Pharmaceutical and healthcare glossary

  • Active delivery system
    A method for optimally delivering medication (active ingredient) to a patient’s organism, in a manner that increases the concentration of the medication in some parts of the body relative to other parts of the body.
    ADL
    Slovak Association of Drug and Medical Device Suppliers (Asociacia Dodavateľov Liekov a Zdravotnickych Pomocok) – An association of legal persons that brings together the entire drug chain – pharmaceutical companies, drug distributors and pharmacy owners – in Slovakia. It aims to represent, promote and protect the legitimate interests of its members; founded in 1992.
    AESGP
    Association of the European Self-Medication Industry – The official representative body of manufacturers of non-prescription medicines, food supplements, and self-care medical devices in Europe. It is composed of national associations and the main multinational companies that manufacture self-care products; founded in Paris in 1964.
    AIFP
    Czech Association of Pharmaceutical Industry (Asociace Inovativniho Farmaceutickeho Prumyslu) – An association of pharmaceutical companies with their own research and development units for innovative pharmaceuticals; established in 1993.
    AIPM
    Russian Association of International Pharmaceutical Manufacturers (Assotsiatsiya mezhdunarodnykh farmatsevticheskikh proizvoditeley) – An association comprised of more than 50 international pharmaceutical companies that provide over 60% of medicines imported to the Russian Federation. AIPM aims to promote economic and legal policies that focus on the development of the pharmaceutical market, the improvement of medical services quality and the expansion of the range of modern medicines; established in 1994.
    Anatomical Therapeutic Chemical (ATC) Classification System
    A system provided by the World Health Organization (WHO) for the classification of therapeutic drugs in which drugs are divided into different groups according to the organ or system on which they act as well as their chemical, pharmacological and therapeutic properties. Drugs are classified into five different levels.
    ANM
    Romanian National Agency for Medicines and Medical Devices (Agentia Nationala a Medicamentului si a Dispozitivelor Medicale) – A public institution subordinated to the Ministry of Health; established in 2010. The aims of ANM include: protecting and promoting public health by assessing documentation in view of marketing authorisation of medicinal products for human use; supervising medicinal products in the therapeutic circuit through inspections and pharmacovigilance; ensuring that health professionals, the pharmaceutical industry, patients, and the general public have access to useful and accurate information on medicinal products authorised for marketing in Romania; maintaining high levels of medical device performance and safety in the country.
    AOTM
    Polish Agency for Health Technology Assessment (Agencja Oceny Technologii Medycznych) – An advisory body to the Ministry of Health; established in 2005. Since 2009, it has been defined as a legal entity. The main task of AOTM is the preparation of recommendations for the ministry on financing for all healthcare services from public funds: drug reimbursement lists; therapeutic drug programmes and hospital chemotherapy drug lists; non-drug technologies (medical devices, surgical procedures, etc.); national and local government healthcare programmes.
    API
    Active Pharmaceutical Ingredient – Any substance or combination of substances used in a finished pharmaceutical product (FPP); intended to furnish pharmacological activity or to otherwise have a direct effect in the diagnosis, cure, mitigation, treatment or prevention of disease, or to have direct effect in restoring, correcting or modifying physiological functions in human beings.
    API prescription
    Prescription of Active Pharmaceutical Ingredient instead of the brand-name drug.
    API sourcing
    Finding, evaluating and engaging suppliers of Active Pharmaceutical Ingredients.
    APMGR
    Romanian Association of Generic Drug Manufacturers (Asociatia Producatorilor de Medicamente Generice) – A non-governmental and independent organisation comprised of generic manufacturers; set up in 2009. APMGR aims to contribute to improving access to generic medicines for Romanian patients.
    ARPharM
    Bulgarian Association of Research-Based Pharmaceutical Manufacturers (Asotsiatsiyata na Nauchnoizsledovatelskite Farmatsevtichni Proizvoditeli) – A non-profit organisation that gathers research-oriented manufacturers of medicine from all over Europe, the United States and Japan, and invests in the development of the Bulgarian pharmaceutical industry; established in 1996. The Association represents the pharmaceutical industry and works to further its reputation; supports various governmental institutions and organisations; and maintains and develops activities related to pharmaceutical and medical research in Bulgaria.
    ARPIM
    Romanian Association of International Drug Manufacturers (Asociatia Romana a Producatorilor Internationali de Medicamente) – A non-governmental, non-profit, non-political, and independent association of international innovative medicine manufacturers in Romania; founded in 1995. ARPIM supports the interests of these companies in Romania.
    ASL
    Association of Slovak Pharmacists (Asociacie Lekarnikov Slovenska) – An independent, non-political, professional, voluntary and autonomous association of pharmacy owners that aims to protect their interests.
  • BATEL
    Bulgarian Association of Pharmaceutical Wholesalers (Bulgarska Asotsiatsiya na Turgovtsite na Edro s Lekarstva) – An association established at the initiative of the pharmaceutical companies Sopharma Trading, Libra and Konsumfarm; aims for the standardisation of the quality of distribution services.
    BDA
    Bulgarian Drug Agency (Izpulnitelna Agentsiya po Lekarstvata) – An institution that, along with the Health Ministry, is responsible for conducting the pharmaceutical policy in Bulgaria; established in 1999. The Agency issues manufacturing authorisations for medicines; presents proposals to the health minister for issuing marketing authorisation and wholesale trade in medicines; provides expertise for quality assessment of the regarding marketing authorisations; registers clinical trials conducted in the country.
    BFS
    Bulgarian Pharmaceutical Union (Bulgarskiyat Farmatsevtichen Suyuz) – A professional association of Master Pharmacists in Bulgaria that aims to represent the pharmacists’ interest in the country; established in 2007.
    BGPharma
    Bulgarian Generic Pharmaceuticals Association (Bulgarskata Generichna Farmatsevtichna Asotsiatsiya) – An association of generic drug manufacturers, members of chambers of commerce, professional organisations, scientists, educators, professionals and other individuals involved in pharmaceuticals, medicine and healthcare whose main objective is to protect the interests of its members and to provide opportunities for developing a stable supply system for health care and medicine in the country; established in 2001.
