News and updates on pharmaceuticals
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
- Chapter 1 - Marketing Authorisations (January 2007)
- Chapter 2 - Mutual Recognition (November 2005)
- Chapter 3 - Community Referral (September 2007)
- Chapter 4 - Centralised Procedure (May 2006)
- Chapter 5 - Guidelines of 16 May 2013 on the details of the various categories of variations, on the operation of the procedures laid down in Chapters II, IIa, III and IV of Commission Regulation (EC) No 1234/2008 of 24 November 2008 concerning the examination of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products and on the documentation to be submitted pursuant to those procedures - C (2013) 2804 (OJ C 223, 2.8.2013, p. 1–79)
Chapter 6 - Community Marketing Authorisation (November 2005)
Please also note the notice of 12/10/2009 ("Droit de regard") here.
- Chapter 7 - General Information
Information regarding veterinary medicinal products authorised centrally and nationally (Mutual Recognition Procedure/Decentralised Procedure) contained in this Chapter is transferred to EMA and CMDv websites, respectively.
An overview of documents replacing the previous sections of Chapter 7 with corresponding website references is available at the following addresses:
- For CMDv : see document titled "Transfer of information contained in Notice to Applicants, Volume 6A, Chapter 7" (November 2012)
- For EMA :
Therefore any reference to chapter 7 should be understood as reference to these webpages. However, guidelines and other interpretative documents to which references may be provided represent the views of their authors.
Volume 6B - Presentation and content of the dossier
- Volume 6B Notice to applicants Veterinary medicinal products (March 2004)
Volume 6B Notice to applicants Veterinary medicinal products Presentation and contents of the dossier (January 2014)
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
Guidelines on Summary of product Characteristics
- Guideline on preparation of Summary of Product Characteristics SPC - Pharmaceuticals for veterinary medicinal products (revision 2 - 07/2006)
- Guideline on preparation of Summary of Product Characteristics SPC - Immunologicals for veterinary medicinal products (revision 3 - 06/2007)
- Guideline on the processing of renewals in the mutual recognition procedure for veterinary medicinal products (Revised February 2006)
- Guideline on the processing of renewals in the centralised procedure (December 2005)
- Application form for renewal of a marketing authorisation (June 2014)
- 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 - June 2014)
- Guideline on the categorisation of New Applications (NA) versus Variations Applications (V) (October2003)
- 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).
Volume 6 - Electronic Submission
Electronic Application Form (New) external link
Electronic Application Forms (Variation - Renewal) external link