Exporting medicines from Malaysia can be a straightforward process, but complications often arise when navigating the diverse regulatory requirements of destination countries.
We have compiled a comprehensive FAQ to assist you:
Regulatory and Compliance
Documentation
Shipment Packaging and Handling
Regulatory and Compliance
When shipping medicine for personal use, it will undergo customs inspection and clearance in the destination country, which may have specific requirements for allowing medicine to enter.
Common requirements for personal use:
Doctor's Prescription and Invoice: You must include a doctor's prescription and an itemized invoice.
Quantity Limits: Typically, you can export up to a three-month supply without requiring special approval.
Approval: Medications containing controlled substances need approval from the destination country's health authority.
The Ministry of Health (MOH), through the National Pharmaceutical Regulatory Agency (NPRA), oversees the regulation and control of pharmaceutical exports in Malaysia.
All medicines exported from Malaysia are required to adhere to the quality standards set by the regulatory authorities of the receiving countries.
For example, the U.S. Food and Drug Administration (FDA) sets the standards for the United States, the European Medicines Agency (EMA) for the European Union, and the Health Sciences Authority (HSA) for Singapore.
These standards usually cover manufacturing practices, purity, potency, labeling, and safety regulations.
Medicines that contain controlled substances are restricted for export and require an export permit from the Pharmaceutical Services Division (BPF) of the Ministry of Health Malaysia (KKM).
Additionally, medicines containing drugs like morphine, heroin, opium, cannabis, etc. are strictly prohibited for export.
Yes, DHL Express accepts prescription drugs for international shipping. However, you must include a doctor’s prescription and an itemised invoice with your shipment.
You can generally send prescription drugs to most countries. However, we need to verify the type of medication and the specific regulations of the destination country before shipping.
Documentation and Permits
To export pharmaceutical products for commercial purposes from Malaysia, you will need to provide the following documents:
- Commercial invoice
- Air waybill (AWB)
- Certificate of Origin
- Customs Declaration Form (K2 form)
- Certificate of Free Sale or Quality Assurance Certificates
- Product Registration
- GMP Compliance
For controlled items, the following additional documents are required:
- Export Permit from The Pharmaceutical Services Division (BPF) of the Ministry of Health Malaysia (KKM)
- Original Import Authorization issued by Competent Authority of Destination Country
- Dangerous Goods Declaration
Export permit applications and approvals for medicines containing controlled items in Malaysia are conducted entirely online and paperless.
You can apply for these permits through the website.
No, not all prescription drugs require a prescription. This depends on customs regulations and the laws of the destination country.
To ship prescription drugs, you need a commercial invoice and the doctor’s prescription attached to the package.
Shipmemt Packaging and Handling
Medicines must be packaged and labelled following the regulations of the destination country.
If the medicine requires temperature control, you can choose our Medical Express Service. We provide a range of packaging options, such as ambient, chilled, and frozen temperatures, and can include dry ice to ensure the medicine remains in optimal condition during delivery.
Most medications that are fully packed and stored at ambient temperature can be transported normally with all necessary documentation attached.
However, if the medicine requires temperature control, you have the option to select our Medical Express Service.
This service offers various packaging options, including ambient, chilled, and frozen temperatures. We can also provide dry ice to ensure that the medicine is delivered in optimal condition.
