Natural Product Registration

The Control of Drugs and Cosmetics Regulations (CDCR) 1984 were promulgated under the Sale of Drug Act 1952. Under the CDCR 1984, Regulation 7(1):

Except as otherwise provided in these Regulations, no person shall manufacture, sell, supply, import, possess or administer any product unless:

  1. The product is a registered product; and
  2. The person holds the appropriate license required and issued under these Regulations.

Natural Product is one of the category of registered product that includes herbal and traditional products. The sub category of natural products are as follow:

  • Traditional Medicine (as defined under the Control of Drugs and Cosmetics Regulations 1984):

Any product used in the practice of indigenous medicine, in which the drug consist solely of one or more naturally occurring substances of a plant, animal or mineral, of parts thereof, in the unextracted or crude extract form, and a homeopathic medicine. It shall not include any sterile preparation, vaccines, any substance derived human parts, any isolated and characterized chemical substances.

  • Finished Herbal Product

Finished herbal products consist of herbal preparations 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, finished products or mixture herbal products to which chemically defined active substance have been added, including synthetic compounds and/ isolated constituents from herbal materials, are not considered to be herbal

  • Herbal Remedy

Any drug consisting of a substance or a mixture of substances produced by drying, crushing and comminuting, but without subjecting to any other process, a natural substance or substances of plant, animal or mineral origin, or any part of such substance or substances.

  • Homeopathic Medicine

Any pharmaceutical dosage form used in the homeopathic therapeutic system in which diseases are treated by the use of minute amounts as of such substances which are capable of producing in healthy persons symptoms similar to those of the disease being treated.

In JasCal Management & Consultancy, we are providing the service of registering Natural Products (Traditional Products) to ensure the natural products are manufactured, sold, supplied, imported, possessed or administered in a lawful manner.