From 1 July 2022 product registrants are to submit a notification to HSA on the lot release information of your imported registered vaccines before you supply them in Singapore.
Notification is not required for the following:
- Unregistered vaccines imported under the Special Access Routes
- Vaccines supplied for use in clinical trials, scientific education, research or non-clinical purpose
- Vaccines imported for purpose of export
Your imported vaccines will fall into one of the two groups:
Group 1: Vaccines placed under routine lot release programme
Vaccines placed under routine lot release by an overseas national regulatory authority (NRA) or national control laboratory (NCL) are categorised under Group 1.
Group 2: Vaccines placed under alternate to lot release programme
Vaccines placed under alternate to lot release (ALR) programme* or other equivalent routes that require no further release by an overseas NRA or NCL are categorised under Group 2.
*For example, US FDA has a process where manufacturers may submit a supplement to request the product be moved from routine lot release and be put onto surveillance. If the supplement is approved, a final release is not necessary prior to distribution of the product, unless US FDA directs the return to routine lot release.
If the vaccine is no longer considered under ALR and placed back on routine lot release by the NRA or NCL, subsequent lots will be treated as Group 1.
How to submit
Submit your notification through the Notification of Vaccine Lot Release Information Form before you supply the vaccines in Singapore. The form can be assessed here.
You will receive a response ID to your email upon successful submission of the notification with relevant supporting documents. You can use the response ID for future correspondence with us about the vaccine lot(s) being notified.
- Submit one form to notify one or multiple lots of the same vaccine within the same shipment.
- If a vaccine of the same lot is imported via multiple shipments, each shipment shall be accompanied by its respective notification form. You may cite the response ID of the first notification when notifying the subsequent shipments and need not re-submit supporting documents if there are no changes.
Supporting documents
Each application shall be accompanied by relevant supporting documents.
Group 1 vaccines
- lot release certificates issued by NRA, NCL or World Health Organization, and
- certificate of analysis
Group 2 vaccines
First application
- approval or acknowledgement letter from any NRA or NCL supporting that the vaccine is under ALR programme.
- manufacturer’s declaration letter that the NRA or NCL has granted approval of ALR of the imported lot(s), and
- certificate of analysis
Subsequent application
- notification response ID of the first notification,
- declaration letter from the company stating no changes to the vaccine’s ALR status as indicated in the original application, and
- certificate of analysis
What happens after submission
Once the notification of lot release information of imported vaccines for local supply is successfully completed, the lot(s) may be distributed and supplied. No approval is required from us. We will contact you via email should we need any clarification.