Data Entry by Applicant Applicant to re-enter data

Yes Submission made within 30 days

No
Data deleted entirely from database

Screening by No
Unit Head

Yes Incomplete Submission

Complete Submission
Yes
First Time?
Approved for payment

No
Payment made No Application Applicant
within 14 days? rejected No Yes
correspond
within 30 days
Yes
Applicant to re-submit data
Type of
All applications Application Full evaluation or traditional product only

Tray of Unit Head Laboratory Services Unit

(Centre for Quality Control)

Assign to evaluator

Pharmaceutical Traditional
Evaluation in process Correspondence
/ Traditional? Sample Testing
Yes
Fail Yes
First Applicant
Pharmaceutical Result
Data time appeals
No
submitted is Applicant Assign to evaluators from
complete?
Additional appropriate units
Information
Yes
Evaluation:
Pass No
Approval by Unit Head 1. Analytical Validation Data
2. Protocol of Analysis
Applicant 3. Certificate of Analysis
Compile report of evaluation
dossier and results of
laboratory sample testing Data
and evaluation No
submitted is
Inform applicant Result is
complete?
released to
Centre for
Registration of
Decision of the
Yes
Re-evaluate Products via
Product
QUEST3
Evaluation
Committee

Satisfactory

Meeting of Application
Re-evaluate
the Drug Approved Generate MAL Print product
Control number certificate
Authority

Rejected

Applicant can appeal to

the Minister

The National Pharmaceutical Control Bureau, Ministry of Health Malaysia

Lot 36, Jalan Universiti, 46200 Petaling Jaya, Selangor, Malaysia
Tel : + 603 7883 5400 Fax : + 603 7956 2924 www.bpfk.gov.my