Malaysia - National Approach on Materials and Equipment Used in Illicit Drug Manufacture


In Malaysia, under Customs Act 1967, the Customs Prohibition of Import Order (2023) established control measures on imports of equipment used in the manufacture of pharmaceutical preparations. Any company intending to import equipment is required to obtain an import permit issued by the Pharmacy Enforcement Division (PED), Ministry of Health. In addition, the distribution is administratively controlled, where imported machines cannot be transferred to other parties without approval from PED accompanied by an End User Declaration Form.

The following documents are required by the competent authorities, for the importation of medicine-making machines before import permits can be granted:

1. Manufacturer's License from Drug Control Authority (for importers that import for their own factory use)

2. End - User Declaration (EUD-Medicine Making Machine- Import)

3. Purchase Order to Supplier (Purchase Order/Proforma Invoice)

4. Machine Specifications/Catalogue/Images of the Machine

5. Customer Order (if the machine is for resale)

6. End - User Declaration (EUD-Medicine Making Machine-Sell/ Purchase)

Source: https://pharmacy.moh.gov.my/ms/dokumen/panduan-umum-permohonan-epermit-import-eksport-dikeluarkan-bpf-kkm.html

 

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