The Health Sciences Authority (HSA) Singapore had released a new Guidance for Reporting of Adverse Effects, Products Defects and Product Recalls for Cosmetic Products in Dec 2023.
The guidance provides information to the cosmetics industry on the reporting of adverse effects, product defects and product recalls of cosmetic products to HSA required under the Health
Products Act 2007 and the Health Products (Cosmetic Products–ASEAN Cosmetic Directive) Regulations 2007.
REPORTING OF ADVERSE EFFECTS AND PRODUCT DEFECTS FOR COSMETIC PRODUCTS:
Under the Health Products (Cosmetic Products – ASEAN Cosmetic Directive) Regulations, the person responsible for placing a cosmetic product in the market must report serious adverse effects and product defects to HSA within the stipulated timelines stated in the guideline.
The following adverse effects must be reported to HSA by the person responsible.
Adverse effect that – :
1) has caused death or is life threatening; or
2) has resulted in any person being hospitalised or has caused any persistent or
significant disability or incapacity in any person.
Refer below link for the guidance document:
https://www.hsa.gov.sg/docs/default-source/hprg-cosmetics/guidance_ae-defect-reporting-and-product-recall_cp_1dec2023f3789679278c40f3806db3d167
The HSA has published Issue 10 of its NEX2US report which is packed with a variety of regulatory news on medicines and medical devices.
https://www.hsa.gov.sg/docs/default-source/announcements/nex2us-newsletter/nex2us-issue-10.pdf?sfvrsn=8974db7e_4
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