Field Descriptions

The following table lists the Field Descriptions for the License configuration section.

Field/Control Name	Description
Trade Name	Enables you to enter the Trade Name under which this product(s) is (are) authorized by this license.
Trade Name J	Enables you to enter the Japanese trade name under which. the product is authorized by this license.
Award Date	Enables you to enter the license award date for this license.
Withdrawn Date	Enables you to enter the license withdrawal date for this license. The withdrawn date cannot be less than the award date.
Market Authorization Holder	Enables you to select a manufacturer or co-marketing partner for this license of the product.
PMDA Re-examination Date	The date of the next PMDA examination.
Biologic / Vaccine	Whether the license is for a Biologic/Vaccine (this can impact the MedWatch report output). If this is option is checked MedWatch will print PLA# not NDA# in section G5. It is included to support the Biologic License Application (BLA) and the Product License Application (PLA) requirements.
Not in Tradename lookup / Not Auto-scheduled	An option to indicate that this license name should not appear in the filter criteria for Auto Scheduling of Reports or trade name lookup browser. When this checkbox is checked, the trade name will not appear for this license in the Trade Name Lookup dialog and this license will not be evaluated or allowed for auto scheduling of the reports, but will be available for manual scheduling of reports. The license will be displayed in event assessment.
Labeled for Single Use	Whether the drug is for single use (such as disposables). If this option is selected it will mark YES in section H5 of the MedWatch device form, otherwise it will mark NO.
OTC Product	This enables you to specify if the Product has been bought as an Over-the-Counter Product.
Pre-1938	For non-company products, enter the data. For company products, this field is updated based on the data available in the license configuration and is ready-only. For study products, this field is fetched based on the primary license number selected in the Console > Studies Configuration. When unblinded at case level, data is enabled irrespective of the product selected in the Study Drug drop-down. Note: The Pre-1938 field available under the Case Form > Analysis > MedWatch tab will not be used in eMDR.
Biosimilar	For non-company products, enter the data. For company products, this field is updated based on the data available in the license configuration and is ready-only. For study products, this field is fetched based on the primary license number selected in the Console > Studies Configuration. When unblinded at case level, data is enabled irrespective of the product selected in the Study Drug drop-down.
Datasheet URL	User can enter a hyperlink to a site giving information about the datasheet of the product.
Authorization Country	This enables you to select the Country for which this license applies. The chosen country does not impact the reporting rules algorithm. This field maps to the Country field in the Reporting rules configuration.
License Type	you can select one of the possible six types: Investigational Drug/Device/Vaccine or Marketed Drug/Device/Vaccine The chosen license type maps to the License type field under each country on the Reporting rules configuration.
Datasheet Name	The datasheet drop-down enables you to associate a datasheet with the License. The field lists the datasheets for all the product families of the added products. The Data Sheet drop-down is enabled when one or more products have been added to the Products list.
Application Type	Enables you to license application type such as IND, NDA, STN etc.
License #	Enables you to enter the License Number of the Trade name.
Company Item Number	Enables you to enter the Company Item number corresponding to the license.
Trade Name J	Enables you to enter the Japanese trade name.
Clinical Compound Number	The number that identifies the specific chemical compound. You can edit this field when the Authorization Country is Japan and the license type is either Investigational Drug or Investigational Vaccine. The Clinical Compound field is only available to users to Oracle Argus Safety Japan.
Product Name (J)	The Product List box displays the list of products (product name, dosage form and strength) that this associated license covers for regulatory reporting purposes.
Product Name	The Product List box displays the list of products (product name, dosage form and strength) that this associated license covers for regulatory reporting purposes.
Hide	When a product is marked as non display, it will not appear in the Trade Name Product lookup dialogue associated with the license tradename.
Countries List	Enables you to select all the countries in which the same license was issued. The system adds the authorization country to the Countries Lise and updates the list when you updates the authorization country.
TIKEN	Selecting the TIKEN checkbox indicates that the customer will not send the investigational report for the other license.
Status Category of New Drugs	The Status Category of New Drugs field captures the Status category of new drugs. This information is transmitted in the J.2.4k element of PMDA E2B R3.
Risk Category of OTC Dugs	The Risk Category of OTC Dugs field captures the risk category of OTC drugs. This information is transmitted to the J.2.5k element of PMDA E2B R3.
Medical Device Terminology	This drop-down field was introduced under the new section header Device Information with the following options: EMDN, GIVD/EDMS, GMDN, Other, UMDNS(ECRI).
Medical Device Terminology-Other	This field becomes enabled only if the Device Terminology field has the Other value selected.
Conformity/ Market Availability	This field contains the details of the Conformity of the device product or Market availability of the device product: First declaration of conformity, Device first CE marked, First placed on the market, First put into service, Software, First Available.
Date of Conformity/ Market Availability	This field provides the Date of Conformity or Market Availability of the Device product.
PMA/510(k)#	This field is associated with medical device information and prints in expedited reports.
Basic UDI-DI	This field contains Basic UDI-DI of the device product.
Nomenclature Code	This field is associated with medical device information and prints in expedited reports.
Nomenclature text	This field contains the Nomenclature text or the Device description of the Device Product.
Medical Device Information	This field contains the details of Medical Device Information based on the Risk Class of the Device.
CE Marked	CE marking is a mandatory conformity marking for certain products sold within the European Economic Area (EEA). For a Marketed or Investigational Device, this field can be set to Yes or No. For all other license types, this field is disabled.
CTPR Group Name	This value is used in Argus Safety when filter periodic report data.
Comments	Enables you to enter information about the element configuration.
Device Company Identification#	Enables you to capture information about the Device Company Identification number.
Device Identification#	Enables you to capture information about the Device Identification number.
Risk Class Type	This field contains the Risk Class Type of the Device Product based on the Medical Device Information.
Notified Body ID number (1)	This field captures the Notified Body ID number associated with the conformity of the Device product.
Notified Body ID number (2)	This field captures the Notified Body ID number associated with the conformity of the Device product.
Certificate Number of the Notified Body (1)	This field captures the Certificate Number of the Notified Body associated with the conformity of the Device product.
Certificate Number of the Notified Body (2)	This field captures the Certificate Number of the Notified Body associated with the conformity of the Device product.