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Procurement of Pharmaceutical Products
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Page 211
Other than questions relating to patents and international agreements dealt with in Chapter 11 on procurement of antiretroviral medicines (ARVs), other medicines required in the care of people with HIV, and related products (such as testing kits) may pose special issues as a result of national regulatory requirements, restricted sources of supply, or the government's participation in the Clinton Foundation's procurement scheme.
The law of most countries provides that only pharmaceutical products approved by the national drug regulatory authority (frequently referred to as "registered" drugs) may be imported into or sold within the country. Consequently, suppliers of pharmaceutical products should always be required to demonstrate compliance with national registration requirements as a condition for contract effectiveness. Countries may provide a fast-track registration process for certain types of drugs (life-saving drugs, unique drugs for which no alternatives exist, or well-established generics).
Because the national drug regulatory authorities of many countries have limited technical capacity, the Bank's prequalification requirements will typically include the condition that the product be prequalified under the WHO-administered United Nations Procurement Quality and Sourcing Project, or authorized under the Pharmaceutical Inspection Convention, the Pharmaceutical Inspection Cooperation Scheme, or the International Conference on Harmonization of Technical Requirements for the Registration of Pharmaceuticals for Human Use. (Pharmaceutical Inspection Convention and Pharmaceutical Inspection Cooperation Scheme: http://www.picscheme.org/index.htm and International Conference on Harmonization of Technical Requirements for the Registration of Pharmaceuticals for Human Use: http://www.ich.org)
Due to supply limitations resulting from patents and registration requirements, many ARVs and related products are single-source or limited source products for procurement purposes. International or national competitive bidding, with or without prequalification, is, therefore, not the rule. Depending on the circumstances, limited international bidding, shopping, direct contracting or procurement through specialized UN agencies, may be the indicated procurement methods. Detailed guidance is provided in the...
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