EMA – Update of the Guideline on post-authorisation procedural advice for users of the centralised procedure

In July, the European Medicines Agency (EMA) has updated its Guideline on post-authorisation procedural advice for users of the centralised procedure.

The Q&A document has been updated from the April 2021 version EMEA-H-19984/03 Rev. 92 to the July 23, 2021 version EMEA-H-19984/03 Rev. 93.

Please find below the questions updated in this new version of Q&A:

  • 3.7. How shall I present my type II Variation application? Rev. Jul 2021

  • 3.8. How shall I present my application for a new or modified therapeutic indication? Rev. Jul 2021

  • 7.3.2. How should non-clinical and/or clinical study reports be provided? Rev. Jul 2021

  • 7.4.1. What can be considered an editorial change and how can it be submitted as part of a type IA/IB/II variation? Rev. Jul 2021

  • 15.9. Under which procedure should I submit my PAM? Rev. Jul 2021

  • 15.12. How shall my submission of PAM be handled (timetable), and what could be the outcome of the evaluation? Rev. Jul 2021

  • 19.4. How shall my Transfer of Marketing Authorisation application be handled (timetable)? Rev. Jul 2021

  • 19.7. How to handle planned/ongoing variations procedures during the Transfer of Marketing Authorisation? Rev. Jul 2021

  • 19.11. Can I include changes to manufacturing sites in my Transfer of Marketing Authorisation application? Rev. Jul 2021

  • 19.13. Can I change the name of a medicinal product as part of a transfer application? Rev. Jul 2021

  • 19.15. Who should I contact if I have a question when preparing my application or during the procedure? Rev. Jul 2021

  • 23. Marketing status updates Rev. Jul 2021

  • 23.1. What is the meaning of “actual marketing” / “placing on the market”? Rev. Jul 2021

  • 23.2. What is the meaning of “cessation of placing on the market”? Rev. Jul 2021

  • 23.3. What is the aim of monitoring the marketing status of medicinal products? Rev. Jul 2021

  • 23.4. What information should be reported to the Agency on the marketing status of CAPs? Rev. Jul 2021

  • 23.5. When to report the marketing status overview of centrally authorised products to the Agency? Rev. Jul 2021

  • 23.6. How to report marketing status updates to the Agency for CAPs? Rev. Jul 2021

  • 23.7. When and how to notify marketing cessations for nationally authorised products to the Agency? NEW Jul 2021

  • 23.8. How will the Agency inform the Member States? Rev. Jul 2021

  • 23.9. How should I request the withdrawal of my central marketing authorisation? NEW Jul 2021

  • 23.10. Which information does the Agency publish about the marketing status of EU medicinal products? Rev. Jul 2021

  • 24.1. What is the sunset clause? Rev. Jul 2021

  • 24.2. Does the sunset clause apply to existing medicinal products? Rev. Jul 2021

  • 24.2. Does the sunset clause apply to existing medicinal products? Rev. Jul 2021

  • 24.6. In case of a protection period to be respected before placing the medicinal product on the market, when will the sunset clause period start? Rev. Jul 2021

  • 24.7. How to request an exemption to sunset clause provision for centrally-authorised products? Rev. Jul 2021

Access the full document through the link: https://bit.ly/3lDt5CQ

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