Home About Qualtech NEWS THAILAND: TFDA published the Draft of Ministry of Public Health Announcement Regarding Cleaning Products Containing Alcohol as a Component for Hygienic Use - February 2019
THAILAND: TFDA published the Draft of Ministry of Public Health Announcement Regarding Cleaning Products Containing Alcohol as a Component for Hygienic Use - February 2019

February 18, 2019

On December 28, 2018 ThaiFDA has published Draft of Ministry of Public Health announcement regarding cleaning products containing alcohol as a component for hygienic use. Based on the power under Section 4 (3), Section 5, Section 6 (2) (4) (5) and (13), Section 44, paragraph two and Section 45, paragraph two of the Medical Device Act BE 2551, the Minister The Ministry of Public Health, with the guidance of the Medical Device Committee, announced as follows:                                                                              

1. In this announcement " Alcohol-based hand sanitizer" means product which contains ethyl alcohol/ethanol, or isopropyl alcohol/ isopropanol and may contain other compounds such as flavouring agents, preservatives which are in various forms such as lotion, solution, cream, gel, foam, spray: including non-pressurized sprays, continuous (bag-on-valve) sprays, and aerosol (no chlorofluorocarbon (CFC) based spray)with the purpose of cleaning hands without using water.                                                                                      

2. All hand cleaning products having alcohol based as hygiene component, manufacturer and importer must prepared the registration of medical device to be notified in order to import the product.                                                                       

3. All hand cleaning products having alcohol based as hygiene component must follows these standard:

(a) Must consist of ethyl alcohol/ethanol or isopropyl alcohol/ isopropanol, combined from or more than 70% by volume. 

(b) Must have EN 1500:2013 Chemical disinfectants and antiseptics Hygienic hand rub or newer. Or have standards that Food and Drug Administration Determined by the announcement in the Government Gazette or other equivalent standards.

(c) Stability test results follows ASEAN guideline on Stability Study of Drug Product.                           

4. Manufacturer and importer of hand cleaning products having alcohol based as hygiene component must provide labelling in Thai or English that are clearly readable on product packages or its container. With at least these following items:                                                                   

(a) Trade name of the product                                  

(b) List of all substances in accordance to which Food and Drug Administration has announced. The list of substances shall be ranged from the amount of quantity form more to least.                  

(c) Name and address of the manufacture site. For importer, provide address of the manufacturer.

(d) Year and Month or Month and Year for manufacture date. Manufacture year must be 4 digits.

(e) Year and Month or Month and Year for expiry date or use before. Expiry date must be 4 digits 

(f) Number or letter indicating LOT number or manufacture number.                                                     

(g) Number of the registration license of medical device to be notified.

(h) Instruction for use and storage methods         

(i) Warning and precautions                                         

(j) Message of “For cleaning hands without water"                                                                                    

(k) Message of "Do not place or use near flames"  

(l) Message of "For external use only" - Labelling (d) (e) (g) (j) (k) and (l) must in in Thai      

5. In the case of importing alcoholic cleaning products for hygienic use, the importers must prepared the labelling on the packages according to clause 4 before selling, within thirty days from the date that  medical device has checked for release.                                                     

6. Registration of the drug certificate holder, or cosmetics certificate holder the hand cleaner containing alcohol as a hygiene component 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.                      

 7. This announcement shall come into force after 180 days from the date following the date of its publication in Government Gazette onwards.

 

Reference

Official press

 

 

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Home About Qualtech NEWS THAILAND: TFDA published the Draft of Ministry of Public Health Announcement Regarding Cleaning Products Containing Alcohol as a Component for Hygienic Use - February 2019