NMRA will recommence accepting applications for foreign manufacturing sites not inspected by a refence authority with effect from 17th October 2022.

1. The applications will be received only on Monday.
2. Application with all documents specified in F-MFR- 001 Issue 03 which is published in NMRA website should be submitted along with the payment receipt.
3. Approval process will follow the procedure prescribed in regulations 2 (3) to 2 (10) in Medicines
4. Approval will be granted only after a GMP inspection.

(Date: 17 October 2022)

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