| Abuse of medicinal products | Persistent or sporadic, intentional excessive use of medicinal products which is accompanied by harmful physical or psychological effects. |
| Adverse event | Any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment [Dir 2001/20/EC Art 2(m)]. An adverse event can therefore be any unfavourable and unintended sign (e.g. an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. |
| Adverse drug reaction - ADR | A response to a medicinal product which is noxious and unintended [DIR 2001/83/EC Art 1(11)]1.Response in this context means that a causal relationship between a medicinal product and an adverse event is at least a reasonable possibility (see Annex IV, ICH-E2A Guideline).Adverse reactions may arise from use of the product within or outside the terms of the marketing authorisation or from occupational exposure [DIR 2001/83/EC Art 101(1)]. Conditions of use outside the marketing authorisation include off-label use, overdose, misuse, abuse and medication errors. |
| Clinical trial | Any investigation in human subjects intended to discover or verify the clinical, pharmacological and/or other pharmacodynamic effects of one or more investigational medicinal product(s), and/or to identify any adverse reactions to one or more investigational medicinal product(s) and/or to study absorption, distribution, metabolism and excretion of one or more investigational medicinal product(s) with the objective of ascertaining its (their) safety and/or efficacy. This includes clinical trials carried out in either one site or multiple sites, whether in one or more Member State [Dir 2001/20/EC Art 2(a)].Ongoing clinical trial: trial where enrolment has begun, whether a hold is in place or analysis is complete, but for which a final clinical study report is not available (see ICH-E2F Guideline, Volume 10 of the Rules Governing Medicinal Products in the EU).Completed clinical trial: study for which a final clinical study report is available (see ICH-E2F Guideline, Volume 10 of the Rules Governing Medicinal Products in the EU). |
| Common name | The international non-proprietary name recommended by the World Health Organization, or, if one does not exist, the usual common name. |
| Compassionate use of a medicinal product | Making a medicinal product available for compassionate reasons to a group of patients with a chronically or seriously debilitating disease or whose disease is considered to be life-threatening, and who cannot be treated satisfactorily by an authorised medicinal product (the medicinal product concerned must either be subject of an application for a central marketing authorisation or must be undergoing clinical trials) [REG (EC) No 726/2004 Art 83(2)]. |
| Deliverable | In the TEDDY project plans or “Work Packages”, particular outcomes or “deliverables” are expected. On the website we list them as Results, and you can see when they are scheduled. You may also be able to access those results, depending on the dissemination policy assigned and what kind of a user you are. |
| Ethics Committee | An independent committee, generally set up at the level of a hospital, consisting of healthcare professionals and nonmedical members, whose responsibility it is to protect the rights, safety and wellbeing of human subjects involved in a trial by approving, reviewing and monitoring clinical trials. |
| EUDRAGENE | An EU-funded pharmacogenetic project on adverse drug reactions |
| Generic medicinal product | A medicinal 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 [REG (EC) No 726/2004 Art 10(2)(b)]. |
| Good Clinical Practice (GCP) | A set of internationally recognized ethical and scientific quality requirements which must be observed for designing, conducting, recording and reporting clinical trials that involve the participation of human subjects. Compliance with this good practice provides assurance that the rights, safety and well-being of trial subjects are protected, and that the results of the clinical trials are credible [Dir 2001/20/EC Art 1(2)]. |
| EU Good pharmacovigilance practices (GVP) | A set of guidelines for the conduct of pharmacovigilance in the EU by the European Medicines Agency in cooperation with competent authorities in Member States and interested parties, and applying to marketing authorisation holders in the EU, the Agency and competent authorities in Member States [Dir 2001/83/EC Art 108(a)]. |
| Herbal medicinal product | Any medicinal product, exclusively containing as active ingredients one or more herbal substances or one or more herbal preparations, or one or more such herbal substances in combination with one or more such herbal preparations [DIR 2001/83/EC Art 1(30)]. |
