Singapore: Health Products (Therapeutic Products) Regulations

 

Singapore has published Health Products (Therapeutic Products) Regulations – Presentation of Therapeutic Products regulations 19 and 20 and Guidance on Therapeutic Product Registration in Singapore: Applicable labelling requirements in Appendix 7 on Points to consider for Singapore Labelling.

Therapeutic products in Singapore are subject to labelling requirements that are either legislated by law or mandated as HSA’s administrative requirements. Legislated labelling requirements, under the Health Products (Therapeutic Products) Regulations, are subject to HSA’s surveillance programme. Administrative labelling requirements, specified in the Guidance on Therapeutic Product Registration in Singapore, are included as part of product registration application.

The two published acts should be read jointly with the Singaporean Health Products Act.

The original texts are available HERE and HERE.