DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (DRGD)Standard Labelling for Health SupplementsName and Strength ofactive substances, RDAPreservative(s) (wherepresent)Alcohol (where present)IndicationDose / Use InstructionFunctional ClaimWarnings (If applicable)Name & address ofMarketingAuthorization HolderName & address ofManufacturerName & address ofRepacker (ifapplicable)Sources (animalorigin)Storage ConditionKeep out of reachof children / Jauhi darikanak-kanakPack SizeDosage FormBatch NumberManufacturing DateExpiry DateMAL ……………………...Note:Product label shall follow the standard labelling for Health SupplementInformation stated in the left and right panel is interchangeable.All information on the label must be truthful and not misleading to the consumers.Batch number, manufacturing date, expiration date: can be stated on label, on top of cap orbottom of bottleNational Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 210
Drug Registration Guidance Document (DRGD)Additional Requirements for Labelling‣ Product with dosage form of soft gel with tail (twist and squeeze) shallinclude the statement „Under parent supervision‟ in the label.‣ For products containing animal origin(s), please add this statement: Thisproduct contains substance(s) from animal origin.‣ For products containing porcine, please add this statement: This productcontains animal part(s) (porcine/pig).Health supplement products with disease risk reduction claims (high) areencouraged to be dispensed under the supervision of pharmacists or medicalpractitioners. At such, the label and package insert of health supplementproducts with disease risk reduction claims (high) shall have the followingstatement:“Please consult a healthcare professional before taking this product”.The front panel must contain the information as specified in DRGD. However,the information on the side panels is interchangeable. Additional cautionarylabelling relating to the safety of the product may be imposed.Specific Labelling Requirement (Label & Package Insert)1. ALFALFAThe following boxed warning shall be included on the labels of productscontaining Alfalfa (Medico sativa):This product contains Alfalfa (Medico sativa).Individual with a predisposition to systemic lupuserythematosus shall consult their phycisian beforeconsuming this product.National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 211
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For product containing Red Yeast Ri
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DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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