European Medicines Agency post-authorisation procedural ...

1 20 December 2021. EMEA-H-19984/03 Rev. 96. Human Medicines Evaluation Division European Medicines Agency post - authorisation procedural advice for users of the centralised procedure Important information regarding ending of Irish language derogation As of 1st January 2022, a derogation expires concerning the status of Irish as a working language of the EU Institutions. This means that Irish will be the authentic language of Commission decisions on marketing authorisations, including the product information they contain, addressed to any marketing authorisation holder established in Ireland, unless they request a language waiver. This will also apply to post - authorisation decisions of the European Commission addressed to EU Member States, including the product information they contain, which will be translated into Irish together with the other official EU languages, for the following procedures: Referrals, Periodic safety update reports (PSURs), post - authorisation safety studies (PASS).

2 Companies should be aware that at a certain point in the future a more extensive use of the Irish language may be required. Please see also: Irish language (EMA webpage) and Guidance on Irish language derogation ending on 1. January 2022. Important technical information As of 1st of November 2021, the registration of new sites and organisations for centrally-authorised medicinal products in Organisation Management Service (OMS) will become mandatory prior to the associated regulatory submissions to the Agency ( transfer of the marketing authorisation , addition of a manufacturing site). The EMA would like to emphasise the importance of these site/organisation registrations in OMS prior to pre- and post - authorisation submissions, in order to avoid any delay in the start of these procedures, as this would constitute a validation blocking issue. Please see also: SPOR Web UI ( ) and Q&A on the mandatory use of OMS for CAPs This integrated version has been created for printing purposes only.

3 Please refer to the individual question & answers as published in the post - authorisation guidance for access to the hyperlinked information. Official address Domenico Scarlattilaan 6 1083 HS Amsterdam The Netherlands Address for visits and deliveries Refer to Send us a question Go to Telephone +31 (0)88 781 6000 An Agency of the European Union European Medicines Agency , 2021. Reproduction is authorised provided the source is acknowledged. Questions and answers are being updated continuously and will be marked by NEW or Rev. with the relevant date upon publication. 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.

4 It will be updated regularly to reflect new developments, to include guidance on further post - authorisation 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.

5 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. European Medicines Agency post - authorisation procedural advice for users of the centralised procedure EMEA-H-19984/03 Page 2/299. Table of Contents 1.

6 Type IA Variations .. 14. When shall I submit my Type IA/IAIN variation(s)? Rev. Dec 2016 .. 14. Can I group the submission of Type IA/IAIN variations? Can they be grouped with other types of variations? Rev. Sep 2014 .. 15. Is the (Co-) Rapporteur involved in the review of Type IA/IAIN variations? Rev. Aug 2014 .. 16. How shall I present and submit my Type IA/ IAIN Variation(s)? Rev. Apr 2021 .. 16. How shall my Type IA/IAIN variation be handled (timetable)? Rev. Oct 2012 .. 20. Can my Type IA/ IAIN be part of worksharing? Rev. Feb 2021 .. 20. What should I do in case of an unfavourable outcome for my Type IA/ IAIN variation(s)? Rev. July 2013 .. 21. What fee do I have to pay for a Type IA/ IAIN variation? Rev. Apr 2021 .. 21. Do I have to submit mock-ups and specimens? Rev. July 2013 .. 22. What changes will trigger new EU number(s) (additional presentation(s))?

7 Rev. Feb 2021 .. 22. How to obtain new EU sub-numbers for Type IAIN variation concerning an additional presentation ( new pack-size)? Rev. Feb 2021 .. 23. When do I have to submit revised product information? In all languages? Rev. Apr 2021 .. 24. How and when will the updated product information Annexes become part of the Marketing authorisation ? Rev. Oct 2012 .. 25. What should be the date of revision of the text for Type IA Variations? New Oct 2010.. 26. Who should I contact if I have a question when preparing my application or during the procedure? Rev. Feb 2021 .. 26. 2. Type IB variations .. 28. What changes are considered Type IB variations? Rev. Oct 28. Is the (Co-) Rapporteur involved in Type IB Variations? Rev. Feb 2019 .. 28. Can I group the submission of Type IB variations? Can they be grouped with other types of variations? Rev. Oct 2013.

8 29. How shall I present and submit my Type IB Variation? Rev. Apr 2021 .. 30. When shall I submit my Type IB Variation? Rev. Apr 2016 .. 32. When do I need a linguistic review for changes in the product information? NEW Apr 2016 .. 33. How shall my Type IB variation be handled (timetable)? Rev. Apr 2016 .. 34. What fee do I have to pay for a Type IB Variation? Rev. Apr 2021 .. 36. Do I have to submit mock-ups and specimens? Rev. Apr 2016 .. 36. How should I submit revised product information? In all languages? Rev. Apr 2021 .. 37. What changes will trigger new EU number(s) (additional presentation(s))? Rev. Feb 2021 .. 38. How to obtain new EU sub-numbers for a Type IB variation concerning an additional presentation ( new pack-size)? Rev. Feb 2021 .. 39. How and when will the updated Annexes become part of the Marketing authorisation ? Rev. Oct 2012.

9 39. European Medicines Agency post - authorisation procedural advice for users of the centralised procedure EMEA-H-19984/03 Page 3/299. Who should I contact if I have a question when preparing my application or during the procedure? Rev. Feb 2021 .. 41. 3. Type II variations .. 42. What changes considered Type II variations? Rev. Dec 2016 .. 42. Do I need to notify the Agency of my intention to submit a Type II variation application? Rev. Feb 2019 .. 42. Which Committee will take the lead in the assessment of a type II variation? NEW Dec 2019 .. 43. Is the Co-Rapporteur involved in Type II Variations? Rev. Dec 2019 .. 43. Is the PRAC Rapporteur involved in type II variations? Rev. Dec 2019 .. 44. Can I group the submission of type II variations? Can they be grouped with other types of variations? Rev. Feb 2015 .. 44. How shall I present my type II Variation application?

10 Rev. Jul 2021 .. 45. How shall I present my application for a new or modified therapeutic indication? Rev. Jul 2021 .. 48. How and to whom shall I submit my Type II Variation application? Rev. Feb 2019 .. 49. When shall I submit my type II variation? Rev. Dec 2019 .. 49. How shall my Type II application be handled (timetable)? Rev. Feb 2019 .. 51. How should parallel type II variations that affect the product information be handled? NEW Dec 2016 .. 55. Which post -opinion steps apply to my type II variation and when can I implement the approved changes? Rev. May 2020 .. 56. What fee do I have to pay for a type II variation? Rev. Apr 2021 .. 60. Do I have to submit mock-ups and specimens? Rev. July 2013 .. 60. When do I have to submit revised product information? In all languages? Rev. Apr 2021 .. 61. What changes will trigger new EU number(s) (additional presentation(s))?