Volume 23, Issue 3 - Non-Clinical Health Writing
Cosmetic regulatory writing
Authors: Lorine Preud'homme, Audrey Depues, Sophie Noiset
Abstract
On 11 July 2013, a new regulation for cosmetics was applied in Europe, Regulation (EC) 1223/2009, replacing Directive 76/768/CEE. This new regulation clarifies the roles and responsibilities of all stakeholders and introduces new notions such as cosmetovigilance and online notification. Compliance and safety of cosmetic products must now be clearly documented for them to be placed on the EU market. Professional medical writers are well positioned to help prepare the documentation needed for cosmetic approval according to this new directive.
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References
- Consumers. Brussels: European Commission. [Updated 2013 Jul 12; cited 2014 Jun 6]. Available from: http://ec.europa.eu/consumers/sectors/cosmetics/documents/revision/index_en.htm
- The European Parliament and the Council of the European Union. Regulation (EC) No 1223/2009 of the European Council and of the Council of 30 November 2009 on cosmetic products (recast) (Text with EEA relevance). Official Journal of the European Union. 22.12.2009; L342/59.
- COLIPA – The European Cosmetics Association. COLIPA Guidelines on the Product Information File (P.I.F.) requirement. Brussels: COLIPA – The European Cosmetics Association; 2011.
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Editoral Board
Editor-in-Chief:
- Phillip Leventhal (4Clinics, Lyon, France)
Co-Editor:
- Stephen Gilliver (TFS Trial Form Support, Lund, Sweden)
Managing Editor
- Victoria White (Tampa, Florida, USA) Email: MEW@emwa.org
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Associate Editors:
- Anuradha Alahari (PAREXEL International, Paris, France)
- Raquel Billiones (Clinipace, Zurich, Switzerland)
- Barbara Grossman (Hawkeye Medical Limited, Berkshire, UK)
- Joselita T Salita (Freelance, Bremen, Germany)
- Katharine Webb (INC Research, in Munich, Germany)
- Nathan Susnik (Hanover Medical School, Hanover, Germany)
Section Editors:
- Alison McIntosh (ICON Clinical Research, Hampshire, UK)
- Karin Eichele (Novartis Pharma, Nürnberg, Germany)
- Greg Morley (Freelance, Madrid, Spain)
- Wendy Kingdom (Wendy Kingdom Ltd., Dulverton, UK)
- Lisa Chamberlain-James (Trilogy Writing and Consulting, Norfolk, UK)
- Maria Koltowska-Haggstrom (Proper Medical Writing Warsaw, Poland)
- Laura Collada Ali (Teksema, Cogne, Italy)
- Simon Page (Cambridge Medical Communication Ltd, Cambridge, UK)
- Hervé Maisonneuve (Freelance, Lyon, France)
- Satyen Shenoy (Describe Scientific Writing & Communications, Cologne, Germany)
- Claire Gudex (Klinisk Institut, Odense, Denmark)
- Evguenia Alechine (Epsilon Scientific Communication, Buenos Aires, Argentina)
- Beatrix Doerr
Ad-hoc Editors:
- Amy Whereat (SpeaktheSpeech Consulting, Asnieres sur Seine, France)
Editor Emeritus:
- Elise Langdon-Neuner (Medical University of Vienna, Austria)