Malaysia Cosmetics Registration QA

HLF-TW-10

What are the categories of cosmetics in Malaysia? What is its official name?
What is the intensity of management of different categories?
What is the governmental authority of cosmetics? Website?

Evershine RD：

A cosmetic product shall mean “any substance or preparation intended to be placed in contact with various external parts of the human body (epidermis, hair system, nails, lips and external genital organs) or with teeth and the mucous membranes of the oral cavity, with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance and/or correcting body odours and/or protecting them or keeping them in good condition”
Cosmetic classification:

1. Creams, lotions, lotions, gels and oils for the skin (hands, face, feet, etc.)

2. Masks (except chemical peeling products)

3. Coloring base (liquid, paste, powder)

4. Cosmetic powder, after-bath powder, hygiene powder, etc.

5. Soap, deodorant soap, etc.

6. Perfume, toilet water and cologne

7. Bath and shower supplies (salt, foam, oil, gel, etc.)

8. Depilatories

9. Deodorants and antiperspirants

10. Hair care products

． Hair Dye and Bleach

． Products for Waving, Straightening and Fixing

． Set up products

． Cleaning Products (Lotions, Powders, Shampoos)

． Conditioning products (lotions, creams, oils)

． Hair products (lotions, polishes, polishes)

11. Shaving products (cream, foam, lotion, etc.)

12. Face and Eye Makeup and Makeup Removers

13. Products for lips

14. Teeth and oral care products

15. Nail Care & Makeup Products

16. Products for external intimate hygiene

17. Sunbath products

18. Sun protection products

19. Skin Whitening Products

20. Anti-Wrinkle/Anti-Ageing Products

Not classified as cosmetic:

1. Products for the treatment of disease/infection

2. Sexual function products: male and female (preserved products for genital area)

3. Oral products

4. Injections: Vitamin C, Collagen, Hyaluronic Acid

5. The product is injected into the nose, eyes and ears

6. The use of the product is beyond the scope of cosmetics (such as massage oil for joint pain, sprain and essential oil for affecting mental and physiological functions)

7. Slimming products

8. Ophthalmic preparations in dropper bottles/containers or in spray form

In Malaysia, the Drug Control Authority (DCA) is the agency responsible for regulating cosmetics.
The National Drug Administration (NPRA) is the secretariat of the DCA and is responsible for the cosmetic notification process and post-market surveillance.

【參考連結】

https://www.npra.gov.my/index.php/en/

HLF-TW-20

If a foreign company wants to sell cosmetics in Malaysia, 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：

A health/cosmetic company needs to be registered locally in Malaysia.
A local health/cosmetic company in Malaysia is required to apply in the name of Cosmetic Notification Holder (CNH), and wholesalers must apply for a wholesaler license to sell or supply registered products through wholesale or from their premises, and the license is valid for 1 year.

Register all businesses (including foreign companies) in Malaysia, managed by the Companies Commission of Malaysia (SSM)’s Business Registry.
All companies must appoint a company secretary within 30 days of incorporation (primary residence in Malaysia is required).
The secretary must be licensed by the Companies Commission of Malaysia (SSM) or be a member of a professional body as specified by the Ministry of Domestic Trade and Consumer Affairs.

Business registration requires the following information:

1. Company name

2. Private or public companies

3. Suggested business type (must be health/cosmetics)

4. Registered Office Address

5. Business address

6. Paid-up capital (minimum RM1)

7. Details of directors and promoters

8. Statement of Directors and Promoters

9. Compliance Statement for the Individual Responsible for Incorporation

10. Additional documents (if available)

【參考連結】

https://www.ssm.com.my/Pages/Home.aspx

HLF-TW-25

假如需要辦理，請問馬來西亞有專業服務公司可以協助辦理化妝品公司營業許可證？

Evershine RD：

Lawoffice

https://www.lawofficemalaysia.com/

JK LIM

https://www.jklim.org/home.html

HLF-TW-30

If a foreign company wants to sell cosmetics in Malaysia, can it assign a Malaysian 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：

Yes. A health/cosmetic company needs to be registered locally in Malaysia.
A local health/cosmetic company in Malaysia is required to apply in the name of Cosmetic Notification Holder (CNH), and wholesalers must apply for a wholesaler license to sell or supply registered products through wholesale or from their premises, and the license is valid for 1 year.

