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Ampoules, vials, and syringe-type containers—packaging formats commonly associated with pharmaceutical and injectable products—are increasingly used for cosmetic products such as serums and concentrated skincare treatments. However, these formats may be subject to regulatory considerations beyond those applicable to conventional cosmetics, as their appearance can create a risk of consumer misunderstanding or misuse.
Thailand is one market where this distinction is particularly important. The Thai Food and Drug Administration (Thai FDA) has established specific requirements for cosmetic products packaged in ampoules, vials, or syringe-type containers, covering their intended use, packaging, labeling, and supporting documentation. In this article, ZMUni Compliance Centre outlines the key requirements that overseas cosmetic brands should understand before entering the Thai market with these products.
Cosmetics packaged in ampoules, vials, or syringe-type containers must have an intended use that falls fully within the legal scope of cosmetics in Thailand. In addition, they must:
1. Not be classified as drugs or medical devices;
2. Not be used with tools or equipment classified as medical devices (e.g., Mesotherapy, Iontophoresis, Microneedle Therapy Systems (MTS) like Microneedle Rollers or Patches, or hypodermic needles);
3. Not be intended for use following medical or aesthetic procedures, such as laser treatments or MTS.
Ampoules: Glass or plastic tubes. If intended for multi-use after opening, a proper dropper/cap must be included in the box.
Vials: Glass or plastic containers sealed with a rubber stopper and aluminum ring (or other suitable material). The container must be easy to open by hand without tools. The rubber stopper must be removable, allowing a nozzle cap included in the package to be attached.
Syringes: Syringe-shaped containers are permitted, but pre-filled syringes ready for injection are prohibited, as are syringes equipped with connectors (e.g., Luer-lock or locking-fit connectors) designed to attach to needles or medical devices.
During the online notification process, the container form must be selected as "SYRINGE / AMPOULE / VIAL."
The Thai FDA currently allows leave-on cosmetics in ampoule, vial, or syringe-type packaging to be notified as cosmetics, provided that they fall within the permitted product categories and intended uses.The permitted uses include:
| No. | Intended Function | Application Area | Method of Use |
|---|---|---|---|
| 1 |
Skin care |
Face |
Leave on; no rinsing required |
| 2 |
Skin care |
Body skin |
Leave on; no rinsing required |
| 3 |
Skin care |
Eye area |
Leave on; no rinsing required |
| 4 |
Skin care |
Hair and scalp |
Leave on; no rinsing required |
| 5 |
Mixed with other cosmetics |
Face |
Leave on; no rinsing required |
| 6 |
Hair and scalp care |
Hair and scalp |
Leave on; no rinsing required |
If a product falls outside the permitted categories or intended uses above, the Thai FDA may conduct a case-by-case assessment, and additional information or a more stringent review may be required.
In addition to the standard documents required for cosmetic notification, companies applying to notify ampoule, vial, or syringe-type cosmetics may need to provide the following supporting documents:
Manufacturer Certification: Detailed instructions for use, clarification that the product is not intended for use with medical devices, and certification that the product is for topical application only and not for injection.
Product Packaging, Labels, and Package Insert: Clear, high-resolution copies of the actual product packaging, labels, and package insert. Non-English documents must be translated into Thai by an accredited language institute, such as a university.
Actual Product Sample: A physical sample of the product.
Misuse Prevention Letter: Clarifying measures taken by the manufacturer/importer to prevent misuse.
Certificate of Free Sale (CFS): Issued by the country of origin and confirming that the product is marketed as a cosmetic.
Sterility Justification: A statement confirming whether the product is sterile. If sterilization is used, justification must be provided as to why it is necessary for a product intended for topical use.
Additional Documentation: Supplementary information may be requested during the authority's review, such as a video demonstrating the product's intended method of use.
Important Note: Products that share the same name as injectable products or medical devices in other markets may be rejected by the Thai FDA.
ZMUni Reminder
For overseas brands, cosmetic compliance in Thailand is not determined by the formulation alone. Packaging format and intended use can also affect how a product is assessed and what requirements apply.
This is particularly important for ampoule, vial, and syringe-type products. Companies developing or adapting these products for the Thai market should assess their packaging and intended use at an early stage, helping avoid unnecessary changes to packaging, labeling, or supporting documentation later in the notification process
