The European Medicines Agency's Committee for Medicinal Products for Veterinary Use prepares scientific guidelines in consultation with regulatory authorities in the European Union (EU) Member States, to help applicants prepare marketing authorisation applications for veterinary medicines. Guidelines reflect a harmonised approach of the EU Member States and the Agency on how to interpret and apply the requirements for the demonstration of quality, safety and efficacy set out in the Community directives.
The Agency strongly encourages applicants and marketing authorisation holders to follow these guidelines. Applicants need to justify deviations from guidelines fully in their applications at the time of submission. Before that, they should seek scientific advice, to discuss any proposed deviations during medicine development.
The guidelines are complementary to European Pharmacopoeia monographs and chapters:
- Status of European Medicines Agency scientific guidelines and European Pharmacopoeia monographs and chapters in the regulatory framework applicable to medicinal products
Compilation of European Commission and Agency guidelines
This section of the website updates and replaces the previous volume 7 of the rules governing medicinal products in the European Union (EudraLex), published by the European Commission.
Depending on each guideline’s status, one or more of the following documents are available:
- concept paper;
- draft guideline;
- overview of comments received during the consultation period;
- adopted guideline.
However, only adopted guidelines form part of volume 7 of EudraLex
The presentational order of the guidelines follows the overall structure of Annex I to Directive 2001/82/EC, although some adjustments have been made to account for the specific nature of certain areas or guidelines.
The following rationale has been applied for the individual sections:
- 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.
Related document types
Historical documents such as 'notes for guidance' are included in the compilation where they have the regulatory status of a guideline. Following the implementation of the procedure on EU guidelines, however, the use of these terms has been discontinued.
The compilation also includes other related documents, such as reflection papers, public statements and questions and answers. They provide additional information on topics of particular concern and/or clarification in areas where scientific knowledge is fast evolving or experience is limited.
Other guidelines, such as regulatory guidelines, good-manufacturing-practice guidelines and pharmacovigilance guidelines, were excluded from this re-organisation exercise. They continue to be published by the European Commission.
- Quality guidelines
- Quality of medicines questions and answers
- Safety and residues guidelines
- Efficacy guidelines
- Immunologicals guidelines
- Novel therapies guidance
How useful is this page?
Average rating:Based on 23 ratings
Add your rating:
- See all ratings
9 ratings2 ratings3 ratings1 ratings8 ratings