The Minister of Public Health has made the following announcement:
1. “Injectable hyaluronic acid " contains hyaluronic acid or sodium hyaluronate as a key component for skin correction.
2. Injectable hyaluronic acid is classified as Licensed Medical Device.
3. Injectable hyaluronic acid can only be marketed to medical facilities, medical practitioners, dental professionals or licensed sellers
4. Injectable hyaluronic acid must comply with the requirements specified in the drug formula prescribed by the Minister under the law on drugs. Product stability test must comply ICH Guideline for Stability Testing of New Drug Substances and Products ASEAN Guideline on Stability Study of Drug Product. However, if the analysis is done by a well-established method, the result must be validated according to international standards (or equivalent standards).
5. Injectable hyaluronic acid must be manufactured by a PIC/S- and ISO 13485-certified manufacturer.
6. Manufacturer and importer of Injectable hyaluronic acid must provide a product label that complies with the following requirements:
6.1 Texts should be in Thai language. Inclusion of other language is optional, but the font sizes should not be larger than Thai texts. Labels should be legibly printed and prominently attached on the outer product packaging or primary container. Labels should contain the following information:
(1) Trade name of the product;
(2) Name and concentration of all components
(3) Packaging quantity
(4) Name and address of the manufacturing site. Importers must provide the address of the manufacturer;
(5) Year and Month or Month and Year for manufacturing date. Manufacturing year must be 4 digits
(6) Year and Month or Month and Year for expiry date. Expiry date must be 4 digits;
(7) Numbers or letters indicating LOT number or manufacture number;
(8) Registration license number of medical device;
(9) Storage methods;
(10) Intended use and instruction for use;
(11) Warning, and precautions;
(12) Auxiliary label: “Please read device documentation before use”;
(13) Auxiliary label: “Sterilized and methods of sterilization”;
(14) Auxiliary label: “Fragile, please handle with care”;
(15) Auxiliary label: “Storage temperature range”;
(16) Auxiliary label: “Avoid sunlight”;
(17) Auxiliary label: "Do not use if the package is damaged or opened" shown in red letters;
(18) Auxiliary label: "Single use only" shown in red letters;
(19) Auxiliary label: “Only for use by medical practitioners or dental professionals ” shown in red letters;
If information (1) (2) (3) (4) (5) (6) and (7) if cannot be translated in Thai, English may be used instead.
(10) and (11) may be placed in device documentation if inclusion in device labelling is not possible.
For information: (12) (13) (14) (15) (16) (17) and (18), if English abbreviations are used, abbreviations must be spelled out in the device documentation.
6.2 Device documentation of Injectable hyaluronic acid that is for domestic selling must have labelling in Thai which is clearly readable on product packages or its container, including of other language is optional. With at least these following items:
(1) Trade name of the product;
(2) Name and concentration of all components;
(3) Packaging quantity
(4) Name and address of the manufacture site. For importer, provide address of the manufacturer;
(5) Number of the registration license of medical device to be licensed;
(6) Storage methods;
(7) Intended use and instruction for use;
(8) Warning, and precautions;
(9) Auxiliary label: “Sterilized and methods of sterilization”;
(10 Auxiliary label: “Fragile, please handle with care”
(11) Auxiliary label: “Storage temperature range”;
(12) Auxiliary label: “Avoid sunlight”
(13) Do not use if the package is damaged or torn" shown in red letters;
(14) Auxiliary label: "Single use only";
(15) Auxiliary label: “The use of Injectable hyaluronic acid can be done by medical practitioners or dental professionals only”
(16) The date of amendment to device documentation.
7. In the case of importing Injectable hyaluronic acid, the importers must prepare the labelling on the packages according to clause 6 before selling, within thirty days from the date that medical device has checked for release.
8. Registration of the drug certificate holder, Injectable hyaluronic acid before the effective date of this notification and wishes to continue operating, must apply for establishment import license along with preparing the registration of medical device to be notified within the period of 30 days from the effective date of this notification.
9. When proceed the registration of medical device to be Licensed within the period of 30 days, the selling of Injectable hyaluronic acid can be continued in operation until the Licensing Authority notifies the disapproval of that product.
10. Registrant of drug certificate holder for Injectable Hyaluronic acid that retrieved their certificate before the effective date of this Announcement can legally market their products until the expiration of their products, or until there is an order to suspend the selling of that Injectable hyaluronic acid
11. This announcement shall come into force after 180 days from the date following the date of its publication in Government Gazette onwards.
Translated from official ThaiFDA announcement, by: