Medical Writing Non-Clinical Health Writing REACH chemical dossiers? Yes, please!

Volume 23, Issue 3 - Non-Clinical Health Writing

REACH chemical dossiers? Yes, please!

Abstract

Medical writing knowledge and skills can be applied relatively easily to other areas of technical regulatory writing, with a bit of home study. One such area is in the compilation and write-up of REACH (Registration, Evaluation, Authorisation, and restriction of Chemicals) chemical dossiers. A concise overview of the legislation, requirements, and dossier content is provided, with links to guidance documents available online for further study.

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References

  1. REACH unofficial consolidated legislation. Available from EUR-LEX [cited 2014 May 31]. Available from: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CONSLEG:2006R1907:20130701:EN:HTML
  2. OECD Harmonised Templates for Reporting Chemical Test Summaries [cited 2014 May 31]. Available from: http://www.oecd.org/ehs/templates/templates.htm
  3. REACH-IT submission portal [cited 2014 May 31]. Available from: https://reach-it.echa.europa.eu/
  4. [cited 2014 May 31] Available from: http://iuclid.echa.europa.eu/
  5. ECHA Submission Manual Part 05 – How to complete a technical dossier for registrations and PPORD notifications ECHA-12-G-34-EN. Release date April 2014 [cited 2014 May 31]. Available from: http://echa.europa.eu/
  6. ECHA Guidance on Registration. ECHA-09-G-04-EN. 09/11/2009 [cited 2014 May 31]. Available from: http://echa.europa.eu/
  7. An Illustrative Example CSR. Part 1: Introductory Note with advice on preparing a chemical safety report. ECHA-12-G-03.1-EN. November 2012 [cited 2014 May 31]. Available from: http://www.echa.europa.eu/web/guest/practical-guides
  8. ECHA Practical Guides [cited 2014 May 31]. Available from: http://www.echa.europa.eu/web/guest/practical-guides
  9. ECHA Practical examples of chemical safety reports [cited 2014 May 31]. Available from: http://www.echa.europa.eu/web/guest/support/practical-examples-of-chemical-safety-reports
  10. CEHTRA. Contact co-author Dr. Philippe Adrian for additional information. Available from: http://www.cehtra.fr/
  11. General principles of dossier preparation and submission. ECHA 2009 webinars [cited 2014 May 31]. Available from: http://eu.europa.eu/fr/support/training-material/webinars

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In the Bookstores
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Erratum

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Raquel Billiones

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Evguenia Alechine

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Victoria White

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Jennifer Bell

Clare Chang

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Joselita T. Salita

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Maria Kołtowska-Häggström

Lingua Franca and Beyond

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Lisa Chamberlain-James

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Evguenia Alechine

My First Medical Writing

Anuradha Alahari

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Tiziana von Bruchhausen

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Jennifer Morris

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Kimi Uegaki

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