Rationale for the combination
|
Not usually
|
Not usually
| ✓ | ✓ | ✓ |
Balancing advantages and disadvantages of the combination
|
Not usually
|
Not usually
| ✓ | ✓ | ✓ |
Marketing status in other countries
| ✓ | ✓ | ✓ | ✓ | ✓ |
Analysis of literature data in the submission
|
Possibly for pharmaceutical development
|
Possibly for pharmaceutical development
| ✓ | ✓ | ✓ |
Pharmaceutical development studies
| ✓ | ✓ | ✓ | ✓ | ✓ |
Good Manufacturing Practice (GMP) certification of sites of manufacture
| ✓ | ✓ | ✓ | ✓ | ✓ |
A full quality data set
| ✓ | ✓ | ✓ | ✓ | ✓ |
Bioavailability data
|
Not usually
|
Not usually
|
Sometimes
| ✓ | ✓ |
Bioequivalence data
| ✓ | ✓ |
Sometimes
|
Sometimes
| ✓ |
Preclinical pharmacology and safety
|
Not usually
|
Not usually
|
Sometimes
| ✓ | ✓ |
Clinical safety and efficacy
|
Not usually
|
Not usually
| ✓ | ✓ | ✓ |
Product information
| ✓ | ✓ | ✓ | ✓ | ✓ |
Plan for passive post marketing surveillance
| ✓ | ✓ | ✓ | ✓ | ✓ |
Plan for active post marketing surveillance
|
Not usually
|
Not usually
| ✓ | ✓ | ✓ |
Assurances
| ✓ | ✓ | ✓ | ✓ | ✓ |