The Pharmaceutical Services Programme, Ministry of Health (PSP, MOH) oversees the importation of registered medicines, including pharmaceuticals, vaccines, traditional medicines, health supplements, and veterinary products, which are approved by the Drug Control Authority (DCA), as well as notified cosmetics, in accordance with the Control of Drugs and Cosmetics Regulations 1984. The import license grants the licensee to import and sell by wholesale or supply the registered medicines from the address of the premises specified in the license. In addition to registered medicines and notified cosmetics, PSP, MOH also regulates the importation of unregistered products intended for clinical trials, through the issuance of a Clinical Trial Import Licence (CTIL).

PSP, MOH also regulates the importation of precursor/controlled substances and medicine making machine into Malaysia under the Customs (Prohibition of Imports) Order 2023. PSP, MOH also regulates the importation of dangerous drugs and psychotropic substances (in the form of raw material and finished goods) under the Dangerous Drugs Act 1952 and the poisons substances under the Poisons Act 1952 respectively.

PSP, MOH issues electronic permit approval through an online web-based system called e-Permit for precursors/controlled substances, and printed Authorizations for dangerous drugs and psychotropic substances. Import approval is a single permit/Authorization basis for each consignment. PSP also issues poisons licences for importation of poisons under the Poisons Act 1952.

The import license application for registered medicines shall be submitted via the online QUEST system. However, for Government Agencies, the import license application is submitted manually using the ‘Application for License for Registered Product for Government Agencies’ form, which can be downloaded from the National Pharmaceutical Regulatory Agency (NPRA) website. However, applications for the Clinical Trial Import Licence (CTIL) are processed outside of this online system.

e-Permit application covers precursors, controlled chemicals and medicine making machine. Precursors are substances scheduled in Table I and II of the United Nations Convention of Illicit Traffic in Narcotic Drugs and Psychotropic Substances, 1988 (1988 Convention). Currently only Table I requires an import permit. Dangerous Drugs Import Authorization application covers all substances listed in the First Schedule of the Dangerous Drugs Act 1952. Psychotropic Substance Import Authorization application covers all substances listed in the Third Schedule of the Psychotropic Substances under the Poisons Act 1952. Poisons licences includes all poisons listed in the First Schedule of the Poisons List under the Poisons Act 1952.

All countries.

Poisons licence is for the importer to import poisons listed under the Poisons Act 1952 and the import license is not meant to restrict the quantity or value of imports but rather to regulate activities involving the importation and wholesale distribution of products registered with the DCA. On the other hand, the CTIL is designed to regulate and oversee the use of unregistered medicines specifically for clinical trial purposes.

Malaysia is a signatory to the United Nations Convention of Illicit Traffic in Narcotic Drugs and Psychotropic Substances, 1988 (1988 Convention) since 1988. Under Article 12 of 1988 Convention, the parties are obliged to take measures to prevent diversion of the precursors and monitor international trade in order to identify suspicious transactions because precursors are frequently been used in the illicit manufacture of narcotic drugs and psychotropic substances.

Apart from that, Malaysia is signatory to the Single Convention on Narcotic Drugs, 1961 (1961 Convention) since 1978. Under Article 31 of the 1961 Convention, parties are obliged to control under licence the import and export of drugs except where such import or export is carried out by a State enterprise or enterprises, and also control all persons and enterprises carrying on or engaged in such import or export.

Malaysia is also signatory to the Convention on Psychotropic Substances, 1971 (1971 Convention) since 1986. Under Article 12 of the 1971 Convention, every party permitting the export or import of substances in Schedule I or II of the Convention shall require a separate import or export authorization.

Poisons licence is for the importer to import poisons listed under the Poisons Act 1952 and it is not restricting the quantity or value for imports.

Is the licensing statutorily required?

For Import Licence of registered medicines and CTIL, both are stated under the Sale of Drugs Act 1952 and Control of Drugs and Cosmetics Regulations 1984.

