Fees/Service Charges for Licences and Certificates of Western Medicines
CURRENT FEES
1. | PRODUCT LICENCE | ||
1 | Application for a licence — NDA & GDA | ||
(a) screening (payable upon submission) | |||
(i) abridged / verification dossier (NDA & GDA) | $500 | ||
(ii) full dossier (NDA)* | $2,500 | ||
| (iii) verification dossier under CECA scheme (GDA) | $550 | ||
(b) evaluation (payable upon acceptance) | |||
(i) GDA abridged dossier | |||
- GDA-1 | $3,500 | ||
- GDA-2 | $2,000 | ||
(ii) NDA abridged dossier | |||
- NDA-1 & NDA-2 | $10,000 | ||
- NDA-3 | $5,000 | ||
(iv) NDA verification dossier | |||
- NDA-1 & NDA-2 | $15,000 | ||
- NDA-3 | $5,000 | ||
(v) NDA Full dossier* | $75,000 | ||
| (vi) verification dossier under CECA scheme (GDA) | |||
| - 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 | |||
(i) screening (payable upon submission) | |||
- abridged / verification dossier | $500 | ||
- full dossier* | $2,500 | ||
(ii) evaluation (payable upon acceptance) | |||
- abridged dossier | |||
- for first strength | $5,000 | ||
- for a subsequent strength | $2,500 | ||
- verification dossier | |||
- for first strength | $7,500 | ||
- for a subsequent strength | $2,500 | ||
- full dossier* | $50,000 | ||
(b) MIV-1 (payable upon submission) | $500 | ||
* Fees will be charged based on per submission (regardless of the number of strengths and/or dosage forms). | |||
2. | IMPORT LICENCE | ||
1 | Application for a licence for | ||
Importation not authorised by product licence holder — per consignment | $250 | ||
2 | Licence for — | ||
Importation not authorised by product licence holder — per consignment | No charge | ||
NEW FEES - Effective Date: 1 January 2011
1. | 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) GDA abridged dossier | |||
- GDA-1 | $3,850 | ||
- GDA-2 | $2,200 | ||
| (ii) GDA verification dossier | |||
| - GDA-1 | $10,000 | ||
| - GDA-2 | $5,000 | ||
(iii) NDA abridged dossier | |||
- NDA-1 & NDA-2 | $11,000 | ||
- NDA-3 | $5,500 | ||
(iv) NDA verification dossier | |||
- NDA-1 & NDA-2 | $16,500 | ||
- NDA-3 | $5,500 | ||
(v) NDA full dossier* | $82,500 | ||
2 | Licence for — | ||
(a) the first year | No charge | ||
(b) each subsequent year | $300 | ||
3 | Application to amend a licence — | ||
(a) MAV-1 | |||
(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 a subsequent strength | $2,750 | ||
- verification dossier | |||
- for first strength | $8,250 | ||
- for a 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). | |||
2. | IMPORT LICENCE | ||
1 | Application for a licence for | ||
Importation not authorised by product licence holder — per consignment | $250 | ||
2 | Licence for — | ||
Importation not authorised by product licence holder — per consignment | No charge | ||
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