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

Kadar pengguna: 1 / 5

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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 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 (Jalan Prof Diraja Ungku Aziz), 46200 Petaling Jaya, Selangor, Malaysia.

  • Phone: +603-7883 5400

 

 

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The Government of Malaysia and the National Pharmaceutical Regulatory Agency are not responsible for any loss or damage caused by the usage of any information obtained from this website.

Site Last Modified

  • Last Modified: Isnin 09 Disember 2024, 11:07:51.
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