有说明的，应逐级写明。

5.文件应註明日期和授权。

6.文件应随时可供相关方使用。

7.所有规格均应由授权人员批准。

8.原包装材料规格应包括：

．材料名称

．材料说明

．测试参数和接受限度

．技术图纸(如适用)

．特殊预防措施，例如：如有必要，存储和安全条件。

9. 散装和成品规格应包括：

．产品名称

．说明

．物理性质

．化学分析和/或微生物分析及其接受限度(如有必要)

．储存条件和安全预防措施(如有必要)

10生产文件

主配方：应根据要求提供。

．产品名称和产品代码/编号

．预期的包装材料和储存条件

．使用的原材料清单

．使用的设备清单

．过程控制及其在加工和包装方面的限制(如适用)

批量生产记录(BMR)：应为每批产品准备批生产记录

．产品名称

．批量公式

．製造工艺简述

．批号或代码

．加工和包装的开始和结束日期

．单个主要设备和使用的线路或位置的标示

．用于加工的设备的清洁记录(视情况而定)

．过程控制和实验室结果，例如 pH 和温度测试记录

．包装线清关检验记录

．在处理的各个步骤期间执行的任何採样

．对特定故障或差异的任何调查

．包装和标籤产品的检查结果

质量控制记录：应保存每次测试、化验结果以及起始材料、中间体、散装产品和成品的放行或拒收的记录。

．测试日期

．材料识别

．供应商名称

．收货日期

．原始批号(如有)

．批号

．质控编号

．收货数量

．取样日期

．质量控制结果

产品信息文件 (PIF)

1. 东盟化妆品指令 (ACD) 要求将产品投放市场的个人或公司保存产品信息文件。

2. ACD 要求的产品信息

．产品的定性和定量成分，如果是香水成分须包含成分的名称和代码以及供应商的身份

．原材料和成品的规格

．符合东盟指南中规定的良好生产规范的生产方法

．评估成品、其成分、化学结构和暴露水平对人体健康的安全性

．使用化妆品对人体健康造成不良影响的现有数据

．化妆品声称的益处的支持数据证明其效果的性质、向监管部门提供分析方法信息

．製造商用于检查与分析证书对应的化妆品成分的可用方法

．用于化妆品微生物控制和化妆品成分化学纯度的标准和/或检查是否符合这些标准的方法

3. 推荐的 PIF 格式：将产品投放市场的公司需要以符合要求并易于当局谘询的方式组织 PIF，建议将 PIF 分为以下 4 个部分：

．第一部分：行政文件和产品概要

．第二部分：原材料质量数据

．第三部分：成品质量数据

．第四部分：安全性和有效性数据

．4 个部分中的每一个应提供一个目录

4. 第一部分：行政文件和产品概要

．行政文件：带有当局确认收据的通知表副本，包括：产品身份、製造商、组装商、进口商和将产品投放市场的公司的地址、产品所有者的授权书或与产品相关的协议书、其他相关行政文件，例如：营业执照、公司註册证书

．产品的定性和定量配方(INCI 或其他 ACD 批准的参考名称和相应的成分浓度)：对于香精，须标示成分的名称和代码以及供应商的身份

．产品介绍和标籤：外部和内部标籤(照片和/或图纸)、消费者信息传单和使用说明(如果产品的一部分出售给消费者)

．製造声明：製造商或公司声明产品是根据东盟 GMP 指南或任何 ACC 批准的等效 GMP 指南製造的、提供产品的批次编码系统/密钥

．根据东盟化妆品安全评估指南的安全评估(摘要)：安全声明(签署的意见声明，包括安全评估员的姓名和资格)、已确认对人类健康的不良影响(摘要)

．包装产品声明支持(摘要)：基于产品成分或进行的测试的产品功效评估总结报告

5. 第二部分：原材料质量数据

．原料/配料的规格和测试方法：每种成分的规格、每种成分的规格相对应的分析方法、指定香精的名称和代码、供应商的名称和地址、符合最新 IFRA 指南的声明

．基于供应商数据、已发布数据或科学委员会报告的原材料安全数据，如东盟化妆品科学机构 (ACSB)、欧盟消费品科学委员会 (SCCP) 或美国化妆品成分审查委员会(CIR)

6.第三部分：成品质量数据

．产品的定性和定量配方(INCI 或其他经批准的 ACD 参考名称和相应的成分浓度)

．配方应说明每种原料/成分的功能

．製造商联繫方式：製造商、组装商和包装商的名称、国家和地址

．製造过程总结

．製造过程、质量控制和相关製造文件的更多详细信息

．用于化妆品微生物控制和化妆品成分化学纯度的标准

．符合检查规范的分析方法

．产品稳定性总结报告，产品保质期低于 30 个月者提供支持有效期的稳定性测试数据和报告或稳定性评估

7.第四部分：安全性和有效性数据

．根据其成分、化学结构和暴露水平签署的成品对人体健康的安全性评估报告

．安全评估员的简历

．已确认或记录的因使用该化妆品而对人体健康造成的不良事件或不良影响的最新彙编报告

．PIF中的不良事件报告预计将由公司定期更新

．基于其成分或进行的测试的产品功效评估的完整签名报告

．应提供支持数据，包括对化妆品声称的益处的文献审查，以证明其效果的性质

8. 负责将化妆品投放市场的公司或个人应将 PIF 保存在标籤上指定的地址，便于监管机构访问。无论是进口商、製造商还是分销商。建议在产品最后一次投放市场后至少保留 PIF 3 年。

