Quality assurance policy for the procurement of essential medicines and other health products. Corporate procurement policy and coordination programme.

The policy document outlines the policies and guidelines for procuring essential medicines and health products. Established to ensure the safety, efficacy, and quality of these products, the policy emphasizes the importance of quality assurance in procurement of medicines and other medical products.

The document further references several WHO standards and guidelines, including the WHO Model List of Essential Medicines, the WHO Global Atlas of Medical Devices, and the WHO Model List of Essential In Vitro Diagnostics. It underscores that all essential medicines and health products procured by procurement agencies should ideally be authorized by the relevant National Regulatory Authority (NRA) in the destination country. However, in specific contexts, such as emergencies, procurement agencies may accept government waivers or other exceptional market authorizations.

The policy sets clear criteria for the procurement of finished pharmaceutical products, prioritizing those prequalified by WHO or approved by a Stringent Regulatory Authority (SRA). It also provides guidelines for suppliers, emphasizing transparency, conflict of interest disclosures, and confidentiality considerations during procurement.

Furthermore, the document details the roles and responsibilities of the WHO Quality Assurance Group, an internal body focused on ensuring the quality of procured products. This policy aims to harmonize with the quality assurance policies of other UN agencies and international organizations, promoting consistent quality assessment tools and procedures within the UN system. These quality assurance systems can also be adopted by any procurement agency.