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European medicines agency pre authorisation procedural advice for users of the centralised procedure

2007-2025

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The document provides comprehensive procedural advice from the European Medicines Agency (EMA) regarding the pre-authorisation process for medicinal products under the centralised procedure. It outlines key aspects such as the importance of pre-submission meetings, eligibility criteria for applications, requirements for various types of applications (including orphan and paediatric), and detailed guidelines on documentation, including product information, risk management plans, and compliance with Good Manufacturing Practice (GMP). The document emphasizes the need for regular updates to guidance based on new legislation and ongoing developments in the pharmaceutical sector.

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What is the difference between the FDA and the EMA guidelines?

The FDA is responsible for regulating a wide range of products for human and animal use in the US, including medicines, medical devices, tobacco products, cosmetics and most foods. In contrast, the EMA governs only human and veterinary medicines and participates in the process of medical devices evaluation.

How and when should the eligibility request be sent to the EMA?

Eligibility request and letter of intent to submit an MAA You must use the EMA Pre-submission request form, which also provides an overview of the type of MAA the EMA should expect to receive from you. You can submit your eligibility request up to 18 months and at least 7 months before you plan to submit your MAA.

What is the EMA centralised procedure?

Centralised authorisation procedure This allows the marketing-authorisation holder to market the medicine and make it available to patients and healthcare professionals throughout the EU on the basis of a single marketing authorisation.

What is the European medicine Agency EMA responsible for?

It is responsible for the scientific evaluation, supervision and safety monitoring of medicines. EMA protects public and animal health in EU Member States, as well as the countries of the European Economic Area, by ensuring that all medicines available on the EU market are safe, effective and of high quality.

How do I submit to EMA?

Submission of the application Applicants should use the electronic common technical document (eCTD) format and submit the application through the eSubmission gateway or web client . If EMA needs additional information to complete its validation of the application, it will ask the applicant to supply this by a deadline.

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).

What are the dates for submission of eligibility requests for 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 the timeline for accelerated assessment?

The accelerated assessment is a procedural tool to reduce the centralised procedure review period of a marketing authorisation applicant from 210 to a maximum of 150 days, excluding clock stops.

European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure. General-EMA/339324/2007-2025

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