With regard to precursors/controlled chemicals, the relevant laws are the Poisons Act 1952 and its Regulations, Customs (Prohibition of Import) Order 2023 and United Nations Convention of Illicit Traffic in Narcotic Drugs and Psychotropic Substances, 1988 (1988 Convention). Import permits are issued under the Customs (Prohibition of Imports) Order 2023, which is made pursuant to the powers conferred by subsection 31(1) of the Customs Act 1967. Goods subjected to import permits are scheduled in the said Order. By virtue of subsection 31(1) of the Customs Act 1967, it is possible for the Executive to abolish the system without legislative approval since the said provision clearly confers powers to the Executive to prohibit the importation into Malaysia either absolutely or conditionally.

For dangerous drugs, the relevant laws are the Dangerous Drugs Act 1952 (DDA 1952) and the Single Convention on Narcotic Drugs, 1961. Import Authorizations are issued pursuant to Section 20 of the DDA 1952. Substances subjected to import authorization are listed in the First Schedule, DDA 1952. By virtue of section 45 of the DDA 1952, it is possible for the Minister to exempt certain drugs and institutions from certain provisions of the Act however it would not be possible to abolish the system without legislative approval.

For psychotropic substances, the relevant laws are the Poisons Act 1952 (PA 1952) and the Convention on Psychotropic Substances, 1971. Import Authorizations are issued pursuant to Section 30 of the PA 1952 and Regulation 4 of the Poisons (Psychotropic Substances) Regulations 1989. Substances subjected to import authorization are listed in the Third Schedule of the Psychotropic Substances, PA 1952. By virtue of section 30 of the PA 1952, the Minister may from time to time, after consultation with the Poisons Board, by order published in the Gazette amend the Third Schedule. However it would not be possible to abolish the system without legislative approval.

For Poisons Licences, the relevant laws are the Poisons Act 1952 and its Regulations. By virtue of section 6 of the PA 1952, the Minister may from time to time, after consultation with the Poisons Board, by order published in the Gazette amend the First Schedule. However, it would not be possible to abolish the system without legislative approval.

Does the legislation leave designation of products to be subject to licensing to administrative discretion?

For dangerous drugs, by virtue of section 45 of the DDA 1952, it is possible for the Minister to exempt certain drugs and institutions from certain provisions of the Act.

For psychotropic substances, by virtue of section 30 of the PA 1952, the Minister may from time to time, after consultation with the Poisons Board, by order published in the Gazette amend the Third Schedule.
For Poisons Licences, by virtue of section 6 of the PA 1952, the Minister may from time to time, after consultation with the Poisons Board, by order published in the Gazette amend the First Schedule.

Is it possible for the government to abolish the system without legislative approval?

For dangerous drugs, psychotropic substances and Poisons Licences it would not be possible to abolish the system without legislative approval.

With regard to precursors/controlled chemicals, by virtue of subsection 31(1) of the Customs Act 1967, it is possible for the Executive to abolish the system without legislative approval since the said provision clearly confers powers to the Executive to prohibit the importation into Malaysia either absolutely or conditionally.
For Poisons Licences, it would not be possible to abolish the system without legislative approval.

See answers 6.1-6.11.

In 2006, the Commission on Narcotic Drugs has requested member States to implement Annual Legitimate Requirements (ALR) for certain precursor Malaysia has started to implement since 2011.

Under the 1961 Convention, member states are obliged to administer the estimates system with regard to the annual medical and scientific requirements for narcotic drugs listed in Schedules I and II of the Convention. Malaysia has implemented the estimates system on dangerous drugs since 2008.

In 1997, pursuant to the Economic and Social Council resolution 1996/30 of 24 July 1996, INCB established assessments of annual licit domestic requirements for psychotropic substances for countries that had not submitted such information and encouraged all Governments to make their own assessments as soon as possible. Malaysia has implemented the Assessment of Psychotropic Substances system on psychotropic substances since 2008.

The quantity of ALR and Estimates per country is submitted yearly to INCB, and the Assessment of Psychotropic Substances once every 3 years. INCB will publish the all three as reported by member States in their official website (http://www.incb.org).

