DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (DRGD)ATC CodeRecommended Pack sizesD07C Corticosteroids,combinations with antibioticsD07CA Corticosteroids, weak,combinations with antibioticsD07CB Corticosteroids, moderatelypotent, combinations withantibioticsD07CC Corticosteroids, potent,combinations with antibioticsD07CD Corticosteroids, very potent,combinations with antibioticsD07CA - Max 100gD07CB - Max 50gD07CC - Max 15gD07CD - Max 15gD08A Antiseptics anddisinfectantsLiquid antiseptics/ disinfectants - 1LitreOthers - max 60gD10A Anti-acne preparations fortopical useExcept for D10AA Corticosteroids,combinations for treatment of acneD11AF Wart and anti-cornpreparationsLiquid preparation - max 250ml(recommended to be used with adispenser)Bar - max 100gAll others - max 60gMax 15mlM02A Topical products for jointand muscular painD11AX11 HyperpigmentationLiquid – 250mlOthers, Max – 60gMax 60gReference: Circulars(bil 16) dlm bpfk02/5/1.3.pdfBil (22) dlm BPFK/02/5/1.3.pdfBil (21) dlm.BPFK/02/5/1.3.pdfBil (24) dlm BPFK/02/5/1.3.pdf(1) dlm. BPFK/02/5/1.4Bil (4) dlm BPFK/PPP/01/03 Jld 1National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 434
Drug Registration Guidance Document (DRGD)APPENDIX 11:GUIDELINE ON FILLING THE ONLINE APPLICATION FORMFOR PRODUCT REGISTRATION VIA QUEST SYSTEMIMPORTANT NOTES:Online application forms are available for different product categories in the QUESTsystem:a) Pharmaceuticals;b) Health Supplements and Natural Products.This appendix may not follow the sequence of the online registration forms.Applicant shall follow and comply with all requirements in the online applicationforms as well as any supplementary documentation requested by the Authority,whichever it may deems fit.Applicant shall ensure that you have clicked on the appropriate section of the displaypanel and fill the correct application form.Applicants are advised to read the explanatory notes in this appendix, as well asrelevant ASEAN or ICH guidelines and checklists, for full information on requirementfor product registration. In order to facilitate the evaluation process the Authority,applicants shall conform to these guidelines as well as the main guidance document.The Authority reserves the right to request for supplementary information in certaincases.National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 435
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PART III: NON-CLINICAL DATADrug Reg
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- All information must be provided
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1.2 EXEMPTION FROM PRODUCT REGISTRA
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For product containing Red Yeast Ri
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DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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