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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.

The Europeans Medicines Agency (EMA) has updated its Q&A guidance on post-authorisation procedural advice for users of the centralised procedure. The revised sections are primarily related to Type IA and IB variations.

The following sections in the document on variations have been revised as of February 2021.

Type IA Variations

• 1.4. How shall I present and submit my Type IA/IAIN variations(s)?
• 1.6. Can my Type IA/IAIN be part of worksharing?
• 1.10. What changes will trigger new EU number(s) (additional presentation(s))?
• 1.11. How to obtain new EU sub-numbers for Type IAIN variation concerning an additional presentation (e.g. new pack-size)?
• 1.15. Who should I contact if I have a question when preparing my application or during the procedure?

Type IB variations

• 2.4. How shall I present and submit my Type IB Variation?
• 2.11. What changes will trigger new EU number(s) (additional presentation(s))?
• 2.12. How to obtain new EU sub-numbers for a Type IB variation concerning an additional presentation (e.g. new pack-size)?
• 2.14. Who should I contact if I have a question when preparing my application or during the procedure?

In addition, the following sections have also been revised during the latest update.
Pre-submission queries service

• 8.2. How should I send queries to the pre-submission queries service?
• Article 61(3) Notifications
• 22.1. What are Article 61(3) Notifications?
• 22.3. When can I submit my 61(3) Notification?
• 22.6. How shall my 61(3) Notification be handled (timetable), and what could be the outcome?

To continue reading this article please go to EMA.