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The Ministry of Health (MoH) Malaysia has published a comprehensive checklist outlining the application requirements for obtaining a license to manufacture dangerous drugs. This Regulatory framework ensures compliance with safety and quality standards in the production of controlled substances.

Key Requirements for a Manufacturing License 

The application process involves multiple steps and documentation, ensuring that manufacturers adhere to legal and regulatory mandates. Below are the core components of the checklist:

1. Application Requirements 

  • A completed application form, duly signed by the applicant and stamped by the company.
  • Permission to possess and use dangerous drugs under Regulation 26 of the Dangerous Drugs Regulations 1952.
  • Exemptions for pharmacy schools, research institutes, or training institutes for manufacturing unregistered products for research purposes under Regulation 15(4) of the Control of Drugs and Cosmetics Regulations 1984.
  • Exemptions for manufacturing unregistered products intended for sample production for product registration under Regulation 15(5) of the Control of Drugs and Cosmetics Regulations 1984.
  • Material Safety Data Sheet (MSDS) for the substances being applied for.

2. Contact Information 

  • Contact person’s name, telephone number, and email address.

3. Pharmacist Details 

  • Name and position of the pharmacist responsible within the company.
  • License number of the pharmacist.
  • Mobile phone number and email address.

4. Company Information  

  • Company name and registered business address.
  • Office telephone number.
  • Business registration number.

5. Manufacturing Details 

  • List of dangerous drugs used in manufacturing.
  • List of manufactured products.
  • Task list related to drug manufacturing.
  • Explanation of investigations and refinements undertaken.
  • Period of use for the applied materials.

6. Supplier Information 

  • Name and address of the suppliers providing raw materials.

7. Signature and Authentication 

  • Signature of the applicant.
  • Official company stamp.
  • Date of application submission.

Regulatory Compliance and Oversight 

The MoH Malaysia oversees the licensing process and ensures strict compliance with safety and quality standards. Adhering to the requirements minimizes legal risks and enhances manufacturing credibility.

Conclusion  

Obtaining a license to manufacture dangerous drugs in Malaysia is a detailed process requiring adherence to strict regulatory guidelines. By ensuring compliance with the Ministry of Health’s checklist, manufacturers can operate within the legal framework while maintaining high safety and quality standards.

Need assistance in navigating Malaysia’s regulatory landscape? Connect with Freyr Solutions today!