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.
Registration with NPRA
The step to initiate the registration process is to be in touch with NPRA, a drug regulatory authority of the health ministry. It then assesses them to ensure the products possess no harm to its consumers and are safe for the retail market.
Who Can Register
That means if the product is sold individually, then the owner must notify; otherwise, the letter of authorization must be shown to notify. Subsequently, if it’s a firm wishing to notify, it must be registered by Syarikat Suruhanjaya Malaysia (SSM) or the Malaysian Registrar of Business (ROB). As for foreigners, it’s important to notify via a local agent.
Victory Pharma will present your products correctly so that seeking NPRA registration and approval becomes easy.
What Happens After Registration
After one or two days of applying for NPRA registration, you can check the status of the application on NPRA’s web portal. The tenure for registration is of 5 years and you may have to apply for renewal.
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.
What You Need to Know
1. What is a Health Supplement (HS)?
A health supplement is any product that supplements a diet and maintains, enhances as well as improves the health function of the human body. These products usually come in small units dosage forms of capsules, tablets, powder, and liquids. Health supplements may contain one or more of the following combinations:
∘ 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
2. What is NOT considered as a HS?
Health supplements do NOT include the following:
∘ 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
3. 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.
Depending on the level of claims, the registration submission may follow:
1. General/Nutritional and Medium Claims – Abridge evaluation
2. Disease Risk Reduction Claims – Full evaluation
4. What do I need for the registration of Health Supplements?
The NPRA has specific dossier requirements. Various details are required such as product name, dosage form, active ingredients, product formula, packing details, manufacturer, etc. You may contact us for further assistance.
1. What is a natural product?
A natural product can be categorized into one of the following four groups:
1. 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.
2. 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.
3. 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).
4. 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.
2. Are there any products that are exempted from registration?
The following preparations do not require registration with the Authority:
∘ 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.
3. Are there any products that are not allowed to be registered?
Some examples of products that are not allowed to be registered are:
∘ 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)
4. What do I need for the registration of natural products?
The NPRA has specific requirements. Various details are required such as product name, ingredients, excipients, indications, packing details, quality control, etc. You may contact us for further assistance.
We also manage Cosmetic Registration.