Paediatrics: Regulatory and procedural guidance

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See the full regulatory and procedural guidance index.

Table of contents

General

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Document(s) Language Status First published Last updated Effective Date
The European paediatric initiative: History of the paediatric regulation (English only)   11/07/2007    
Joint European Commission/European Medicines Agency document: Priorities for implementation of the regulation on medicinal products for paediatric use (English only)   01/09/2006    
Brochure - Better medicines for children (English only)   24/02/2009 29/03/2011  
Guidance on the content and the format of data to be collected by the Member States on all existing uses of medicinal products in the paediatric population (English only) adopted 01/10/2007    
Example of a template for communicating a Member State's data on all existing uses of medicinal products in the paediatric population to the Agency (English only) adopted 04/12/2007    
Revised priority list for studies into off-patent paediatric medicinal products (English only)   11/09/2009 09/02/2012  
The network of paediatric networks at the European Medicines Agency: Implementing strategy (English only)   15/01/2008    
Paediatric Committee (PDCO) dates for 2010 (English only)   20/05/2009    
Paediatric Committee (PDCO) dates for 2011 (English only)   20/05/2009    
Submission deadlines for 2010-2011 for PIP applications and applications for waivers and answers to the request for modification plan of the application (English only)   20/05/2009    
Submission deadlines for 2010-2011 for submitting request for compliance check (English only)   20/05/2009    
Submission deadlines for 2010-2011 for submitting a request for a modification to an agreed PIP (English only)   20/05/2009    
Recommendation of the Paediatric Committee to the European Commission regarding the symbol (English only)   01/12/2007    
Report from the Paediatric Committee (PDCO) on its first anniversary (English only)   11/07/2008    

Related links

Paediatric Investigation Plan (PIP) and waivers

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Document(s) Language Status First published Last updated Effective Date
Template for letter of intent to submit an application (English only)   04/01/2010 03/02/2010  
Electronic form for paediatric investigation plan application and request for waiver (English only)   28/05/2009 09/12/2010 01/03/2011
European Medicines Agency/Paediatric Committee summary report template (English only)   14/12/2008 01/02/2012  
Re-examination procedure of paediatric investigation plan and/or waiver opinions by the Paediatric Committee (PDCO) (English only)   29/01/2008    
Template letter for applicant - waiving right for a re-examination request (English only)   24/11/2008 11/08/2011  
Standard operating procedure for decision-making process for Paediatric Committee opinions on paediatric investigation plans and product-specific waivers (English only) adopted 03/12/2007 04/07/2011 03/12/2007
Request for modification of an agreed paediatric investigation plan (English only)   28/05/2009 16/06/2011  
Annual report on deferral granted in the paediatric investigation plan (English only)   19/06/2000 09/12/2010 01/03/2011
Request for confirmation of the applicability of the EMEA decision on class waivers (English only)   21/07/2008    
P/60/2008: European Medicines Agency decision of 8 September 2009: on a class waiver on a class of medicinal products in accordance with Regulation (EC) No 1901/2006 of the European Parliament and of the Council as amended (English only) adopted 08/09/2008    
P/63/2010: EMA decision of 20 December 2010 on a class waiver on condition(s) (English only) adopted 02/11/2009 10/01/2011  
Standard operating procedure for decision-making process for Paediatric Committee opinions on class waivers (English only) adopted 03/12/2007 10/11/2011 14/11/2011
Standard Operating Procedure for Handling of applications for paediatric investigation plan (PIP) and/or waiver from presubmission to PDCO opinion (English only) adopted 03/07/2009   03/07/2009

Marketing Authorisation Procedures

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Document(s) Language Status First published Last updated Effective Date
Questions and answers on the procedure of paediatric-investigation-plan compliance verification at the European Medicines Agency (English only) adopted 08/03/2011 14/09/2011 08/06/2011
Request for compliance check on an agreed paediatric investigation plan form (English only)   14/06/2010 09/12/2010 01/03/2011
Submission deadlines for 2012 and 2013 for submitting request for compliance check (English only)   12/03/2010 20/04/2011  
Submission deadlines for 2010-2011 for submitting request for compliance check (English only)   20/05/2009    

Article 46 of the Paediatric Regulation

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