Health Supplement
Answer: Health Supplement (HS) means any product that is used to supplement a diet and to maintain, enhance and improve the health function of human body. It is presented in small unit dosage forms (to be administered) such as capsules, tablets, powder, liquids and shall not include any sterile preparations (i.e. injectables, eye drops). It may contain one or more, or the following combination:
- Vitamins, minerals, amino acids, fatty acids, enzymes, probiotics, and other bioactive substances;
- Substances derived from *natural sources, including animal, mineral and botanical materials in the forms of extracts, isolates, concentrates, metabolite;
- Synthetic sources of ingredients mentioned in (i) and (ii) may only be used where the safety of these has been proven.
2. What are the requirements for health supplement product registration?
Answer: Kindly refer to the Drug Registration Guidance Document (Appendix 6 -Guideline on Registration of Health Supplements) for the required registration documents.
3. What are the stability study requirements for a product to have a 3-year shelf life?
Answer: A product can be granted a 3-year shelf life if 2 batches of satisfactory complete real time stability data at Zone IV B storage condition is submitted.
4. Can the application of a product be accepted if the stability data is not conducted under the Zone IV B condition (For example, under 25°C condition)?
Answer: The application can be accepted if the following documents are provided:
- Supporting documents to show that the product is unstable at Zone IV B storage condition.
- 2 batches of satisfactory complete real time stability data at the proposed storage condition (eg. 25°C 75% RH).
5. What if the COA finished product is not satisfactory?
Answer : The product may be rejected if the COA of finished product is not satisfactory. LOU will not be accepted.
6. Are FPQC, IPQC and protocol analysis also mandatory to be submitted?
Answer : FPQC, IPQC and protocol analysis are not mandatory for product with general claims but are mandatory for product with functional / disease risk reduction claims or in modified release dosage form.
