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Research Journal of Pharmacy and Technology
Year : 2019, Volume : 12, Issue : 12
First page : ( 6041) Last page : ( 6048)
Print ISSN : 0974-3618. Online ISSN : 0974-360X.
Article DOI : 10.5958/0974-360X.2019.01049.7

Drug Recall Procedure in ASEAN Countries

Jabeen Sara1,*, Sridhar S1,**, Balamuralidhara V2,***

1Regulatory Affairs Group, JSS Academy of Higher Education & Research, Sri Shivarathreeshwara Nagara, Mysore-570015, Karnataka, India

2Assistant Professor, Regulatory Affairs Group, Department of Pharmaceutics, JSS College of Pharmacy, JSS Academy of Higher Education & Research, Sri Shivarathreeshwara Nagara, Mysore-570015, Karnataka, India

*Corresponding Author E-mail: sarajabeen066@gmail.com

**sridhars953585@gmail.com

***baligowda@jssuni.edu.in

Online published on 24 February, 2020.

Abstract

Once the product is successfully placed in the market which after a period of time was found to pose risk to human health is required to be recalled from the market to protect the health of the public, where in, the recall of the product consist of well-established written procedures and systems to record, access, investigate and review the potential quality defects to safe guard the public health from the low quality or damaged products. The recall of the product should be effective and prompt for medicinal products and investigational medicinal product from the distribution chain and necessitate the application of quality risk principles for investigation and assessment of the quality defects. The main objective in the process of product recall from the market, regulatory authorities plays an important role in guiding manufacturers by benchmarking the standard procedure for the efficient recall of the quality defect products from the chain, the procedures & classification under which the recall falls and its timeline for the efficient recall of the product is also guided by the authority to protect the health of the public and animals in case of the veterinary products in ASEAN member countries where different recall procedures are opted. The present study highlights the comparison of recall procedure among Malaysia, Philippine, Thailand, Singapore, Vietnam which falls under ASEAN countries.

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Keywords

Recall, Regulatory Authority, Distribution chain, Malaysia, Philippine, Thailand, Singapore, Vietnam.

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