Medical Writing Non-Clinical Health Writing Cosmetic regulatory writing
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Volume 23, Issue 3 - Non-Clinical Health Writing

Cosmetic regulatory writing

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

  1. 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
  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.

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