6.3.2 Registration of Combination Pack (Combo Pack)
          6.3.3 Registration of For Export Only (FEO) Product
          6.3.4 Designation and Registration of Orphan Medicines (Appendix 13)
          6.3.5 Variants
          6.3.6 Multiple Applications
          6.3.7 Second or Third Source
    6.4 Evaluation routes (Appendix 14)

7. Regulatory Requirements

    7.1 Requirements for Full Evaluation and Abridged Evaluation    (Appendix 15)         
    7.2 Bioequivalence (BE) Requirements (Appendix 16)         
    7.3 Product Name  (Appendix 17)
    7.4 Ingredients (Appendix 18)        
    7.5 Indications         
    7.6 Labelling Requirements (Appendix 19, 19A, 20)
    7.7 Special Conditions for Registration of a Particular Product or Group of Products  (Appendix 21)
    7.8 Educational Materials (Appendix 22)    
    7.9 Packaging           
          7.9.1      Shrink wrapping              
          7.9.2      Starter Pack/ Patient Initiation Pack/ Dose Adjustment Pack         
          7.9.3      Patient Dispensing Pack (Appendix 23)

    7.10 Proposed Package Insert             
    7.11 Consumer Medication Information Leaflet (RiMUP)         
    7.12 Product Authentication
    7.13 Language             
    7.14 Halal Logo            
    7.15 Directives           

8. SUBMISSION OF APPLICATION

9. SCREENING OF APPLICATION
    9.1 Satisfactory       
    9.2 Non-Satisfactory             

10. EVALUATION OF APPLICATION
      10.1 Initiation of Review        
      10.2 Correspondence             
      10.3 Evaluation Timeline for Product Registration       

11. REGULATORY OUTCOME
      11.1 Decisions of the Authority           
      11.2 Product Registration Number     
      11.3 Certificate of Registration            
      11.4 Appeal Towards Decision of the Authority (Appendix 24)