30 June 2004

To: All Product Licence Holders

Legislative Changes and Implementation of Patent Linkage from 1 July 2004

With reference to HSA's recent public consultation for the Medicines (Amendment) Bill 2004 in April 2004, we wish to inform you that after taking into account the feedback received, the Medicines (Amendment) Bill 2004 was passed in Parliament on 15 June 2004 and subsequently approved by the President.

2.  The Medicines (Amendment) Act has now been gazetted and shall take effect from 1 July 2004. The Medicines (Licensing, Standard Provisions and Fees)(Amendment) Regulations 2004 have also been gazetted to take effect from 1 July 2004. Copies of the legislation can be purchased from the Legal Publications Retail Outlet (refer to myepb website for purchase information - http://www.myepb.com/script/legalpub.asp). You may also wish to note that the Singapore Statutes are available online at http://statutes.agc.gov.sg/.

3.  With effect from 1 July 2004, all product licence applicants are required to declare patent related information using the declaration form prescribed in Part I of the Sixth Schedule of the Medicines (Licensing, Standard Provisions and Fees) Regulations 2004.

4.  HSA is obliged under the US-Singapore Free Trade Agreement to implement the new requirement with effect from 1 July 2004. We seek your cooperation to familiarize yourselves with the new requirements and the declaration form which contains self-explanatory details. Should you require further clarification, please e-mail your enquiry to: HSA_Drug_Registration@hsa.gov.sg. You may also contact HSA officers whose names and telephone numbers are provided below.

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