Fees/Service Charges for Licences and Certificates of Western Medicines
Effective date: 1 January 2011
(A) PRODUCT LICENCE
1. Application for a licence – NDA & GDA
a) Screening (Payable upon submission)
(i) Abridged/Verification Dossier (NDA & GDA) $550
(ii) Full Dossier (NDA)* $2,750
b) Evaluation (Payable upon acceptance)
(i) NDA Abridge Dossier (Chemical Drugs & Biologics)
- NDA-1 & NDA-2 $11,000
- NDA-3 $5,500
(ii) NDA Verification Dossier (Chemical Drugs & Biologics)
- NDA-1 & NDA-2 $16,500
- NDA-3 $5,500
(iii) NDA Full Dossier* $82,500
(iv) GDA Abridged Dossier
- GDA-1 $3,850
- GDA-2 $2,200
(v) GDA Verification Dossier
- GDA-1 $10,000
- GDA-2 $5,000
(vi) GDA Verification Dossier (CECA Scheme)
- GDA-1 $10,000
- GDA-2 $5,000
2. Licence for
a) the first year No charge
b) each subsequent year $300
3. Application to amend a licence
a) MAV-1 (Chemical Drugs & Biologics)
(i) Screening (Payable upon submission)
- Abridged/Verification Dossier $500
- Full Dossier* $2,500
(ii) Evaluation (Payable upon acceptance)
- Abridged Dossier
- for first strength $5,500
- for subsequent strength $2,750
- Verification Dossier
- for first strength $8,250
- for subsequent strength $2,750
- Full Dossier* $51,000
b) MIV-1 (Payable upon submission) $550
* Fees will be charged based on per submission (regardless of the number of strengths and/or dosage forms).
(B) IMPORT LICENCE
1. Application for a licence
a) Importation not authorised by product licence holder – $250
per consignment
2. Licence for
a) Importation not authorised by product licence holder – No charge
per consignment
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