Comparative Study of Legal Requirements and International Standards Governing the Packaging of Medicines and Medical Equipments

Document Type : Scientific Paper

Authors

1 Ph.D of Law and Doctor Dentistry, Virtual University of Medical Sciences, Tehran, Iran

2 Master of International Trade Law, Islamic Azad University, Pardis

3 Basic Lawyer of a Justice, Tehran, Iran

Abstract

Globalization in the field of health means the development, implementation and harmonization of the rules and technical standards of health-oriented goods, including medicine, medical equipment and cosmetics, which are linked to the obligations of international trade and domestic trade regulations. Packaging is an essential element of any export operation that affects not only the safety, but also the costs, communications and even marketing of a product. The exporter is always responsible for export packaging and must ensure that the packaging of the product is based on “Incoterms” (“International Commercial Terms”: used to separate costs and responsibilities between the seller and the buyer) and will prevent damage to the product. Due to the importance of packaging health-oriented goods to human health, the World Trade Organization, the Food and Drug Administration, and the World Standardization Organization have set specific guidelines, regulations, and standards for the packaging of goods in global trade. Research has been conducted on them. In order to define the position of packaging in the international legal system and determine the legal duties of producers; In this scientific research, first of all, the importance of packaging in international trade and the responsibilities and rights of producers and their adherence to the laws of the US Food and Drug Administration and the World Trade Organization have been discussed and compared with different countries. Improving and expanding the position of packaging in the Iranian legal system, in particular, will create a strong rule in the country's Food and Drug Administration.

Keywords


1. افراسیابی، ن؛ (اسفندماه 1389). «بسسته بندی»، انتشارات شرکت سهامی نمایشگاه های بین المللی.##
2. کاتلر، ف؛ آرمسترانگ، گ؛ (1376). «اصول بازاریابی»، ترجمه بهمن فروزنده، انتشارات آترپات.##
3. Philip Kotler, Gary Armstrong (2008) “Principles of marketing, 12th edition,” Pearson education Inc.##
4. Draskovic Nikola, (2018). “Comparative perceptions of consumer goods packaging: Croatian consumers's perspectives,” international journal of management Cases.##
5. Edward Goldberg,(1995). “Improvement of packaging as one of the key terms of the efficient economy development,” A Thesis submitted to the Department of Packaging Science College of Applied Science and Technology.##
6. Nityanand zadbuke, Sadhana shahi, (2-013). “Bhushan gulecha, abhay padalkar, and mahesh thube,” Journal of Pharmacy.
7. Shabani, Faton, (2015). “Non-conformity of goods in light of the united nations convention on contracts for the international## sale of goods and the law on obligations of the republic of macedonia as part of south-eastern european law,” Academic Journal of Interdisciplinary Studies MCSER Publishing, Vol 4##
8.Indira Carr, (2010). “International trade law,” 4th Edithin, Routledge. Cavendish.##
9. Dillon, Sara, (2002). “International trade and economic how and uropean unicon,” Hart Publishing.##
10. Honnold, John O. (1999). “Uniform Law for International sales under the 1980 United nations convention,” 3rd ed.##
11. Graham dukes, (2006). “The law and ethics of the pharma ceytical industry,” Elsevier.##
12.Mehta Kunal etc, (2017). “Recent trends in pharmaceutical”, Packaging: A Review: internatonal Journal in pharmaceutical and chemical Sciences.##
13. Adam Page, Nick Waite (2006). “Packaging legislation and regulations for cosmetics and toiletries,” Pira International Ltd, UK.##
14 Adam Page, Nick Waite, (2006). “Packaging Legislation and Regulations for Pharmaceuticals,” Nick Waite (Editor), Pira International Ltd, UK.##
15. Mazitova, Nailya N.; Simonova, Nadejda I.; Onyebeke, Lynn C.; Moskvichev, Andrey V.; Adeninskaya, Elena E.; Kretov, Andrey S.; Trofimova, Marina V.; Sabitova, Minzilya M.; Bushmanov, Andrey Yu .(1 July 2015). “Current Status and Prospects of Occupational Medicine in the Russian Federation”. Annals of Global Health.##
16. Yuliya Vinogradova, (2014). “Russia: Registration of medical devices and equipment, U.S. Department of commerce.” http://files.export.gov/x_1358142.pdf.##
17. Nick Waite. (2006). “Packaging legislation and regulations for medical devices,” Pira international Ltd, UK.##
18. Japan Pharmaceutical Manufacturers Association (2018). “Pharmaceutical administration and regulations in Japan, Japan pharmaceutical manufacturers association.” http://www.jpma.or.jp/english/parj/pdf/2018.pdf.##
19. Nadipineni Ashok Kumar* , Dileep KG, Ravindra CK, Suthakaran R, (2014). “An overiew of chinese drug regulatory system: Areview”, International Journal of Drug Regulatory Affairs; 2014, 2(3), 14-18.##
20. Nupur Chowdhury, Pallavi Joshi, Arpita Patnaik, Beena Saraswathy. (2015). “Administrative structure & functions of drug regulatory authorities in India,” Indian Council for Research on International Economic Relations.##