Generic Product Registration
Introduction
What is Generic Medicine?
A generic product refers to a product that is essentially equivalent to an existing registered product in Malaysia. However, the term “generic” does not apply to biologic products. Generics can be further divided into two categories:
1. Scheduled Poison
Also known as Controlled Medicine or Controlled Poison, these are products containing substances listed in the First Schedule of the Poisons Act 1952.
2. Non-Scheduled Poison
Also referred to as Non-Poison or Over-the-Counter (OTC) products, these contain active ingredients not listed in the First Schedule of the Poisons Act 1952. This category excludes products where the active ingredients are classified under health supplements, natural products, or cosmetics.
Non-Scheduled Poison products are further evaluated through two possible approaches:
- Full Evaluation
- Abridged Evaluation
Product Registration Process
Generic Product Registration in Malaysia
Frequently Asked Questions
What are generic products?
Generic products are classified into two categories:
i. Scheduled Poison (also known as Controlled Medicine or Controlled Poison):
These are products that contain substances listed in the First Schedule of the Poisons Act 1952.
ii. Non-Scheduled Poison (also known as Non-Poison or Over-the-Counter (OTC)):
These products contain active ingredients not listed in the First Schedule of the Poisons Act 1952 and exclude those classified under health supplements, natural products, or cosmetics.