Field

Description

Local Approval Data

Country (B.4.k.4.2/G.k.3.2)

The country that approved the product.

Local Tradename

The local tradename of the product. The name under which a business firm operates.

Or

The name appears in the Local tradename, Approval type and Approval no. fields.

When you Enter the Product description and tab out all the applicable indication screen displays the indication record

Approval Type

The approval type for the product.

Regulatory authorities approve the product at various stages of drug development to product release in the market.

Approval No. (B.4.k.4.1/ G.k.3.1/G.k.CN.4)

The authorization number provided to the country by the regulatory authority to have approved for the study or the post marketing depending on what stage of approval is the product in.

For example: When the study is approved the regulatory authority approves for the IND application and provides the approval with the number called approval no. Similarly for the NDA for Post Marketing.

Approval no. (Chinese) (G.k.CN.4)

The Chinese authorization number provided to the country by the regulatory authority to have approved for the study or the post marketing depending on what stage of approval the product is in.

Submission Type

The type of approval submission in a particular country.

Product Type

To indicate the product type, select one of the options:

• Drug

• Vaccine

• Device

• Combination

Marketing Authorization Holder (B.4.k.4.3/ G.k.3.3)

Enter the company unit that has the authorization to use this Approval number.

Or

The unit code and name appear in the corresponding fields.

MAH received via Import

This is a read-only field that displays the imported MAH (B.4.k.4.3) data, which does not match the Company unit available in the Lookup. This data is imported into ARISg while importing a case from ESM.

If the imported MAH (B.4.k.4.3) matches  the existing Company Unit, then the MAH code is displayed in the Marketing authorization holder (B.4.k.4.3) field.

When the imported MAH (B.4.k.4.3) does not match the available Company units, then choose the correct MAH value from the Marketing authorization holder (B.4.k.4.3) field using the lookup. If you do not select any value from the lookup, then the application distributes the case with blank value in the Marketing authorization holder (B.4.k.4.3) field.

This field value is considered when printing the AER Data report.

Identification No. Of Notifiedbody

The Identification number assigned to the device by the authority.

Class Of Device

The class to which the device belongs.

There are 3 FDA regulatory classifications of medical devices: Class I, Class II and Class III. The classifications are assigned by the risk the medical device presents to the patient.

Role Of Authority

Indicates whether the Authority is acting as a Reference Member State or Rapporteur.

The values specified in this field are copied to the case when the product is selected from the CPD lookup.

Package Information

Information on the delivery of the medical product supplied by the manufacturer or distributor.

The package information, Medicinal product Id and MedID operation date  gets displayed, when you select local tradename from the CPD lookup.

Medicinal Product ID (G.k.2.1.KR.1b/ /D.10.8.r.2b/G.k.2.1.1b/G.k.2.1.KR.1b)

The medicinal product identifier of the product to support E2B R3.

An identifier (ID) assigned to a medicinal product by the regulator of the country or territory of authorization.

While entering the product approval details in CPD (Company Product dictionary), the Medicinal Product ID and Medicinal operation date are specified. When the Product is selected from the application using Company Product look up, the medicinal product identifier is auto populated.

MedID Operation Date

The operation date of the medicinal product identifier (MedID).

Scientific name

The scientific or common (generic) name of the medicinal product without any other descriptors.

Invented name

The invented name (trade name) of the medicinal product without the trademark or any other similar designations reflected in the Medicinal Product Name.

Strength name

The strength reflected in the Medicinal Product Name.

For example, in the Medicinal Product Name “SoothingMed 2.5 % Cream”, the strength name part is “2.5 %”.

Form name

The form name in the Medicinal Product Name.

Trademark name

The trademark name reflected in the Medicinal Product Name.

Intented use name

The intended use reflected in the Medicinal Product Name.

Device name

The device reflected in the Medicinal Product Name.

Container name

The container reflected in the Medicinal Product Name.

Lot No. Information

Batch/Lot No.G.k.4.r.7

The Batch/Lot number (identification number assigned to a particular quantity or lot of material from a single manufacturer) of the product that caused the adverse event.

Expiry Date Text

Additional information on the expiry date for the product that caused the adverse event.