WHO TRS (Technical Report Series) 1019, 2019 Annex 5

WHO TRS (Technical Report Series) 1019, 2019 Annex 5

Guidelines on import procedures for medical products

1. Introduction:

1.1 Public health considerations demand that medical products should not be treated in the same way as ordinary commodities. Their manufacture and subsequent handling within the distribution chain, both nationally and internationally, must conform to prescribed standards and be rigorously controlled. These precautions serve to assure that patients receive quality assured medical products, and to prevent the infiltration of substandard and suspected falsified medical products into the supply system.

1.2 The availability of medical products is sometimes limited, owing to economic constraints, difficulty in meeting norms and standards in their production, and lack of resources in their supply chain. These conditions lead to market penetration by substandard and suspected falsified medicines, which poses hazards for public health and forces the diversion of public health resources from other uses. In light of this, investments towards strengthening strategies at the customs level are deemed crucial to ensure quality-assured medical products for patients (1, 2).

1.3 The global economy of scale and scope that characterizes modern trade requires continuous improvement in border control. This includes a departure from the traditional reactive control system to a risk-based and proactive approach. A country’s risk-based surveillance scheme should identify risks and define the controls that will protect patients from substandard, falsified and unregulated medical products. A risk-based approach can improve the cost–benefit ratio with existing or reduced resources, through more effective and efficient controls. These guiding principles were endorsed in 1994 by the World Health Assembly in resolution WHA47.17 as having global relevance (3).

1.4 Within the context of its revised medicines strategy adopted in 1986 by the Thirty-ninth World Health Assembly in resolution WHA39.27 (4), the World Health Organization (WHO) developed National drug regulatory legislation: guiding principles for small drug regulatory authorities (5), which established a regulatory approach in line with the resources available within a small national regulatory authority (NRA), and were intended to assure not only the quality, but also the safety and efficacy of medical products distributed under its aegis.

1.5 The principles emphasize the need for the effective use of the WHO Certification Scheme on the Quality of Pharmaceutical Products Moving in International Commerce (6, 7). This constitutes a formal agreement between participating Member States to provide information on any medical products under consideration for export, notably on its marketing authorization in the country of origin and whether or not the manufacturer complies with the WHO good manufacturing practices for pharmaceutical products (8).

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WHO TRS (Technical Report Series) 1019, 2019 Annex 5:

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