Switzerland_(Swissmedic)

For the region of Switzerland, the second page of the Application Wizard contains the following fields.

Application Number: Number assigned to the application by Swissmedic. Must be 9 digits without leading zeros. If unknown, enter pending (case sensitive).

Application Folder: Name for the folder where the application will be saved.

Product Information: Enter at least two product names.

Each Product Name must have an associated Product Type.

At least one product of the type Invented Name must be provided.

At least one product of the type International Non-Proprietary Name should be provided.

Name: Dosage form in English. EU standard terms are strongly recommended. Lower case letters are preferred per regional standards.

Galenic Name: German, French, or Italian term of the dosage form. EU standard terms are strongly recommended.

Language: Select from the language list provided in a dropdown.

Marketing Authorization Number: The number assigned to the product identifying the product and its galenic form.

This is a 5-digit-number and is only assigned once a positive preliminary notice is issued.

If unknown, enter pending (case sensitive).

The third page of the Application Wizard contains the following fields.

Applicant: The name of your company.

This should always remain constant, both within an application and across applications, unless there is a legitimate name change.

After you create your first application, existing value(s) will be presented in the dropdown list for you to choose from.

Sequence Number: Unique four-digit number, generally the next number in the sequence (0000 is typically used for the first sequence).

Sequence Type: Choose from the region-specific list provided.

Regulatory Activity In: Allows you to assign an application and regulatory activity to the submission you are creating.

Description: Description of the sequence’s contents such as New Active Substance or Renewal of a Marketing Authorization.

DMF Holder: The name of the company submitting the DMF. Enter n/a (case sensitive) if the submission is not a DMF.

DMF: The number assigned to the DMF (alphanumeric).

Enter pending (case sensitive) if the assigned DMF number is not known.

Enter n/a (case sensitive) if the submission is not a DMF.

PMF Holder: The name of the company submitting the PMF. Enter n/a (case sensitive) if the submission is not a PMF.

PMF: The number assigned to the PMF.

Enter pending (case sensitive) if the assigned PMF number is not known.

Enter n/a (case sensitive) if the submission is not a PMF.

Article 13 TPA: Check if compliant.