Licensing and Certification of Manufacturers

  3. Amend an active ingredient manufacturer's licence

Amend an active ingredient manufacturer's licence

Find out the different type of amendments for an active ingredient manufacturer's licence.

You must submit an amendment application for changes to your approved licence such as company or applicant details, scope of activities and premises.

Amend company or applicant details

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 such as name and contact details for active licences and applications.

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.

Amend other licence details

You must submit an amendment application when:  

  •  there is any change or proposed change to any particulars provided in the application.
  • if there are significant changes that affects the authorised activities and scope described in the approved licence.

Examples include:

  • The premises where the manufacturing activities occur.
  • The manufacturing, including processing, quality control testing, storage and distribution operations.
  • The Responsible Person(s) named in the licence.
  • Outsourced activities named in the licence.

Please take note of the different type of amendment applications prior to submission.

Amendment with Technical Assessment

Technical assessment will be conducted for amendments which have impact on the product’s quality, authorised activities in the licence. Such technical assessment may include the conduct of an on-site inspection.

Examples of amendments which require technical assessment are:
  • Addition of type of active ingredients manufactured (e.g. sterile biological, non-sterile chemical active ingredients)
  • Introduction of new manufacturing processes
  •  Addition of warehouse
 

Amendment without Technical Assessment

  

Evaluation of administrative changes (without technical assessment) to the licence will be performed by desktop assessment via the review of supporting documents that are required to be submitted with the amendment applications.

Examples of amendments which do not require technical assessment are:

  • Update of responsible persons
  • Removal of manufacturing processes
  •  Removal of warehouse

Inclusion of a new manufacturing site or change of manufacturing sites are not considered amendments. Company will need to apply for a new manufacturer’s Licence for a new manufacturing site and cancel the current manufacturer’s licence for the old site once the transfer of the manufacturing operations to the new site is completed.

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).

Fees and turnaround time

 Refer to active ingredient licence and certificate fees and turnaround time for more information.
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