EMA post-authorisation procedural advice for users of the centralised procedure

May 24, 2022

Person typing on a laptop with icons floating in the air.

This guidance document addresses a number of questions which marketing authorisation holders (MAHs) may have on post-authorisation procedures. It provides an overview of the Agency’s position on issues, which are typically addressed in discussions or meetings with MAHs in the post-authorisation phase. It will be updated regularly to reflect new developments, to include guidance on further postauthorisation procedures and to reflect the implementation of the new European legislation.

Revised topics will be marked by “New” or “Rev” upon publication. The Agency emphasises the importance of pre-submission meetings between MAHs and the EMA/(Co-) Rapporteur. The product team is available to address any questions MAHs may have regarding a particular upcoming post-authorisation applications. Where appropriate, a pre-submission meeting could be organised at the Agency in order to obtain further procedural and regulatory/legal advice.

This guidance information and fruitful pre-submission dialogue between MAHs and the Agency should enable MAHs to submit applications, which are in conformity with the legal and regulatory requirements and which can be validated and processed promptly.

In addition, MAHs are strongly recommended to inform the Agency and (Co-) Rapporteur of all upcoming post-authorisation submissions for the following 6-12 months, in order to allow optimal planning, identification of procedural issues and handling of overlapping applications.

Note:

It should be highlighted that this document has been produced for guidance only and should be read in conjunction with "The Rules governing Medicinal Products in the European Union, Volume 2, Notice to Applicants".

MAHs must in all cases comply with the requirements of EU Legislation. Provisions, which extend to Iceland, Liechtenstein and Norway by virtue of the EEA agreement, are outlined in the relevant sections of the text.

Download Guidance Document

Interested in learning more? Contact us today to find out how we can help not only with your EMA/FDA submissions, but all of your global regulatory needs.

TAGS:

Person typing on laptop.

July 19, 2022

EMA Pre-authorisation guidance (Human Regulatory)

EMA Pre-authorisation guidance Table of contents 1. Types of applications and applicants 2. Steps prior to submitting the application 3. Preparing the dossier 3.1 Product name, product information...

August 1, 2022

UK Paediatric Investigational Plans – what do you need to know?? …and how is it all working in practice??

If a marketing authorisation is planned to be submitted in England, Scotland, and Wales (GB), an MHRA-approved paediatric investigational plan (PIP) is required. Up until January 1, 2021, PIPs were...

February 22, 2022

Battle of the Regulators: Comparing FDA’s Accelerated Approval and EMA’s Conditional Marketing Authorisation

Battle of the Regulators: Comparing FDA’s Accelerated Approval and EMA’s Conditional Marketing Authorisation: The Food and Drug Administration (FDA) and the European Medicines Agency (EMA) offer...