Register all businesses (including foreign companies) in Malaysia, managed by the Companies Commission of Malaysia (SSM)’s Business Registry.
All companies must appoint a company secretary within 30 days of incorporation (primary residence in Malaysia is required).
The secretary must be licensed by the Companies Commission of Malaysia (SSM) or be a member of a professional body as specified by the Ministry of Domestic Trade and Consumer Affairs.

Business registration requires the following information:

1. Company name

2. Private or public companies

3. Suggested business type (must be health/cosmetics)

4. Registered Office Address

5. Business address

6. Paid-up capital (minimum RM1)

7. Details of directors and promoters

8. Statement of Directors and Promoters

9. Compliance Statement for the Individual Responsible for Incorporation

10. Additional documents (if available)

CNH should report the adverse event to the National Drug Regulatory Authority (NPRA), regardless of the source of the report (consumer, healthcare professional, etc.). All serious adverse events should be reported.
Reports of non-serious adverse events are not required.
All serious adverse events must be reported whenever there is reason to suspect that cosmetic products may be the cause of the reaction.

【參考連結】

https://www.ssm.com.my/Pages/Home.aspx

https://www.npra.gov.my/index.php/en/cosmetics-guideline-annex-i-vii

HLF-TW-35

假如需要辦理指派馬來西亞公司擔任營業代理人，請問馬來西亞有專業服務公司可以協助？

Evershine RD：

OriBionature

https://oribionature.com/

COSDERM

https://cosderm.com.my/

DCM

https://www.decosmeticsmalaysia.com/home-1

HLF-TW-40

Do foreign companies need to apply for an approval before importing cosmetics sold to Malaysia?
If yes, which authority is in charge? What documents are required? What is the application process?
Do cosmetics packaging and labeling require prior approval? In addition to Malaysian, which other languages ​​are allowed? Website?

Evershine RD：

It is required to apply on behalf of a local health/cosmetics company in Malaysia as the Cosmetic Notification Holder (CNH).
The manufacture, sale, supply, import or distribution of all cosmetic products must be notified to NPRA prior to sale in Malaysia.
A foreign company wishing to bring cosmetic products into Malaysia must first appoint a local agent as a cosmetic notification holder (CNH). Cosmetic notification holders are responsible for placing cosmetic products on the market.

The Cosmetic Notification Holder (CNH) must be a locally registered company in the cosmetics sector, with a permanent address and registered with the Companies Commission of Malaysia (health/cosmetics-related company as indicated by its business scope).
All notification submissions are made online through the Quest system on the NPRA website.
Membership must be registered, a notification form for each cosmetic product must be completed, and payment completed.
CNH may not manufacture or import cosmetic products until authorized.

needed file:

1. Product Details

． Product name, product type, intended use and product description

． Manufacturer’s and assembler’s name and address (if available)

2. CNH’s name, address, contact number, email

3. Importer’s name, address (if available)

4. Complete product ingredient list

． The content of restricted ingredients must be declared, i.e. percentage (%)

． Power of Attorney/Declaration/Contract Manufacturing (if applicable)

5. Product labeling

Note: Any documents and materials submitted to NPRA must be in either Malay or English.
Translations in other languages must be endorsed or licensed.

Cosmetic labeling requirements: The outer packaging of cosmetics must be marked with the following contents (if there is no outer packaging, it must be marked on the direct packaging of cosmetics).

1. The name of the cosmetic product and its function, unless it is clear from the product description

2. Instructions for use of cosmetics, unless clear from the product name or appearance

3. Complete ingredient list. Ingredients must be declared in descending weight order when added.

． Perfume and fragrance compositions and their raw materials may be referred to simply as perfumes, scents, aromas or flavors. Ingredients with a concentration of less than 1% can be listed in any order after ingredients with a concentration of greater than 1%. Colorants can be listed in any order after the other ingredients, depending on the name used in the specification.

． For decorative cosmetics sold in multiple shades, all colorants used in the range can be listed, provided the term “may contain” or “+/-” is added. Ingredients shall be designated using the nomenclature in the latest edition of the Standard Reference.
Botanicals and plant extracts should be identified by their genus and species.

However, the following should not be considered ingredients:

． Impurities in the raw materials used

． Assistive Technology Materials Used in Preparation but Not Used

． The material acts as a solvent, or a carrier for perfume and fragrance compositions

4. Country of manufacture;

5. CNH’s name and address

6. Weight or volume content in metric and imperial

7. Production batch number

8. The date of manufacture or expiration date of the product, in an unambiguous manner (eg month/year).

． Dates should be clearly indicated and should consist of months and years or in the order day, month, and year.
The minimum shelf life should be the date that the product has been stored under appropriate conditions until it continues to perform its original function, in particular, to maintain compliance with safety requirements. It should be preceded by the words due date.
If necessary, this information shall be supplemented by a description of the conditions that must be met in order to guarantee the specified durability. For cosmetic products with a minimum shelf life of less than 30 months, the expiration date must be stated.

