Evaluation of Nano-Packagings Guidline for Pharmaceutical Products in According to Pharmacopeia and International Legistalations

Document Type : Original Article

Authors

1 Faculty of Pharmacy, Islamic Azad University, Pharmaceutical Sciences Branch, Tehran, Iran

2 Food and Drug Laboratory Research Center, Food and Drug Administration, Ministry of Health and Medical Education, Tehran, Iran

Abstract

The pharmaceutical industry has achieved significant gains through nanotechnology. Nowadays, due to the use of nanotechnology, there are thousands of nano-products on the market for human use, but there is still little information about health hazards and health data or toxicity profiles. In many countries, especially Iran, due to the uncertainty in existing policies and regulations, no action has been taken to provide a specific pattern for nanotechnology process products, especially in the packaging industry.

Keywords

References

1.تاج الدین, ب. رمدانی، ن.(۱۳۹۳)، «نانو، فنّاوری نوین در بسته­بندی - معایب و مزیت­ها»، بیست و دومین کنگره ملّی علوم و صنایع غذایی، گرگان، دانشگاه علوم کشاورزی و منابع طبیعی گرگان، دسترس در:
https://www.civilica.com/Paper-NCFOODI22-NCFOODI22_127.html
2. سازمان غذا و دارو ایران، (آبان ماه 1394)، «چک لیست ارزیابی پرونده مواد اولیه ظروف بسته­بندی مواد غذایی بر پایه فنّاوری نانو قابل دسترس در» :
http://www.fda.gov.ir/item/2207
3. EPA; nanoparticle , available at :http://epa.gov/ncer/nano/questions/index.html
4. Scientific Basis for the Definition of the Term “Nanomaterial”, 6 July 2010 , available at :
http://ec.europa.eu/health/scientific_committees/emerging/docs/scenihr_o_030.pdf.
5. Europen commission, )2009(, “Guideline on the readability of the labelling and package leaflet of medicinal products for human use,” Amendment of Directive 2001/83/EC by Directive 2004/27/EC.
6. European commission, (2015), “Guideline on the packaging information of medical product for human use aphorized”, by the union Directive 2012/26/EU1 and Regulation (EC) No726/2004 as amended for the last time by Regulation (EU) No 1027/20122).
7. Commission Regulation (EU) No. 10/2011 of 14 of January (2011). “on Plastic Materials and Articles Intended to Come in Contact with Food”. Official Journal of the European Union.
8. EMEA,(European Medicines Evaluation Agency)-London, 19 May 2005. EMEA/CVMP/205/04.
9.http://www.safenano.org/knowledgebase/regulation/substances/eu-reach-clp-regulations/.
10. FDA, (June 2014), “draft guidance for industry considering whether an FDA regulated product involves the application of nanotechnology available”. at:https://www.fda.gov/downloads/regulatoryinformation/guidances/ucm401695.pdf .
11. Mark n duvall, (2012). “FDA Regulation of nanotechnology,”.
12. FDA, FDA (February 2012). “Regulation of Nanotechnology,available at:” http://www.bdlaw.com/assets/attachments/323.pdf
13. FDA- Guidance for Industry Safety of Nanomaterials in Cosmetic Products June (2014).
14. WHO, (2002). “Annex 9– WHO  Technical Report Series ,”. No. 902.
15. REACH- RNC/RIP-oN2/FPR/1/Final 01 July 2011.
16. TGA (May 2011). “labelling and packaging regulatory framework ,” https://www.tga.gov.au/tga-labelling-and-packaging-regulatory-framework.

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History

  • Receive Date: 22 May 2018
  • Revise Date: 23 August 2018
  • Accept Date: 23 August 2018
  • Publish Date: 23 August 2018

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