DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (DRGD)NO.SPECIFIC LABELLING REQUIREMENTS (SUBSTANCE SPECIFIC)17. ASPARTAMEThe following statement shall be included on the labels and in the packageinserts of products containing Aspartame:WARNINGUnsuitable for phenylketonurics.18. BEE POLLENThe following statement shall be included on the labels and in the packageinserts of product containing bee pollen:This product contains Bee Pollen and may cause severe allergic reactions,including fatal anaphylactic reactions in susceptible individuals.Asthma and allergy sufferers may be at greater risks.19. BENZOYL PEROXIDEThe following statement shall be included on the labels and in the packageinserts of products containing Benzoyl peroxide:WARNINGDo not use this medication if you have sensitive skin or if you are sensitive tobenzoyl peroxide. This product may cause irritation, characterized by redness,burning, itching, peeling, or possible swelling.20. BENZYL ALCOHOLThe following statement shall be included on the labels and in the packageinserts of products containing Benzyl alcohol:As this preparation contains benzyl alcohol, its use should beavoided in children under two years of age.Not to be used in neonates.National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 364
Drug Registration Guidance Document (DRGD)NO.SPECIFIC LABELLING REQUIREMENTS (SUBSTANCE SPECIFIC)21. BLACK COHOSH (CIMICIFUGAE RACEMOSAE)The following statement shall be included on the labels and in the packageinserts of products containing Black Cohosh (Cimicifugae Racemosae):WARNINGStop taking this product if signs and symptoms suggestive of liver injurydevelop such as tiredness, loss of appetite, yellowing of the skin and eyes orsevere upper stomach pain with nausea and vomiting or dark urine andconsult your doctor immediately.Patients using herbal medicinal products should tell their doctor about it.Reference: Circular Bil (61) dlm BPFK/02/5/1.3: Pernyataan Amaran Produk Mengandungi'Black Cohosh'22. BROMAZEPAMPlease refer to SEDATIVE – HYPNOTIC PRODUCTS23. BROMOCRIPTINEPlease refer to DOPAMINERGIC INGREDIENT24. BROMPHENIRAMINEThe following statement shall be included on the labels and in the packageinserts of liquid oral products containing Brompheniramine:WARNINGWhen used for treatment of cough and cold:(a) Not to be used in children less than 2 years of age(b) To be used with caution and doctor‟s/ pharmacist‟s advice in children2 to 6 years of age.Reference: Circular Bil (34) dlm. BPFK/PPP/01/03: Kenyataan Amaran Pada Label danSisip Bungkusan Produk Persediaan Cecair Oral Untuk Rawatan Batuk dan Selsema (Coughand Cold) yang Mengandungi Antihistamin, Antitusif dan Dekongestan (Sebagai Bahan AktifTunggal atau Kombinasi)National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 365
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ATTACHMENT 1Drug Registration Guida
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PART IV: CLINICAL DOCUMENTSDrug Reg
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ATTACHMENT 2Drug Registration Guida
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APPENDIX 5:Drug Registration Guidan
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1. GENERAL INFORMATIONSDrug Registr
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Route of AdministrationTAMC(CFU/g o
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e) Example of label approved by the
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DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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