9. Special precautions to be observed in use, especially conditions of use and warnings, must appear on the label and any special precautionary information for the cosmetic product.

10. All marked contents should be easy to read, clear, understandable and indelible.

11. The information on the label should be in Malay and/or English.

Animal-derived ingredient declaration:

1. There must be a statement (in any format) on the product label indicating the presence of ingredients of animal origin

2. For ingredients of bovine or porcine origin, the exact animal must be declared

3. A valid contact number for CNH.

If the size, shape or nature of the container or package does not meet the details of the permitted display regulations, flyers, brochures, hang tags, display boards, shrink wrap, etc. may be used instead, with at least the following:

1. Cosmetics name

2. Production batch number

3. If the cosmetic product is imported in bulk containers, at least the following details shall appear on the container:

． Cosmetic name

． Manufacturer’s name and manufacturing lot number

4. All marked contents should be easy to read, clear, understandable and indelible.

Halal Mark: Products have been certified and approved as Halal by this or any authorised Islamic body of the Ministry of Islamic Development Malaysia (Jabatan Kemajuan Islam Malaysia, JAKIM) and can be voluntarily marked on approved cosmetic products.

【參考連結】

https://www.npra.gov.my/index.php/en/component/content/article/37-faq/620-cosmetic?Itemid=437

https://www.npra.gov.my/index.php/en/cosmetics-guideline-annex-i-vii

HLF-TW-45

請問在馬來西亞有哪些專業服務機構，可以協助辦理化妝品產品許可證？

Evershine RD：

VOLT

https://voltconsultancy.com/

LKEY Consultancy

https://www.lkeyconsultancy.com/

HLF-TW-50

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?
In addition to Malaysian, which other languages ​​are allowed? Website?

Evershine RD：

It is required to apply on behalf of a local health/cosmetics company in Malaysia as the Cosmetic Notification Holder (CNH).

The manufacture, sale, supply, import or distribution of all cosmetic products must be notified to NPRA prior to sale in Malaysia.
A foreign company wishing to bring cosmetic products into Malaysia must first appoint a local agent as a cosmetic notification holder (CNH). Cosmetic notification holders are responsible for placing cosmetic products on the market.

The Cosmetic Notification Holder (CNH) must be a locally registered company in the cosmetics sector, with a permanent address and registered with the Companies Commission of Malaysia (health/cosmetics related company as indicated by its business scope).
All notification submissions are made online through the Quest system on the NPRA website.
Membership must be registered, a notification form for each cosmetic product must be completed, and payment completed.

CNH may not manufacture or import cosmetic products until authorized.needed file:

1. Product Details

． Product name, product type, intended use and product description

． Manufacturer’s and assembler’s name and address (if available)

2. CNH’s name, address, contact number, email

3. Importer’s name, address (if available)

4. Complete product ingredient list

． The content of restricted ingredients must be declared, i.e. percentage (%)

． Power of Attorney/Declaration/Contract Manufacturing (if applicable)

5. Product labeling

Note: Any documents and materials submitted to NPRA must be in either Malay or English. Translations in other languages must be endorsed or licensed.

Cosmetic labeling requirements: The outer packaging of cosmetics must be marked with the following contents (if there is no outer packaging, it must be marked on the direct packaging of cosmetics).

1. The name of the cosmetic product and its function, unless it is clear from the product description

2. Instructions for use of cosmetics, unless clear from the product name or appearance

3. Complete ingredient list. Ingredients must be declared in descending weight order when added.

． Perfume and fragrance compositions and their raw materials may be referred to simply as perfumes, scents, aromas or flavors. Ingredients with a concentration of less than 1% can be listed in any order after ingredients with a concentration of greater than 1%. Colorants can be listed in any order after the other ingredients, depending on the name used in the specification.

． For decorative cosmetics sold in multiple shades, all colorants used in the range can be listed, provided the term “may contain” or “+/-” is added. Ingredients shall be designated using the nomenclature in the latest edition of the Standard Reference. Botanicals and plant extracts should be identified by their genus and species.

