DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (DRGD)1.4.2 CLASSIFICATION CRITERIA ................................................................... 462. DATA EXCLUSIVITY ...................................................................................... 512.1 HOW TO APPLY.............................................................................................. 512.2 APPLICABILITY AND DATE OF COMING INTO FORCE ............................... 522.3 GRANT OF DATA EXCLUSIVITY.................................................................... 522.4 CONSIDERATION OF OTHER APPLICATIONS UPON THE GRANT OF DATAEXCLUSIVITY ................................................................................................. 542.5 NON-APPLICATION OF DATA EXCLUSIVITY ............................................... 542.6 APPEAL ........................................................................................................... 553. APPLICATION FORMALITIES ....................................................................... 563.1 WHO CAN APPLY FOR PRODUCT REGISTRATION .................................... 563.2 RESPONSIBILITY OF APPLICANT................................................................. 563.3 HOW TO APPLY.............................................................................................. 574. FEES ............................................................................................................... 584.1 FEES IMPOSED .............................................................................................. 584.2 MODE OF PAYMENT ...................................................................................... 585. TYPES OF APPLICATION .............................................................................. 595.1 REGISTRATION OF PRODUCTS ................................................................... 595.1.1 APPLICATION FOR PRODUCT REGISTRATION FOR THE FOLLOWINGCATEGORIES: .......................................................................................... 595.1.2 REGISTRATION OF COMBINATION PACK (COMBO PACK) ................. 595.1.3 REGISTRATION OF PRODUCT FOR EXPORT ONLY (FEO) ................. 615.2 AMENDMENTS TO PARTICULARS OF A REGISTERED PRODUCT ........... 615.2.1 VARIATION ............................................................................................... 615.2.2 CHANGE IN MANUFACTURING SITE ..................................................... 625.2.3 CHANGE IN PRODUCT REGISTRATION HOLDER ................................ 625.2.4 NEW/ ADDITIONAL INDICATION ............................................................. 625.2.5 APPLICATION FOR A CONVENIENT PACK ............................................ 635.3 RENEWAL OF PRODUCT REGISTRATION ................................................... 63National Pharmaceutical Control BureauFirst Edition, January 201318
Drug Registration Guidance Document (DRGD)5.4 CERTIFICATES ............................................................................................... 635.4.1 CERTIFICATE OF PHARMACEUTICAL PRODUCT (CPP)...................... 635.4.2 GOOD MANUFACTURING PRACTICE (GMP) CERTIFICATE ................ 645.5 LICENSES ....................................................................................................... 645.6 CLINICAL TRIAL IMPORT LICENCE (CTIL)/ CLINICAL TRIAL EXEMPTION(CTX) ............................................................................................................... 656. GENERAL CONDITIONS FOR REGISTRATION OF DRUG PRODUCTSUNDER THE CONTROL OF DRUGS AND COSMETICS REGULATIONS1984 ................................................................................................................ 666.1 REGISTRATION NUMBER ............................................................................. 666.2 PRODUCT PARTICULAR ............................................................................... 666.3 LABELLING ..................................................................................................... 666.4 PRODUCT AUTHENTICATION ....................................................................... 666.5 INDICATIONS, SPECIAL CONDITIONS ......................................................... 676.6 ADVERSE REACTIONS, COMPLAINTS ......................................................... 676.7 HOLDER OF REGISTRATION CERTIFICATE ................................................ 676.8 WITHDRAWAL FROM REGISTRATION ......................................................... 676.9 CANCELLATION, SUSPENSION, AMENDMENT BY THE AUTHORITY ....... 686.10 DIRECTIVES ................................................................................................... 687. USE OF HALAL LOGO ................................................................................... 69SECTION B: PRODUCT REGISTRATION PROCESS8. FLOW OF REGISTRATION PROCESS .......................................................... 708.1 PRE-SUBMISSION OF APPLICATION ........................................................... 718.1.1 CATEGORY OF PRODUCT ...................................................................... 718.1.2 METHOD OF EVALUATION ..................................................................... 718.1.3 REQUIREMENTS FOR PRODUCT REGISTRATION ............................... 748.1.4 CONDITIONS APPLIED ON PRODUCT REGISTRATION ....................... 75National Pharmaceutical Control BureauFirst Edition, January 201319
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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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