BOMRA PRODUCT Registration

Process Workflow
Key: = start/end/connector = decision =activity = Documentation/Record

__________________________________________________________________________________________

Applicant

Payment of Screening Fee

Submission of CD dossier Screening

+ Proof of screening fee Applications
payment Log

Screening (Check Dossier

Screening
for Completeness using
report
Checklist
+ proof of payment)

No Yes

Send deficiency Send a letter to Letter to

letter to the Applicant for full applicant
Applicant submission & fees

Applicant submits Screening

dossier for re- Applications
screening Applicant submits hard copy Log
application form, Proof of
registration fee payment,
Screening (Check Samples Screening
Dossier for report
Completeness using
Checklist)
Receiving into Applications Log -Applications
indicating evaluation pathway Log
Yes (expedited, SRA, WHO PQ) & -Samples Log
No
Sample Log

Send deficiency Entry into IMS

letter to the Letter to
Applicant applicant
 Manager allocates dossier
to 1st assessor
End
Cont.
Evaluation
1st Assessment report

Manager allocates dossier to

2nd assessor

2nd Assessment Evaluation

report

Queries?

Yes No

Send queries to Letter to

Report discussed at applicant
applicant
Pre-registration
Submission of (peer review)
Response by the meeting Responses
Applicant Log Book
Manager allocates
response for 1st
assessment

Assessment
1st assessment report

Prepare summary
report for Registration
Manager allocates Committee meeting Registration
for 2nd assessment Committee
Report

2nd Assessment
Consideration at
Queries?
Registration Committee
meeting
Yes,1st/2nd No/ Yes,3rd
response response

-Registration/
Rejection/Query
Regist Rejec Letter
Send Queries to Defer tion -Minutes
ration
applicant