Scientific guidelines

Important note on document formats: All Microsoft Office documents submitted to the European Medicines Agency must be in a format compatible with MS Office 2003. Office 2007 and Office 2010 formats cannot currently be accepted.

The Agency’s Committee for Medicinal Products for Veterinary Use (CVMP) prepares scientific guidelines, in consultation with the competent authorities of the EU Member States, to help applicants prepare marketing-authorisation applications for medicinal products for veterinary use.

Guidelines are intended to provide a basis for practical harmonisation of the manner in which the EU Member States and the Agency interpret and apply the detailed requirements for the demonstration of quality, safety and efficacy contained in the Community directives. They also help to ensure that applications for marketing authorisation are prepared in a manner that will be recognised as valid by the Agency.

Combined presentation of former EudraLex Volume 7 and subsequent European Medicines Agency scientific Guidelines on the Agency website

Further to the publication and implementation of the procedure on European Union Guidelines by the Agency, an exercise has been undertaken to streamline the presentation of existing and future Guidelines for Human and Veterinary Medicinal Products.

One result of the streamlining exercise is the compilation in this area of the Agency website of all guidelines relating to medicinal products for veterinary use previously published by the European Commission in the Volume 7 of 'The rules governing medicinal products in the European Union' (also known as 'EudraLex') plus their subsequent revisions and supplements published by the Agency.

The presentational order of the guidelines in this compilation has been adapted to follow the main structure of Annex I to Directive 2001/82/EC, also taking into account the draft revision of this Annex. While the overall structure of Annex I has been followed, some compromises have been made to account for the specific nature of certain areas or guidelines.

The following rationale has been applied for the individual sections:

Pharmaceuticals
Quality (Non-immunologicals): The Annex I structure was generally followed, although some distinct product types (for example, herbals) have been placed in a discrete section.
Safety and residues: The Annex I structure was generally followed. In addition there is a section on guidelines regarding the establishment of maximum residue limits (MRLs).
Efficacy: Guidelines have been organised into therapeutic groups.

Immunologicals
The Annex I structure was generally followed.

Historical documents such as 'Notes for Guidance' are included in the compilation where they have the status of a guideline. Following the implementation of the procedure on European Union guidelines, however, the use of these terms has been discontinued.

Other guidelines such as Regulatory Guidelines, GMP Guidelines and Pharmacovigilance Guidelines are excluded from this reorganisation exercise. They will continue to be published by the European Commission.

Documents, which do not have the status of a Guideline, such as position papers or Questions and Answers, can be found on the websites of the responsible working parties. Agreed terms for scientific documents other than Guidelines are Public Statements, Reflection Paper and Questions and Answers.

For ease of reference concept papers and draft guidelines have also been organised in accordance with the revised structure. 

However it should be noted that only adopted guidelines form part of EudraLex Volume 7.

Reference:

• Procedure for European Union guidelines and related documents within the pharmaceutical legislative framework (EMEA/P/24143/2004 Rev. 1 correction)
  • Related template: Submission of comments
• Volumes 1 to 10 of The rules governing medicinal products in the European Union (EudraLex) are available on the European Commission's Pharmaceuticals website
• Annex I to Directive 2001/83/EC is available through the European Union law portal, EUR-Lex

Annex I to Directive 2001/83/EC - Introduction
(2nd paragraph)
In assembling a dossier for an application for marketing authorisation, applicants shall take into account the Community guidelines relating to the quality, safety and efficacy of veterinary medicinal products published by the Commission in The rules governing medicinal products in the European Community.