EMA: Update of the Q&A Documents "Centralised Procedures"

In July and September 2021, the European Medicines Agency (EMA) published the updated and revised versions of the "Questions & Answers (Q&A)" documents on centralised procedures on their website. These Q&A catalogues are intended to provide guidance and information for marketing authorization holders and applicants of centralised procedures and provide answers to potential questions at different stages of the centralised marketing authorization application process.

Pre-authorisation procedural advice

Questions regarding topics before and during the submission of a centralized procedure are listed and answered in the revised document "European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure". The latest version (as of July 2021) again draws attention to the fact that from the end of September 2021 the use of the so-called "Organisation Management Service (OMS)" will be mandatory and that registration in this service should take place prior to submission of the marketing authorization.

Updates have been made in the following passages as a result of this:

• Paragraph 2.2. 
• Paragraph 2.4. 
• Paragraph 2.6. 
• Paragraph 2.7. 
• Paragraph 2.8.4. 
• Paragraph 2.9.4.

Section 2.10 was newly added. "How should I notify the Agency if I no longer wish to pursue my application?", which describes the procedure for withdrawing the application for authorisation, lists the relevant contact details.

Also newly included is the question "3.3.3. What information regarding transfer of test methods is required for different active substance or finished product release testing sites in the MAA for testing of biological medicinal products?", which deals with the requirements for validation protocols in the context of an analytical method transfer for immunochemical, immunological and biological test methods for the release testing of active substances and finished medicinal products.

Paragraphs 3.5.5. and 3.5.15., which consider the topic of "Risk Management Plans", have also been revised and renewed.

Post-authorisation procedural advice

The Q&A document "European Medicines Agency post-authorisation procedural advice for users of the centralised procedure" was also revised in July and September 2021 and the latest version was published on the EMA website. This question and answer catalogue is devoted to topics that may be relevant after the marketing authorization has been granted. These include, for example, explanations on how to deal with variations or marketing authorization extensions.

Updates in July 2021

Changes and updates made in July 2021 affected the following paragraphs and supersets:

• Paragraphs 3.7. and 3.8. Type II Variation and New or modified therapeutic indication 
• Paragraphs 7.3.2. and 7.4.1. (Non-) Clinical changes and Editorial changes 
• Paragraphs 15.9. and 15.12. Post-Authorization Measures (PAMs) 
• Paragraphs 19.1., 19.4., 19.5., 19.7., 19.11., 19.13. and 19.15. Transfer of Marketing Authorization 
• Paragraphs 23.1., 23.2., 23.3., 23.4., 23.5., 23.8. and 23.10. Marketing status updates 
• Paragraphs 24.1., 24.2., 24.3., 24.4., 24.5., 24.6. and 24.7. Sunset clause monitoring

New passages have been added to paragraph 23 and address questions 23.7. "When and how to notify marketing cessations for nationally authorised products to the Agency?", 23.9. "How should I request the withdrawal of my central marketing authorisation?"  and 23.11. "Is there an obligation to market a medicine which is authorised for a paediatric indication, following completion of an agreed paediatric investigation plan, and the product has already been marketed with other indications?".

Update in September 2021

• Paragraph 23.6. "How to report marketing status updates to the Agency for CAPs?"

This section, which was already revised in July 2021, was now updated again in September. Here, mainly the passage on the question "How do I submit baseline data for already authorized products in IRIS?" was added and minor additions were made to the already existing text passages.

The new versions of the "Q&A" documents for centralised procedures can be found at:

1) Pre-authorisation procedural advice

2) Post-authoristaion procedural advice

On the EMA website you will find general information on the subject of "Organisation Management Service (OMS)".