Coding a Product Indication to Use MedDRA Terms

You can code the indication for a product to use MedDRA terms.

Required access role: Regulatory Lead

Before you begin: View the Indications page for the required product.
  1. On the page toolbar, click Enable Edit.

    If you need to create the indication, see Indications Page: Creating Indications.

  2. Select the indication you want to code.
  3. From the Actions menu or toolbar, select Indication Coding.

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

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

    Market Registration adds the classification to the indication.

The app closes the window and shows the Regulatory category for the product.

To view the indication coding:

  1. Click the Indications category.
  2. Click the name of the indication.
  3. Click the MedDRA Classifications category.
Note: When you code the indication for a product using an MedDRA term then add that product to a submission, the app creates a copy of the indication (including the MedDRA classification) and attaches it to the to the submission and the submission master record. If you later add codes to the product, those codes are not copied to the submission or submission master record.