Workflow For Manual Registration Of For Export Only (FEO) Products

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1.  Applicant to submit dossier/application and payment of new FEO products manually to finance department.

2.  Finance department will issue receipt & submit documents to PPP.

3.  Evaluation and correspondence processes will be carried out manually.

4.  Upon DCA decision, the product will only be updated and shown in Q3+ after 14 calendar days once PPPS received full and complete data from PPP.

     a)  The data must be in Microsoft word for text field info and attachments must be in PDF or JPEG only with size < 5Mb.

     b)  All the active ingredients/excipients/dosage form/packaging/manufacturer referred in the dossier must be the same as what are readily available in Q3+.

5. Online receipt, correspondence and remark during evaluation will not be available online in Q3+.

National Pharmaceutical Regulatory Agency (NPRA)
Lot 36, Jalan Universiti, 46200 Petaling Jaya, Selangor, Malaysia.
  • Email: npra@npra.gov.my
  • Phone: +603-7883 5400
  • Fax: +603-7956 2924, +603-7956 7075

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  • Last Modified: Monday 10 December 2018, 14:32:16.
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