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Research Journal of Pharmacy and Technology
Year : 2018, Volume : 11, Issue : 11
First page : ( 4875) Last page : ( 4877)
Print ISSN : 0974-3618. Online ISSN : 0974-360X.
Article DOI : 10.5958/0974-360X.2018.00887.9

Regulatory Labeling Requirements and its Labeling Comparison between US and EU

Sravanthi Vasa Lakshmi*, Kamaraj Raju

Department of Pharmaceutical Regulatory Affairs, SRM College of Pharmacy, SRM Institute of Science and Technology, Kattankulathur-603203, Kanchipuram, Tamil Nadu, India

*Corresponding Author E-mail: vasasravanthi1111@gmail.com

Online published on 30 January, 2019.


Label means any written, graphic or printed matter on the immediate container or a wrapper of a drug package. The product label is very important when compared to all other aspects and plays a very important role in the documentation. Also product labeling plays very important role in product safety standards. Labeling regulations should not be neglected and if so it may result product get refused or subject to a forced recall. The information provided in a label is useful for all the health care professionals and consumers. The correct labeling methods may avoid many medication related errors. The review of this article is to provide information regarding regulations in labeling in the US, EU-and give an explanation regarding how to design the label and the difference in the labeling of product between US and EU.



Label, regulation, US, Europe, Product safety.


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