Product Family Attributes
The available attributes for a product family depend on the product family type.
You see only the attributes available for the product family type.
Key for Product Family Type:
- FV = flu vaccine
- P = pharmaceutical
- MD = medical device
- PMD = pharmaceutical-medical device
- V = veterinary
- All = all product family types
| Attribute | Product Family Type | Description |
|---|---|---|
| Active Ingredients | FV, P, PMD, V | Active ingredients to associate with the product family by Substance Selection list. If defined in data administration for the active ingredient entity, the compound number is the active ingredient name. |
| Approved Trade Names | FV, P, V, PMD | Trade names that are approved in a PDS for the product family. By default, the field is hidden. |
| Associated Trade Names | FV, P, V, PMD | Trade names that are associated, but not approved for the product family. |
| ATC (Available/Selected) | FV, P, PMD, V | Anatomical therapeutic chemical class code in which the product family is categorized. |
| Development Sponsor | FV, P, PMD, V | Sponsor of the clinical trials. By default, the field is hidden. |
| Division | MD, PMD | Division of the Office of Device Evaluation (ODE) Review Divisions with which the product family is associated. By default, the field is hidden. |
| EURD ID | FV, P, PMD, V | When the medicinal product is part of a PSUR single assessment procedure in accordance with the European Union reference date dates and frequency of submission of periodic safety reports list (EURD list), the EURD ID shall be provided. The EURD ID shall be derived from the procedure number of the PSUR single assessment, which is published in the EURD list Excel file available on the 'Periodic safety update reports' webpage. |
| Family Code | All | Company-specific code for the product family. |
| Family Name | All | Standard name recognized internally and across countries. |
| International Birth Date | All | For a pharmaceutical product family, the date an approval was first given. For a medical device product family, the date the product family was first launched. By default, the field is hidden. |
| Product Family Add Comment | All | Comments you want to share with others in a discussion thread, stamped with the date and time you enter the information and your user ID. |
| Product Family Comments | All | Discussion thread that includes all comments entered by users, including the date and time the comments were entered and the user ID of the person who entered them. |
| Product Family Concerned Parties | All | Users who may be copied on notifications about this entity. Use semi-colons (;) to separate e-mail addresses; click the Search Person icon to choose from available users. |
| Product Family Comorbidity(s) | FV, P, MD, PMD | Any comorbidity (concurrent condition) or co-infection described as part of the indication as it is referenced in the regulated product information. |
| Product Family Description | All | Text that describes the product family. |
| Product Family Indication(s) (For Veterinary Product Family Type, this field is Product Family Indications/Intended Use) | All | List of all possible indications/intended use for the product family.
When modifying a product family, you cannot disassociate indications/intended use values from the product family if those values are associated with a CTA application. You must first disassociate the indications/intended use values from the CTA before you can disassociate them from the product family. Value is presented in concatenation of Indications/Intended Use, MedDRA Level and MedDRA Version fields. |
| Product Family Keywords | All | Words you can use to search for the product family. |
| Product Family Status | All | Status of the product family. By default, the field is hidden. |
| Product Family Status Date | All | Date the product family status is effective. By default, the field is hidden. |
| Product Family Type | All | Type of products associated with this product family (for example, pharmaceutical, medical device). |
| PSUR Data Lock Date | FV, P, PMD, V | Date up to which information is to be compiled for the PSUR. By default, the field is hidden. |
| Generic Name | FV, P, PMD, V | Generic name given to a product family. By default, the field is hidden. |
| PSUR Due Date | FV, P, PMD, V | When the periodic safety update report is due. By default, the field is hidden. |
| Reason | All | Reason for creating, modifying or deleting a product family. |
| Reason for Comments | All | Comments related to reason entered by users. |
| Show in Tree | All | To show or hide product families in the tree on the home page. |
| Therapeutic Area | FV, P, PMD, V | Therapeutic area with which the product family is associated. By default, the field is hidden. |
| Therapeutic Classes (Available/Selected) | FV, P, PMD, V | Therapeutic classes in which the product family is categorized. By default, the field is hidden. |
| User ID | User name to validate user identity. | |
| Password | User password to validate user identity. |