BE Export applications

Previous flow of activities Flow of activities as per new rules

Application Form 29 NOC R & D Application Form 29 NOC R & D

Batches manufactured for test and Note: Developing & optimizing test formula for BE Batches manufactured for test and analysis Note: Developing & optimizing test formula for BE study and stability
analysis at R & D study and stability study at R & D study

Combined Application: Note: 3 Month stability data, (Initial application Combined Application: Note:
1. BE application - Form 44 can be with 1 month), 1. BE application - Form CT-05 3 Month stability data, (Initial application can be with 1 month),
2. Import of RLD - Form 12 Toxicity data (In case of Injection) 2. Import of RLD - Form CT-16 Toxicity data (In case of Injection)
3. Application to manufacture API*/ CT-10: application for mfg. ND/IND
Formulation for BE - Form CT-10/CT- CT-12: application for mfg. formulations containing unapproved API
12/CT-13 CT-13: application for mfg. unapproved API
Fees: Fees:
BE permission - Rs. 25,000 for unapproved CT-05 - Rs. 2 lakhs
molecule, Rs. 15,000 approved molecule CT-16 - Rs. 5000 per product
Form 12 - Rs. 5000 per product, Rs. 2000 for CT-10/CT-12/CT-13 - Rs. 5000 per product
additional product *API if unapproved in India
45 days 90 days
Combined: Note: Combined: Note:
1. BE Permission BE permission - utilize in 2 years 1. BE permission - Form CT-07 CT-11 - Permission to mfg. ND/IND
2. Permission for Import of RLD - Form 11 - validity 3 years 2. Permission to Import RLD - Form CT-17 CT-14 - Permission to mfg. formulations containing unapproved API
Form 11 3. Permission to manufacture API*/ CT-15 - Permission to mfg. unapproved API
Formulation for BE - Form CT-11/CT-
14/CT-15 CT-17 issued with, BE Protocol No., Clinical trial site, Ethics committee
details, Name of investigator
CT-11/14/15 issued with, Quantity to be manufactured, Mfg. name and
site address, BE Protocol No., Clinical trial site, Ethics committee details,
Name of investigator

Validity:
CT-07 (1 years)
CT-17 (3 years)
CT-11/14/15 (3 years)
15 days
BE batches manufactured at plant Note: It is paralleliy done with BE application. Form 29 form SLA for API/Formulation at Form-29 to be applies with Form CT-11/CT-14/CT-15
under Form 29 Plant
(No separate permission required)
1. Mfg. API* for formulation for BE dosing *API if unapproved in India
2. Supply API to Formulation plant
3. Mfg. formulation batch for BE dosing

Notify test and reference COAs with Notify test and reference COAs with
EC approval EC approval

BE study Initiation BE study Initiation