On 28th March 2024, HSA revises “Appendix 7: Points to Consider for Singapore Labelling of the Guidance on Therapeutic Product Registration in Singapore”. The guidance has been updated to include the following changes:
i) Removal of mandatory requirement for manufacturing date to be reflected on the outer carton/inner label.
ii) Flexibility for either the manufacturer, product owner or registrant’s name and address to be included on the outer carton/ inner label.
iii) Removal of mandatory requirement for precautionary statement on interchangeability of biosimilar products in the PI.
iv) Minor editorial updates.
The updated guidance is available at the following link: https://www.hsa.gov.sg/docs/default-source/hprg-tpb/guidances/appendix-7_points-to-consider-for-singapore-labelling.pdf?sfvrsn=2ee40213_15