Data to be recorded may include any or all of the following elements; some of these data are applicable only to domestic companies.
Data Describing Companies and Institutions
Code |
Activity (e.g., manufacturer, |
Authorization to handle |
Full name (e.g., Pharmachem |
|
importer, retail pharmacy, |
|
psychotropic and narcotic |
| |
Laboratories of Karibland, |
|
QC laboratory, etc.) |
|
drugs |
| |
Ltd.) |
Status (e.g., currently active, |
Reports of previous |
Short name (e.g., Pharmachem) |
|
cancelled, operational |
|
inspections |
Mailing address |
|
licence expired, etc.) |
Planned inspections |
Plant address |
Date of validity of status |
Various types of |
Phone and fax |
Responsible pharmacist |
|
authorization |
E-mail |
Property/functional relations |
|
numbers |
Contact person |
|
with other companies |
|
Data Describing the Item for which the Application Is Submitted
Application number |
Limitations of distribution/use |
Official product information |
Date of reception |
Origin |
|
sheet (indications, |
Applicant name |
Human/veterinary |
|
contraindications, etc.) |
Representative of the applicant |
Linkage code with social |
Internal evaluation sheet |
| |
(or other company related in |
|
security or other system |
|
(information not to be |
| |
some way to the application) |
Physical location of the |
|
published, assessment |
Drug product name/trademark |
|
application files |
|
reports) |
Type of product |
Shelf life and storage |
Prices |
| |
(brand/generic) |
|
conditions |
Distributors/importers |
Product generic name |
Manufacturers involved in the |
Veterinary information |
Dosage strength |
|
different phases of production |
General description of the |
Dosage form |
|
and their roles and |
|
appearance of the drug item |
Primary container and its |
|
responsible persons |
Analytical information |
| |
specifications |
Active and inactive ingredients |
Regulatory status in other |
Presentation(s) |
|
and their quantities and |
|
countries |
Type of MA requested/issued |
|
functions, using INNs when |
|
Dispensing category |
|
available |
|
Narcotic/psychotropic |
Therapeutic classification |
|
Routes of administration |
|
|
Data Describing Status
• Decisions made at the different steps of the assessment process, indicating dates at which each step starts/ends, and responsible person
• Date and type of final decision
• Date and cause of rejection of applications or cancellation of marketing authorization
• Date of issuance of marketing authorization and renewal of marketing authorization
• Date on which marketing started, was suspended, was resumed
• Post-marketing information on adverse drug reactions (ADR), stability, other, and date on which each of these was valid
Data Describing Variations
• Data before and after variation, date of variation, person who authorized the variation