DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (DRGD)d) A product which is packed together with diluent(s)/ adjuvant(s) is NOTconsidered as a combination pack.e) Labelling requirement specifically for combination pack is shown inTable IV:No. Outer Label Immediate Label1. Name of combination packIndividual name for each productsOR name of combination pack2.3.4.5.Registration number for thecombination packName and address ofmanufacturer and productregistration holderBatch number of thecombination pack productExpiry date(according to the shortestexpiry date from the individualproducts)Individual registration number foreach products OR registrationnumber for combination packName and address ofmanufacturer and productregistration holderIndividual batch number for eachproductsIndividual expiry date for eachproductsNote:These labeling requirements for a combo pack shall as well be subjectedto other labelling requirements as stated in Appendix 9.1: Label (mock-up)for Immediate Container, Outer Carton and Proposed Package Insert)National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 60
Drug Registration Guidance Document (DRGD)5.1.3 REGISTRATION OF PRODUCT FOR EXPORT ONLY (FEO)a) Refers to locally manufactured products for export only which are notmarketed locally with a different formulation (e.g. colour or strength ofingredients) or shape compared to a registered product;b) For products containing ingredients/ formulations which are not allowedby the Authority for local use, applicant shall submit a confirmation inwriting from the competent authority of the importing country that there isno objection to the importation and sale of the said ingredients/formulations. Evidence of registration of the said formulation with thecompetent authority in importing country may be submitted as supportingdata;c) Upon application, a Certificate of Pharmaceutical Product (CPP) will beissued to the applicant for the registered FEO products;d) For a registered product which is marketed locally and intended to beexported, new registration for export only is NOT necessary if there is nochange in the formulation or appearance of the registered product. In thiscase, a CPP will be issued to the applicant for the registered product,together with an explanation/ declaration letter of any difference(s) to theimporting country (e.g. a product exported with a different product name),upon application.5.2 AMENDMENTS TO PARTICULARS OF A REGISTEREDPRODUCT5.2.1 VARIATIONVariation refers to change of particulars of a registered product. No change ofany particulars of a registered product shall be made without prior approvalfrom NPCB. The registration of a product shall be reviewed for suspension orcancellation if changes are made without prior approval of the Authority.There are two types of variation, which are Variation Type I and VariationType II.For details, please refer to Section E: 16.1 Variation.National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 61
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PART III: NON-CLINICAL DATADrug Reg
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For product containing Red Yeast Ri
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DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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