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Singapore – Public Consultation on Proposed Changes to the Health Products Act.

17 November, 2014

The Health Sciences Authority (the “HSA“) has launched a series of public consultations on 27 October 2014 for its proposal to streamline regulations of pharmaceutical products.

 
Currently, regulations for pharmaceutical products are spread out across the Medicines Act and Poisons Act. The proposed changes seek to consolidate the provisions under the different Acts to the Health Products Act, which presently only deals with medical devices and cosmetic products.

 
The proposed changes, which should be finalised in the third quarter of 2015, include the following:

 
(a) pharmaceutical products will be known as “therapeutic products”, which are defined as health products that are “intended for a therapeutic, preventive, palliative or diagnostic purpose, and its scope includes chemical and biologic drugs”;

 
(b) removal of the existing permit system for advertisements of therapeutic products to industry self-regulation;

 
(c) all direct-to-consumers advertisements of Pharmacy Only Medicines are to carry advisories/warnings as required by the HSA;

 
(d) inclusion of provisions on telepharmacy by licensed retail pharmacies into the Health Products Act; and

 
(e) introducing four sets of subsidiary legislation for areas such as clinical trials, manufacture, registration, import, supply, presentation, advertisement, adverse event reporting and enforcement.

 
The first public consultation on advertising regulations will close on 23 November 2014. The second public consultation on clinical trial regulations will commence in November 2014.

 
All interested parties may give feedback to the HSA by fax or email. More details of the public consultation are available on HSA’s website, which can be accessed at this link.

 

Baker McKenzie

 

For further information, please contact:

 

Andy Leck, Principal, Baker & McKenzie.Wong & Leow

andy.leck@bakermckenzie.com

 

Lim Ren Jun, Baker & McKenzie.Wong & Leow

ren.jun.lim@bakermckenzie.com

 
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