Medical Writing Non-Clinical Health Writing Veterinary regulatory writing in Europe

Volume 23, Issue 3 - Non-Clinical Health Writing

Veterinary regulatory writing in Europe


Regulatory writing for the veterinary pharmaceutical industry is in many ways similar to other types of regulatory writing, but there are also clear differences. This article outlines the veterinary regulatory structure in Europe and, in particular, dossier content, competent regulatory authorities, as well as registration procedures. Adjacent fields of regulatory writing are addressed and an overview of typical documents is given. Furthermore, specific veterinary regulatory information sources for medical writers are provided.

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  1. European Commission. Eudralex – the rules governing medicinal products in the European Union. Available from:
  2. Goebel-Lauth S. Medical writing for the veterinary pharmaceutical industry – specialists needed. The Write Stuff 2011;20(1):29–30.
  3. Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products, as amended.
  4. European Medicines Agency Website. Veterinary regulatory, scientific guidelines. Available from:
  5. International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH) website:
  6. International Federation for Animal Health Europe (IFAH-Europe) website:



Non-clinical health writing
President's Message
EMWA social media team
Opportunities in veterinary writing
Veterinary regulatory writing in Europe
Exploring veterinary science, a little-known translation specialisation
Cosmetic regulatory writing
REACH chemical dossiers? Yes, please!
Pesticide dossiers, an opportunity for medical writers
Nanoapplications – From geckos to human health
Medical writing for in vitro diagnostics: A different approach for the ‘hidden’ side of healthcare
Writing bioanalytical reports
Letter to the Editor: Because you're worth it?
Cost comparison of salaried and freelance medical writers working in Europe
Profile: An interview with Fernando Navarro on the brand new platform ‘Cosnautas’
Key factors a pharmaceutical company should consider while outsourcing medical writing services
Working with authors to develop high-quality, ethical clinical manuscripts: Guidance for the professional medical writer
News from the EMA
The Webscout
English Grammar and Style - Points of view
Medical Communication
In the Bookstores
Out On Our Own

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