DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (DRGD)a For 1:10 and 1:50 000 dilution ratios only the Hahnemannian method of manufacture(multi-flask method) is used.b For 1:100 dilution ratios a C potency is assumed to use the Hahnemannian method ofmanufacture (multi-flask method) and can also be denoted as CH. When theKorsakovian method of manufacture (single-flask method) is used, the potency isdesignated as CK or K.Sarcodes: Homeopathic medicines made from healthy animal tissues or secretions. InGreek, sarcode means fleshly.Source material (raw material, starting material, mother substance): Sourcematerial is the original raw material used for the production of homeopathic medicines.This material is obtained from natural sources, e.g. of botanical, zoological,microbiological, mineral, chemical, animal and human origin, or synthetic procedures.Source materials may undergo preliminary treatment in order to be further processed.Stock: Substances or preparations made from the source materials (e.g. bymaceration, succussion or trituration) used as starting points for the production ofhomeopathic medicines.National Pharmaceutical Control BureauFirst Edition, January 201316
Drug Registration Guidance Document (DRGD)CONTENTSGUIDELINE HISTORY……………………………………………………………………… 2PREAMBLE………………………………………………………………………………….. 4ABBREVIATIONS & ACRONYMS………………………………………………………... 6GLOSSARY…………………………………………………………………………………..12SECTION A: GENERAL OVERVIEW1. INTRODUCTION ............................................................................................. 251.1 REGISTRATION OF PRODUCTS ................................................................... 271.1.1 REGISTRABLE PRODUCTS .................................................................... 281.1.2 NON-REGISTRABLE PRODUCTS ........................................................... 281.1.3 EXEMPTIONS FOR PRODUCTS USED IN CLINICAL TRIALS ANDMANUFACTURING SAMPLES FOR REGISTRATION ............................. 311.2 CATEGORIES OF PRODUCT ......................................................................... 321.2.1 NEW DRUG PRODUCTS .......................................................................... 321.2.2 BIOLOGICS ............................................................................................... 341.2.3 GENERICS ................................................................................................ 351.2.4 HEALTH SUPPLEMENTS ......................................................................... 361.2.5 NATURAL PRODUCTS ............................................................................. 361.3 FOOD - DRUG - INTERFACE PRODUCTS .................................................... 381.3.1 INTRODUCTION ....................................................................................... 381.3.2 CLASSIFICATION OF FDI PRODUCTS ................................................... 391.3.3 PICTORIAL GUIDE TO CLASSIFICATION OF FOOD-DRUG INTERFACEPRODUCTS .............................................................................................. 421.3.4 ADDITIONAL GUIDANCE NOTES FOR FOOD PRODUCTS ..................... 441.4 MEDICAL DEVICE - DRUG - COSMETIC INTERFACE PRODUCTS............. 461.4.1 INTRODUCTION ....................................................................................... 46National Pharmaceutical Control BureauFirst Edition, January 201317
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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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