    Biologic medical product, also known as a biological product
    A medicinal product used as therapeutics to treat diseases. Examples include a vaccine, blood or blood component, allergenic, somatic cell, gene therapy, tissue, recombinant therapeutic protein, and living cells. Biologics are created by biologic processes, rather than being chemically synthesised.
    Biotechnology
    Technology that uses biological systems, dead organisms, or derivatives thereof, to make or modify products or processes for specific use. It has four main applications: medicine, agriculture, environmental and non-food (industrial) areas.
    BLC
    Bulgarian Medical Association (Bulgarskiyat Lekarski Suyuz) – A professional organisation of doctors that defends doctors’ interests; established in 1901.
    Borderline product
    A product that exists on the borderline between medicinal products and other products, i.e., dietary supplements, cosmetics, etc.
    Branded generic
    A generic sold by the manufacturer under a specific brand name; different from the international non-proprietary name.
  • CAFF
    Czech Association of Pharmaceutical Companies (Ceska Asociace Farmaceutickych firem) - An association aimed at uniting and defending the common interests of companies that are engaged in research, development, production, marketing and promotion of medicinal products in Czech Republic. The CAFF sees as its main activities the support of the economic, legal and professional interests of its members (including the provision of advisory and information services to all members); established in 2001.
    CANAMED
    National Catalogue of Medicines in Romania (Catalogul National al Preturilor Medicamentelor) – A national catalogue of prices of medicinal products for human use that are authorised for marketing.
    CASP
    Czech Association of Special Foods (Ceska Asociace Pro Specialni Potraviny) – An association of legal entities that represents the common interests of its members – manufacturers and distributors of food supplements – both at the national and international levels; established in 2000.
    Categorisation Committee in Slovakia (Kategorizacna rada pre lieciva a lieky)
    An advisory body for the Ministry of Health that determines which pharmaceuticals should be reimbursed and at what share of the retail price reimbursement should be made. The Categorisation Committee consists of three types of representatives: from the Ministry of Health, the Slovak Medical Chamber, and health insurance funds.
    CEBK
    Central Register of Clinical Trials in Poland (Centralna Ewidencja Badan Klinicznych) – An organisational unit of the Office for Registration of Medicinal Products, Medical Devices and Biocides; CEBK maintains records of clinical trials taking place in Poland.
    CEP
    Certificate of Suitability of Monographs of the European Pharmacopoeia – A certificate granted by the Certification Secretariat of the European Directorate for the Quality of Medicine; the certification can be used by manufacturers of pharmaceutical products in their applications for marketing authorisation to demonstrate compliance of the substance with the monographs of the European Pharmacopoeia and Directives 2001/83/EC and 2001/82/EC.
    CFR
    Romanian College of Pharmacists (Colegiul Farmacistilor din Romania) – An organisation of pharmacists aiming to ensure enforcement of regulations and rules that organise and regulate the profession of pharmacists and to promote the rights and interests of its members; established in 1997.
    CHMP
    Committee for Medicinal Products for Human Use – A committee at the European Medicines Agency that is responsible for preparing opinions on questions concerning medicines for human use. CHMP replaced the former Committee for Proprietary Medicinal Products (CPMP).
    Claw-back system
    A system that requires pharmaceutical market players to contribute to the public health system with an amount determined on the basis of revenues obtained from public funding (either reimbursement, hospital consumption, or other use sponsored by state).
    Clinical chemistry
    The largest segment of the in vitro diagnostics market. The category includes equipment and reagents for determining levels of metabolites, enzymes, proteins (including acute-phase proteins), and selected hormones. These analyses are helpful in assessing how the homeostasis state was disturbed as a result of disease.
    Clinical trial
    A research programme conducted with patients to evaluate a new medical treatment, drug, or device; the purpose of a clinical trial is to find new and improved methods for treating different diseases and special conditions.
    CLK
    Czech Medical Chamber (Ceska Lekarska Komora) – An autonomous professional organisation of physicians. Any doctor in the medical profession in Czech Republic must be a member of the chamber, which is responsible for ensuring that its members conduct themselves in accordance with the profession’s laws and ethics. The chamber also represents the rights of its members; established in 1991.
    CLnK
    Czech Chamber of Pharmacists (Ceska Lekarnicka Komora) – An autonomous non-political professional organisation that brings together pharmacists; established in 1991.
    CMD(h)
    Coordination Group for Mutual Recognition and Decentralised Procedure (human) – An EU group for the examination of questions related to marketing authorisation for a medicinal product in two or more Member States in accordance with the mutual recognition procedure or decentralised procedure; established in 2004.
    CNAS
    Romanian National Health Insurance Fund (Casa Nationala de Asigurari de Sanatate) – The third-party payer in Romania.
    COCIR
    European Coordination Committee of the Radiological, Electromedical and Healthcare IT Industry – A non-profit trade association representing the medical technology industry in Europe; founded in 1959.
    Combinatory drug
    A drug containing two different active pharmaceutical ingredients.
    Commission for the Prices of Pharmaceuticals
    The Bulgarian Health Ministry’s Commission responsible for reviewing and setting the prices of drugs reimbursed by the Ministry of Health and the National Health Insurance Fund. The Commission’s members are representatives from the Ministry of Health, Ministry of Economy, National Health Insurance and Drug Agency, Ministry of Finance, and the Ministry of Labour and Social Policy.
    Complementary health insurance
    A type of insurance policy which enables one to use other methods of treatment than those included in the guaranteed healthcare basket.
    Compulsory health insurance
    Health insurance for health care costs; usually instituted as a programme of healthcare reform in a relevant act. It may be administered by the public sector, the private sector, or a combination of both. It usually covers citizens, permanent residents, and employees. As with other social contributions, health contributions are paid by the employer and/or employees.