However, the following should not be considered ingredients:

． Impurities in the raw materials used

． Assistive Technology Materials Used in Preparation but Not Used

． The material acts as a solvent, or a carrier for perfume and fragrance compositions

4. Country of manufacture;

5. CNH’s name and address

6. Weight or volume content in metric and imperial

7. Production batch number

8. The date of manufacture or expiration date of the product, in an unambiguous manner (eg month/year).

． Dates should be clearly indicated and should consist of months and years or in the order day, month, and year. The minimum shelf life should be the date that the product has been stored under appropriate conditions until it continues to perform its original function, in particular, to maintain compliance with safety requirements. It should be preceded by the words due date. If necessary, this information shall be supplemented by a description of the conditions that must be met in order to guarantee the specified durability. For cosmetic products with a minimum shelf life of less than 30 months, the expiration date must be stated.

9. Special precautions to be observed in use, especially conditions of use and warnings, must appear on the label and any special precautionary information for the cosmetic product.

10. All marked contents should be easy to read, clear, understandable and indelible.

11. The information on the label should be in Malay and/or English.

Animal-derived ingredient declaration:

1. There must be a statement (in any format) on the product label indicating the presence of ingredients of animal origin

2. For ingredients of bovine or porcine origin, the exact animal must be declared

3. A valid contact number for CNH.

If the size, shape or nature of the container or package does not meet the details of the permitted display regulations, flyers, brochures, hang tags, display boards, shrink wrap, etc. may be used instead, with at least the following:

1. Cosmetics name

2. Production batch number

3. If the cosmetic product is imported in bulk containers, at least the following details shall appear on the container:

． Cosmetic name

． Manufacturer’s name and manufacturing lot number

4. All marked contents should be easy to read, clear, understandable and indelible.

Halal Mark: Products have been certified and approved as Halal by this or any authorised Islamic body of the Ministry of Islamic Development Malaysia (Jabatan Kemajuan Islam Malaysia, JAKIM) and can be voluntarily marked on approved cosmetic products.

【參考連結】

https://www.npra.gov.my/index.php/en/component/content/article/37-faq/620-cosmetic?Itemid=437

https://www.npra.gov.my/index.php/en/cosmetics-guideline-annex-i-vii

HLF-TW-55

請問在馬來西亞有哪些專業服務機構，可以協助以外國公司名義辦理化妝品產品許可證？

Evershine RD：

VOLT

https://voltconsultancy.com/

LKEY Consultancy

https://www.lkeyconsultancy.com/

YC

https://www.yc-consultancy.com/

HLF-TW-60

What documents are required when importing approved cosmetics into Malaysia? What is the procedure?
Any preparation is required to submit to the Ministry of Health and Welfare for selling products? Website?

Evershine RD：

A local health/cosmetic company in Malaysia is required to apply for import in the name of the Cosmetic Notification Holder (CNH).

The manufacture, sale, supply, import or distribution of all cosmetic products must be notified to NPRA prior to sale in Malaysia.
A foreign company wishing to bring cosmetic products into Malaysia must first appoint a local agent as a cosmetic notification holder (CNH). Cosmetic notification holders are responsible for placing cosmetic products on the market.

The Cosmetic Notification Holder (CNH) must be a locally registered company in the cosmetics sector, with a permanent address and registered with the Companies Commission of Malaysia (health/cosmetics-related company as indicated by its business scope).
All notification submissions are made online through the Quest system on the NPRA website. Membership must be registered, a notification form for each cosmetic product must be completed, and payment completed. CNH may not manufacture or import cosmetic products until authorized.

needed file:

1. Product Details

． Product name, product type, intended use and product description

． Manufacturer’s and assembler’s name and address (if available)

2. CNH’s name, address, contact number, email

3. Importer’s name, address (if available)

4. Complete product ingredient list

． The content of restricted ingredients must be declared, i.e. percentage (%)

． Power of Attorney/Declaration/Contract Manufacturing (if applicable)

5. Product labeling

Note: Any documents and materials submitted to NPRA must be in either Malay or English. Translations in other languages must be endorsed or licensed.

To import goods into Malaysia, import duty, excise duty, sales tax is required to be declared to the Royal Malaysian Customs Department (JKDM) and paid for duties/taxes.

1. Customs declaration: All goods imported into Malaysia must be declared through one of the following methods

．Designated Customs Broker

．Self Declaration (AEO Programme – AEO Portal)

．Direct users

2. Commodity classification: The importer needs to obtain confirmation of the goods to be imported into Malaysia by obtaining the correct tariff code of the goods if any duties/taxes are to be paid.

