Registration of Health Supplements and Natural Products
Introduction
Secure Your Health Supplement Registration with Ease
With its vibrant economy and ever-growing market rate Malaysia is one of the most desired food enterprises and health supplement manufacturers. As a manufacturer of health supplements and natural products, it may feel compelling to jump into the Malaysian market.
The health ministry in Malaysia takes its business very seriously. It is compulsory to get health supplements registration before marketing them.
Victory Pharma Consultancy has all the expertise to help you ace your way to get health supplements registration in Malaysia. With us, the process of health supplement registration in Malaysia will be the least of your worries.
Registration of Health Supplements and Natural Products
Overview of Registration Laws
The health guidelines designed by the health ministry in Malaysia are very strict, and before marketing your health supplements and natural products; all the products must be registered under NPRA (National Pharmaceutical Regulatory Agency).
NPRA works under the supervision of Kementerian Kesihatan Malaysia (KKM), known as the Health Ministry.
As a leading Pharma Consultancy, we assist health care firms in handling all activities to get registration of health supplements from KKM. We assist in submitting documentation regarding supplement products on QUEST3+, a system controlled by NPRA. NPRA follows through this process to ensure every marketed product has no side effects to its consumers.
Products not registered under NPRA are illegal to be marketed, and doing so will have severe consequences.
We will break down the entire process to help you understand the basics of how we pilot the entire registration process. Before you can market your product or start selling publicly, you need to follow through the following process.
Victory Pharma Consultancy
Understanding NPRA Registration
for Health Supplements
From application to approval, we streamline the NPRA registration process to ensure compliance and market readiness.
How can Victory Pharma Consultancy Help
We are very familiar with the NPRA and its rules as we are based in Malaysia.
Our staff is trained and skillful at what they do and can seamlessly captain you through the entire product.
We believe in enabling firms to reach the Malaysian market easily to do their business.
We ensure an on-time notification process and have very responsive customer service to help resolve all queries.
Registration of Health Supplements and Natural Products
Frequently Asked Questions
Health Supplements
What is a Health Supplement (HS)?
- 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) where the safety of these has been proven
What is NOT considered as a HS?
- Any product as a sole item of a meal
- Any injectable and sterile preparation such as eyedrops
- Any cells, tissues, organs, or any substance derived from the human body
- Any other route of administration other than the oral route
- Any substance listed in the Schedule of the Poison Act
What are the types of HS claims?
- General or Nutritional Claims: the product must contain a minimum of 15% of the Codex Nutrient Reference Value (NRV) per daily dose of the vitamin(s) and/or mineral(s). Other ingredients must be substantiated by evidence to which it has been supported. For example, if a vitamin is less than 15% NRV, then the specific claim for this vitamin is not allowed unless there is evidence to support an effect below this value.
- Functional Claims (medium): similar to a product making General/Nutritional Claim, the product must contain a minimum of 15% of the Codex Nutrient Reference Value (NRV) per daily dose of the vitamin(s) and/or mineral(s). Other ingredients must be substantiated by evidence to which it has been supported. For example, if a vitamin is less than 15% NRV, then the specific claim for this vitamin is not allowed unless there is evidence to support an effect below this value.
- Disease Risk Reduction Claims (high): the product must be substantiated by evidence to which it has been supported.
1. General/Nutritional and Medium Claims – Abridge evaluation
2. Disease Risk Reduction Claims – Full evaluation
What do I need for the registration of Health Supplements?
Natural Products
What is a natural product?
- Traditional Medicine: any product used in the practice of indigenous medicine, in which the drug consists solely of one or more naturally occurring substances of a plant/animal/mineral, of parts thereof, in the unextracted or crude extract form, and homeopathic medicine. It shall not include any sterile preparation, vaccines, any substance derived from human parts, any isolated and characterized chemical substances.
- Finished Herbal Product: herbal preparations that are made from one or more herbs. If more than one herb is used, the term “mixture herbal product” can also be used. Finished herbal products and mixture herbal products may contain excipients in addition to the active ingredients. However, products which contain chemically-defined active substances (including synthetic compounds and isolated constituents from herbal materials), are not considered to be herbal.
- Herbal Remedy: any drug which consists of a substance/mixture of substances produced by drying, crushing, or comminuting. However, it is not subjected to any other process, a natural substance or substances of plant/animal/mineral origin, or any part of such substance(s).
- Homeopathic Medicine: any pharmaceutical dosage form used in the homeopathic therapeutic system in which diseases are treated by the use of minute amounts of such substances which are capable of producing in healthy person symptoms similar to those of the disease being treated.
Are there any products that are exempted from registration?
- Extemporaneous preparation prepared and given directly to the patient by any traditional practitioner during the course of treatment
- Traditional preparation containing plants/animal parts/mineral substance or a mixture of these substances of natural origin that is produced only through drying, without any process involved (e.g. raw herbs)
- Traditional preparation containing plants/animal parts/mineral substance/extracts or a mixture of these substances of natural origin traditionally used as food, spices, or flavouring of food that do not have any medicinal claim
- Traditional preparations used for cosmetic purposes, such as to whiten or improve the appearance of skin/hair/teeth. These have to be notified as a cosmetic product.
Are there any products that are not allowed to be registered?
- Traditional preparation with the indication listed in “List of Non-Permissible Indications for Natural Product”
- Traditional preparation containing ingredient known or reported to cause any adverse effect on humans
- Traditional preparation containing a combination of plants/animal parts/mineral substance of natural origin: (1) With chemical/synthetic substance with therapeutic effect; (2) With vitamins and amino acids
- Traditional products containing ingredients derived from human origin (e.g. human placenta)