    Counterfeit medication
    A medication or pharmaceutical product produced and sold with the intent to deceptively represent its origin, authenticity or effectiveness. A counterfeit drug may contain inappropriate quantities of active ingredients (or none), may be improperly processed within the body (e.g., absorption by the body), may contain ingredients that are not on the label (which may or may not be harmful), or may be supplied with inaccurate or fake packaging and labelling.
    CR
    Computed radiography – Similar to conventional radiography, but instead of using film to create an image, an imaging plate, made of photostimulable phosphor, is used.
    CRO
    Contract Research Organisation – A company that conducts various phases of clinical trials for a hiring company/under contract.
    CT
    Computed tomography (also X-ray computed tomography) – Imaging diagnostics method that utilises computer-processed X-rays to produce tomographic images, or “slices,” of specific areas of the body. It typically consists of a series of X-ray tube detectors to obtain a cross-sectional image of the body. The detectors revolve around the body and take readings from various angles, which are later reconstructed by the software. CT can be single, dual, or have 4, 8, 16, 32, 64, 128, or 256 slices. The larger the number of slices, the better the quality of the image and the shorter the amount of time it takes to obtain an image. CT has a wide number of applications, including thoracic and cardiac imaging. However, certain issues have surfaced in the recent past about the disadvantages of CT, as it utilises ionising radiation.
  • DDD – Defined daily dose
    A statistical measure of drug consumption, defined by the World Health Organization (WHO) and used to standardise the comparison of drug usage between different drugs or between different health care environments.
    Decentralised procedure
    A European authorisation procedure based on the principle of recognition of the assessment by the Reference Member State. The decentralised procedure may be used to obtain a marketing authorisation in several Member States when the applicant does not yet have a marketing authorisation in any country.
    Dermocosmetic
    A product on the border between cosmetics and medicines; apart from a cosmetic value, they exhibit slight medicinal properties or improve treatment. The law, however, does not distinguish between products with slight medicinal properties: a given preparation has medicinal properties and is then either acknowledged as a medicine or not and is then classified as a different product, e.g., a cosmetic product.
    Dietary supplement
    A preparation intended to provide vitamins, minerals, amino acids, fatty acids, fibre, lecithin, etc., in a normal diet. Dietary supplements are comprised of herbal products, bee products, oil products, enzymatic preparations and other products containing, for example, coenzyme Q or shark cartilage. Dietary supplements are subject to the provisions of food regulations.
    DR
    Digital radiography – Similar to conventional radiography, but rather than using film to create an image, a digital image capture device is used instead.
    DRG
    Diagnosis related groups – A system to classify hospital cases into one of 467 groups. The system was developed in anticipation to use it for reimbursement, to replace “cost-based” reimbursement. DRGs are assigned by a “grouper” programme based on ICD (International Classification of Diseases) diagnoses, procedures, age, sex, discharge status, and the presence of complications or comorbidities.
    Drug development industry
    A complex activity that consists of medical and laboratory expertise, including toxicology, preclinical evaluation, clinical trial design and implementation. It is aimed at improving the safety and efficacy of new drugs before they come to market.
    DTP
    Direct-to-pharmacy distribution model – A model in which the pharmacy places an order for products with a specialised logistics operator acting on behalf of the manufacturer. The operator delivers the merchandise and collects payment for it on behalf of the manufacturer. Throughout the distribution process, the products remain the property of the manufacturer until products are bought by the pharmacy. The wholesaler, which does not feature in this model at all, plays a different role when compared to the traditional distribution model.
  • ECG (EKG)
    Electrocardiography – A transthoracic interpretation of the electrical activity of the heart over a period of time as detected by electrodes attached to the outer surface of the skin and recorded by a device external to the body.
    Economic Committee
    A commission established by the Reimbursement Act in Poland; consists of representatives of the Health Ministry and the President of the National Health Fund (NFZ); is responsible for negotiations with pharmaceutical companies for official selling prices of reimbursed products, levels of reimbursement, and the duration of reimbursement and risk-sharing instruments.
    EDMA
    European Diagnostics Manufacturers Association – An industry association that represents the interests of the IVD market throughout Europe. It represents over 500 companies that are engaged in the research, development, manufacturing and distribution of IVD products across Europe.
    EDMF
    European Drug Master File – A document prepared by a pharmaceutical manufacturer and submitted solely at its discretion to the appropriate regulatory authority in the intended drug market. The document provides the regulatory authority with confidential, detailed information about facilities, processes, and articles used in the manufacturing, processing, packaging, and storing of one or more human drugs.
    Electronic prescribing (e-prescribing)
    The use of an automated data entry system to generate a prescription that is then transmitted through a special network to a pharmacy in such a way that the data goes directly into the pharmacy’s computer system.
    EMA
    European Medicines Agency – A decentralised agency of the European Union, located in London. The Agency is responsible for the scientific evaluation of medicines developed by pharmaceutical companies for use in the European Union.
    Essential drug
    A drug, according to the World Health Organization (WHO), that satisfies the health care needs of the majority of the population. It should therefore be available at all times in adequate amounts, in appropriate dosage forms, and at a price the community can afford.
    External price referencing
    A pricing method which imposes a price cap for pharmaceuticals based on prices of identical or comparable products in foreign countries.
  • FDA
    Food and Drug Administration – An agency within the Department of Health and Human Services of the United States (whose name dates to 1930) that is responsible for protecting and promoting public health through the regulation and supervision of food safety, tobacco products, dietary supplements, prescription and OTC pharmaceutical drugs, vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), and veterinary products.
    FDG
    Fluorodeoxyglucose – A radiopharmaceutical used in PET-CT examinations.
    Finished form of drugs
    A form in which a drug is produced and dispensed, e.g., capsules and tablets.
    FSMP
    Food for Special Medical Purposes – Food specifically formulated, processed and intended for the dietary management of diseases, disorders or medical conditions of individuals who are being treated under medical supervision and for the exclusive or partial feeding of people whose nutritional requirements cannot be met by normal foods.