3. Check if the item is a controlled commodity or an imported contraband:

．Check whether the goods to be imported are regulated goods or goods whose importation is prohibited or restricted by the authorities.

．Confirm permission/approval prior to import.

4. Declaration and preparation of customs release documents: Each importer shall make a complete and true declaration of the imported goods in person or by his agent upon arrival or arrival in Malaysia.

． Electronic customs declaration

． Submit import license (electronic file or copy)

．Bill of Lading / Air Waybill

．Invoice (Purchase Order or Letter of Credit)

．Packing List

．Certificate of country of origin

．Other relevant documents (inspection certificate, analysis certificate, composition certificate, halal certificate, product specification certificate, etc.)

5. Goods inspection: JKDM reserves the right to inspect the goods to ensure that the imports comply with laws and regulations.

6. Pay Duties/Taxes Import: Duties/taxes payable on the goods must be paid by the importer upon arrival of the goods.
Payment can be made over the counter or electronically.

7. Customs Approval

8. Customs release

9. Preservation of documents: Import records are kept in Malaysia for seven years

【參考連結】

https://www.npra.gov.my/index.php/en/component/content/article/37-faq/620-cosmetic?Itemid=437

http://www.customs.gov.my/en/pages/main.aspx

HLF-TW-70

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

Evershine RD：

Good Manufacturing Practice (GMP):

1. All cosmetic products must be produced in accordance with the Good Manufacturing Practice Guidelines for Cosmetics or equivalent

2. Local manufacturers are required to undergo regular inspections by NPRA’s GMP auditors; for foreign manufacturers, documentation demonstrating GMP compliance shall be provided as required by NPRA.

3. Standards equivalent to GMP:

(1) Good Manufacturing Practices for Pharmaceutical Products, World Health Organisation (WHO)

(2) Australian Code of Good Manufacturing Practice for Therapeutic GoodsSunscreen Products, Therapeutic Goods Administration (TGA)

(3) ISO Standard 22716: Cosmetics – Good Manufacturing Practices (GMP) – Guidelines on Good Manufacturing Practices

4. Documents required for Good Manufacturing Practice (GMP)

(1) Material specifications of the original packaging

．Material name

．Material Description

．Test parameters, acceptance limits

．Technical Drawings (if applicable)

．Special precautions such as storage and safety conditions (if necessary)

(2) Bulk, finished product specifications

．Product name

．Illustrate

．Physical properties

．Chemical analysis and/or microbiological analysis and their acceptance limits (if necessary)

．Storage conditions and safety precautions (if necessary)

(3) Production documents

(4) Main formula

．Product name, product code/number

．Expected Packaging Materials, Storage Conditions

．List of raw materials used

．List of equipment used

．Process controls and their limitations on processing and packaging (if applicable)

(5) Batch Production Record (BMR): A batch production record must be prepared for each batch of products.

．batch formula

．Brief description of the manufacturing process

．Lot number or code

．Start and end dates for processing and packaging

．Identification of major equipment lines or locations

．Cleaning records of equipment responsible for processing

．Process control and laboratory results such as pH and temperature test records

．Packaging line inspection record

．Any sampling performed during individual steps

．any investigation of a specific fault or discrepancy

．Inspection results of packaged and labelled products

(6) Quality control records: Records of each test, release or rejection of assay results for starting materials, intermediates, bulk products and finished products need to be maintained.

．Material identification

．Supplier name

．Date of receipt

．Original lot number (if available)

．Batch number

．Quality control number

．Receipt quantity

．Sampling date

．Quality Control Results

Product Information File (PIF):

1. CNH shall be responsible for providing all product information, certificates, documents and data required by NPRA. PIFs can be in archival form (that is, a collection of paper records stored in a specific location) or in electronic format.

