The Ministry of Health (MoH), Malaysia, has issued detailed guidance on the procedures for obtaining permits and licenses to purchase, use, and store psychotropic substances for industrial purposes. These are governed under the Poisons (Psychotropic Substances) Regulations 1989 under Poison Act 1952 and related frameworks.

This guidance provides clarity on the permit and license application process, the types of licenses required, eligibility criteria, and storage and documentation requirements to ensure compliance with National Regulatory Standards.

Permit for Purchase and Use of Psychotropic Substances (Industrial Use) 

Date of Release: 18 April 2025

This document outlines the procedure for applying for a Permit to Purchase and Use Psychotropic Substances specifically for industrial use. Key aspects include:

Applicant & Company Requirements 

• Only Malaysian citizens or permanent residents are eligible.
• Companies must be registered with the Companies Commission of Malaysia (CCM).
• Limited liability partnerships must also fulfill CCM registration.

Required Documents 

• Copy of identity card
• Letter of appointment or proof of business ownership
• Work permit (if applicable)
• Passport-sized photo
• Supporting documents must be uploaded to My.Pharma-C 2.0 system.

Storage & Premises Compliance 

• Must adhere to the Poisons Regulations 1989.
• Substances must be stored only at the location stated in the permit.

Permit Validity & Cancellation 

• Valid for 12 months, expiring annually on 30 June.
• Cancellations must be submitted at least 14 days in advance, along with proper stock management documentation.

Application Process 

• Done via the SPIKES online system.
• Application fee: RM300.00
• Inspections may be conducted as needed.

Licensing Guide for Sodium Hydroxide & Psychotropic Substances (Types B & E) 

This supplementary document offers detailed guidance for obtaining:

• Type B License – For manufacturing, processing, or storage.
• Type E License – For possession and use.
• Permit Application – For sodium hydroxide and related psychotropic substances.

It clarifies:

• License holder responsibilities.
• Requirements for safe handling and storage.
• Penalties for non-compliance.

This framework ensures that only authorized individuals or companies manage these controlled substances in compliance with Malaysian health regulations.

These comprehensive guidelines aim to streamline the process of obtaining permits and licenses for psychotropic substances and support responsible industrial usage under strict Regulatory control.

Looking to streamline your Regulatory process in Malaysia? Connect with Freyr today to learn more.