With Excel Herbal, registration has never been easier!
Excel Herbal help clients interact with National Pharmaceutical Regulatory Agency, NPRA (Formerly known as National Pharmaceutical Control Bureau), Ministry of Health Malaysia. As a regular partner, we possess very comprehensive knowledge on how to get your desired products registered and approved in fastest possible way!
Or, would you like to slash the duration? Get our pre-registered formulation, and speed up!
Submission to the Ministry of Health for classification.
Classifications are based the submitted packaging and ingredient list.
It is the first step before more in-depth details are required.
Traditional products are products which have been traditionally used for a set of preapproved claims with exceptions of claims which have significantly strong science to validate its claim.
This category includes non-edible products such as balms and creams as well as edible products in liquid, powders and capsule forms.
Supplements are products which are intended to “supplement” the diet taken in forms such as pills, capsules, tablets, liquids or powders and not represented as a conventional food or as a sole item of a meal or the diet.
As active ingredients found in the product increase so does the cost due to the increased complexity of evaluation.
Food – as defined under the Food Act 1983 and Food Regulations 1985, includes every article manufactured, sold or represented for use as food or drink for human consumption or which enters into or is used in the composition, preparation, preservation, of any food or drink and includes confectionery, chewing substances and any ingredient of such food, drink, confectionery or chewing substances. This includes food for special dietary use for persons with a specific disease, disorder or medical condition, and food which contain quantities of added nutrients allowable under the Food Act and Regulations.
- Pharmaceutical products containing scheduled poisons.
- Pharmaceutical products containing non-scheduled poisons (OTC)
Includes:
+ Medicated plaster with medicines
+ Antiseptic/ Disinfectants for use on the human body
+ Diagnostic agents for human use (in vivo)
+ Dietary supplement e.g. Probiotics, Chitosan - Traditional products
Includes:
+ Homeopathic medicines
+ Ayurvedic medicines
+ Medicated plaster
+ Herbal teas
+ Dietary supplements eg. Spirulina, Chlorella, Royal Jelly, Bee Pollen, Aloe Vera juice, Noni juice, Extract of chicken with herbs - Veterinary products
Includes:
+ Oral solution, oral suspension & emulsions
+ Granules
+ Paste
+ Water soluble powder
+ Injectable
+ Powder for injection
+ Oral powders
+ Capsule, tablet
+ Topical ophtalmic and otic products
* Guidance Decision Tree
