Table Of Contents (TOC) for MOZAMBIQUE

MOZAMBIQUE

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DOSSIER REQUIRMENTS

PART-I, A: SUMMARY OF THE PROCESS

1.1       ADMINISTRATIVE INFORMATION:----------------------------------------

1.1

Type of process (complete / Abbreviated)-----------------------------------------        

1.1

Proposed name of the medicine----------------------------------------------------- 

1.1

Quantitative and qualitative composition regarding active substances and  Excipientes                                                                                                

1.1

Pharmo-therapeutic classification-------------------------------------------------- 

1.1

Pharmaceutical form and dosage---------------------------------------------------

1.1

Presentation----------------------------------------------------------------------------

1.2

Validity / storage conditions---------------------------------------------------------

1.2

Classification according to the prescription method------------------------------

1.2

Name and address of applicant------------------------------------------------------

1.3

Manufacturer of the finished product-----------------------------------------------

1.3

1.2       PART-I, B: CHARACTERISTICS OF THE MEDICINE

1.2.1    SUMMARY OF THE CHARACTERISTICS OF THE MEDICINE

12.1.1  Name of the medicine-----------------------------------------        

1.4

1.2.1.2 Quantitative and qualitative composition of active substance -

1.4

Pharmaceutical form and its content terms of weight, volume or number of units-

1.4

Validity / storage conditions------------------------------------     

1.4

1.2.1.5    Therapeutical indications----------------------------------------   

1.4

1.2.1.6    Dosage and method of administration-------------------------     

1.4

1.2.1.7    Counter-indications-----------------------------------------------    

1.5

1.2.1.8    Interactions of medicines----------------------------------------     

1.5

1.2.1.9    Use in case of pregnancy or breastfeeding --------------------                 

1.6

1.2.1.10   Effects regarding abilities of driving or using machinery----

1.7

1.2.1.11              Side effects---------------------------------------------------------              

1.7

1.2.1.12              Name of medicine registration’s holder------------------------ 

  1.2.2    LABEL

Name of the medicine------------------------------------- ------      

1.8

Quantitative and qualitative composition of active substance per unit, volume or weight- Pharmaceutical form and its content terms of weight, volume or number of units---

1.9

Validity--------------------------------------------------------------

1.9

Registration number----------------------------------------------

1.9

Name of registration holder------------------------------------  

1.10

Classification according to the method of prescribing-------

1.10

Particular concerns of storage, when that is the case---------                           

1.10

The expression ‘external use’ in red print, when that is the  case         -----

1.10

PART-II , CHEMICAL AND PHARMACEUTICAL DOCUMENTATION

A-1: COMPOSITION-------------------------------------------------------------------------

2.1

A.1.1   Qualitative and quantitative composition, including components of possible   coatings, capsule, etc.-------------------------------------------------------

2.1

A.1.2   Description of primary and secondary packaging its possible interactions

with the medication and control methods used.-------------------------------------

2.2

A.1.3   Functions of components not active.----------------------------------------------   

2.32

A-2: MANUFACTURER-------------------------------------------------------------------    

2.33

A.2.1   Formula of manufacturer----------------------------------------------------------

2.33

A.2.2   Description of preparation and methods of control-----------------------------

2.37

A-3: RAW MATERIALS--------------------------------------------------------------------  

2.48

A.3.1   Chemical description of active substance and excipientes--------------------     

2.48

A.3.2    Predictable impurities, specifications and control methods--------------------   

2.51

A.3.3    Identification of the manufacturer and analytical bulletin------------------------ 

2.57

A-4: FINISHED PRODUCT-----------------------------------------------------------------    

2.165

A.4.1   Specifications of global controls------------------------------------------------------ 

2.165

A.4.2   Specifications of control over active substances-------------------------------------

2.189

A.4.3   Data regarding sterility and pyrogenics (if applicable)---------------------------   

2.261

A.4.4   Analytical bulletin of finished product-----------------------------------------------  

2.262

A-5: STABILITY OF FINISHED PRODUCT------------------------------------------------ 

2.284

A.5.1   Duration of studies---------------------------------------------------------------------

2.284

A.5.2   Conditions of studies------------------------------------------------------------------      

2.285

A.5.3   Number and depth of studied batch------------------------------------------------

2.300

A.5.4   Trials done and its limitations, including possible degrading products.--pne----

2.301

PART 111 – DOCUMENTATION ABOUT SAFTY

A-1: TOXICITY

A-1.1   Summary description of the toxicity of the medicine, including summary of studies undertaken and bibliographic references, when available. --------------------------

3.1

A-2: REPRDUCTION FUNCTION AND EMBRYO-FOETUS PERENTAL TOXICITY

A-2.1   Summary description of the effects of the medicine on the reproduction function, embryofoetus and prenatral toxicity, including as summary of the studies undertaken and bibliographic references, when applicable------------------------------------

3.4

A-3: MUTAGENIC AND CARCINOGENIC POTENTIAL

A-3.1   Summary description of existing data regarding the potential mutagenic and carcinogenic effects, including  a summary of the studies undertaken and bibliographic references, when applicable.------

3.6

A-4: PHARMACODYNAMIC AND PHARMACOCINETIC

A-4.1   Summary description of the action mechanisms and pharmacodynamic of the medicine, including a summary of the studies undertaken and bibliographic references,

when applicable                                                                                                                         

3.9

A-5: OTHER INFORMATION ABOUT SAFETY --------------------------------------

3.11

PART 1V – DOCUMENTATION REGARDING EFFECTIVENESS

A-1: CLINICAL PHARMACOLOGY

Summary description of therapeutic action mechanisms and pharmacocynetics of medicine including a summary of the studies undertaken and bibliographic references, when available

A-2: CLINICAL EXPERIENCE

4.1

Summary description of clinical trails of the undertaken, as well as the data regarding the pharmacovigilence available, including a summary of the studies undertaken and bibliographic references, when applicable  ---                                                                                                  

4.4