Definitions

Health Product Management refers to all activities required to ensure the continuous and reliable availability of quality-assured health products, to achieve programmatic targets, while adhering to the procurement principles of UNDP. It comprises six basic functions (Product selection, Forecasting/Quantification, Procurement, Storage and Inventory Management, Distribution, Rational Use) and is supported by management systems (Planning and administration, Organization and management, Information management, Human resources management) as well as policy and legal frameworks.

Health procurement, in the context of this document, refers to all activities associated with the sourcing and purchasing of health products.

Health products includes: (i) pharmaceutical products; (ii) diagnostic products; (iii) vector control products; and (iv) consumable/single-use health products, including products such as PPE, condoms, insecticides, therapeutic nutritional support, general laboratory items and injection syringes.

Diagnostic products includes: any durable and non-durable in-vitro diagnostic product and microscopes and imaging equipment used for diagnosis, screening, surveillance or monitoring purposes.

In-vitro diagnostic products includes: a medical device, whether used alone or in combination with other devices, intended by the manufacturer for in-vitro examination of specimens derived from the human body solely or principally to provide information for diagnostic, monitoring or compatibility purposes including, reagents, calibrators, control materials, specimen receptacles, software, and related instruments, apparatus and other articles (Global Harmonization Task Force Document SG1/N045:2008).

Medical device includes: any instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, software, material or other similar or related article, intended by the manufacturer to be used, alone or in combination, for human beings, for one or more of the specific medical purpose(s) of:

• diagnosis, prevention, monitoring, treatment or alleviation of disease,
• diagnosis, monitoring, treatment, alleviation of or compensation for an injury,
• investigation, replacement, modification, or support of the anatomy or of a physiological process,
• supporting or sustaining life,
• control of conception,
• disinfection of medical devices,
• providing information by means of in vitro examination of specimens derived from the human body;

and does not achieve its primary intended action by pharmacological, immunological or metabolic means, in or on the human body, but which may be assisted in its intended function by such means.

Quality assurance, refers to all measures taken from manufacturing processes to selection and the use of health products, including Quality Monitoring, to ensure that the products are of the quality required for the manufacturer’s intended (registered) use.

Quality control is one part of quality assurance and is concerned with sampling, specifications and testing, and with the procurement agency’s documentation and acceptance/rejection procedures which ensure that the necessary and relevant tests are carried out and that products are not accepted for use, sale or supply until their quality has been judged to be satisfactory.

National Pharmaceutical Policy (NPP), most national health authorities have adopted their own NPP which defines the key principles and responsibilities for regulation and the quality assurance requirements for health products circulating in the country. The NPP is usually complemented by a NPP implementation plan which describes, for each policy component, the responsibilities and main activities.

National Regulatory Authority, is the national body that administers the full spectrum of regulatory activities for pharmaceuticals and other health products, including – for example – the following functions: Registration and Marketing Authorization, Pharmacovigilance, Market Surveillance and Control, Licensing Establishments, Regulatory Inspections, Laboratory Testing (Quality control), Clinical Trials Oversight, and NRA Lot (batch) Release.

Insecticide Treated Nets (ITNs): the umbrella term for all nets treated with an insecticide, insect-growth regulator and/or synergist. The term long-lasting insecticide treated net (LLIN) is only being used for ITN classes for which physical and chemical durability have been comprehensively demonstrated against the WHO thresholds of 20 washes and 3 years of use in the field. In practice, this means that only nets treated with a pyrethroid insecticide alone are presently referred to as LLINs in the WHO Guidelines. Other nets which are now prequalified include nets containing “a pyrethroid insecticide and the synergist piperonyl butoxide” (PBO nets), and nets containing “two active ingredients” (dual ai nets).