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edited by AIFA’s Office of Osmed and HTA


A health professional, who may be a medical practitioner, nurse or other professional, who has the first encounter with an individual and controls the individual's entry into the health care system. [Source: WHO. A Glossary of Terms for Community Health Care and Services for Older Persons]
A physician (medical doctor) who does not limit his/her practice to certain disease categories and assumes the responsibility for the provision of continuing and comprehensive medical care or referring to another health care professional. In all EU countries, GP is treated as a specialisation. [Source: EUROSTAT. Definitions and data collection specifications on health care statistics (non-expenditure data)]
A pharmaceutical product which has the same qualitative and quantitative composition in active substances and the same pharmaceutical form as the reference medicinal product, and whose bioequivalence with the reference medicinal product has been demonstrated by appropriate bioavailability studies. The different salts, esters, ethers, isomers, mixtures of isomers, complexes or derivatives of an active substance shall be considered to be the same active substance, unless they differ significantly in properties with regard to safety and/or efficacy. In such cases, additional information providing proof of the safety and/or efficacy of the various salts, esters or derivatives of an authorised active substance must be supplied by the applicant. The various immediate-release oral pharmaceutical forms shall be considered to be one and the same pharmaceutical form. Generics can be classified in branded generics (generics with a specific trade name) and unbranded generics (which use the international non-proprietary name and the name of the company). [Source: Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use]
Generic policies include any policy in place to promote the use of generics and/or (licensed) off-patent products. It includes generic substitution, international non-proprietary name (INN) prescribing or a range of other measures.
Practice of substituting a pharmaceutical, whether marketed under a trade name or generic name (branded or unbranded generic), by a pharmaceutical, often a cheaper one, containing the same active ingredient(s). [Source WHO. A model quality assurance system for procurement agencies]
A method of hospital cost-containment in which participating hospitals must share a prospectively set budget. Method for allocating funds among hospitals may vary but the key is that the participating hospitals agree to an aggregate cap on revenues that they will receive each year.
A standard for the design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of clinical trials that provides assurance that the data and reported results are credible and accurate, and that the rights, integrity, and confidentiality of trial subjects are protected. [Source: ICH Guideline for Good Clinical Practice]
Good distribution practices are that part of quality assurance that ensure that the quality of a pharmaceutical products is maintained through adequate control throughout the numerous activities which occur during the distribution process. [Source: WHO. Good distribution practices (GDP) for pharmaceutical products]
That part of quality assurance which ensures that pharmaceutical products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the marketing authorisation. [Source: WHO. Quality assurance of pharmaceuticals. A compendium of guidelines and related materials, 1999]
The gross domestic product (GDP) is defined as the gross expenditure on the final uses of the domestic supply of goods and services valued at purchasers values less imports of goods and services. Comparisons of gross domestic products are arguably best based on purchasing power parities (PPP) and not on market exchange rates. [Source: OECD. Society at a glance, 2001]
Formation of an alliance of several purchaser to negotiate product price based on increased volume. This includes bulk procurement through a tender system, at a national or regional level. [Source: Global Conference on the Future of Hospital Pharmacy]
A systematically developed tool which describes aspects of a patient's condition and the care to be given. A good guideline makes recommendations about treatment and care, based on the best research available, rather than opinion. It is used to assist clinician and patient decision-making about appropriate health care for specific clinical conditions. [Source: NICE Glossary]
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