Yearly basis. The importers can apply the permit/authorization at any time throughout the year. The validities of permit and authorization are 3 months (precursors/controlled chemicals) and 6 months (dangerous drugs and psychotropic substances) respectively, from the approved date but should not exceed 31 December of the current year.

Globally, there are 4 precursor substances which currently require ALR. The companies with approved ALR need to submit an import application and PSP, MOH will monitor the import transaction from time to time. Under the 1988 Convention, the government of the exporting country obliged to notify prior export to the government of the importing countries via INCB online portal. The name and address of importers and exporters are supplied in the

Importation of all goods (raw material and finished product) containing Dangerous Drugs or Psychotropic Substances are dependent on the approved estimates and assessments respectively. The import authorizations are issued to local importers with approved estimates/assessments. Once the importation is completed, the importer is required to return the endorsed Authorization to the PSP, MOH in order for the estimates/assessments to be reconciled. A copy of the Authorization, complete with names and addresses of importers and exporters, is sent to the competent national authority of the exporter country for their reference.

Companies may submit Import permit application once ALR has been approved and starting from 1 January of the year.

The result of ALR narcotic estimates and psychotropic substance assessment applications will be issued before 1 January of the particular year while the import permit for precursor/controlled chemicals will be processed within 3 working Dangerous drug and psychotropic substance import authorizations will be processed within 7 working days of receiving a complete application.

Can be the same day.

Import permit will be processed by PSP, MOH. The importer does not have to approach more than one administrative organ.

For precursor/controlled chemicals, all importation of substances listed under the Customs (Prohibition of Imports) Order 2023 requires import permit and will be processed within 3 working days. For Dangerous Drug and Psychotropic Substance, Import Authorizations are required. The authorizations are issued upon receiving an application from the importer (not automatically).

No.

See answers 7.a-7.d.

Import poisons licence must be applied prior to any importation.

Application for licence must be submitted in advance. Request for an immediate licence is subjected to a genuine and emergency request, provided that the application completely fulfils the requirements.

The prerequisite licence is valid per year basis except for non-scheduled substances under the Poisons Act 1952.

The importer does not have to approach more than one administrative organ.

Under what circumstances may an application for a licence be refused other than failure to meet the ordinary criteria?

The Deputy Director General of Health (Pharmaceutical Services) has the authority to refuse any application of import license if applicant committed an offence against the law or failed to comply with the requirements/ directives. 

Are the reasons for any refusal given to applicants?

Reasons for refusal would normally be given to the applicant.

Have applicants a right of appeal in the event of refusal to issue a licence?

Yes.

If so, to what bodies and under what procedures?

Applicant can make written appeal to the Minister within 14 days from the date of decision and the decision by the Minister shall be final.

What persons or firms are eligible to apply for a licence?

Only a person working in a registered company or a registered pharmacist in possession of Poison Licence under Poisons Act 1952 is eligible to apply for a precursor/controlled chemicals import permit/ Poisons Licences.

Only a registered pharmacist in possession of a Type A Poison Licence in a company with an Importer Licence is eligible to apply for a dangerous drug/psychotropic substance Import Authorization.

Only companies registered in Malaysia are eligible to apply for an Import License. The company must either be the holder of the registered products or be appointed by the Product Registration Holder (PRH). 

Is there a published list of authorized importers?

The list of Poisons Licences holder can be access online at www.pharmacy.gov.my.

A list of authorized importers can be found on NPRA's website (https://quest3plus.bpfk.gov.my/pmo2/index_license.php). Meanwhile approved CTIL can also be found on the website (https://www.npra.gov.my/index.php/en/component/content/article/225-english/1527106-approved-clinical-trial-import-license.html?Itemid=1391)

All application must fulfil the requirements as below:

Import licence

• The details of the company
  
• The details of two (2) responsible persons
  
• The details of the license holder
  
  • A copy of Company/ Business Registration Certificate
    
  • A copy of the License Holder’s Identity Card/Passport (if foreigner). Copy of Identity Card/Passport and Type A License (wholesale) must belong to the same License Holder if the application involves Scheduled Poison A products
    