| Herbal preparations | Preparations obtained by subjecting herbal substances to treatments such as extraction, distillation, expression, fractionation, purification, concentration or fermentation. These include comminuted or powdered herbal substances, tinctures, extracts, essential oils, expressed juices and processed exudates [DIR 2001/83/EC Art 1(32)]. |
| Herbal substances | All mainly whole, fragmented or cut plants, plant parts, algae, fungi, lichen in an unprocessed, usually dried, form, but sometimes fresh. Certain exudates that have not been subjected to a specific treatment are also considered to be herbal substances. Herbal substances are precisely defined by the plant part used and the botanical name according to the binomial system (genus, species, variety and author) [DIR 2001/83/EC Art 1(31)]. |
| Homeopathic medicinal product | Any medicinal product prepared from substances called homeopathic stocks in accordance with a homeopathic manufacturing procedure described by the European Pharmacopoeia or, in the absence thereof, by the pharmacopoeias currently used officially in the Member States. A homeopathic medicinal product may contain a number of principles [DIR 2001/83/EC Art 1(5)]. |
| Immediate packaging | The container or other form of packaging immediately in contact with the medicinal product |
| Immunological medicinal product | Any medicinal product consisting of vaccines, toxins, serums or allergen products: (a) vaccines, toxins and serums shall cover in particular: (i) agents used to produce active immunity, such as cholera vaccine, BCG, polio vaccines, smallpox vaccine; (ii) agents used to diagnose the state of immunity, including in particular tuberculin and tuberculin PPD, toxins for the Schick and Dick Tests, brucellin; (iii) agents used to produce passive immunity, such as diphtheria antitoxin, anti-smallpox globulin, antilymphocytic globulin; (b) “allergen product” shall mean any medicinal product which is intended to identify or induce a specific acquired alteration in the immunological response to an allergizing agent [DIR 2001/83/EC Art 1(4)]. |
| Investigational drug | Experimental product under study or development. This term is more specific than investigational medicinal product, which includes comparators and placebos (see ICH-E2F Guideline, Volume 10 of the Rules Governing Medicinal Products in the EU). |
| Investigational medicinal product | An investigational medicinal product is a pharmaceutical form of an active substance or placebo being tested or used as a reference in a clinical trial, including products already with a marketing authorisation but used or assembled (formulated or packaged) in a way different from the authorised form, or when used for an unauthorised indication, or when used to gain further information about the authorised form [Dir 2001/20/EC Art 2(d)]. |
| Labelling | Information on the immediate or outer packaging [DIR 2001/83/EC Art 1(25)]. |
| Medicinal prescription | Any medicinal prescription issued by a professional person qualified to do so. |
| Medicinal product | Any substance or combination of substances presented as having properties for treating or preventing disease in human beings; or which may be used in or administered to human beings either with a view to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or to making a medical diagnosis [DIR 2001/83/EC Art 1(2)]. |
| Medicinal products derived from human blood or human plasma | Any medicinal product based on blood constituents which is prepared industrially by a public or private establishment, such as a medicinal product including, in particular, albumin, coagulating factor(s) and immunoglobulin(s) of human origin [DIR 2001/83/EC Art 1(10)]. |
| Misuse of a medicinal product | Situations where the medicinal product is intentionally and inappropriately used not in accordance with the authorised product information. |
| Misuse of a medicinal product for illegal purposes | Misuse for illegal purposes is misuse with the additional connotation of an intention of misusing the medicinal product to cause an effect in another person. This includes, amongst others: the sale, to other people, of medicines for recreational purposes and use of a medicinal product to facilitate assault. |
| Name of the medicinal product | The name which may be either an invented name not liable to confusion with the common name, or a common or scientific name accompanied by a trade mark or the name of the marketing authorisation holder [DIR 2001/83/EC Art 1(20)].The common name is the international non-proprietary name (INN) recommended by the World Health Organization, or, if one does not exist, the usual common name [DIR 2001/83/EC Art 1(21)].The complete name of the medicinal product is the name of the medicinal product followed by the strength and pharmaceutical form. |
