Application Code Guidelines

As the application codes differ for various countries, the guidelines will help you while entering application code or number values in Ennov InSight.

When publishing with Ennov InSight , the following should be considered:

• For US applications, the application code is always a 6-digit number.
• For Canadian applications, the application is generally an 'e' followed by a 6-digit number (for example, e123456).
• For Japan the application code is generally 'ectd-' followed by a 6-digit number (for example, ectd-123456). This is the default value that appears in the Submission Number property when you use the Create eCTD wizard. The value must be numeric.
• For the EU, applications numbers are generally not available until you have filed and numbers may vary by country. It is best to enter with an application number that is unique and meaningful according to the specification. Samples may include a country abbreviation or an internal drug code abbreviation or number, for example: uk-h-323-001.
• The Application Code value must be populated with valid characters for it to be automatically and correctly formatted in the top level directory of an eCTD. You can update the Application number in the Regional XML within the assembly structure on the regional information folder.