11 March 2010

GUIDELINE TO APPLY FOR THE TRANSFER OF PRODUCT LICENCE

LICENCE TRANSFER GUIDELINE

11 March 2010

1.
2.

This guideline is intended to provide assistance in the application for the transfer of product licence. The company to which the product licence(s) are to be transferred must
(a) (b) be a registered business entity in Singapore; and has 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 PRISM@HSA. 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. 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. 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. 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 Regulatory Support Unit either via dispatch or by post; the document should bear the company letterhead of the product owner and include the product name and its corresponding product licence number;

4.

5.

6.

7.

(ii)

(iii) authorizing the new licensee to hold the product licence(s) on their behalf in Singapore (effective date to be stated); (iv) withdrawing the authorization granted previously to the existing licensee (effective date to be stated); and (b) Letter from the new licensee confirming possession of the relevant product registration files received 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

HEALTH SCIENCES AUTHORITY HEALTH PRODUCTS REGULATION GROUP

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LICENCE TRANSFER GUIDELINE

11 March 2010

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. There is no fee chargeable for the transfer of the product licence. Both the existing and new licensees will be notified of the outcome of the transfer application. 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. 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 product licence(s). For enquiry, please contact the Regulatory Support Unit at telephone 6866-3438/ 6866-3437, fax: 6478-9032 or email: HSA_MedProd_Enquiry@hsa.gov.sg.

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HEALTH SCIENCES AUTHORITY HEALTH PRODUCTS REGULATION GROUP

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Contact Officer: Thomas KOH Senior Regulatory Manager Regulatory Support Unit Pharmaceuticals & Biologics Branch/ Generics & Biosimilars Branch Pre-marketing Division Health Products Regulation Group Health Sciences Authority 11 Biopolis Way, #11-03 Helios Singapore 138667 www.hsa.gov.sg T: 6866 1055 F: 6478 9032