EudraLex - Volume 6
Notice to Applicants and Regulatory Guidelines for Medicinal products for Veterinary use
Volume 6 of the publications “The rules governing medicinal products in the European Union” contains a list of regulatory guidelines related to procedural and regulatory requirements such as renewal procedures, dossier requirements for Type IA/IB variation notifications, summary of product characteristics (SPC), package information and classification for the supply, readability of the label and package leaflet requirements.
This Notice to Applicants has been prepared by the European Commission, in consultation with the competent authorities of the Member States and the European Medicines Agency. This Notice has no legal force and does not necessarily represent the final views of the Commission. In case of doubt, therefore, reference should be made to the appropriate Community Directives and Regulations.
Volume 6A dealing with procedures for marketing authorisation;
Volume 6B dealing with the presentation and content of the application dossier.
Volume 6A - Procedures for marketing authorisation
January 2007
Chapter 1 - Marketing Authorisations
November 2005
Chapter 2 - Mutual Recognition
September 2007
Chapter 3 - Community Referral - Pdf Version - Word Version
May 2006
Chapter 4 - Centralised Procedure
February 2010
Chapter 5 - Guideline on the operation of the procedures laid down in Chapters II, III and IV of Commission Regulation (EC) No 1234/2008 of 24 November 2008 as well as on the documentation to be submitted pursuant to these procedures.
- Procedural note concerning the Guideline on the operation of the procedures laid down in chapters II, III, and IV of commission regulation (ec) 1234/2008 of concerning the examination of variations to the Terms of Marketing Authorisations for Medicinal Products for human use and veterinary medicinal products (March 2011)
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November 2005
Chapter 6 - Community Marketing Authorisation
February 2010
Chapter 7 rev 9.7 - General Information
Volume 6B Notice to applicants Veterinary medicinal products Presentation and contents of the dossier - March 2004
Volume 6B gives to guidance to applicants for marketing authorisations for veterinary medicinal products on the presentation of the data requirements and summaries of the dossier
PART I - Summary of the dossier / Administrative data
1A - Revision 7.2 - 0ctober 2008 : PDF - Word Format
Guidelines on Summary of product Characteristics
- Guideline on preparation of Summary of Product Characteristics SPC - Pharmaceuticals for veterinary medicinal products - revision 2 July /2006
- Guideline on preparation of Summary of Product Characteristics SPC - Immunologicals for veterinary medicinal products - revision 3 June 2007
- Guideline on the processing of renewals in the mutual recognition procedure for veterinary medicinal products - revision February 2006
- Guideline on the processing of renewals in the centralised procedure - December 2005)
- Application form for renewal of a marketing authorisation and guidance for the completion of the application form - February 2007
Application Form : PDF format - Word format
- Guideline on Dossier requirements for Type IA and Type IB Notifications - Revision 1 June 2006
Word Format
Application form for variation to a marketing authorisation for medicinal products (human and veterinary) to be used in the mutual recognition and the centralised procedure - December 2009.
Application Form : PDF format - Word format - December 2009
- Guideline on the categorisation of New Applications (NA) versus Variations Applications (V) - October 2003
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- Guideline on the packaging information of veterinary medicinal products authorised by the Community - (blue box) - January 2008
- Guidance on the Assessment of environmental risks of veterinary medicinal products - June 2009
- Guidance on environmental risk assessment for veterinary medicinal products consisting of or containing genetically modified organisms (GMOs) as or in products - March 2006
- Guideline on the definition of a potential serious risk to human or animal health or for the environment in the context of Article 33(1) and (2) of Directive 2001/82/EC (Official Journal C 132, 7/6/2006 p. 32 - 35)
Annex
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- Electronic Application Form-New - version 2.1, September 2009 - zip file (for download only right click and Save Target As...)
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- Electronic Application Form-Variation - version 1.1, September 2009 - zip file (for download only right click and Save Target As...)
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E- lectronic Application Form-Renewal - version 1.0, September 2009 - zip file (for download only right click and Save Target As...)
For further explanations, see volume 2B - (Human)