DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (<strong>DRGD</strong>)GLOSSARYIndigenous Medicine: As defined under Regulation 2, the CDCR 1984, indigenousmedicine means a system of treatment and prevention of disease established throughtraditional use of naturally occurring substancesLicensed importer: A person to whom an import license has been issued underRegulation 12, CDCR 1984 (as defined in Regulation 2, CDCR 1984)Licensed wholesaler: A person to whom a wholesaler's licence has been issuedRegulation 12, CDCR 1984 (as defined in Regulation 2, CDCR 1984)Manufacturer: A company that carries out at least one step of production as well as thefinal release of the finished product.Manufacturing: The definition of „manufacturing‟ includes:a) The making or assembling of the product;b) The enclosing or packing of the product in any container in a form suitable foradministration or application, and the labelling of the container and;c) The carrying out of any process in the course of any of the foregoing activities.(as defined in Regulation 2, CDCR 1984)Medicinal Product: The term refers to „product‟ as stated in Regulation 2, CDCR 1984which is applicable to pharmaceutical and natural productsOTC: Refers to Generic (Non-Scheduled Poison)Product Owner: A person, company or entity who is the legal/ registered owner of theproduct formulation and/or process with whom the marketing authorization holder has acontract (glossary used in ACTD and ACTR).Product Registration Holder: The company or corporate or legal entity in the field ofpharmaceuticals whose name the marketing authorization has been granted. This partyis responsible to all aspects of the product, including quality and compliance with theconditions of marketing authorization. The authorized holder must be subjected tolegislation in the country that issued the marketing authorization, which normally meansbeing physically located in that country (glossary used in ACTD and ACTR).National Pharmaceutical Control BureauFirst Edition, January 201312
Drug Registration Guidance Document (<strong>DRGD</strong>)The Authority: Refers to Drug Control Authority (DCA)The System: Refers to QUEST system in website of NPCBGlossary for Homeopathic Products:Active substance: Active substances are considered to be source materials processedby one or a sequence of homeopathic manufacturing procedures listed inpharmacopoeias in official use and other officially recognized documents (e.g. mothertinctures, dilutions or triturations).Diluent: Substance used for the preparation of a stock/ starting material or thepotentisation process and which may also represent the substance of the dosage form.Liquid diluents usually consist of purified water, aqueous solution, glycerol or ethanol ofa suitable concentration or for which there is an appropriate monograph. Thecommonest solid diluent is usually lactose monohydrate.Dilution: Dilution has two meanings in homeopathy:For a product, a dilution is a liquid homeopathic preparation which is potentised asdescribed below (see the definition of potentisation). Individual dilutions are alsocalled potencies;As a procedure, dilution means the de-concentration process of a liquid or a solidpreparation. One part of each stage in the preparation of a homeopathic medicinefrom its stock or previous dilution (potency) by adding one part of a previous solid orliquid phase to a predetermined weight or volume of the diluent (see Potentisationbelow). Dilution occurs at all stages of production of the homeopathic medicineswhether by addition of solid excipient in trituration or the addition of diluent in theliquid phase and succussion.Dosage form: a dosage form in homeopathy complies with any relevant specificationsfor that dosage form for which an appropriate characterization exists in apharmacopoeia in official use, or in other officially recognized documents. The mostcommonly encountered homeopathic dosage form, the globule (pillule or pellet), is asolid spherule which consists of lactose, sucrose or any other suitable vehicle. Usually,preformed globules are impregnated with a dilution or directly by a mother tincture. Thehomeopathic dosage form tablet is a solid preparation which complies with any relevantNational Pharmaceutical Control BureauFirst Edition, January 201313
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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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