CRED Managing Variations Effectively

Work Flow for National and MR Type IAs

MAH sends application to MHRA

Application is received by the MHRA and screened.

Outcome from RMS

Rejected

eCTD or NeeS formats

No

CMS

CTS

Yes

Entry is created on MHRA database within 5 days of receipt.

Type of procedure ?

Notification of Receipt

RMS

NAT

1. Acceptance of Notification. 2. Rejection (Non Acceptance of Notification)

Review Phase (Day 0-30)

No

MHRA

Completes Procedure

Checked to establish if conditions and documentation requirements are met.

Grouped?

3.

Acceptance of Grouped Notification Rejection of Grouped Notification Partial Acceptance of Grouped Notification

Yes

4.

5.

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