2. The file content contains the following points

(1) Administrative documents and product overview

．Product identity, name and address of manufacturer, assembler, importer and CNH

．Product Owner’s Letter of Authorization or Declaration and Contract Manufacturing (if applicable)

．Other relevant administrative documents, e.g. business license, company registration certificate

．Fragrance, name and code of ingredient and identity of supplier

．Outer and inner labels

．Consumer Information Flyer and Instructions for Use

．A document issued/endorsed by an accreditation body (indicating that it was manufactured in accordance with the Cosmetic GMP Guide or any equivalent guide)

．Batch Coding System/Key for Products

．Safety Statement (signed statement of opinion, including the name and qualifications of the safety assessor)

．Adverse effects on human health confirmed (summary)

．Summary Report of Product Efficacy Assessment

(2) Quality data of raw materials

．Specifications of Each Ingredient

．Analysis method corresponding to the specification of each component

．The name, address and declaration of compliance of the fragrance supplier

．Flavor materials (please specify the product name and code)

．Raw material safety data available in the supplier area: published data or reports from scientific committees such as the ASEAN Cosmetic Science Body (ACSB), the European Union Scientific Committee on Consumer Products (SCCP) or the U.S. Cosmetics Ingredient Review Committee (CIR).

(3) Quality data of finished products

．Qualitative and quantitative formulation of the product (INCI or other approved reference designation and corresponding ingredient concentration), which must state the function of each raw material/ingredient

．Manufacturer, assembler, packer’s name, country and address

．Summary of Manufacturing Process

．Provide more details about the manufacturing process, quality control and related manufacturing documentation as required by NPRA

．Standard for cosmetic microbiological control and chemical purity of cosmetic ingredients

．Analysis method for each inspection specification

．Stability test data/reports or stability assessments supporting expiration date

(4) Safety and efficacy data

．Signed safety assessment report of finished product to human health based on its composition, chemical structure and exposure level

．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 product

3. Note: CNH should keep PIF at the address specified on the label for easy access by regulatory agencies, and it is recommended to keep it for at least 3 years after the product was last placed on the market.

Good Distribution Practice (GDP)

1. Importers and wholesalers must adhere to the principles of Good Distribution Practice (GDP).

2. The written description shall describe the different actions that may affect the quality of the material and/or product and/or cosmetic or distribution activity:

．Receipt and Check Delivery

．Storage, cleaning and maintenance of premises (including pest control)

．Record of storage conditions

．On-site inventory and cargo security in transit

．Pull records from saleable inventory

．Customer order record

．Returned materials and/or products and/or cosmetics, recall programs, etc.

3. These procedures shall be approved, signed and dated by authorized personnel.

4. Each action shall be recorded as it is carried out and shall be carried out in such a way that all significant activities or events can be traced.

5. Records should be legible and easily accessible.

6. Retention of documents related to the distribution of materials and/or products and/or cosmetics shall comply with national requirements.

【參考連結】

https://www.npra.gov.my/index.php/en/cosmetics-guideline-annex-i-vii

https://www.npra.gov.my/index.php/en/faqs-compliance-and-licencing/frequently-asked-questions-faqs-licensing.html

HLF-TW-75

馬來西亞化妝品審核機構，能夠接受海外檢驗機構的檢驗資料嗎？假如是的話，有些被認可的機構？網頁？

Evershine RD：

外國製造商需要在製造商所在的國家/地區，由授權機構簽發、認可的符合化妝品 GMP 的文件或聲明。
NDRA 認可的有PIC/S 網站上列出的機構。

網頁：https://picscheme.org/en/members

HLF-TW-77

請問在馬來西亞有哪些化妝品檢驗機構可以提供化妝品檢驗服務？網頁？

Evershine RD：

Furley

https://furleybio.com/manufacture/

HEALTHMEDIC

http://www.healthmedic.my/index.php

Sirim

https://www.sirim-qas.com.my/

HLF-TW-80

After a foreign subsidiary imports cosmetics and entrusts a distributor in Malaysia 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：

A local health/cosmetic company in Malaysia is required to apply in the name of Cosmetic Notification Holder (CNH), and wholesalers must apply for a wholesaler license to sell or supply registered products through wholesale or from their premises, and the license is valid for 1 year.

CNH should report the adverse event to the National Drug Regulatory Authority (NPRA), regardless of the source of the report (consumer, healthcare professional, etc.). All serious adverse events should be reported.
Reports of non-serious adverse events are not required.
All serious adverse events must be reported whenever there is reason to suspect that cosmetic products may be the cause of the reaction.

【參考連結】

https://www.npra.gov.my/index.php/en/component/content/article/37-faq/620-cosmetic?Itemid=437

https://www.npra.gov.my/

HLF-TW-85

請問在馬來西亞有哪些專精於化妝品銷售與消費權益相關法律服務的業者？

Evershine RD：

Lawoffice

https://www.lawofficemalaysia.com/

JK LIM

https://www.jklim.org/home.html

Low & Partners

https://www.lowpartners.com/