Health Products Regulation
E-Services / Forms for Administrative Matters
|Service & Form||Description|
|Client Registration and Identification Service (CRIS)||
For companies to apply for a CRIS Account, which is required for authorisation of employees to transact with HSA on the company’s behalf via e-Services in PRISM and MEDICS.
|Change of Business/ Company Information||
To update changes in business information such as company name, company address, contact details and other information.
To apply for HSA PIN to access e-Services in PRISM and MEDICS.
Database for checking the following information:
|Application form for Interbank GIRO||
To arrange for interbank GIRO for payment of various regulatory fees.
E-Services / Forms for Regulatory Matters
For the regulation of health products, there are two main e-Service platforms for business entities /companies to transact with HSA.
|Pharmaceutical Regulatory Information System (PRISM)||
E-Service platform for companies dealing with the following products and activities:
· Clinical Trials
|Medical Device Information & Communication System (MEDICS)||
E-Service platform for companies dealing with medical devices.
E-Services/Forms for Specific Health Products and Activities
Companies that deal in specific health products or carry out certain regulated activities may transact with HSA via the specific e-Services below.
|Health Products & Activity||Description|
|Therapeutic Products||To access PRISM and relevant Forms for therapeutic products registration.|
To access MEDICS and relevant Forms for medical device registration and licensing.
|Chinese Proprietary Medicines||
To access PRISM and relevant Forms for listing of Chinese Proprietary Medicines (CPMs).
|Cosmetic Products & Oral Dental Gums||
To access PRISM and relevant Forms for cosmetic product notification and registration of oral dental gums.
To access PRISM and relevant Forms for clinical trial applications.
|Manufacturing, Importation & Distribution||
To access PRISM and relevant Forms for licensing and certification of dealers (i.e. manufacturers, importers/exporters, suppliers) and pharmacies.
|Medical Advertisements & Sales Promotion||
To access PRISM and relevant Forms for medical advertisement and sales promotion permits.
|Adverse Event Reporting||
Adverse Event Reporting Form and Guidelines for healthcare professionals and companies to report adverse events and safety information to HSA.
To access LicenceOne, PRISM and relevant Forms for tobacco product licences.
|E-Appointment||To make an e-Appointment for Blood Donation|
|Parental Consent Form||Consent form for blood donors who are from 16 to 17 years old|
|Guarantor’s Undertaking for Foreign Donor||For foreign donor using a fixed Singapore address of a Singapore citizen or permanent resident who is willing to act as point of contact for blood donor|
|Forensic Medicine||Application form for Autopsy / Toxicology-related report|
|Pharmaceuticals, Cosmetics & Tobacco||Testing services from HSA’s Pharmaceutical, Cosmetics, and Cigarette Laboratory.|