Questions and answers: Article 35 veterinary referral procedures

The European Medicines Agency (EMA) provides guidance in the form of questions and answers (Q&As) on Article 35 veterinary referral procedures handled by the Committee for Medicinal Products for Veterinary Use (CVMP).

These Q&As provide an overview of EMA's practical and operational aspects on handling of Article 35 referral procedures. EMA updates the Q&As regularly. Revised topics are marked 'New' or 'Rev.' on publication.

A PDF version of these Q&As is available:


The Q&As are for guidance only and should be read in conjunction with the rules governing medicinal products in the European Union, volume 6A, chapter 3, notice to applicants.

Marketing authorisation holders (MAH) must in all cases comply with the requirements of European Union legislation.

Initiation of an Article 35 referral procedure

During the assessment

Committee for Medicinal Products for Veterinary Use (CVMP) opinion

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