Get the free MAA Pre-submission meeting request form

13 October 2020 EMA/571057/2010Marketing Authorization Application (MAY) Presubmission meeting request from This presubmission meeting request form provides an overview of the most relevant topics

How to fill out maa pre-submission meeting request

How to fill out maa pre-submission meeting request

1. Visit the official website of the regulatory authority where you plan to submit the MAA (Marketing Authorization Application) for your product.
2. Look for the section dedicated to pre-submission meetings and locate the request form for a MAA pre-submission meeting.
3. Fill out the form with details such as your contact information, product name, proposed indication, proposed submission date, and any specific topics or questions you would like to discuss during the meeting.
4. Submit the completed form through the specified method (online submission, email, etc.) as per the instructions provided on the website.
5. Await confirmation from the regulatory authority regarding the scheduled date and time for the pre-submission meeting.

Who needs maa pre-submission meeting request?

1. Companies or individuals planning to submit a Marketing Authorization Application (MAA) for a new medicinal product or a significant change to an existing product may need a pre-submission meeting request.

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What is maa pre-submission meeting request?

The maa pre-submission meeting request is a formal request made by an applicant to meet with the regulatory authority before submitting a Marketing Authorization Application (MAA). This meeting allows the applicant to discuss their proposal, seek feedback, and address any concerns in order to improve the quality of the submission.

Who is required to file maa pre-submission meeting request?

Any applicant planning to submit a Marketing Authorization Application (MAA) is required to file a pre-submission meeting request with the regulatory authority.

How to fill out maa pre-submission meeting request?

The maa pre-submission meeting request form can usually be found on the regulatory authority's website. The applicant must complete the form providing details about the proposed product, objectives of the meeting, and proposed dates for the meeting.

What is the purpose of maa pre-submission meeting request?

The purpose of the maa pre-submission meeting request is to facilitate open communication between the applicant and the regulatory authority, allowing for clarification of requirements, discussion of potential issues, and alignment on submission expectations.

What information must be reported on maa pre-submission meeting request?

The maa pre-submission meeting request typically requires information such as the applicant's name and contact details, proposed product details, meeting objectives, proposed meeting dates, and any specific topics for discussion.