  • Gamma camera
    A device used to image gamma radiation-emitting radioisotopes during a technique known as scintigraphy.
    GCP
    Good Clinical Practice – An international standard of quality that is provided by the International Conference on Harmonisation (ICH). ICH is an international body that defines standards that governments can transpose into regulations for clinical trials involving human subjects. Good Clinical Practice guidelines include protection of human rights as a subject in clinical trial. It also provides assurance of the safety and efficacy of the newly developed compounds. Good Clinical Practice Guidelines provide standards on how clinical trials should be conducted as well as define the roles and responsibilities of clinical trial sponsors, clinical research investigators, and monitors.
    GENAS
    Slovak Association of Generic Drug Manufacturers (Asociacia Generickych Vyrobcov) – A voluntary non-profit association of legal entities that brings together manufacturers of generic drugs. The main objective of the Association is to serve as an economic association representing the common interests of pharmaceutical companies and promoting the use of generic drugs; established in 2000.
    Generic drug
    An equivalent of innovative medicines marketed, in the majority of cases, after the latter's patent expiration. It has the same quality, safety and therapeutic efficacy, intended use, dosage, active pharmaceutical substance, and pharmaceutical form as the originator’s product.
    Generic substitution
    A scheme allowing pharmacists to dispense a generic version of a medication even if a doctor had prescribed a specific original product.
    GIF
    Polish Main Pharmaceutical Inspectorate (Glowny Inspektorat Farmaceutyczny) – The governmental authority responsible for supervising the conditions of production, the quality, and the turnover of medicinal products in order to protect the safety, health, and life of citizens using medicinal products that are available at pharmaceutical wholesalers, pharmacies, pharmacy outlets, etc.
    GIS
    Polish Chief Sanitary Inspectorate (Glowny Inspektorat Sanitarny) – The governmental authority responsible for performing specialised tasks related to public health through the exercise of control and supervision of the hygienic conditions in different areas of life such as working conditions, education conditions, food conditions, etc. Further, the inspectorate also collects epidemiological data on certain diseases and issues decisions on occupational diseases.
    GLP
    Good Laboratory Practice – A quality system of management controls for research laboratories and organisations to ensure uniformity, consistency, reliability, reproducibility, quality, and integrity of chemical (including pharmaceuticals) non-clinical safety tests.
    GML
    Czech Pharmacy Guild (Gremium Majitelu Lekaren) – A professional association whose main objective is to defend the professional and economic interests of the owners of pharmacies. Besides legislative activities for its members, it offers economic, tax and legal advice; established in 1996.
    GMP
    Good Manufacturing Practice – A production and testing practice that helps to ensure a quality product. Its main aim is to ensure that products are manufactured and controlled in accordance with both the quality standards appropriate for their intended use and the required marketing authorisation in order to minimise risks in pharmaceutical production.
    GP
    General practitioner – A doctor who deals with diseases that do not require a specialist’s treatment; works in primary care.
    Guaranteed health services basket
    A list of services guaranteed within compulsory health insurance (positive) or not guaranteed within compulsory health insurance (negative).
    GYEMSZI
    Hungarian Institute for the Improvement of Quality and Organisation in the Pharmaceutical Industry and in Healthcare (Gyogyszereszeti es Egeszsegugyi Minoseg- es Szervezetfejlesztesi Intezet) – An institute established in 2011 as part of the policy conception that started the restructuring of healthcare as formulated in the Semmelweis Plan pertaining to the reform of the Hungarian healthcare system. The task of the institute is to create a well-functioning healthcare background and to bring efficiency to the health sector by the formulation of the strategy of health quality improvement and patient safety, the elaboration of the conception of professional development and the methodological background of different levels of care, the performance of patient pathway management and development policy tasks.
  • Healthcare market
    The value of all healthcare procedures provided to patients by healthcare facilities (in-patient and out-patient) in an analysed period of time. The can be financed through both public and private funds.
    HMPC
    Committee on Herbal Medicinal Products – A committee of the European Medicine Agency that is responsible for preparing the Agency's opinions on herbal medicines; established in September 2004.
    Homeopathic medicine
    A product prepared by repeatedly diluting a chosen substance in alcohol or distilled water, followed by forceful striking on an elastic body, called succussion. Each dilution followed by succussion is said to increase the remedy’s potency. Dilution usually continues well past the point where none of the original substance remains. Homeopathy itself is a system of alternative medicine originated in Germany in the 18th century according to which a substance that causes the symptoms of a disease in healthy people will cure similar symptoms in sick people.
    Hospital (drug) market
    The value (and volume) of drugs purchased by hospitals in an analysed period of time.
    Hospital pharmacy
    A pharmacy located on the premises of a hospital.
    HTA
    Health Technology Assessment – A way of assessing the ways science and technology are used in healthcare and disease prevention. It covers medical, social, economic and ethical issues. It provides policy-makers with objective information so that they can formulate health policies that are safe, effective, patient-focused and cost-effective.
  • IGY
    Association of Innovative Pharmaceutical Manufacturers (Innovativ Gyogyszergyartok Egyesulete) – An association of research-based pharmaceutical companies in Hungary representing the interests of its members on the local pharmaceutical market; established in 1992.
    iHETA
    Czech Institute for Health Economics and Technology Assessment (Institut pro Zdravotni Ekonomiku a Technology Assessment) – An organisation supporting research, education and training in the fields of economics and public health, pharmacoeconomics, outcomes research and health technology assessment.
    Imaging diagnostics
    A branch of diagnostics that create images of the human body for clinical purposes or medical science. It covers radiography, magnetic resonance imaging, computed tomography, ultrasonography and positron emission tomography.
    Immunology and immunochemistry
    A segment of the IVD market. The segment comprises areas such as allergology, tumour markers, autoimmune diseases, rapid immunological tests and infectious immunology (a section of the segment involved in detection of pathogenic microorganisms in humans).
