EMA – Update of Pre-authorisation guidance for users of the centralised procedure

In July and September, the authority EMA (European Medicines Agency) updated the document Questions and Answers (Q&A) on issues that are typically addressed in discussions or meetings with marketing authorization holders in the application phase.

Check below the updated questions published in the new version of the document:

2.2. How and when should the eligibility request be sent to EMA? Rev. Jul 2021

2.3. What are the dates for submission of eligibility requests? Rev. Sep 2021

2.4. What is the procedure for appointment of Rapporteurs/Co-Rapporteurs and their assessment teams? Rev. Jul 2021

2.6. When should I submit my marketing authorisation application? Rev. Jul 2021

2.7. How should I notify a change in the contact person and/or intended submission date of my application? Rev. Jul 2021

2.8. Is my product eligible for an accelerated assessment? Rev. Jul 2021

2.9. How is a marketing authorisation application pre-submission meeting conducted at EMA? Rev. Jul 2021

2.10. How should I notify the Agency if I no longer wish to pursue my application? NEW Jul 2021

3.3.3. What information regarding transfer of test methodes is required for different active substance or finished product release testing sites in the MAA for testing of biological medicinal products? NEW Jul 2021

3.5.5. How shall I present my RMP? Rev. Jul 2021

3.5.15. When should I submit the RMP Annex 1 to Eudra Vigilance? Rev. Jul 2021

Access the full document through the link: https://bit.ly/3ktdZ1R

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