化妆品安全评估

1.使用该成分的化妆品类别。

2.使用方法(例如涂抹、喷涂、涂抹和洗掉等)。

3.产品中成分的浓度。

4.用于每个应用的产品数量。

5.应用频率。

6.皮肤接触的总面积。

7.接触部位(例如粘膜、晒伤的皮肤)。

8.接触时间(例如冲洗型产品、免洗型产品)。

9.可合理预见的可能增加暴露的滥用。

10.消费者类型(例如儿童、皮肤敏感的人)。

11.预计的消费者数量。

12.适用于暴露在阳光下的皮肤区域。

13.可能进入人体的数量。

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.

【参考连结】

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
外国子公司进口化妆品后，如果委託菲律宾的经销商销售，经销商需要化妆品营业许可证吗？
假如化妆品有品质瑕疵的话，外国子公司和经销商各自的责任为何？是连带责任吗？还是可以规范由外国子公司负责？

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：

在菲律宾从事化妆品的进出口、贸易、零售和分销的企业需要从菲律宾食品药物管理局(FDA)获得经营许可证(LTO)及完成产品註册。

化妆品不良事件

1.负责将化妆品投放市场的公司应向菲律宾食品药物管理局(FDA)报告，无论报告的来源(消费者、医疗保健专业人员等)如何。

2. 报告内容

．每例严重不良事件：应报告所有严重的不良事件。不要求报告非严重不良事件。
只要合理怀疑化妆品可能是引起反应的原因，就必须报告。

．合理怀疑一词一般意指有证据表明存在因果关係或关联。

．在向监管机构报告之前，应对每一种非严重、单一严重不良反应发生率高的情况进行适当的医学和科学判断。

3. 报告时间

．致命或危及生命的不良事件应尽快向监管机构报告(例如通过电话、传真、电子邮件或书面形式)，但不得迟于 7 个日曆日，然后在另外 8 个日曆日内填写不良化妆品事件报告表，并提供监管机构可能要求的任何其他信息。

．其他严重不良事件：所有其他非致命或不危及生命的严重不良事件必须尽快报告，但不得迟于首次发现后 15 个日曆日。

4. 化妆品不良事件报告表

．公司资料：姓名和地址、公司、报告人的姓名和指定电话号码、 传真号码、电子邮件。

．产品详情：产品名称(如产品通知)、成分列表和包装尺寸(请附上单独的列表)、产品类型/预期用途、製造商名称和製造国、到期或生产日期、批号。

．不良事件详情：姓名/姓名首字母、身份证或护照号码、年龄性别、民族/国籍、不良事件发生日期。

．不良事件描述(如有必要，请使用并附上单独的报告)：上次使用该产品与出现症状之间的延迟：产品是如何使用的：该人是否因不良反应住院?是否就医?结果。

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

【参考连结】

https://www.fda.gov.ph/downloadables/

https://www.fda.gov.ph/downloadables/#

HLF-ph-85

各国化妆品登记法规问答集

联繫我们
Email：mnl4ww@evershinecpa.com
或
菲律宾永辉BPO有限公司
联络人：苏 玉 燕  副总经理
手机：+886-928-486-835
skype: rachelsu8
wechat: r0928486835
电话：+886-2-2717-0515 分机:104

全球永辉服务据点参考资料:
永辉100%关係企业
永辉总部、台北永辉、厦门永辉、北京永辉、上海那灵、深圳常新、纽约永辉、加州永辉、德州永辉、凤凰城永辉、东京永辉、首尔永辉、河内永辉、越南胡志明、曼谷永辉、新加坡永辉、吉隆玻永辉、雅加达永辉、马尼拉永辉、墨尔本永辉、澳洲雪梨、孟加拉永辉、新德里永辉、印度孟买、杜拜永辉、法兰克福永辉、巴黎永辉、伦敦永辉、荷兰永辉、西班牙永辉、义大利永辉、罗马尼亚永辉、多伦多永辉、墨西哥永辉、捷克永辉。
其他已提供中文化服务城市：
迈阿密、亚特兰大、俄克拉荷马、密歇根、西雅图、特拉华；
柏林; 斯图加特;布拉格；布加勒斯特；班加罗尔；泗水；
高雄、香港、深圳、东关、广州、清远、永康、杭州、苏州、崑山、南京、重庆、许昌、青岛、天津。
永辉潜在可服务城市 (2个月筹备期)：
我们为IAPA会员所,总部在伦敦，全球300个会员所，员工约1万人。
我们为LEA会员所,总部在美国芝加哥，全球600个会员所，员工约2万8千人。
Evershine is local Partner of ADP Streamline® in Taiwan.
(版本:2022/03)
更多城市更多服务  请点击 网站导览