Apply for a controlled drugs licence

Find out the requirements and how to apply for a licence to import, wholesale, export and manufacture controlled drugs in Singapore.

Overview

Compliance to the Misuse of Drugs Act Chap 185 (MDA) and the Misuse of Drugs Regulations Reg 1 (MDR) is mandatory for all persons handling controlled drugs.

You will require a licence to import, wholesale, export or manufacture controlled drugs in Singapore.

You must be a pharmacist registered with the Singapore Pharmacy Council to apply and be the licence holder to wholesale or manufacture controlled drugs in Singapore.

Import

Import requirements

Apart from preparations listed in the First Schedule to the Misuse of Drugs Regulations, you will need a licence to import controlled drugs (CDIL) to import all other controlled drugs. The CDIL is not renewable. Upon expiry, you will need to submit a new application for a CDIL.

If you are importing controlled drugs for subsequent wholesale supply, a licence to sell controlled drugs by wholesale (CDWL) will also be required. 

Import of products containing controlled drugs

Requirements

Therapeutic products

Each CDIL is specific to:

  • One product. If your company intends to import more than one product, you are required to submit a licence application for each product.
  • A single import consignment only (one-time) and is valid for six months. The CDIL will be invalidated upon the date of import or date of licence expiry, whichever is earlier.

Depending on the type of activities you are conducting, you must also hold the relevant therapeutic product dealer's licences or approvals to import the products into Singapore before applying for the CDIL. 

Active pharmaceutical ingredients, laboratory reagents or veterinary products

Each CDIL is specific to:

  • One product. If your company intends to import more than one product, you are required to submit a licence application for each product.
  • A single import consignment only (one-time) and is valid for six months. The CDIL will be invalidated upon the date of import or date of licence expiry, whichever is earlier.

To apply for a CDIL, you must also hold a valid Form A Poisons Licence.

Diagnostic test kits

Each CDIL:

  • Can be utilised for multiple consignments of the list of products and specified quantity that has been approved by us.
  • Is valid for one year.
  • Is invalidated upon the date of final import or date of licence expiry, whichever is earlier.

To apply for a CDIL, you must also hold a valid medical device importer’s licence or approval (if the test kit is classified as a medical device) or a valid Form A Poisons Licence.

Documents required

You need the following information or items to complete your application, where applicable:

Documents required for import

Applicable for

Consignment approval of an unregistered therapeutic product for patient's use. Import of an unregistered therapeutic product for patient's use.

Purchase order from overseas customer.

An unregistered therapeutic product or active pharmaceutical ingredient imported solely for re-export.

List of controlled drugs containing the following information:
  • Name of the diagnostic test kit.
  • Quantity of diagnostic test kits to be imported.
  • Concentration and volume of each controlled drug contained within each diagnostic test kit.

Import of diagnostic test kits.

Wholesale

Wholesale requirements

Apart from preparations listed in the First Schedule to the Misuse of Drugs Regulations, you will need a licence to sell controlled drugs by wholesale (CDWL) to store and supply other controlled drugs by wholesale. You must be a pharmacist registered with the Singapore Pharmacy Council to apply and be the licence holder of a CDWL. A CDWL is required if you are manufacturing or importing controlled drugs for subsequent wholesale supply, or if you are exporting controlled drugs.

The CDWL is valid for 12 months and is specific to the controlled drugs listed in the approved licence. You can submit a renewal application for a CDWL before expiry.

Wholesale of products containing controlled drugs

Requirements

Therapeutic product

To apply for a CDWL, you must also hold a valid therapeutic products wholesaler's licence or approval.

Active pharmaceutical ingredients, laboratory reagents or veterinary products

To apply for a CDWL, you must also hold a valid Form A Poisons Licence.

Diagnostic test kits

To apply for a CDWL, you must also hold a valid medical device wholesaler’s licence or approval (if the test kit is classified as a medical device) or a Form A Poisons Licence.

Documents required

You need the following information or items to complete your application:

  1. Site layout.
  2. List of controlled drugs.
  3. Standard Operating Procedures (SOPs) on handling of controlled drugs.
  4. Requisition form or signed order template.
  5. Controlled Drug Register Part I and Part 2 template.
  6. Pharmacist Practising Certificate issued by the Singapore Pharmacy Council.

When your licence application is received, we will inform you on the date for an audit of your premises. Any findings from the audit will have to be rectified before the audit can be closed out. The licence will be approved and issued 10 working days from date of audit close out, if your company has complied with the requirements.

