EMA updates Procedural Guidance for Application Preparation

The EMA has updated the guidance document “European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure”. The document continues to provide applicants and marketing authorisation holders with a structured collection of procedural questions and answers relating to the centralised procedure. The document comprises 150 pages in total and is divided into the following chapters:

1. Types of applications and applicants

2. Steps prior to submitting an application

3. Preparing the dossier

4. Submission, validation and fees

5. Assessment of the application

6. Data exclusivity, marketing protection and market exclusivity

For each question, the revision date of the corresponding answer is provided. For a better overview, the questions and answers in the document are also presented in an index on the EMA website. The questions in the various chapters can be expanded individually.

What has changed?

The most important change concerns the use of the IRIS platform. In future, it will serve as the central electronic submission route for various activities during the preparatory phase of a marketing authorisation application. In this context, several procedural descriptions have been revised, and previous references to submissions via the EMA Service Desk have been removed.

The following questions have been revised:

Question 1.7: “What is an application for a paediatric use marketing authorisation (PUMA)?”

Question 2.1: “Is my medicinal product eligible for evaluation under the centralised procedure?”

Question 2.2: “How and when should the eligibility request be sent to EMA?”

Question 2.4: “What is the procedure for appointment of Rapporteurs/Co Rapporteurs and their assessment teams?”

Question 2.7: “How should I notify a change in the contact person and/or intended submission date of my application?”

Question 2.8: “Is my product eligible for an accelerated assessment?”

Question 2.9: “How are marketing authorisation application pre-submission interactions structured at the EMA?”

Question 2.10: “How should I notify the Agency if I no longer wish to pursue my application?”

The specific changes to the individual questions are described in the EMA document with tracked changes available on the Agency’s website