Bulk Product
Any product that has completed all processing stages up to, but not including, final packaging.
Chronic Care
The ongoing provision of medical, functional, psychological, social, environmental and spiritual care services that enable people with serious and persistent health and/or mental conditions to optimise their functional independence and well-being, from the time of condition onset until problem resolution or death.
Cost-benefit Analysis
Compares the cost of a medicinal intervention to its benefit. Both costs and benefits must be measured in the same monetary units (e.g. euro, dollars).
Efficacy
Efficacy is the extent to which an intervention does more good than harm under ideal circumstances.
Fixed Dose Combination (FDC) Product
A combination of two or more active substances in a fixed ratio of doses. This term is used generically to mean a particular combination of active substances irrespective of the formulation or brand. It may be administered as single entity products given concurrently or as a finished pharmaceutical product.
Marketing Authorization Holder
The Marketing Authorization Holder holds the authorization to place a medicine on the market and is responsible for marketing it. The marketing authorization holder may be a natural or legal person.
Medication Error
Any preventable event that may cause or lead to inappropriate medication use or patient harm while the medication is in the control of the health care professional, patient, or consumer.
New Molecular Entity (NME)
It is a chemical molecule developed by the innovator company in the early discovery stage, which after undergoing clinical trials could translate into a pharmaceutical that could be a cure for some disease.
Palliative Care
The active total care offered to a person and that person’s family when it is recognized that the illness is no longer curable, in order to concentrate on the person’s quality of life and the alleviation of distressing symptoms.
Patent
A patent is a set of exclusive rights granted by a state (national government) to an inventor or their assignee for a limited period of time in exchange for public disclosure of its invention. Typically, however, a patent application must include one or more claims defining the invention which must be new, non-obvious, and useful or industrially applicable.
Pharmacopoeia
Pharmacopoeia (literally, the art of the medicine compounder), in its modern technical sense, is a book containing directions for the identification of samples and the preparation of combination products, and published by the authority of a government or a medical or pharmaceutical society.
Pharmacovigilance
Pharmacovigilance is the process and science of monitoring the safety of medicines and taking action to reduce risks and increase benefits from medicines. It is a key public health function.
Polypharmacy
The administration of many medicines at the same time or the administration of an excessive number of medicines.
Primary Care
Basic or general health care focused on the point at which a patient ideally first seeks assistance from the medical care system.
Recall
Process by which medications are removed from distribution channels and returned to the manufacturer due to safety concerns (such as inadvertent product contamination) or other product integrity concerns (including sub-potency, inappropriate labelling, etc.).
Risk-benefit Balance
An evaluation of the positive therapeutic effects of the medicine in relation to its risks (any risk relating to the quality, safety or efficacy of the medicinal product as regards patients' health or public health and any risk of undesirable effects on the environment).
Secondary Care
Services provided by medical specialists who generally do not have first contact with patients. These are typically specialists (e.g., cardiologists, urologists, dermatologists).
Self-medication
Self-medication is the treatment of common health problems with medicines especially designed and labelled for use without medical supervision and approved as safe and effective for such use.
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