  • A copy of Business License (Local Authority) for business premises
    
  • A copy of Business License (Local Authority) for store (if any)
    
  • A copy of the License Holder’s Type A License (wholesale). This document is necessary if products imported/ wholesaled are Scheduled Poison A products or any other products that require a Pharmacist
    
  • For renewal application, documents (c) to (e) together with a copy of previous Import License shall be submitted
    
  
  

Clinical Trial Import Licence (CTIL)

• CTIL application form
  
• Receipt for processing fee
  
• A copy of Company Registration Certificate
  
• Letter of Authorisation, if applicable
  
• A copy of the applicant’s Poison Type A Licence or annual retention certificate (ARC)
  
• For other applicant, a copy of the applicant’s Malaysia National Registration Identity Card
  
• A copy of the opinion of the EC
  
• Clinical trial protocol
  
• Declaration by investigator/principal investigator
  
• GCP certificate and CV for investigator/principal investigator
  
• Informed consent form
  
• Pharmaceutical data for product that require CTIL
  
• Label for all products that require CTIL
  
• Evidence of Good Manufacturing Practice Compliance
  
• Investigator’s Brochure
  
• Overall risk and benefit assessment
  
• A copy of scientific advice from other regulatory agencies, if applicable
  

CTIL application form can be assessed here: https://www.npra.gov.my/easyarticles/images/users/1140/NPRA-427-01-2-Borang-Permohonan-CTIL-Mei-2024.pdf

Import Application for Precursor & Other Controlled Substance:

• Purchase Order (PO) to supplier;
  
• Raw materials' usage record (If keeping stock);
  
• Purchase Order (PO) from buyer;
  
• A copy of buyer's Poisons Licence if buyer resells poison;
  
• End-User Declaration Form - Filled up by end user; and
  
• Safety Data
  

Import Application for Medicine Making Machine:

• Manufacturer's Licence    from    Drug    Control    Authority                          (DCA)     (for     pharmaceutical manufacturers);
  
• Medicine Making Machine Import Declaration Form;
  
• Purchase Order (PO) to supplier/Proforma Invoice;
  
• Packing List;
  
• Machine Specifications/Catalogue/Picture of Machine; and
  
• Purchase Order (PO)/Proforma Invoice from buyer (If resells).
  

Import Application for Dangerous Drugs and Psychotropic Substances:

• Pharmacist's Type A Licence;
  
• Approval Letter for Annual Estimates/Assessments;
  
• Company's Import Licence/Company's Manufacturing Licence;
  
• Product Registration Certificate/Proof of Product Registration/Company's Import List;
  
• Import Exemption Letter from the Drug Control Authority (for importation of unregistered products);
  
• End User Declaration and purchase order from research facility (import for research purposes);
  
• Clinical Trial Import License (import for clinical trials); and
  
• Permit to purchase and use psychotropic substances (import for use in industries).
  

Poisons Licences:

The requirements for Poisons Licence application can be view online via http://www.pharmacy.gov.my and https://mypharma-c.pharmacy.gov.my/login.php.

Customs declaration form, invoice, approved import permit, Poisons Licence.

A processing fee of RM500 for import licence. The CTIL application processing fee is RM 500 per product.

No.

The import license is valid for one (1) year or until 31 December of the same year. Meanwhile for CTIL, the licence is valid for 3 years. Variation application for CTIL renewal can be made within 6 months before the CTIL expiration date.

Import permit for precursor/controlled chemicals is valid for 3 months. While for Dangerous Drugs and Psychotropic Substances is 6 months. Poisons licences is valid for one year and it is issued in yearly basis. The applicant can submit a new application for extension.

No.

No.

No.

Yes. Exemptions from applying for import licence are applicable for:

• Importation of unregistered product/cosmetic for the purpose of research in a school of pharmacy or a research or training institution or in order to obtain samples for purposes of registration.
  
• Importation of any product solely for the purpose of treatment of any person suffering from life-threatening illness subject to such conditions or restrictions.