HSA SAR support for clinics and hospitals needing unregistered therapeutic products for named patients.
INNORINI PTE. LTD. (UEN 202015523Z) provides Special Access Route (SAR) support in Singapore for clinics, hospitals, and healthcare institutions that need to import unregistered therapeutic products for named patients where no suitable registered alternative is available. We handle SAR eligibility checks, application documents and product sourcing, and coordinate with an HSA-licensed importer through to delivery. SAR approvals are valid for up to 6 months and are patient-specific.
At a glance
The Special Access Route is an HSA regulatory pathway that allows unregistered therapeutic products to be imported and supplied in Singapore under specific conditions. It is designed for patients who need a medication that is not registered in Singapore and for which no suitable registered alternative exists.
SAR is not a general import licence. Each approval is tied to a specific patient, prescribing doctor, product, and quantity. The product must be supplied directly to the licensed healthcare institution for administration to that patient.
HSA does not assess the safety, quality or efficacy of products supplied through SAR; the requesting doctor or dentist is fully responsible for their use. Approval needs an unmet medical need: no registered treatment option, and a patient whose health would be clinically compromised without the product. For named patients, a product may also qualify when it offers a substantive clinical advantage over registered therapies.
| Regulator | Health Sciences Authority (HSA), Singapore |
|---|---|
| Purpose | Import unregistered therapeutic products for named patients or hospital buffer stock |
| Named-Patient validity | 6 months, max 3 months supply per patient per consignment |
| Buffer Stock validity | 12 months, for MOH Standard Drugs List or Hospital Pharmacy and Therapeutics List |
| Turnaround time | 14 working days (excluding stop-clock for clarifications) |
| Fees | None |
| Patient scope | Named patient only (not general supply) |
| Eligible applicants | Licensed hospitals/clinics, retail pharmacies, or licensed companies acting for clinics |
| Company requirement | Importer's Licence + Wholesaler's Licence + qualified pharmacist as Responsible Person |
| Key condition | No suitable registered alternative in Singapore |
| Submission | Online via Corppass, application form Sections A to E |
There are three categories of eligible SAR applicants in Singapore:
Innorini supports clinics through this route with SAR applications, documentation and sourcing. A company that imports and supplies on a clinic’s behalf must hold both an HSA Importer’s Licence and a Wholesaler’s Licence.
The Named-Patient SAR process involves the prescribing doctor, the clinic, the HSA-licensed importer, and Innorini as your SAR coordinator. Each step has specific forms and documentation requirements.
The prescribing doctor determines that no registered alternative in Singapore is suitable for the patient. The doctor assesses the unregistered product as clinically appropriate.
Doctor's action: Clinical assessment, patient diagnosis, treatment plan
The doctor fills in the HSA Signed Request Form for Named-Patient Application, including clinical justification, reasons for not using registered alternatives, patient diagnosis, proposed dosage, and duration. The doctor signs a declaration assuming full responsibility for the product's use on the patient.
Form required: HSA Signed Request Form for Named-Patient Application Type (PDF, under Special Access Routes)
Doctor must also: Document informed patient consent, declare MOH compliance, declare SMC Ethical Code compliance
The clinic provides the completed Signed Request Form to Innorini. We confirm product source, pricing, and timeline. We confirm which HSA-licensed importer will hold the application, with a qualified pharmacist named as Responsible Person.
Innorini provides: Product sourcing confirmation, quotation, timeline estimate
The applicant completes HSA’s online application form (Sections A to E) and attaches the doctor’s Signed Request Form. Innorini prepares the documents with you. For the first application of a product, product labels (outer, inner, package insert) in English are also required. Up to 2 requests for the same application type and the same product can be included in one application.
Forms required: HSA online application form (Sections A-E) via Corppass + Signed Request Form + product labels (first application only)
Reference number: 24-character alphanumeric ID issued upon submission
HSA’s target is a decision within 14 working days, excluding stop-clock time if they request clarification or additional information. The outcome is sent by email. If approved, the reference number serves as the consignment approval number.
Innorini manages: Any HSA queries or requests for additional information during review
The licensed importer brings the product in from an approved overseas supplier, with cold chain where required and customs clearance. Innorini coordinates sourcing and timing. The product is labelled with the patient's name (named-patient supply). Quantity is limited to a maximum of 3 months' supply per patient.
Note: Controlled drugs and psychotropic substances require additional import licences
The product is delivered directly to the licensed clinic (not to the patient). The clinic dispenses to the named patient under the doctor's care. The doctor monitors patient response and any adverse events.
Clinic receives: Product with patient name label, dispensing documentation
Named-Patient approval is valid for 6 months. If the patient needs ongoing supply, a new application is required. Product labels are not needed for subsequent applications unless the labels have changed.
Buffer Stock alternative: For hospitals needing essential medicines on the MOH Standard Drugs List, the Buffer Stock Signed Request Form offers 12-month validity
Completed and signed by the prescribing doctor. Includes clinical justification, patient details, and doctor's declaration of responsibility.
Who fills it: Doctor
When: Step 2
Download from HSAFor hospitals and clinics importing essential medicines listed on the MOH Standard Drugs List or Hospital Pharmacy and Therapeutics List as stock. 12-month validity.
Who fills it: Hospital pharmacist / clinic
When: Alternative to Named-Patient
Download from HSACompleted by the applicant (the clinic, or a licensed importer acting for it) and submitted via Corppass. Innorini prepares it with you. Includes applicant details, product details, requester information, and declaration. Up to 2 requests per application.
Who fills it: The applicant, prepared with Innorini
When: Step 4
Access HSA e-serviceOuter label, inner label, and package insert in English. Required for the first application of each product. Not required for subsequent applications unless labels change.
Who provides: Manufacturer / Innorini
When: Step 4 (first application)
Our free checklist to help doctors and clinics prepare all required documentation before submitting a SAR application. Includes what the doctor needs, what the clinic needs, and what Innorini handles.
Who uses it: Doctors, clinic staff, pharmacists
When: Before Step 2
Download Checklist (PDF)Official HSA guidance document covering the full SAR process, eligibility criteria, application requirements, and post-approval obligations.
Who reads it: Regulatory affairs staff, pharmacists
When: Reference throughout
View on HSA websiteIf the unregistered product is investigational (not approved by any HSA reference agency, or rejected for safety/efficacy reasons), the doctor must also obtain professional consensus from one or more local peer clinicians.
This can be in the form of email correspondence or other documentation, per SMC Ethical Code Section B6 paragraph 4 and SMC Handbook Section B6.1 on innovative therapies in dire clinical situations.
Registration status changes. Some medicines that doctors assume are unavailable are in fact registered in Singapore, while some well-known brands have been withdrawn and are no longer registered. Before every SAR application we check the product against HSA’s current register of therapeutic products, because SAR is only appropriate when no suitable registered alternative exists. Search the HSA register →