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.
http://ec.europa.eu/enterprise/pharmaceuticals/eudralex/homev2.htm

Index Questions & Answers:

• Active Substance Master File  [Track version] (April 2017)

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

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

• Biologicals [Track version] (July 2016)

• 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

• EU enlargement [Track version] (December 2012)

• Generics [Track version] (April 2017)

• Homeopathics (October 2012)

• Paediatric Regulation [Track version] (January 2015)
  Further Q&As have been published on the EMA website

• Pharmacovigilance Legislation [Track version] (May 2017)

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

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

• Product Information/Information on Medicinal Products (October 2012)

• QP declaration [Track version] (April 2017) 

• Renewals (November 2012)

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

• Usage Patents (October 2012)

• Variations [Track version] (May 2017)

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