DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (DRGD)B5. Attachment of Stability Data DocumentationReports of stability studies shall provide details of :- the batches placed under study (a minimum of 2 batches arerequired);- containers/ packaging type;- conditions of storage during study (temperature, humidity, etc);- duration of study and frequency (interval) of the tests/ observations;- the tests performed (including degradation products beingmonitored) and acceptance limits.SECTION C: PARTICULARS OF PACKINGThis section is subjected to requirements as stated in Appendix 10: Guide forImplementation of Patient Dispensing Pack for Pharmaceutical Products inMalaysia. Please refer the appendix for details.Please enter particulars of packing in the following sub-sections:C1 : Pack Size- Please select pack size by weight or volume or quantity; and unitC2 : Immediate Container Type- Please select container type, e.g. aluminium, glass, metal, paper, plastic,others (if others, please specify)- Please enter description of container type- Please attach attachment of container type at table appeared after „Add‟button at the bottom page is clickedC3 : Barcode/ Serial No.- Please key in if any (optional)C4 : Recommended Distributor‟s Price- Please key in if any (optional)National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 450
Drug Registration Guidance Document (DRGD)C5 : Recommended Retail Price- Please key in if any (optional)and then click button „Add‟ to save all the entered informations.Note:To add next particulars, repeat the same process until all packings are listedaccordingly. To remove any item from the listing, select item from the listing andclick the “Remove” button.SECTION D: LABEL (MOCKUP) FOR IMMEDIATE CONTAINER, OUTERCARTON AND PROPOSED PACKAGE INSERTThis section is subjected to requirements as stated in Appendix 9: LabellingRequirements and other appendices (where applicable). Please refer theappendices for details.Please attached label (mock-up) i.e. draft of the actual product label andproposed package insert at the following sub-sections:D1. Label (Mock-up) for Immediate ContainerD2. Label (Mock-up) for Outer Carton (Unit Carton)D3. Proposed Package InsertSECTION E/ SECTION F: SUPPLEMENTARY DOCUMENTATION (ANDPARTICULARS OF PRODUCT OWNER, MANUFACTURER, IMPORTER ANDOTHER MANUFACTURER)a) Product OwnerPlease select one of the following for status of product owner:- Manufacturer or- Product registration holder or- Product registration holder & manufacturer or- Others (If the product owner is neither of the above status) – Please entername and address of the product owner.National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 451
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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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