Malaysian business licence·Federal

Permit to Purchase and Use Psychotropic Substances (Methadone & Buprenorphine)

Issued by Ministry of HealthPoison Act 1952; Poison Regulations (Psychotropic Substances) 1989

Overview

This license is issued to registered medical practitioners for the purpose of opioid substitution therapy using psychotropic substances like Methadone and Buprenorphine. It allows the holder to purchase and use these substances in their medical practice.

Key details

Governing Act

Poison Act 1952; Poison Regulations (Psychotropic Substances) 1989

Agency fees

RM 300 processing fee

Validity

1 year (renewable annually)

Issuing authority

Ministry of Health

Fees shown are government / local-authority fees payable to the issuing agency. Emerhub charges a separate service fee for handling the application end-to-end.

Eligible applicants

Registered medical clinics/hospitals under the Private Healthcare Facilities and Services Act 1998 [Act 586] / Facilities conducting opioid substitution therapy.

Application requirements

- Application for the Permit to Purchase and Use Psychotropic Substances (Methadone & Buprenorphine) is made online through the Integrated Management and Control System for Substances (SPIKES) at www.myspikes.gov.my. - Applicants can refer to the Permit Application Guide for further information about the permit. - Users can refer to the SPIKES user manual available on the system portal for guidance. - Any further inquiries regarding the application can be directed to the Pharmacy Enforcement Division at the headquarters or to the state-level Pharmacy Enforcement Branch where the permit is applied.

Agency fee breakdown

1. Processing fee for the Permit to Purchase and Use Psychotropic Substances (Methadone & Buprenorphine) is RM300.00, payable via Money Order/Postal Order/Bank Draft made out to: 'DIRECTOR OF STATE HEALTH...'. (Insert the name of the state where the permit is applied). 2. Money Order/Postal Order/Bank Draft must be sent manually to the state CPF office where the permit is applied along with supporting documents and a printed application form generated in the SPIKES system. 3. The validity period of the Psychotropic Substance Permit (Methadone & Buprenorphine) is not more than 12 months and expires on June 30.

These are amounts payable to Ministry of Health. Emerhub's service fee is quoted separately when you engage us.