Updates on labelling, package leaflet and variations (EMA)

by Global Pharmacovigilance Team
February 10, 2021
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On 09 Feb 2021, European Medicines Agency (EMA) has provided updates on labelling and package leaflet and variations. Here you can find the list of questions related to each topic.

Updates on labelling, package leaflet and variations (EMA)

Changing the labelling and package leaflet (Article 61(3) notifications)

What are Article 61(3) Notifications? Rev. Feb 2021
Is the Rapporteur involved in 61(3) Notifications?
When can I submit my 61(3) Notification? Rev. Feb 2021
How shall I present my 61(3) Notification? Rev. Aug 2014
How and to whom shall I submit my 61(3) Notification? Rev. Feb 2019
How shall my 61(3) Notification be handled (timetable), and what could be the outcome? Rev. Feb 2021
What fee do I have to pay for a 61(3) Notification?
Do I have to submit mock-ups and specimens? Rev. Aug 2014
How and when will the updated Annexes become part of the Marketing Authorisation? Rev. Aug 2014
Will there be any publication on the outcome of my 61(3) Notification? Rev. Apr 2012
Who is my contact at the European Medicines Agency during post-authorisation procedures? Rev. Feb 2019

Type-IA variations: questions and answers

When shall I submit my Type IA/IAIN variation(s)? Rev. Dec 2016
Can I group the submission of Type IA/IAIN variations? Can they be grouped with other types of variations? Rev. Sep 2014
Is the (Co-) Rapporteur involved in the review of Type IA/IAIN variations? Rev. Aug 2014
How shall I present and submit my Type IA/ IAIN Variation(s)? Rev. Feb 2021
How shall my Type IA/IAIN variation be handled (timetable)? Rev. Oct 2012
Can my Type IA/ IAIN be part of worksharing? Rev. Feb 2021
What should I do in case of an unfavourable outcome for my Type IA/ IAIN variation(s)? Rev. July 2013
What fee do I have to pay for a Type IA/ IAIN variation? Rev. May 2020
Do I have to submit mock-ups and specimens? Rev. July 2013
What changes will trigger new EU number(s) (additional presentation(s))? Rev. Feb 2021
How to obtain new EU sub-numbers for Type IAIN variation concerning an additional presentation (e.g. new pack-size)? Rev. Feb 2021
When do I have to submit revised product information? In all languages? Rev. Aug 2014
How and when will the updated product information Annexes become part of the Marketing Authorisation? Rev. Oct 2012
What should be the date of revision of the text for Type IA Variations? New Oct 2010
Who should I contact if I have a question when preparing my application or during the procedure? Rev. Feb 2021

Type-IB variations: questions and answers

What changes are considered Type IB variations? Rev. Oct 2013
Is the (Co-) Rapporteur involved in Type IB Variations? Rev. Feb 2019
Can I group the submission of Type IB variations? Can they be grouped with other types of variations? Rev. Oct 2013
How shall I present and submit my Type IB Variation? Rev. Feb 2021
When shall I submit my Type IB Variation? Rev. Apr 2016
When do I need a linguistic review for changes in the product information? NEW Apr 2016
How shall my Type IB variation be handled (timetable)? Rev. Apr 2016
What fee do I have to pay for a Type IB Variation? Rev. May 2020
Do I have to submit mock-ups and specimens? Rev. Apr 2016
How should I submit revised product information? In all languages? Rev. Apr 2016
What changes will trigger new EU number(s) (additional presentation(s))? Rev. Feb 2021
How to obtain new EU sub-numbers for a Type IB variation concerning an additional presentation (e.g. new pack-size)? Rev. Feb 2021
How and when will the updated Annexes become part of the Marketing Authorisation? Rev. Oct 2012
Who should I contact if I have a question when preparing my application or during the procedure? Rev. Feb 2021