Medicinal Products- Product Licence
Revised Fee (S$) | |||
1 | Application for a Licence- NDA & GDA | ||
a) | Screening | | |
| (i) Abridged/Verification Dossier (NDA & GDA) | 550 | |
| (ii) Full Dossier (NDA) | 2,750 | |
b) | Evaluation | | |
| (i) GDA Dossier | | |
| - GDA-1 | 3,850 | |
| - GDA-2 | 2,200 | |
| (ii) Abridged (NDA) Chemical Drugs & Biologics | | |
| - NDA-1 & NDA-2 | 11,000 | |
| - NDA-3 | 5,500 | |
| (iii) Verification (NDA) Chemical Drugs & Biologics | | |
| - NDA-1 & NDA-2 | 16,500 | |
| - NDA-3 | 5,500 | |
| (iv) Full Dossier (NDA) | 82,500 | |
2 | Application to amend a licence | ||
a) | MAV1 - Chemical Drugs & Biologics | | |
| (i) Evaluation | | |
| - Abridged Evaluation for First Strength | 5,500 | |
| - Verification Evaluation for First Strength | 8,250 | |
| - Abridged/Verification Evaluation For a Subsequent Strength | 2,750 | |
| - Full Dossier | 51,000 | |
b) | MIV-1 - Chemical Drugs & Biologics | 550 | |
Cosmetic Products - Annual Notification
1 | Cosmetic Products deemed to be of higher risk1 | ||
a) | Single product | 25 | |
b) | Variant | | |
| (i) First 3 variants | 25/variant | |
| (ii) 4th and subsequent variants | 5/variant | |
2. | Cosmetic Products deemed to be of lower risk2 | ||
a) | Single product | 10 | |
b) | Variant | | |
| (i) First 3 variants | 10/variant | |
| (ii) 4th and subsequent variants | 5/variant | |
For retention on the cosmetic product, the above fee is applicable.
1Cosmetic Products deemed to be of higher risk are cosmetic products to be applied around the eyes, on the lips, hair dyes containing phenylenediamines and oral and dental care products.
2Cosmetic Products deemed to be of lower risk are all other cosmetic products not listed above such as skin whitening products, moisturisers, etc.