    INFARMA
    Employers’ Union of Innovative Pharmaceutical Companies (Zwiazek Pracodawcow Innowacyjnych Firm Farmaceutycznych) – An association of 32 pharmaceutical companies operating in Poland that conduct research and development and produce innovative drugs including biotech products. INFARMA’s goal is to put forward initiatives that help create systemic solutions for the healthcare system; established in 2006.
    INN
    International non-proprietary name – An official non-proprietary or generic name given to a pharmaceutical substance; as designated by the World Health Organization (WHO).
    Innovative medicine
    The first version of a drug developed and patented by an originator company. The product is covered by exclusive rights to marketing.
    IPDDL
    Chamber of Manufacturers and Distributors of Laboratory Diagnostics in Poland. (Izba Producentow i Dystrybutorow Diagnostyki Laboratoryjnej) – IPDDL, which associates 23 companies, aims to integrate IVD manufacturers and distributors in Poland and initiatives regarding the awareness of in vitro diagnostics and its position within the healthcare system. It represents the Polish IVD market at EDMA. Established in 2001.
    IVD
    In vitro diagnostics: laboratory diagnostics – A branch of diagnostics which provides diagnostic information by examining specimens derived from the human body (blood, urine, and tissue samples). IVD covers clinical chemistry, immunology and immunochemistry, haematology, histology, cytology, microbiology and molecular diagnostics. IVD tests are used to diagnose and monitor different types of diseases in a laboratory or other healthcare establishments (e.g., hospitals) or at home.
  • MAGYOSZ
    Hungarian Pharmaceutical Manufacturers Association (Magyar Gyogyszergyartok Orszagos Szovetsege) – The association’s main tasks include reconciliation and representation of the professional interests of its members; networking between the members; monitoring local and foreign pharmaceutical research, development, production, trade and economic activities; providing professional information to members as necessary. Founded in 1990.
    MAH
    Marketing Authorisation Holder – A person/company that holds the authorisation to place a medicinal product on the market and is responsible for that medicinal product.
    Medical device
    A medical product used mainly in diagnostics but also in treatment, including the performance of various medical procedures. It may be an instrument, apparatus, appliance, software, material, implant, in vitro device, or any other related article.
    Medical sales representative
    A seller of a pharmaceutical company’s products such as drugs and medical equipment to a variety of customers including general practices, primary care trusts, hospitals and pharmacies.
    Medicinal product
    Any substance or combination of substances presented for treating or preventing disease in human beings or animals, or any substance or combination of substances which may be administered to human beings or animals with a view to making a medical diagnosis or to restoring, correcting or modifying physiological function(s) in human beings or in animals.
    MEKISZ
    Hungarian Dietary Supplement Manufacturers and Distributors Association (Magyarorszagi Etrend-kiegeszito Gyartok es Forgalmazok Egyesulete) – An association of companies dealing with the manufacture and distribution of dietary supplements that represents the interests of its members in Hungary; established in 2003.
    MGYK
    Hungarian Chamber of Pharmacies (Magyar Gyogyszereszi Kamara) – A professional advocacy organisation of pharmacy professionals that contributes to laws related to pharmacy and pharmacists; established in 1989. In 1994, achieved status as public organisation.
    Microbiology
    A segment of IVD market that is comprised of the application of varied methods for detecting and identifying all microorganisms occurring in the human body, the hospital environment, and other types of the human environment. Products for this segment include culture mediums and basic tests for enzymatic activity of microorganisms, microorganism structure, and drug susceptibility of microorganisms.
    Molecular diagnostics
    The fastest developing segment of IVD market. It is now generally used to study interactions between organisms (DNA, RNA, and protein tests), e.g., screening tests for detecting mutations causing hereditary diseases such as cystic fibrosis; blood tests for detecting the nucleic acids of, for example, HIV or hepatitis viruses; molecular oncology (detection of oncology markers); and histocompatibility testing (useful in organ transplantation).
    MRI
    Magnetic Resonance Imaging – Imaging diagnostics method that makes use of the property of nuclear magnetic resonance to image nuclei of atoms inside the body. MRI images the body in different planes by placing the patient in a powerful static magnetic field, which aligns the hydrogen atoms within the body. The technique evaluates the water content of the tissue structures, making them discernible. MRI systems are: open bore or standard. The high costs of MRI can be attributed to the high infrastructure costs, maintenance fees, and cost per procedure.
    MRP
    Mutual Recognition Procedure – A procedure used by pharmaceutical manufacturers who have been granted a marketing authorisation for selling pharmaceuticals in one European Union (EU) Member State to request that same authorisation in other Member States. When this occurs, the initial Member State where the product was approved has 90 days to provide the details surrounding that particular product to secondary Member States for which the manufacturer is applying to be able to market its product. After receiving the information from the initial Member State, the secondary Member State will have an additional 90 days in which to provide a response.
  • NCZI
    Slovak National Health Information Centre (Narodne Centrum Zdravotnickych Informacii) – A state organisation established by the Slovak Ministry of Health. The Centre covers tasks in the area of health service informatics, the standardisation of information system in health services, the collection, processing and provision of health statistical data, and the provision of librarian-informational services in the field of medical sciences and health services. It is also operates national health registries and national administrative registries.
    NFZ
    Polish National Heath Fund (Narodowy Fundusz Zdrowia) – The third-party payer in Poland.
    NHIF
    National Health Insurance Fund (Natsionalna Zdravnoosiguritelna Kasa) – The third-party payer in Bulgaria.
    NIA
    Polish Pharmaceutical Chamber (Naczelna Izba Aptekarska) – A self-governing professional body of pharmacists that represents their own professional, social and economic interests; established in 1939.
    NNW
    A type of insurance covering the consequences of personal accidents.
    Non-pharmacy outlet
    An herbal medicine store, specialist medicine store, pet shop (with veterinary products) or general store that may sell OTC medicinal products.
    Non-refundable medicine
    A medicine not subjected to reimbursement.
    Non-reimbursed medicine
    See: non-refundable medicine.
