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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 [Tracked] (November 2012)

Advice from CMDh (October 2012)

Applications for MA [Tracked version] (January 2013)

Biologicals (October 2012)

CMDh Referrals [Tracked version] (January 2013)

eSubmissions - The use of eCTD on MRP/DCP (May 2010)
Further Q&As covering issues of eCTD dossier submission and handling under the new variations regulation

EU enlargement [Tracked] (December 2012)

Generics (October 2012)

Homeopathics (October 2012)

Paediatric Regulation [Track version] (January 2011)
Further Q&As have been published on the EMA website

Pharmacovigilance Legislation [Tracked] (May 2013)

Post referral phase (November 2012)

Product Information/Information on Medicinal Products (October 2012)

PSURs (Transitional arrangements for nationally authorised products) [Tracked] (March 2013)

Renewals (November 2012)

Traditional Herbal Medicinal Products [Tracked version] (March 2013)

Usage Patents (October 2012)

Variations [Tracked version] (May 2013)

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