How do specialized import stores build their supply chain and deal with import regulations?

Alfonso Llanes, Master Degree in International Development

Answered just now

In general, recommendations for the importer can be found at: http://www.regulations.gov.

A specialized store needs to determine the regulatory agency that would oversee the business operation while considering that products fall under different classifications that must match the agency with oversight authority.

Guidance Documents Published by the International Council for Harmonization (ICH)

International Council for Harmonization - Efficacy

International Council for Harmonization - Joint Safety/Efficacy (Multidisciplinary)

International Council for Harmonization - Quality

International Council for Harmonization - Safety

· Know the foreign firms that produce the products they purchase and any other firms with which they do business and through which such products pass (e.g., consolidators, trading companies, distributors);

· Understand the products that they import and the vulnerabilities associated with these products;

· Understand the hazards that may arise during the product life cycle, including all stages of production; and

· Ensure proper control and monitoring of these hazards.

These Good Importer Practices are broadly organized under four guiding principles:

· Establishing a Product Safety Management Program;

· Knowing the Product and Applicable U.S. Requirements;

· Verifying Product and Firm Compliance with U.S. Requirements throughout the Supply Chain and Product Life Cycle; and

· Taking Corrective and Preventive Action When the Imported Product or Firm Is Not Compliant with U.S. Requirements.

Control, Monitor, and Verify Product Compliance during Entry.

· Conduct a risk-based monitoring program of incoming products to target your resources where they will likely have the greatest positive impact on product safety. Such a program could include the following:

· Examination of shipping records;

· Examination of certifications, certificates of analysis, letters of guarantee, etc.;

· Physical examination of the product, packaging, and labeling; and

· Risk-based product sampling and testing by the importer or an independent third party, to ensure the product is authentic, and meets company specifications and U.S. requirements. Importers should use appropriately accredited laboratories.

Each product is classification falls under applicable regulations as follows:

Product Category

Relevant Agency

Applicable Law

Roles & Responsibilities

Websites