Glossary
A
The patient’s ability to obtain medical care, including medicines, and a measure of the proportion of a population that reaches appropriate health…
Initiative in which a payer provides temporary or interim funding for a particular technology or service to facilitate the collection of information…
Ingredient that alone or in combination with one or more other ingredients is considered to fulfil the intended activity of a medicine.
Synonym:…
A prospectively planned process, starting with the early authorization of a medicine in a restricted patient population, followed by iterative phases…
Adherence to long term therapy is defined as the the extent to which a person’s behaviour – taking medication, following a diet, and/or executing…
Advanced therapy medicinal products are based on manufacturing processes focussed on various gene transfer-produced bio-molecules, and/or…
A response to a medicinal product which is noxious and unintended and which occurs at doses normally used in man for the prophylaxis, diagnosis or…
The extent to which medicines and further health care products are available to the people who need them at a price they / their health system can…
Dispensation of a medicine (often generic) by the pharmacist with a different active ingredient (or combination product) but the same therapeutic…
A classification system of medicines where the active ingredients are divided into different groups according to the organ or system on which they…
Rules that prohibit agreements between market operators that would restrict competition, and the abuse of dominance, and their enforcement. …
A system where potential buyers place competitive bids on assets and services. The asset or service in question will sell to the party that places…
Government entities responsible for designing the regulatory framework and implementing policies (e.g. ministries, public agencies). In the European…
In procurement, award criterion means the criterion that the purchaser (contracting authority) uses to select the winning tender. Several award…
B
A specific quantity of material produced in a process or series of processes so that it is expected to be homogeneous within specified limits. In the…
Two medicinal products are bioequivalent if they are pharmaceutically equivalent or pharmaceutical alternatives and if their bioavailabilities after…
A characteristic that is objectively measured and evaluated as an indicator of normal biological processes, pathogenic processes, or pharmacologic…
A medicine that contains one or more active biological substances. A biological substance is produced by or extracted from a biological source and…
A biological medicine that is developed to be similar to an existing biological medicine (the 'reference medicine'). Biosimilar medicines can only be…
Practice of setting the price of a biosimilar medicine, in relationship to the reference medicine price, usually at a certain percentage lower than…