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.

The Notice to Applicants was first published in 1986 and is regularly updated.

Volume 6A - Procedures for marketing authorisation

• January 2007
  Chapter 1 - Marketing Authorisations(151 KB)
• November 2005
  Chapter 2 - Mutual Recognition(141 KB)
• September 2007
  Chapter 3 - Community Referral - PDF Version of Chapter 3(97 KB) - Word Version of Chapter 3(210 KB)
• May 2006
  Chapter 4 - Centralised Procedure(117 KB)
• 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.(805 KB)  български (bg) čeština (cs) dansk (da) Deutsch (de) eesti keel (et) ελληνικά (el) español (es) français (fr) italiano (it) magyar (hu) Malti (mt) Nederlands (nl) polski (pl) português (pt) română (ro) slovenčina (sk) slovenščina (sl) suomi (fi) svenska (sv)
  • Procedural note(9 KB) 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)
• November 2005
  Chapter 6 - Community Marketing Authorisation(94 KB)
• February 2010
  Chapter 7 rev 9.7 - General Information(436 KB)

Volume 6B - Presentation and content of the dossier

Volume 6B Notice to applicants Veterinary medicinal products Presentation and contents of the dossier(540 KB) (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 format of 1A - Revision 7.2(174 KB) - Word format of 1A - Revision 7.2(479 KB) )

 Volume 6C - Regulatory Guidelines

Guidelines on Summary of product Characteristics

• Guideline on preparation of Summary of Product Characteristics SPC - Pharmaceuticals for veterinary medicinal products (revision 2 - 07/2006)(328 KB)
• Guideline on preparation of Summary of Product Characteristics SPC - Immunologicals for veterinary medicinal products (revision 3 - 06/2007)(68 KB)
• Guideline on the processing of renewals in the mutual recognition procedure for veterinary medicinal products (Revised February 2006)(44 KB)
• Guideline on the processing of renewals in the centralised procedure (December 2005)(66 KB)
• Application form for renewal of a marketing authorisation (October 2012)
  PDF format of the application form (44 KB)- Word format of the application form(176 KB)
• Guideline on Dossier requirements for Type IA and Type IB Notifications Revision 1 (June 2006)
  PDF format of the guideline(302 KB) - Word format of the guideline(934 KB)
• Guideline on the details of the various categories of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products (2010/C 17/01)(2 MB)  български (bg) čeština (cs) dansk (da) Deutsch (de) eesti keel (et) ελληνικά (el) español (es) français (fr) italiano (it) latviešu valoda (lv) lietuvių kalba (lt) magyar (hu) Malti (mt) Nederlands (nl) polski (pl) português (pt) română (ro) slovenčina (sk) slovenščina (sl) suomi (fi) svenska (sv)  - Word format en(2 MB) (February 2010)
• 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 of the application form(142 KB) - Word format of the application form(2 MB) (December 2009)
• Guideline on the categorisation of New Applications (NA) versus Variations Applications (V) (October 2003)(316 KB)
• Guideline on the packaging information of veterinary medicinal products authorised by the Community - (blue box) (January 2008)(194 KB)
• Guidance on the Assessment of environmental risks of veterinary medicinal products (June 2009)(82 KB)
• Guidance on environmental risk assessment for veterinary medicinal products consisting of or containing genetically modified organisms (GMOs) as or in products (March 2006)(73 KB)
• Guideline on the definition of a potential serious risk to human or animal health or for the environment(107 KB)  čeština (cs) dansk (da) Deutsch (de) eesti keel (et) ελληνικά (el) español (es) français (fr) italiano (it) latviešu valoda (lv) lietuvių kalba (lt) magyar (hu) Nederlands (nl) polski (pl) português (pt) slovenčina (sk) slovenščina (sl) suomi (fi) svenska (sv) 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(21 KB)

 Volume 6 - Electronic Submission

• Electronic Application Form (New)  external link

• Electronic Application Forms (Variation - Renewal) external link

For further information, see volume 2B - (Human)

 

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