Assigning a MedDRA Classification to an Indication

You can associate a MedDRA classification with an indication.

Required access role: Regulatory Lead

Before you begin: View the Properties page for the required indication. You can search for the indication, or access it from the Indication category for a product or submission.
Note: You can also directly code an indication for a product with the MedDRA term. See Coding a Product Indication to Use MedDRA Terms.
  1. In the category button bar, click MedDRA Classification.
    This page lists all the columns that define a preferred term, plus the version number of the dictionary in which it is included.
  2. Click Add Classification.

    The search page that opens includes the same filter toolbar and columns as the MedDRA Classification page (see MedDRA Classification Detail View or MedDRA Classification Structure View). No dictionary entries show in the list until you apply filter criteria.

  3. Enter filter criteria for any dictionary level names. After entering criteria, click Filter. Depending on your screen resolution, you might need to click > > Filter.
  4. Select the required dictionary terms. You can select multiple items.
  5. Click Submit.

    Market Registration adds the classification to the indication. If needed, you can click Remove Classification to remove any selected classifications from the list.

When you add an indication and its MedDRA term to a product, the app copies the indication to the submission managing that product, and from the submission to the submission master record. If you add the indication to the submission, the app does not copy that indication to a product because the submission could cover multiple products.