Amend licence to wholesale or manufacture controlled drugs

Amendments requiring site inspection

Site inspections may be conducted by us for certain amendments such as those that would have direct impact on the product’s quality, such as:

• Inclusion of new warehouse or change in location or address of current warehouse for the storage of controlled drugs.

• Inclusion of new storage conditions (e.g. cold chain) to the warehouse.

• Renovation of warehouse which involves a change in layout and infrastructure namely with respect to security and storage facilities.

Amendments not requiring site inspection

The following amendments do not require a site inspection:

• Deletion of existing warehouse.

• Addition or deletion of controlled drugs to be sold.

Note: While these amendments generally do not require site inspection, there may be cases where we may still conduct one if it is deemed necessary.

Documents required

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

1. Site layout.

2. Standard Operating Procedures (SOPs) on handling of controlled drugs.

3. List of controlled drugs.          

   • The name of the product.

   • The strength, concentration and volume of each controlled drug contained within each product.

Amendments requiring site inspection

Site inspections may be conducted by us for certain amendments such as those that would have direct impact on the product’s quality, such as:

• Addition or amendment of manufacturing site address.

  • Each licence to manufacture controlled drugs (CDML) is issued with a specific manufacturing address and postal code. If your company is relocating the manufacturing premises to a different address (i.e. postal code), please apply for a new CDML instead.

  • Your company may file for amendment application if there is addition or relocation of manufacturing activities within the approved building such as addition of unit or floor.

• Addition or amendment of warehouse address, including addition of third party logistic warehouse.

• Addition of cold-chain activities.

• Addition or amendment of manufacturing activities (i.e. manufacture or primary assembly or secondary assembly) for approved dosage forms.

Amendments not requiring site inspection

The following amendments do not require site inspection:

• Amendment of person in-charge of production or quality control.

• Addition or amendment or deletion of contract testing laboratory address or type of analytical test performed.

• Deletion of approved manufacturing site address or warehouse address.

• Deletion of approved manufacturing activities or dosage form.

• Addition of new dosage forms for secondary assembly.

Note: While these amendments generally do not require site inspection, there may be cases where we may still conduct one if it is deemed necessary.

Documents required

You need to submit the information or items where relevant to support your amendment 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.

   • Note: 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) available from PIC/S Publication.

3. Certificate of Accreditation of the contract testing laboratory.

4. Letter of approval issued by the agency / institution that approves the use of the warehouse(s) for the storage of health products.

5. List of manufacturing equipment available and their function. 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.