Manufacturer's Licence (Health Sciences Authority)

Manufacturer's Licence (Health Sciences Authority) | Bestar

Manufacturer's Licence (Health Sciences Authority)

A Manufacturer's Licence, issued by the Health Sciences Authority (HSA) of Singapore, is required for any company that manufactures certain healthcare products in the country. There are two main types of Manufacturer's Licences:

• Manufacturer's Licence for Therapeutic Products (TPML): This license is required for companies that manufacture therapeutic products, such as medicines, vaccines, and medical devices.

• Active Ingredient Manufacturer's Licence: This license is required for companies that manufacture active ingredients, which are the components of a therapeutic product that have a medicinal effect.

Companies that hold a valid TPML are exempt from needing a separate Therapeutic Product Importer's Licence (TPIL) to import therapeutic products needed for manufacturing activities, and a Therapeutic Product Wholesaler's Licence to wholesale the therapeutic products they've manufactured.

In order to obtain a Manufacturer's Licence, companies must comply with the relevant Good Manufacturing Practice (GMP) standards. GMP is a system for ensuring that products are consistently produced and controlled according to quality standards.  The HSA conducts inspections of manufacturing facilities to verify compliance with GMP.

Here are some additional details about Manufacturer's Licences in Singapore:

• Application process: Applications for Manufacturer's Licences are submitted online through the Health Sciences Authority's Licensing Information Management System (LIMS).

• Fees: The fees for Manufacturer's Licences vary depending on the type of licence and the complexity of the manufacturing activities.

• Renewal: Manufacturer's Licences are valid for a period of five years and must be renewed before they expire.

For more information on Manufacturer's Licences in Singapore, you can visit the Health Sciences Authority's website: https://www.hsa.gov.sg/active-ingredients/manufacturers/overview

How Bestar can Help

Manufacturer's Licence (Health Sciences Authority)

Our expertise lies in business and financial services.

Depending on your specific needs, Bestar is able to assist in some peripheral aspects:

• Company Incorporation: If you're establishing a new company to manufacture healthcare products, Bestar can help with the incorporation process https://www.bestar-sg.com/post/company-incorporation-services.

• Compliance:  Bestar offers general compliance services for businesses, which could be helpful in understanding and adhering to some of the business regulations that apply to manufacturers https://www.bestar-sg.com/post/corporate-secretarial-services.
  

For the Manufacturer's Licence application and navigating the health regulations, consult with Bestar.