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Transfer of Product Licence

This guideline outlines the process for transferring a product licence from one company to another in Singapore. Applicants must submit the transfer application online via PRISM@HSA within 30 days of notification. Both the existing and new licensees must provide authorization letters, and the existing licensee must withdraw any pending variation applications. If approved, the transfer is completed within 14 working days and the new licensee then assumes all regulatory responsibilities for the product.

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138 views4 pages

Transfer of Product Licence

This guideline outlines the process for transferring a product licence from one company to another in Singapore. Applicants must submit the transfer application online via PRISM@HSA within 30 days of notification. Both the existing and new licensees must provide authorization letters, and the existing licensee must withdraw any pending variation applications. If approved, the transfer is completed within 14 working days and the new licensee then assumes all regulatory responsibilities for the product.

Uploaded by

Maruf Rassel
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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Download as PDF, TXT or read online on Scribd
You are on page 1/ 4

06 AUGUST 2014

GUIDELINE FOR TRANSFER OF


PRODUCT LICENCE

GUIDELINE FOR TRANSFER OF PRODUCT LICENCE

06 August 2014

1.

This guideline is intended to provide assistance in the application for the


transfer of product licence.

2.

The company to which the product licence(s) are to be transferred must


(a)
be a registered business entity in Singapore; and
(b)
have an existing CRIS company account with HSA. For more
information, please visit CRIS@HSA.

3.

Applications for the transfer of product licence(s) are to be made online via
Transfer@PRISM.

4.

The company currently holding the product licences (termed existing


licensee) has to login to PRISM@HSA to initiate the transfer of the affected
product licence(s) via Transfer@PRISM. Information such as the UEN
(Unique Entity Number) of the company to which the licences are to be
transferred and email address of the authorized person acting on behalf of
the new company are required. Upon submission, a transaction number will
be generated by the system and an acknowledgement page can be printed
for record purposes.

5.

The company to which the product licence(s) are to be transferred (termed


new licensee) will be notified accordingly through the email. Upon receipt
of the email notification, the new licensee has to click on the hyperlink
provided in the notification and login to PRISM@HSA to submit the
application for the transfer of the selected product licence(s) via
Transfer@PRISM. The new licensee has 30 calendar days from the date of
the notification, to submit the application via PRISM.

6.

Only valid product licences can be included in the application. A maximum


of 20 product licences is allowed for each application. Upon successful
submission, an application number will be generated by the system and an
acknowledgement page can be printed for record purposes.

7.

All applications must be accompanied with the following documents to be


attached to the application:
(a)

Letter of Authorization (LoA) from the product owner:


(i) original of the document is to be submitted to the Therapeutic
Products Branch (TPB) either via despatch or by post;

HEALTH SCIENCES AUTHORITY HEALTH PRODUCTS REGULATION GROUP

Page 2 of 4

GUIDELINE FOR TRANSFER OF PRODUCT LICENCE

06 August 2014

(ii) the document should bear the company letterhead of the product
owner and includes the full product name which is registered in
Singapore and its corresponding product licence number;
(iii) authorizing the new licensee to hold the product licence(s) on its
behalf in Singapore (with effective date clearly stated);
(iv) withdrawing the authorization granted previously to the existing
licensee; and
(b)

Letter from the new licensee confirming arrangement to take over the
relevant product registration files from the existing licensee.

8.

All pending variation applications relating to the affected product licence(s)


have to be withdrawn by the existing licensee. Upon successful transfer of
the product licence(s), the new licensee may re-submit the variation
application(s) and fee, if applicable, will be chargeable.

9.

The application timeline is within 14 working days upon complete


submission of the application.

10.

Currently, there is no fee is payable for the transfer of the product licence.

11.

Both the existing and new licensees will be notified of the outcome of the
transfer application.

12.

Upon successful transfer of the product licence(s), the new licensee will be
able to view the latest licensing information via Enquire@PRISM and the
access rights of the previous licensee will cease with immediate effect.

13.

Once the product licence(s) have been transferred, the new licensee will be
responsible for all matters relating to the product registration, including but
not limited to, compliance with the legal requirements under the Medicines
Act, following up of all outstanding related issues and compliance with any
condition stipulated in the transferred product licence(s).

14.

For enquiry, please contact the Therapeutic Products Branch (TPB) at


telephone 6866-3438 / 6866-1055, fax: 6478-9032 or email:
HSA_MedProd_Licensing@hsa.gov.sg.

HEALTH SCIENCES AUTHORITY HEALTH PRODUCTS REGULATION GROUP

Page 3 of 4

Contact Officer:
Thomas KOH
Senior Regulatory Manager
Regulatory Support Unit (RSU)
Therapeutic Products Branch (TPB)
Pre-marketing
Health Products Regulation Group
Health Sciences Authority
11 Biopolis Way, #11-01 Helios
Singapore 138667
www.hsa.gov.sg
Tel: 6866-1055
Fax: 6478 9032

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