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Taiwan to Implement 6 Administrative Measures Mainly about GMP, Border Inspection, Labelling

  •   2 Jul 2019
  •    Ye Chen
  •  1067
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    Takehome:

    Taiwan is to implement 6 new/updated administrative measures including:

     
    • Implementation Rules for Cosmetic Hygiene Safety Administration Act, 
    • Border Inspection Methods for Imported Cosmetics, 
    • Cosmetics Product Categories that Require GMP 
    • Cosmetics Manufacturers that Are Exempted from Factory Registration,
    • Labeling requirements for “Medicated” Cosmetics
    • Documents Required for the Change of Registration Information and License Information of Specific Purpose Cosmetics.
    .

    Implementation Rules for Cosmetic Hygiene Safety Administration Act(2019.7.1)[1]
    Main changes:
    1. Name changed fromImplementation Rules for Statue for Control of Cosmetic Hygiene to Implementation Rules for Cosmetic Hygiene Safety Administration Act.
    2. Add the definition of the person who should be responsible for product notification and building product information file.
    3. Add the definition of place of origin for cosmetics.
    4. Add the definition of manufacturing sites.
    5. Exceptional situations when pharmacists or professional technicians should be hired to supervise the manufacturing of cosmetics.
    6. Add the explanation of sealing procedure and practitioners’ reservation obligations.
    7. Redefines the situations in which cosmetics advertisements violate regulations.

    Border Inspection Methods for Imported Cosmetics(2019.7.1)[2]
    Main content:
    1. Documents required: Application form, the photocopy of imported product declaration, other documents required by other inspection administrations.
    2. Inspection Methods: On-site inspection; sampling; inspection batch by batch
    3. Different approaches to products with different results of inspection
    4. Fee charging

    Cosmetics Product Category that Should Comply with Good Manufacturing Practice(2019.7.1)[3]
    Cosmetic categoryImplementation date
    Specific purpose cosmeticsJul. 1, 2024
    General cosmetics used for infants, used around the eyes or mouthJul. 1, 2025
    General cosmetics (except for cosmetics used for infants, used around the eyes or mouth)Jul. 1, 2026
    Note: Hand-made soaps manufacturers exempted from factory registration do not need to comply with GMP.

    Cosmetics Manufacturers that Are Exempted from Factory Registration(2019.7.1)[4]
    1. Hand-made soaps manufacturing sites whose kitchen area or power capacity and scale of thermal energy of its production equipment do not reach the standards in Factory Management Guidance.
    2. Manufacturing sites that only package cosmetics.
    3. The above manufacturing sites still need to follow Standards for Cosmetics Manufacturing Factory.

    The Sentence that Should Be Labelled on the Package if Imported Cosmetics Have the term “Medicate” or Similar Words on the Package(2021.7.1)[5]
    If imported cosmetics have “Medicate” or similar words on the package and are regulated in the places (countries) of origin or countries of sale as OTC drug or quasi drug, a sentence should be labelled on the package, which is “ This product is a cosmetic and not a medicine.”

    Documents Required for the Change of Registration Information and License Information of Specific Purpose Cosmetics(2019.7.1)[6]
     Application form for Registration Information changeOriginal licenseOriginal verification certificate for leaflet, label and packageNew leaflet, label and package draft (Two)Testing ReportIngredient list (Domestic products Exempted)Approved License for manufacturing and sale issued by the producing countryNotification letter sent to the original manufacturer (Domestic productsexempted)The photocopy of pharmacist license or degree certificate of technical personnel, employment certificate of this person(Imported products exempted)Other materials
    Chinese or English product name changeXXX⚪ (Products only changing Chinese name exempted)X 
    New product models  or product color changeXXX 
    New Product items XXX 
    Main ingredients or formulations ChangeXX 
    leaflet, label and package Change XXXX 
    Cosmetic purpose changeXXXXX 
    Company’s name changeXXXXXXXPhotocopy of company registration or business registration certificate
    Manufacturer’s name, address ChangeXXX1.Factory registration certificate (Imported products exempted)
    2.If there is a commissioned manufacturer, commission information on the manufacturing process should be submitted
    Add specific names for exported products (only for Domestic products)XXXXX 
    License transfer registrationXXXXXX1.The transfer form signed by both sides
    2.Products list
    3.A photocopy of the transferee’s company registration or business registration certificate
    4.Factory registration certificate after transfer (Imported products exempted)
    5.The original document of the foreign manufacturer's transfer of the import agency right plus verification (Domestic products exempted)

    If you have needs to translate these regulations, you are welcome to contact us by cosmetic@chemlinked.com
     

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    ABOUT THE AUTHOR

    ChemLinked Editor

    Ye Chen is a cosmetic editor in the ChemLinked team, whose major job is to interpret, track and analyze the latest cosmetic regulatory and marketing changes in China and the rest of the Asia Pacific area. Her main focus is in mainland China, Taiwan (district) and Australia.

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