    NPP
    Named Patient Programme – A programme scheme established by pharmaceutical companies which allows either individual (or “named”) patients or groups of patients to access investigational drugs if they cannot meet trial criteria, enable access to patients in clinical trials after the trial ends, but prior to marketing authorisation, and enable patient access to a drug in a country without a company’s supporting infrastructure. In a similar manner, a Named Patient Programme can also be used to provide access to the drug while its reimbursement issues are being clarified.
    Nuclear medicine
    It can be segmented into two sub-segments: the gamma camera market and the PET scanners market. Radioisotopes are injected into the blood and a gamma camera or a PET scanner is used to track the isotopes as they reach the target organ. The radioisotopes emit radiation, which is detected by the imaging equipment. The potential for nuclear imaging to provide information on functional aspects make it a very interesting area in which healthcare authorities can invest.
    NZOZ
    Non-public healthcare facility (niepubliczny zaklad opieki zdrowotnej) in Poland – A healthcare facility (a hospital, clinic, surgery, etc.) that is not run by a public entity; it can be transformed (commercialised) into a company and still be run by a local entity or by a private entrepreneur, church or foundation. From the beginning it can be private, whether an investment of a private entity or other. It is worth noting that after the introduction of the Law on Healthcare Activities on 1 July 2011, the division on NZOZ and SP ZOZ is no longer relevant, although many medical facilities still operate under this name.
  • OEP
    Hungarian National Health Insurance Fund (Orszagos Egeszsegbitzositasi Penztar) – The third-party payer in Hungary.
    Online pharmacy
    A pharmacy that operates through the internet and sends the filled prescriptions/orders to customers through the mail or shipping companies.
    Orphan disease
    A rare disease; any disease that affects a small percentage of the population.
    Orphan drug
    A pharmaceutical product that has been developed specifically to treat a rare medical condition, the condition itself being referred to as an orphan disease.
    OSNSS
    Polish Non-public Autonomy Hospitals Association (Ogolnopolskie Stowarzyszenie Niepublicznych Szpitali Samorzadowych) – An association consisting of hospitals set up as trading partnerships through local self-government entities.
    OTC
    Over-the-counter products, i.e., products sold without a prescription (OTC drugs, dietary supplements and other medicinal products).
  • PACS
    Picture Achieving and Communication System – In imaging diagnostics it provides storage of and access to images from various medical instruments.
    Parallel trade
    In the pharmaceutical industry it occurs where drug prices vary from country to country due to national price regulation. In such circumstances, a wholesaler in “low-price” country A will be able to achieve a better price by selling its product in “high-price” country B rather than on the domestic market in country A. Price differences can be due to national regulations, exchange variations, or prices setting strategies by pharmaceutical companies.
    Parapharmacy
    A new type of drugstore that offers the whole range of OTC products such as OTC drugs, dermocosmetics and dietary supplements along with other beauty products, which can be widely advertised.
    PET-CT
    Positron emission tomography-computed tomography – A method of imaging diagnostics (nuclear medicine). It combines in a single gantry system both positron emission tomography (PET) and x-ray computed tomography (CT). It has revolutionised many fields of imaging diagnostics by adding precision anatomic localisation to functional imaging.
    Pharmaceutical contract manufacturing
    The manufacturing of medicines or their components for another company.
    Pharmaceutical market
    The value (and volume) of drugs and other health-related products (such as parapharmaceuticals) sold at pharmacies, at non-pharmacy channels (such as retail shops), through the internet, and those purchased by hospitals and other healthcare facilities. The pharmaceutical market can also be understood in terms of the value (and volume) of drugs sold by wholesalers to pharmacies or by manufacturers to wholesalers.
    Pharmacy
    A retail outlet where drugs are sold/given to patients; pharmacies usually sell Rx, OTC drugs, parapharmaceuticals such as dietary supplements, dermocosmetics, as well as dressing, toothpaste, and medical devices. It can be also a branch of medical and chemical sciences which deals with medications, their application, composition, etc.
    Pharmacy point
    An establishment that fulfils a function similar to a pharmacy; a pharmacy point can only be located in a village where there is no running pharmacy freely available. A pharmacy point leads the limited retail trade of medicinal drugs, for example, except for ones in the form of ampoules, psychotropic drugs, and narcotic drugs.
    PIC/S
    Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme – Two international instruments between countries and pharmaceutical inspection authorities, which together provide an active co-operation in the field of GMP. The mission of PIC/S is to lead the international development, implementation and maintenance of harmonised GMP standards and quality systems of inspectorates in the field of medicinal products. This is to be achieved through: developing and promoting harmonised GMP standards and guidance documents; training competent authorities, in particular inspectors; assessing (and reassessing) inspectorates; and facilitating the cooperation and networking for competent authorities and international organisations.
    PIU
    Polish Insurance Association – A local trade organisation representing all insurance companies operating in Poland. The main task of the PIU is to support the legislature to establish relevant legislation.
    Placebo
    A harmless pill, medicine, or procedure prescribed more for the psychological benefit to the patient than for any physiological effect; a substance that has no therapeutic effect, used as a control in testing new drugs.
    Positive Drug List
    A list of drugs reimbursed by a national health insurance fund.
    Prescription fee
    A fee paid by the patient to the pharmacist for every prescription presented in the pharmacy.
    Price-volume agreement
    A method of sharing risk between the manufacturer and the public payer, based on pre-agreed relation of price of the drug to the volume of sales.
    Primary care
    The care provided by physicians specifically trained for and skilled in comprehensive first contact and continuing care for persons with any undiagnosed sign, symptom, or health concern (the “undifferentiated” patient) not limited by problem origin (biological, behavioural, or social), organ system, or diagnosis. The domain of primary care includes the primary care physician, other physicians who include some primary care services in their practices, and some non-physician providers.
    Private healthcare market
    The healthcare market which comprises payments for drugs and medical equipment directly from patients’ pockets; cost of rehabilitation, diagnostic tests and doctors’ appointments covered directly from patients’ pockets; undocumented payments (the grey economy), e.g., so-called tokens of gratitude for medical staff; subscriptions offered by medical companies together with occupational healthcare services; health insurance offered by insurance companies; other payments covered directly by patients.
