Repackaging
This article was originally published in SRA
Executive Summary
Korean wholesalers to be banned from repackaging medicines into smaller packs
Korean wholesalers to be banned from repackaging medicines into smaller packs
From 7 October, the Korea Food and Drug Administration (KFDA) will ban wholesalers from opening primary pharmaceutical containers so as to split them into smaller pack sizes. Since the implementation of regulations in July 2000 on the “separation of dispensing from prescribing”, the government has permitted wholesalers to repackage medicines to meet pharmacies' demand. For example, they may open containers/packs of 100 tablets, and split them into ten separate packs of ten tablets per pack. However, many problems have arisen, including noncompliance with good manufacturing practices.
In 2004, the Ministry of Health and Welfare drafted a proposal to prohibit this activity in compliance with the Pharmaceutical Affairs Law1. The prohibition was announced in October 2005, with a two-year grace period2.
Korea also implemented rules in October 2006 that require manufacturers and importers to provide pharmacies with small product packs, in order to save drug purchase costs and minimise surplus stock for retail pharmacies3.
KUKWHAN CHOI
References
1. The Regulatory Affairs Journal - Pharma, 2004, 15(5), 369
2. KFDA announcement, 7 October 2005
3. The Regulatory Affairs Journal - Pharma, 2005, 16(8), 601