Veterinary pre-submission Q&A: Introduction

This section of the website contains questions related to pre-submission guidance for new veterinary medicines that applicants or marketing authorisation holders (MAHs) may encounter. It provides an overview of the European Medicines Agency's position on issues that are typically addressed in discussions or meetings with applicants/MAHs.

These pages are updated regularly to reflect new developments, to include guidance on further pre-authorisation procedures and to reflect the implementation of new European legislation. New or revised topics are marked 'New' or 'Rev.' on publication.

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 (vet.applications@ema.europa.eu) in advance of your planned submission.

Pre-submission meetings

Update: Please note that in light of the Agency’s Relocation to Amsterdam due to the United Kingdom's withdrawal from the European Union ('Brexit'), pre-submission meetings, for which the requests have been received after 1 October 2018, will be held remotely (teleconference or virtual meeting facility) until the Agency is fully established in the permanent premises. Applicants will be asked to to provide the remote set-up details before the meeting (for example, toll-free dial in numbers for a teleconference) and coordinate the audio-visual set up for the presentation, if applicable.

Furthermore, no pre-submission meetings will be accepted during a limited period from 11 February 2019 to 15 March 2019, when the Agency’s physical move to the temporary premises takes place.

The Agency emphasises the importance of pre-submission meetings, around seven months prior to the anticipated date of submission of the application.

These are a vital opportunity for applicants to obtain procedural, regulatory and legal advice from the Agency.

These questions and answers and successful pre-submission meetings should enable applicants to submit applications that conform with regulatory requirements and can be validated speedily.

Pre-submission meetings also enable applicants to establish contact with the Agency staff who will be involved with the application.

To request a pre-submission meeting, use the request form:

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