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Este manual destina-se a orientar os requerentes sobre como preencher o formulário de candidatura eletrónico para a autorização de comercialização.
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How to fill out electronic pre-submission of maa
How to fill out ELECTRONIC PRE-SUBMISSION OF MAA INSTRUCTIONS MANUAL
01
Begin by accessing the ELECTRONIC PRE-SUBMISSION OF MAA INSTRUCTIONS MANUAL document.
02
Read the introduction to understand the purpose and importance of the manual.
03
Follow the step-by-step guidelines provided for filling out each section of the submission form.
04
Ensure that all required fields are completed accurately and comprehensively.
05
Attach any necessary supporting documents as specified in the instructions.
06
Review the entire submission for completeness and correctness before finalizing.
07
Submit the completed form electronically as outlined in the submission instructions.
Who needs ELECTRONIC PRE-SUBMISSION OF MAA INSTRUCTIONS MANUAL?
01
Pharmaceutical companies preparing for regulatory submissions of marketing authorization applications.
02
Regulatory affairs professionals involved in the submission process.
03
Research and development teams requiring guidance on compliance with submission protocols.
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People Also Ask about
How long is the EMA approval process?
Typically, the EMA review process takes about 210 days, but this does not include the time the company may need to respond to questions or provide additional information.
How long does it take to get a marketing authorisation?
The assessment of a marketing authorisation application for a new medicine takes up to 210 'active' days. This active evaluation time is the time spent by EMA experts to evaluate the evidence provided by the applicant in support of a marketing authorisation application.
How to submit an EMA?
You should read the booklet carefully. 2.1. 1 There are two methods of submitting EMAs: Online and paper-based submission. The Help Centre gives further information about Submitting an End-of-Module Assessment (EMA) to help you prepare and submit your online submission or paper submission.
How long is the EMA clock stop?
The first clock-stop usually lasts three months and the second clock-stop one month. Overall, the assessment of a new medicine usually lasts around a year.
How and when should the eligibility request be sent to the EMA?
The eligibility request should be submitted 18 to 7 months before the planned MAA submission date and submitted to EMA 10 calendar days before the planned and published CHMP meeting date. Decision of eligibility is received in the week following CHMP meeting where the discussion took place.
What is a MAA filing?
Marketing Authorisation Application (MAA) is an application submitted by a drug manufacturer seeking marketing authorisation, that is permission to bring a medicinal product (for example, a new medicine or generic medicine) to the market.
What are the dates for submission of invented name requests?
Additional detail on the EMA procedure for checking proposed invented names is also provided. A name review request should be submitted once CHMP has confirmed the product is eligible for evaluation under the Centralised Procedure (this can happen 18 to 7 months prior to planned MAA submission date).
How to submit an EMA?
You should read the booklet carefully. 2.1. 1 There are two methods of submitting EMAs: Online and paper-based submission. The Help Centre gives further information about Submitting an End-of-Module Assessment (EMA) to help you prepare and submit your online submission or paper submission.
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What is ELECTRONIC PRE-SUBMISSION OF MAA INSTRUCTIONS MANUAL?
The ELECTRONIC PRE-SUBMISSION OF MAA INSTRUCTIONS MANUAL is a guideline document that outlines the process and requirements for submitting applications for marketing authorization electronically in a structured format.
Who is required to file ELECTRONIC PRE-SUBMISSION OF MAA INSTRUCTIONS MANUAL?
Companies and organizations that seek to obtain marketing authorization for new medicinal products are required to file the ELECTRONIC PRE-SUBMISSION OF MAA INSTRUCTIONS MANUAL as part of their application process.
How to fill out ELECTRONIC PRE-SUBMISSION OF MAA INSTRUCTIONS MANUAL?
To fill out the ELECTRONIC PRE-SUBMISSION OF MAA INSTRUCTIONS MANUAL, applicants must follow the specific guidelines provided in the manual, including completing all necessary sections accurately and ensuring that all required documentation is attached.
What is the purpose of ELECTRONIC PRE-SUBMISSION OF MAA INSTRUCTIONS MANUAL?
The purpose of the ELECTRONIC PRE-SUBMISSION OF MAA INSTRUCTIONS MANUAL is to standardize and streamline the submission process for marketing authorization applications, ultimately facilitating faster and more efficient review by regulatory authorities.
What information must be reported on ELECTRONIC PRE-SUBMISSION OF MAA INSTRUCTIONS MANUAL?
The information that must be reported includes details about the product, applicant information, data on product safety and efficacy, manufacturing processes, labeling, and other relevant documentation required for a complete application.
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