Veterinary pre-authorisation guidance under Directive 2001/82/EC and Regulation (EU) 726/2004


This guidance only applies to procedures initiated under Directive 2001/82/EC and Regulation (EU) 726/2004 before 28 January 2022.

This section of the website provides pre-authorisation procedural guidance for marketing authorisation applicants and holders for applications submitted on or before 27 January 2022 to be concluded in accordance with Directive 2001/82/EC and Regulation (EU) 726/2004. It provides an overview of the European Medicines Agency's position on issues that are typically addressed in discussions or meetings with applicants/MAHs.

Separate guidance is available for marketing authorisation applications submitted on or after 28 January 2022:

These questions and answers have been produced for guidance only and should be read in conjunction with the Rules Governing Medicinal Products in the European Union, Volume 6B, Notice to Applicants.

All of the information previously available on the European Commission website in Chapter 7 of the Notice to Applicants (Volume 6A) related to marketing authorisation applications for centrally authorised veterinary medicines is now primarily available in these questions and answers.

Applicants and MAHs must in all cases comply with the requirements of Community legislation. Provisions that extend to Iceland, Liechtenstein and Norway by virtue of the European Economic Area agreement are outlined in the relevant sections of the text.

These questions and answers on pre-submission guidance address the following topics:

Questions 1-20

Eligibility, rapporteurs, legal basis, invented name, legal status, accelerated review, duplicate applications, fees, fees for inspections, fee waivers/reductions, Maximum Residue Limits (MRLs), mock-ups/specimens, samples, applicant location, detailed descriptions of the pharmacovigilance system (DDPS),batch release .

Questions 21-39

Active substance master file (ASMF), genetically modified organisms (GMOs), materials of animal or human origin, local representatives, submission, validation, timetables, peer review, application number, GMP inspections, GCP inspections, quality review of documents (QRD), pre-submission meetings, small and medium enterprises (SMEs), innovation task force (ITF), pharmaceutical legislation, logo and symbols on outer packaging, change of applicant.

If your question is not answered here please contact the Agency ( in advance of your planned submission.

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