Medical Writing Non-Clinical Health Writing Veterinary regulatory writing in Europe
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Volume 23, Issue 3 - Non-Clinical Health Writing

Veterinary regulatory writing in Europe

Abstract

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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References

  1. European Commission. Eudralex – the rules governing medicinal products in the European Union. Available from: http://ec.europa.eu/health/documents/eudralex/index_en.htm
  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: http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000173.jsp&mid=WC0b01ac058002d89a
  5. International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH) website: http://www.vichsec.org/.
  6. International Federation for Animal Health Europe (IFAH-Europe) website: http://www.ifaheurope.org/

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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
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Nanoapplications – From geckos to human health
Medical writing for in vitro diagnostics: A different approach for the ‘hidden’ side of healthcare
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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’
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News from the EMA
The Webscout
English Grammar and Style - Points of view
Medical Communication
In the Bookstores
Out On Our Own
Erratum

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  • Victoria White (Tampa, Florida, USA)
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  • Amy Whereat (SpeaktheSpeech Consulting, Asnieres sur Seine, France)

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