The European Medicines Agency's Committee for Medicinal Products for Veterinary Use (CVMP) prepares scientific guidelines in consultation with regulatory authorities in the European Union (EU) Member States, to help applicants prepare marketing-authorisation applications for human medicines. Guidelines provide a basis for practical harmonisation of how the EU Member States and the Agency interpret and apply the detailed requirements for the demonstration of quality, safety and efficacy that are 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. The Agency advises applicants to discuss any proposed deviations with EU regulators during medicine development through scientific advice.
For the assurance of the quality of medicines, 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.
Documents that do not have the status of a guideline, such as position papers, reflection papers or question-and-answer documents, continue to be published in the relevant working-party folders within CVMP: Working parties and other groups.
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.