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List of Revised Fees (from 1 January 2011)

Medicinal Products- Product Licence

Revised Fee  (S$)
(from 1 Jan'11)

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.

 


Last updated on 17 Mar 2011 18:02:08
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