| Non-interventional study | A post-authorisation safety study fulfilling cumulatively the following requirements: the medicinal product is prescribed in the usual manner in accordance with the terms of the marketing authorisation; the assignment of the patient to a particular therapeutic strategy is not decided in advance by a trial protocol but falls within current practice and the prescription of the medicine is clearly separated from the decision to include the patient in the study; and no additional diagnostic or monitoring procedures are applied to the patients and epidemiological methods are used for the analysis of collected data. Non-interventional studies are defined by the methodological approach used and not by the scientific objectives. Non-interventional studies include database research or review of records where all the events of interest have already happened (this may include case-control, cross-sectional, cohort and other study designs making secondary use of data). Non-interventional studies also include those involving primary data collection (e.g. prospective observational studies and registries in which the data collected derive from routine clinical care), provided that the conditions set out above are met. In these studies, interviews, questionnaires and blood samples may be performed as normal clinical practice. Non-interventional studies do not fall in the scope of Directive 2001/20/EC. |
| Off-label use | All uses of a marketed drug not detailed in the SPC including therapeutic indication, use in age-subsets, appropriate strength (dosage), pharmaceutical form and route of administration |
| Overdose | Administration of a quantity of a medicinal product given per administration or cumulatively which is above the maximum recommended dose according to the haracteri product information. Clinical judgement should always be applied. |
| Outer packaging | The packaging into which the immediate packaging is placed. |
| Package leaflet – PL | A leaflet containing information for the user which accompanies the medicinal product [Dir 2011/83/EC Art 1(26)]. The PL contains the same information as the SmPC but is written in a patient friendly language |
| PDCO – Paediatric Committee | A committee set up at the European Medicines Agency whose main responsibility of the PDCO is to assess the content of paediatric investigation plans and adopt opinions on them in accordance with Regulation (EC) 1901/2006 as amended. This includes the assessment of applications for a full or partial waiver and assessment of applications for deferrals |
| Periodic safety update reports | The periodical reports containing the records referred to in Article 104, Dir 2001/83/EC |
| Pharmacovigilance | Science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine-related problem (see “The importance of pharmacovigilance”, WHO).In line with this general definition, underlying objectives of pharmacovigilance in accordance with the applicable EU legislation for are: preventing harm from adverse reactions in humans arising from the use of haracteri medicinal products within or outside the terms of marketing haracterizes or from occupational exposure; and promoting the safe and effective use of medicinal products, in particular through providing timely information about the safety of medicinal products to patients, healthcare professionals and the public. Pharmacovigilance is therefore an activity contributing to the protection of patients’ and public health. |
| Pharmacovigilance system | A system used by the marketing haracterizes holder and by Member States to fulfil the tasks and responsibilities listed in Title IX of Directive 2001/83/EC and designed to monitor the safety of haracteri medicinal products and detect any change to their risk-benefit balance [DIR 2001/83/EC Art 1(28d)].In general, a pharmacovigilance system is a system used by an haracterize to fulfil its legal tasks and responsibilities in relation to pharmacovigilance and designed to monitor the safety of haracteri medicinal products and detect any change to their risk-benefit balance. |
| Placebo | A simulated or otherwise medically ineffectual treatment that is used in clinical trials used to compare with the active treatment. A placebo is made up of an inert and innocuous substance to look like the active treatment. |
| Post-authorisation safety study – PASS | Any study relating to an authorised medicinal product conducted with the aim of identifying, characterising or quantifying a safety hazard, confirming the safety profile of the medicinal product, or of measuring the effectiveness of risk management measures [DIR 2001/83/EC Art 1(15)].A post-authorisation safety study may be an interventional clinical trial or may follow an observational, non-interventional study design. |
