You must submit an amendment application for changes to your approved licence such as company or applicant details and scope of activities.
You may amend your company's information in order to change particulars such as company name and address, provided there is no change to the company's Unique Entity Number (UEN). For change in UEN, you will need to apply for a new CRIS account and thereafter submit a new application.
You may also amend the applicant's details for licences and applications, such as name and contact details.
Note: Amendments to company or applicant details will affect all registrations and licences your company has with us. There are no fees for such amendments.
An amendment application has to be submitted when there are changes to your approved licence details, such as for scope of activities and premises.
Site inspections may be conducted by us for certain amendments, such as:
Company's SOPs pertaining to the respective activities. SOPs and related recording form describing the scope, process and quality assurance to ensure that quality and security of the products are ensured through the supply chain.
Contractual agreement with contract acceptor for the outsourced activity (e.g. engaging 3rd party to deliver the medication) with clear roles and responsibilities between contract giver and contract acceptor.
Validation documents of computerised system to support e-pharmacy service, if applicable.
The following amendments do not require site inspections:
Cessation of additional services or activities, such as:
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.
Refer to therapeutic product fees and turn-around-time for more information.
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).
Regulatory overview
Register your product
Apply for post-approval variation
Reclassify your product
Dealer's licensing and certification
Retain, cancel or transfer product registration
Risk management plan requirements
Report adverse events
Report or recall defective products
Retail pharmacy licensing
Clinical trials
Product consultation
Advertisements and promotions
CPP and SLS
International collaboration
Medicines quality and compliance monitoring
Listing of approvals and post-registration actions
Guidance documents
Fees and turnaround time
PRISM (Therapeutic products)
Infosearch