Module 1.0 - Correspondence

Use this section to include:

• Your application cover letter.
• Your responses to our requests we make for information during the screening/evaluation of your application.
• Any other correspondence you may have received from us before submitting your application. For example, an email from us about:
  • data requirements for a new registration application
  • using a particular code and application level for a change application.

Module 1.0.1 Cover letter (letter of application)

Follow the guidance on Preparing an OTC application cover letter.

Include the cover letter in Module 1.0.1 for all applications. Notification requests do not require a cover letter.

The cover letter must:

• be on a company letterhead
• be signed by a person authorised to conduct business on behalf of the applicant. The person must be listed on our client database and may be a company employee or an agent
• include the necessary information for a cover letter.

Module 1.0.3 Responses to request for information

Only use this section to include your responses to requests for information that we may send during screening or the evaluation of your application.

You will not need to include a document in this section when you first submit your dossier.

Preparing your response to a request for information

Prepare a letter or an email that includes:

• the submission ID
• the medicine name, active ingredient details and dosage form of the medicine
• a comprehensive response to each question in our request.

Referencing CTD documents

When you reference CTD documents in your response, make sure you include detailed references to the CTD module, the tab identifier and the page number. For example, 'See Module 3, 3.2.P.4.3 Method validation, p 23'.

Include the submission ID if you are referencing CTD documents submitted as part of a previous application.

Including new documents that belong elsewhere in the CTD

Include the document as an attachment to the letter or email or, if an eCTD submission, in the appropriate part of the CTD i.e. elsewhere in Module 1 or in Modules 2-5.

Include a reference to the location with the answer to the question in Module 1.0.3

For example: if the answer requires a revised version of the Finished Product Specification:

• include any comments with the answer in Module 1.0.3, making reference to the location of the document in the CTD format (i.e. module 3.2.P.5.1)
• include a new version of the Finished Product Specification as an attachment to the correspondence. If an eCTD submission, include a new version of the specification in Module 3.2.P.5.1.