Please be informed that there has been an update on the Guidance Notes for Active Pharmaceutical Ingredient (API) Information Required for Product Registration. The updated document is available for download:
The summary of changes on Guidance Notes for Active Pharmaceutical Ingredient (API) Information Required for Product Registration are outlined below:
|
Version |
Description of Updates |
Effective date |
|
Version 6.1 |
Updating of Appendix IV: Addition of Lysine Hydrochloride, Taurine, Histidine Hydrochloride Monohydrate, Potassium Acetate, Sodium Dihydrogen Phosphate Dihydrate, Fish Oil (Rich in Omega-3-Acids) & Magnesium Acetate as examples of Atypical API. |
July 2022
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