    Public-private partnership (PPP)
    A government service or private business venture which is funded and operated through a partnership of government and one or more private sector companies.
    PZPPF
    Polish Association of Pharma Industry Employers (Polski Zwiazek Pracodawcow Przemyslu Farmaceutycznego) – An association representing manufacturers of generic drugs; established in 2002. It aims to protect the rights and represent the interests of employers to the authorities, government, local governments, trade unions, and bodies of the European Union.
  • Radiography
    A method of imaging diagnostics which uses X-rays. Form of electromagnetic radiation which can identify bone structures.
    Rare disease
    See: orphan disease.
    REACH
    The Regulation on Registration, Evaluation, Authorisation and Restriction of Chemicals, which came into force on 1 June 2007. It streamlines and improves the former legislative framework on chemicals, including those used in the pharmaceutical industry of the European Union.
    Reimbursed medicine
    Medicines subject to reimbursement (by the state through the National Health Insurance Fund); also known as a refundable medicine.
    RIS
    Radiology information system – A computerised database used by radiology departments to store, manipulate, and distribute patient radiological data and imagery.
    Rx drug
    Prescription medicine.
    RZN
    Federal Service on Surveillance in Healthcare and Social Development (RosZdravNadzor) – A subordinate executive authority in the Ministry of Health and Social Development in Russia responsible for control and surveillance. Its main functions are granting marketing authorisation of medical devices, controlling quality, controlling the import of authorised medical products and APIs, pharmacovigilance, controlling the pricing of medical products, licensing of pharmaceutical wholesale and retail distribution (including that of narcotic and psychotropic substances), and controlling quality of medical assistance and social services.
  • SAFS
    Slovak Association of Research Based Pharmaceutical Companies (Slovenska Asociacia Farmaceutickych Spolocnosti Orientovanych na Vyskum a Vyvoj) – An association of international pharmaceutical companies which aims at fostering the economic, legal, and professional interests of its members and contributing to a better understanding of all the issues of pharmaceutical research and new drugs development. The SAFS also promotes the implementation of transparent principles, procedures, and the criteria of the registration, categorisation, and reimbursement of drugs so that all manufacturers have equal conditions. Established in 1997.
    Scintigraphy
    A method of imaging diagnostics (nuclear medicine) in which radiopharmaceuticals are taken internally and the emitted radiation is captured by external detectors (gamma cameras) to form two-dimensional images.
    SDH
    Social Determinates of Health – The conditions in which people are born, grow, live, work and age, including the health system. These circumstances are shaped by the distribution of money, power and resources at global, national and local levels. The social determinants of health are mostly responsible for health inequities: the unfair and avoidable differences in health status seen within and between countries.
    SLeK
    Slovak Chamber of Pharmacists (Slovenska Lekarnicka Komora) – A professional organisation of pharmacists; established in 1991.
    SMO
    Site Management Organisation – An organisation that provides services related to clinical trials to a contract research organization (CRO), a pharmaceutical company, a biotechnology company, a medical device company, or a clinical site. The site is usually a hospital or a similar health care institution that has adequate infrastructure and staff to meet the requirements of the clinical trial protocol.
    SOR
    Hospital emergency department (Szpitalny Odzial Ratunkowy) – An organisational entity of the hospital and national emergency system; duties include initial diagnosis of emergency cases and treatment for stabilisation of people in an emergency state.
    SP ZOZ
    Independent public healthcare centre in Poland (samodzielny publiczny zaklad opieki zdrowotnej) – A healthcare organisational facility in Poland created by the Ministry of Health or other central administration unit, voivodeship, local authority, or public medical university. It is worth noting that after the introduction of the Law on Healthcare Activities on 1 July 2011, the division of NZOZ and SP ZOZ is no longer relevant, although many medical facilities still operate under the latter name.
    SPC
    Summary of Product Characteristics – A specific document required within the European Commission before any medicinal product is authorised for marketing. This summary is the definitive description of the product both in terms of its properties – chemical, pharmacological and pharmaceutical, etc. – and the clinical use to which it can put.
    SPC
    Supplementary Protection Certificate – An intellectual property right that provides an additional monopoly that comes into force after expiry of a patent upon which it is based. This type of right is available for various regulated, biologically active agents, namely human or veterinary medicaments and plant protection products (e.g., insecticides, and herbicides).
    SPECT
    Single-photon emission computed tomography – A method of imaging diagnostics (nuclear medicine). It uses gamma rays and is able to provide 3D information.
    SUKL
    Czech State Institute for Drug Control (Statni Ustav Pro Kontru Leciv) – The governmental institution responsible for ensuring surveillance of the quality, efficacy and safety of medicinal products for human use and medicinal products used in health care. The SUKL also supervises pharmacies, wholesalers, manufacturers of medicinal products and medical devices, prepares assessment reports on medicinal products for human use, issues marketing authorisations and performs withdrawal or suspension of marketing or marketing authorization of medicinal products or medical devices, runs decision-making processes in the area of maximum prices of medicines and the amounts and conditions of reimbursements for medicines, and controls advertising of medical products and maintains database of registered drugs and medical devices.
    SUKL
    Slovak State Institute for Drug Control (Statny Ustav Pre Kontrolu Lieciv) – The government institution responsible for ensuring surveillance of the quality, efficacy and safety of medicinal products for human use and medicinal products used in health care. The SUKL also supervises pharmacies, wholesalers, manufacturers of medicinal products and medical devices, prepares assessment reports on medicinal products for human use, issues marketing authorisations and performs withdrawal or suspension of marketing or marketing authorization of medicinal products or medical devices, runs decision-making processes in the area of maximum prices of medicines and the amounts and conditions of reimbursements for medicines, controls advertising of medical products and maintains database of registered drugs and medical devices.
