Medical Writing Non-Clinical Health Writing Cosmetic regulatory writing

Volume 23, Issue 3 - Non-Clinical Health Writing

Cosmetic regulatory writing


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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  1. Consumers. Brussels: European Commission. [Updated 2013 Jul 12; cited 2014 Jun 6]. Available from:
  2. 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.
  3. COLIPA – The European Cosmetics Association. COLIPA Guidelines on the Product Information File (P.I.F.) requirement. Brussels: COLIPA – The European Cosmetics Association; 2011.



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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