Recalls
This article was originally published in SRA
Executive Summary
Argentina introduces new recall procedures for pharmaceuticals
Argentina introduces new recall procedures for pharmaceuticals
The Argentinan National Medicines, Food and Medical Technology Administration, Anmat, has introduced a new regulation that sets out definitions, responsibilities and procedures that pharmaceutical companies should follow when recalling a product1. Manufacturers, importers, exporters and distributors that do not comply may face legal sanctions.
Anmat Disposition 1402/2008, which came into effect on 20 March, updates the requirements on recall management, follow-up and audits. The regulation comprises seven sections (introduction, definitions, recall effectiveness, recall strategy, publications, responsibilities, recall follow-up and recall completion) and revises the existing pharmaceutical good manufacturing practice regulations (Disposition No 2819/04).
Although the GMP regulations had a section on product recalls, they did not provide sufficient detail with respect to the recall procedures. The section simply said that, as a principle, pharmaceutical companies should arrange a recall system in order to be able to effectively and quickly recover a defective product, or when there is doubt as to its quality. The new regulation also applies to manufacturers, importers, exporters and distributors of personal hygiene products, cosmetics and perfumes.
In developing the new regulation, Anmat took into consideration the recall procedures in Canada and the US.
MIGUEL JC NAPOLITANO
References
1. Anmat Disposition 1402/2008, Boletín Oficial de la República Argentina, No 31.369, 19 March 2008