    Supplementary/supplemental health insurance
    A type of insurance policy designed to cover the gaps that a regular/compulsory health insurance may have. Other supplemental plans may provide a cash benefit paid out over a period of time or given in one lump sum. The cash can be used to cover lost wages, transportation related to a health condition, or used to pay for food, medication, and other unexpected expenses due to an illness or injury. There is also another meaning of this term: a kind of insurance policy which makes it possible to choose a doctor, have higher standard room in a hospital, or additional nursing care within procedures offered by compulsory health insurance.
    Supply chain management
    A network of flows from initial suppliers to final recipients. This network covers flows of supplies, production, distribution and other flows related to customer service, operations regarding research, development, marketing, etc. Supply chain management, if defined in this way, consists of the integration of key processes from supplier to final user in order to add value to products, services and information.
    SVOPL
    Czech Association of Manufacturers of OTC Drugs (Sdruzeni Vyrobcu Volne Prodejnych Lecivych Pripravku) – A non-profit association of pharmaceutical companies that manufacture and distribute OTC drugs; aims at promoting the economic, legal and professional interests of its members and at spreading knowledge about OTC drugs in Czech Republic.
    SZP CR
    Association of Health Insurance Companies of the Czech Republic (Svaz Zdravotních Pojistoven CR) – An association that brings together all six labour health insurance companies in Czech Republic. SZP CR defends the common interests of those health insurance companies and their clients in relation to government agencies, professional associations and health care providers. Established in 1997.
  • Third-party payer
    An organisation other than the patient (first party) or health care provider (second party) involved in the financing of personal health services.
    Traditional medicine
    A medicine based on organic and natural ingredients (e.g., herbs); the ingredients, which have been used medicinally since before the era of modern medicine, are neither generic nor innovative.
    Transparency Council (Rada Przejrzystosci)
    An advisory body of the Polish Health Technology Assessment Agency (AOTM) on the reimbursement of healthcare provision and medical products.
  • UDZS
    Slovak Healthcare Surveillance Authority (Urad pre Dohľad nad Zdravotnou Starostlivosťou) – A legal entity vested with performing surveillance over provision of health care and public health care insurance in the field of public administration. Main tasks of the authority are health care supervision, public health insurance supervision, and arbitration on the level of the relationship (health insurance company and provider; policyholder and provider; policyholder and health insurance company). Established in 2004
    Ultrasonography
    Medical sonography – A method of imaging diagnostics. Ultrasound consists of a transducer that transmits sound waves that are then reflected by anatomical structures. The echoes are transmitted back and electronically processed to appear as an image on the monitor. The major applications of ultrasound are obstetrics, abdominal organs, gynaecology and urology. The capabilities, such as acquiring real-time images without ionising radiation, make ultrasound a very popular and patient-friendly modality. Abdominal ultrasound is most widely and effectively used in the detection of gall and kidney stones as well as the examination of the kidneys, liver and spleen. The ultrasound process has seen various technological advances, including the development of Doppler systems and 3D and 4D imaging capabilities, that have led to better diagnoses.
    Unbranded generic
    A generic drug sold by the manufacturer under a name that is identical to the INN name of the active ingredient.
    URPL
    Polish Office for Registration of Medicinal Products, Medical Devices and Biocides (Urzad Rejestracji Produktow Leczniczych, Wyrobow Medycznych i Produktow Biobojczych) – A government administrative authority responsible for granting marketing authorisations for medicinal products, biocidal products, marketing and use of medical devices and clinical trials, including veterinary clinical trials.
    UVZSR
    Public Health Authority of the Slovak Republic (Urad Verejneho Zdravotnictva Slovenskej Republiky) – A Bratislava-based non-profit state organisation that falls under the budget of the Slovak Ministry of Health and is responsible for public health in Slovakia. The scope of activities of the authority includes solving and improving social determinates of health (SDH).
    UZIS
    Czech Institute of Health Information and Statistics (Ustav Zdravotnickych Informaci a Statistiky CR ) – An institute that gathers statistical data related to health; established in 1960 by the Czech Ministry of Health.
  • VHI
    Voluntary Health Insurance – A private insurance against the risk of incurring medical expenses among individuals, paid in addition to compulsory health insurance.
    VsZP
    General Health Insurance Company (Vseobecna Zdravotna Poistovna) – Slovak state-controlled health insurance fund.
    VZP
    General Health Insurance Company (Vseobecna Zdravotni Pojistovna) – Czech state-controlled health insurance fund.
  • WHO
    World Health Organisation – A directing and coordinating authority for health within the United Nations system. It is responsible for providing leadership on global health matters, shaping the health research agenda, setting norms and standards, articulating evidence-based policy options, providing technical support to countries, and monitoring and assessing health trends.
    WOSP
    Great Orchestra of Christmas Charity (Wielka Orkiestra Swiatecznej Pomocy) – One of the largest non-government, non-profit charity organisations in Poland. The main aim of WOSP is to protect health and to save the lives of children by providing medical equipment to public hospitals. During grand finales, which are held in January every year (nationwide fundraiser lasting for one day), it collects money for medical equipment purchases.
  • ZHNVLP
    Vital and Essential Drugs in Russia (Zhiznenno Neobkhodimyye i Vazhneyshiye Lekarstvennyye Sredstva) – the list of medicines approved by the government of the Russian Federation for state regulation of prices for medicines.
    ZOL
    Nursing and medical unit (zaklad opiekunczo-leczniczy) – A round-the-clock inpatient facility in Poland, which deals with treatment, rehabilitation, care, and provision of accommodations and food for patients who no longer require hospitalisation but need to be under a doctor’s supervision.
    ZOZ (zaklad opieki zdrowotnej)
    A former name for a healthcare facility in Poland, currently known as a healthcare entity (podmiot leczniczy). After the adoption of the Law on Healthcare Activities on 1 July 2011, the term ZOZ is no longer relevant, although many medical facilities still operate under this name.
    ZUS
    Social Insurance Institution (Zaklad Ubezpieczen Spolecznych) – A national organisation in Poland having legal status that collects social premium and distributes relevant benefits such as rent and pensions.