Volume 23, Issue 3 - Non-Clinical Health Writing
Veterinary regulatory writing in Europe
Author: Susanne Goebel-Lauth
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
- European Commission. Eudralex – the rules governing medicinal products in the European Union. Available from: http://ec.europa.eu/health/documents/eudralex/index_en.htm
- Goebel-Lauth S. Medical writing for the veterinary pharmaceutical industry – specialists needed. The Write Stuff 2011;20(1):29–30.
- 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.
- 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
- International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH) website: http://www.vichsec.org/.
- International Federation for Animal Health Europe (IFAH-Europe) website: http://www.ifaheurope.org/
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