After licence approval, regular routine audits will be conducted to assess your company’s continued compliance. The frequency of the routine audit would depend on risk factors like the activities conducted by your company and your compliance level with the regulatory requirements. Unannounced audits may also be conducted.

Export

Export requirements

If you are exporting controlled drugs (other than preparations listed in the First Schedule to the Misuse of Drugs Regulations), you will need a licence to export controlled drugs (CDEL). The CDEL is not renewable. Upon expiry, you will need to submit a new application for a CDEL.

As export is a type of wholesale dealing, you will also need a licence to sell controlled drugs by wholesale (CDWL) before you can apply for a CDEL.

Export of products containing controlled drugs

Requirements

Therapeutic products

Each CDEL is specific to:

  • One product. If your company intends to export more than one product, you are required to submit a licence application for each product.
  • A single export consignment only (one-time) and is valid for six months. The CDEL is invalidated upon the date of export or date of licence expiry, whichever is earlier.

Active pharmaceutical ingredients, laboratory reagents or veterinary products

Each CDEL is specific to:

  • One product. If your company intends to export more than one product, you are required to submit a licence application for each of the products.
  • A single export consignment only (one-time) and is valid for six months. The CDEL is invalidated upon the date of export or date of licence expiry, whichever is earlier.

Diagnostic test kits

Each CDEL is specific to:

  • Can be utilised for multiple consignments of the list of products and specified quantity that has been approved by us.
  • Is valid for one year.
  • Is invalidated upon the date of final export or date of licence expiry, whicehever is earlier.

To apply for a CDEL, you must also hold a valid medical device wholesaler's licence or approval (if the test kit is classified as a medical device) or a valid Form A Poisons Licence.

Documents required

You need the following information or items to complete your application, where applicable:

  1. Import authorisation to import controlled drug. This document is issued by the competent authority in the importing country to the company intending to import the controlled drug. You may obtain this copy from your overseas customer.
  2. List of controlled drugs (applicable only to diagnostic test kits). The list should contain the following information:
    • The name of the diagnostic test kit.
    • The quantity of diagnostic test kit to be exported.
    • The concentration and volume of each controlled drug contained within each diagnostic test kit.

Manufacture

Manufacture requirements

You will need to apply for a licence to manufacture controlled drugs (CDML) to manufacture controlled drugs. You must be a pharmacist registered with the Singapore Pharmacy Council to apply and be the holder of a CDML.

You must also hold the following licences to conduct related activities in accordance to your CDML:

  • Licence to import controlled drugs (CDIL) to import controlled drugs as raw materials, for the purpose of manufacturing a controlled drug.
  • Licence to sell controlled drugs by wholesale (CDWL) to wholesale, including export of your self-manufactured controlled drug.
  • Licence to export controlled drugs (CDEL) to export your self-manufactured controlled drug.

Documents required

You need the following information or items to complete your application:

  1. Business profile registered with ACRA.
  2. Site Master File, a scanned copy of the document can be submitted as attachment to the application. Please note that the Site Master File should be prepared in accordance with the Explanatory Notes for Pharmaceutical Manufacturers on the Preparation of a Site Master File (SMF).
  3. Certificate of Accreditation of the contract testing laboratory, if any.
  4. Letter of approval issued by the agency or institution that approves the use of the warehouses for the storage of health products, if applicable.
  5. List of manufacturing equipment available and their function, if applicable. Please only provide a brief description of the information requested.
  6. List of quality control equipment available and function of each equipment, if applicable. Please only provide a brief description of the information requested.
  7. Details of the dosage forms and products manufactured and/or assembled, including the name, strength and product licence number (if any). Please also indicate if your company is acting as a contractor acceptor (i.e. manufactures partially or wholly for others) for these products.

When your licence application is received, we will inform you on the date for an audit of your premises. Any findings from the audit will have to be rectified before the audit can be closed out. The licence will be approved and issued 10 working days from date of audit close out, if your company has complied with the requirements.

After licence approval, regular routine audits will be conducted to assess your company’s continued compliance. The frequency of the routine audit would depend on risk factors like the activities conducted by your company and your compliance level with the regulatory requirements. Unannounced audits may also be conducted.

Fees and turnaround time

Refer to controlled drug fees and turnaround time for more information.

How to apply

Submit your application through PRISM. Ensure you have the following before you access the e-service:

If you encounter technical issues, e-mail the HSA helpdesk or call 6776 0168 (from 7.00 am to midnight daily).

Share