Questions & Answers

Introduction:

This Question and answers section gives advice on regulatory issues in connection with the Mutual Recognition and Decentralised Procedures. Reference is made, where additional information is available from CMDh guidance documents.

For general regulatory guidance on the interpretation and implementation of the new pharmaceutical legislation, please refer to the Notice to Applicants, where updated guidance will be published by the European Commission.
https://ec.europa.eu/health/documents/eudralex/vol-2_en

Index Questions & Answers:
 

• Active Substance Master File [Track version] (November 2022)

• Advice from CMDh [Track version] (September 2014)

• Applications for MA  [Track version] (April 2017)

• Biologicals [Track version] (February 2020, correction May 2024)

• CMDh Referrals  [Track version] (February 2016)

• eSubmissions[Track version] (June 2015)
  Further Q&As covering issues of eCTD dossier submission and handling under the new variations regulation
  Guidance on ASMF in eCTD format

• EU enlargement [Track version] (December 2012)

• Generics [Track version] (March 2020)

• Homeopathic medicinal products [Track version] November 2019

• Impact of EU-USA Mutual Recognition Agreement on marketing authorisation applications and relevant variations

• Implementation of the Medical Devices and In Vitro Diagnostic Medical Devices Regulations ((EU) 2017/745 and (EU) 2017/746) 

• Labelling requirements for metered dose inhalers containing fluorinated greenhouse gases (September 2024)

• Paediatric Regulation [Track version] (June 2023)
  Further Q&As have been published on the EMA website

• Pharmacovigilance Legislation  [Track version] (September 2024)

• Post-Authorisation Efficacy Studies (PAES) in MRP/DCP(November 2015) 

• Post referral phase [Track version] (March 2017)

• Product Information/Information on Medicinal Products [Track version] (October 2017)

• QP declaration [Track version] (December 2021) 

• Renewals  [Track version] (April 2023)

• Traditional Herbal Medicinal Products  [Track version] (March 2013)

• Usage Patents (May 2019) [Track version]

• Variations [Track version] (May 2024)

• Variations to an existing pharmacovigilance system as described in the DDPS (March 2011)