| Post-authorisation safety and efficacy studies – PASS/PAES | A PASS is a study of an haracteri medicine which identifies, haracterizes or quantifies a safety hazard, confirms the safety profile of the medicine, or gauges the effectiveness of risk management measures during its lifetime.A PAES aims to clarify the efficacy for a medicine on the market including efficacy in everyday medical practice.The purpose of the information in a PASS/PAES is to support regulators in decision-making on the safety and benefit-risk profile of a medicine. |
| Proprietary medicinal product | Any ready-prepared medicinal product placed on the market under a special name and in a special pack |
| Public service obligation | The obligation placed on wholesalers to guarantee permanently an adequate range of medicinal products to meet the requirements of a specific geographical area and to deliver the supplies requested within a very short time over the whole of the area in question. |
| PUMA- Paediatric-use Marketing Authorisation | A new type of marketing authorisation that may be requested for a medicine which is already authorised, but no longer covered by intellectual property rights (patent, supplementary protection certificate), and which will be exclusively developed for use in children. |
| Radionuclide generator | Any system incorporating a fixed parent radionuclide from which is produced a daughter radionuclide which is to be obtained by elution or by any other method and used in a radiopharmaceutical |
| Radionuclide kit | Any preparation to be re-constituted or combined with radionuclides in the final radiopharmaceutical, usually prior to its administration. |
| Radionuclide precursor | Any other radionuclide produced for the radio-labelling of another substance prior to administration. |
| Radiopharmaceutical | Any medicinal product which, when ready for use, contains one or more radionuclides (radioactive isotopes) included for a medicinal purpose |
| Representative of the marketing authorisation holder | The person, commonly known as local representative, designated by the marketing authorisation holder to represent him in the Member State concerned |
| Risk to public health | All risks with regard to the quality, safety and efficacy of the medicinal product |
| Risk-benefit balance | An evaluation of the positive therapeutic effects of the medicinal product in relation to the risks as defined in point 28 (Dir 2004/27/EC), first indent. |
| Risks related to use of the medicinal product | Any risk relating to the quality, safety or efficacy of the medicinal product as regards patients’ health or public health; -any risk of undesirable effects on the environment. |
| Serious adverse reaction | An adverse reaction which results in death, is life-threatening, requires inpatient hospitalisation or prolongation of existing hospitalisation, results in persistent or significant disability or incapacity, or is a congenital anomaly/birth defect. |
| Strength of the medicinal product | The content of the active substances expressed quantitatively per dosage unit, per unit of volume or weight according to the dosage form |
| Substance | Any matter irrespective of origin which may be:•human, e.g. human blood and human blood products; animal, e.g. micro-organisms, whole animals, parts of organs, animal secretions, toxins, extracts, blood products; vegetable, e.g. micro-organisms, plants, parts of plants, vegetable secretions, extracts; chemical, e.g. elements, naturally occurring chemical materials and chemical products obtained by chemical change or synthesis |
| Summary of product characteristics – SmPC | Formerly known as SPC, it refers to the text prepared according to Article 11 of Directive 2001/83 describing the properties of the medicinal product. |
| Traditional herbal medicinal product | A herbal medicinal product that fulfils the conditions laid down in Article 16a(1) Dir 2001/83/EC. |
| Unexpected adverse reaction | An adverse reaction, the nature, severity or outcome of which is not consistent with the summary of product characteristics. |
| Unlicensed use | All uses of a drug which has never received a European Marketing Authorisation as medicinal for human use in either adults or children. |
| Wholesale distribution of medicinal products | All activities consisting of procuring, holding, supplying or exporting medicinal products, apart from supplying medicinal products to the public. Such activities are carried out with manufacturers or their depositories, importers, other wholesale distributors or with pharmacists and persons authorized or entitled to supply medicinal products to the public in the Member State concerned. |
| Well established use – WEU | When the constituent(s) of a medicinal product have a recognised efficacy and acceptable level of safety. There is then no need to supply results of toxicological and pharmacological tests (in directive 2001/82/EC and 2001/83/EC, article 10). |
