Finished Pharmaceutical Product (FPP) means a medicine presented in its finished dosage form that has undergone all stages of production, including packaging in its final container and labelling. 

Medical devices include 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, 
• cleaning, disinfection or sterilization of medical devices, 
• providing information by means of in vitro examination of specimens derived from the human body, 

and which 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. 

The term “medical device” covers a wide range of products with different level of risk, such as: tongue depressor, crutches, catheter, pace-maker, nuclear magnetic resonance apparatus (NMR), intraocular implant, heart valve, thermometer, suture or in-vitro diagnostic tests: blood grouping test, malaria rapid test or blood glucose monitoring device. 

Acute malnutrition is a form of under-nutrition caused by a decrease in food consumption and/or illness that results in sudden weight loss or oedema. Acute malnutrition can be moderate or severe and, in humanitarian settings, is treated with a combination of community-based management and therapeutic foods/Ready-to-Use Therapeutic Foods (RUTFs). The purchase of such therapeutic foods has to comply with the quality standards outlined in Annex 5 of the Grant Agreement.

A FPP is pre-qualified if authorised for use by the National Medicine Regulatory Authorities (NMRA) in the country where it will be used (market authorisation or import permit) and 

• if pre-qualified by the WHO Pre-qualification programme; 
• or if authorised for use by a Stringent Regulatory Authority (SRA); 
• or at least if the manufacturing site demonstrates compliance with the European Union (EU) Guidelines to Good Manufacturing Practice of Medicinal Products for Human and Veterinary Use or with WHO’s Good Manufacturing Practice for pharmaceutical products (GMP) to a Stringent Inspectorate Body or a qualified expert. 

The proof of quality of FPP that Partners need to record in their files must be issued by:

• the WHO pre-qualification programme; or
• a Stringent Regulatory Authority (market authorisation); or
• a Stringent Inspection Body (GMP certificate); or
• a qualified expert (GMP report); or
• an HPC. 

For medical devices, the quality criteria should be aligned to the risk classification. The medical devices of the lowest risk classification can be purchased according to the specifications described by the humanitarian organisation and without further investigation.

A medical device of other risk classification is pre-qualified: 

• if pre-qualified by WHO Pre-qualification Programme (for IVD and male circumcision devices); or
• if it is pre-qualified by UNFPA (condoms and Intrauterine Contraceptive Devices (IUD)); or
• if authorised for use by one of the regulatory authorities of the funding members of the GHTF (Australia, Canada, EU, Japan and USA); or
• if the manufacturer demonstrates implementation of the Quality Management System (QMS) to a Conformity Assessment Body recognised to one of the GHTF country funding members or a qualified expert. 

The proof of quality of medical devices that Partners need to record in their files must be issued by:

• the WHO pre-qualification programme (for IVD and male circumcision device); or
• UNFPA (condoms and IUD); or
• a Notified Body (if the product is CE marked) or the regulatory authorities of USA, Japan, Canada or Australia; or
• a conformity assessment body recognised by one of the five countries from the member of GHTF; or
• a qualified expert; or
• an HPC.