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.


Attribute	Product Family Type	Description
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	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
Veterinary Product Family Type, this field is Product Family Indications/ Intended Use)		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.