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Audit and Licensing of Manufacturers

Under the Medicines Act, all local manufacturing facilities engaged in the manufacture or assembly of medicinal products and Chinese Proprietary Medicines (CPM) must be licensed with Health Sciences Authority. The manufacturers are expected to comply with the relevant legislative and regulatory requirements, and Good Manufacturing Practice (GMP) standard.

For more information, please click the hyperlinks below:


With effect from 1 April 2004, all new overseas manufacturers who intend to register their “western” medicinal products in Singapore will be subjected to GMP Conformity Assessment.

For more information, please click the hyperlink below:


 

Target Processing Timeline

Issuance of new Manufacturer's Licence – 10 working days from date of audit close out


Last updated on 24 May 2011 15:29:26
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