Malaysia Malaysia’s new guidelines on voluntary registration scheme for surface disinfectants

Malaysia’s new guidelines on voluntary registration scheme for surface disinfectants

In January 2022, the National Pharmaceutical Regulatory Agency (NPRA) of Malaysia published the Revision 2.0 of the Guidelines for the Registration of Surface Disinfectant (hereinafter “the Guidelines”). Currently, surface disinfectants are not being formally regulated in Malaysia. However, in response to the increased demand and supply of surface disinfectants due to the COVID-19 pandemic, a voluntary product registration scheme has been initiated to ensure the safety and efficacy of such products. The Guidelines provide the detailed requirements under the voluntary registration scheme and stipulate what information must be contained in product labels, what standards must be used for testing, and what active ingredients can be used.

The Guidelines can be downloaded from:
https://www.npra.gov.my/images/Guidelines_Central/surface_disinfectant/Guidelines_For_The_Registration_of_Surface_Disinfectantspdf.pdf

 

Scope

The scope of the Guidelines encompasses surface disinfectants to be used only on non-porous hard surfaces. Specifically, covered disinfectants are those used in:

i) healthcare facilities and veterinary areas;

ii) food areas: processing, distribution and retailing of food of animal or vegetable origin;

iii) domestic and institutional areas: all public areas where disinfection is not medically indicated (homes, catering, schools, nurseries, transports, hotels, offices etc.); and

iv) industrial areas: packaging, biotechnology, pharmaceutical, cosmetic, etc. industries.

On the other hand, the following products are not subject to the Guidelines:

i) Any household product primarily used for general cleaning;

ii) Products used on soft/porous surfaces (e.g. fabric, leather);

iii) Rinse-off products;

iv) Products used on medical devices or medical device surfaces; and

v) Products that utilize ultraviolet-C (UVC) sterilisers.

Registration

Surface disinfectant product registration is voluntary. When applying for registration, a complete dossier including the related documents listed below must be submitted to the NPRA. After the NPRA’s evaluation, successfully registered product will be given a serial number, and the product details will be uploaded on the NPRA website (https://www.npra.gov.my/index.php/en/informationen/new-products-indication/surface-disinfectants-approved.html). Each registration will be valid for 2 years and must be renewed 2 months before the expiry date. There is no registration fee required.

Related documents:

  • Company SSM Certificate*
  • Manufacturer’s Name & Address
  • Product Label
  • Material Safety Data Sheet (MSDS)
  • Registration Certificate from Country of Origin (for imported products)
  • Certificate of Analysis (CoA)
  • Stability Data
  • Efficacy Test Report

* SSM is an abbreviation in Malay that means “Companies Commission of Malaysia”

All active ingredients in finished products must be listed under Appendix I of the Guidelines, or recognized by relevant authorities, such as, European Chemical Agency (ECHA) and U.S. Environmental Protection Agency (EPA). In the Appendix I, the names and recommended concentrations for 16 substances are listed** (e.g., the recommended concentration for ethyl alcohol is 70% or more). Efficacy tests must be conducted based on European Standard (EN) or equivalent as stated in the Guidelines.
** CAS Registration Numbers are not included in the Appendix I.

The product label must contain the following information:

i) Product name

ii) Intended use (if not clear from product name or presentation)

iii) Direction of use

iv) Company name and local contact number

v) Active ingredients and concentration

vi) Country of origin

vii) Batch number

viii) Production date/expiry date

ix) Warning/precaution including

a. Not to be used on skin

b. Keep out of reach of children

x) Storage condition

xi) Net weight/volume