The new standard has made clear provisions on the container’s characteristics, notification application documents, and labeling requirements for cosmetics packaged in ampere, vial, and syringe containers.

In May 2023, the Thai Food and Drug Administration (Thai FDA) introduced a revised criteria for reviewing notifications of ampoule, vial, and syringe cosmetics. The new standard aims to safeguard the safety and quality of such cosmetics, prevent their misuse and abuse, and provide clear guidance for businesses.

The revised standard highlights several crucial provisions that businesses need to adhere to:

1. Distinct Classification

The updated standard clearly state that cosmetics packaged in ampoules, vials or syringes shall not be classified as drugs, nor be used in conjunction with medical devices or be intended for use after a medical procedure such as laser treatment and Microneedle Therapy System (MTS).

2. Container Requirements

The revised standard outlines that cosmetic containers of ampoule, vial, and syringe types must have the below characteristics:

3. Documentation Requirements

Enterprises are required to provide the following supporting documents for review when filing a notification:

1. Certification from manufacturers, explaining the usage method and explicitly stating that the product is strictly for external application, but not for injection or use with medical devices.
2. Clear and visible images of the actual product for sale, and its labels, tubes, boxes, bottles, and inserts. If the attached documents are in a language other than English, a Thai translation from a government-recognized language institution should be provided. Besides, there must be a warning on the label such as "Do not inject or use in conjunction with medical devices. For external application only", or similar statements on the outer box label and the product bottle, to ensure consumer’s awareness.
3. Product samples.
4. A statement from the manufacturer or importer, outlining the measures undertaken by the company to prevent misuse.
5. Additional supporting documents may be requested if the notification officers require further clarification, such as pictures and videos demonstrating the use of the product or a Certificate of Free Sale (CFS) from the country of origin, proving that this product is indeed a cosmetic item.

4. Differentiation

In cases where the product name of an ampoule, vial, or syringe cosmetic is the same as a product used for injection or used with medical devices in foreign countries, the manufacturer must modify the product name, label design, or label color to avoid consumer’s confusion. The label must also bear a warning such as "Do not inject or use in conjunction with medical devices. For external use only" or a similar message.

Reference Links

[1] Criteria for Considering the Notification of Cosmetics in the Form of Ampoule, Vial and Syringe (Revised in May 2023)

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