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Clinical trials in CIS countries 2012 - Russia, Ukraine, Belarus and Georgia
Medical devices market in Poland 2012 Dietary supplements market in Poland 2011 OTC market in Central and Eastern Europe 2011 Distribution on the pharmaceutical market in Russia and Ukraine 2011 Non-pharmacy OTC market in Poland 2011 Private healthcare market in Russia and Ukraine 2011 Pharmaceutical contract manufacturing and API sourcing in Central Europe and the Balkan states 2011 Private healthcare market in Central Europe 2011 Private healthcare market in Poland 2011 see more reports » |
Pharma glossaryActive delivery systems Targeted drug delivery systems, a method of delivering medication (active ingredient) to a patient's organism optimally - in a manner that increases the concentration of the medication in some parts of the body relative to others. AESGP Association of the European Self-Medication Industry AIPM Association of International Pharmaceutical Manufacturers, Moscow AOTM Agency for Health Technology Assessment (Agencja Oceny Technologii Medycznych), Poland API Active Pharmaceutical Ingredient API sourcing Finding, evaluating and engaging suppliers of pharmaceutical active ingredients (API) ATC Anatomical Therapeutic Chemical classification of pharmaceuticals Biotechnology A kind of technology that uses biological systems, dead organisms, or derivatives thereof, to make or modify products or processes for specific use. It has three main applications: medicine, agriculture, environmental and non-food (industrial) areas. At present bioproducts can be used in many areas of biomedicine such as pharmacogenomics, molecular markets, targeted therapies, diagnosis and personalised medicines, as well as the food industry (e.g. functional food and nutraceuticals). Borderline products Products which exist on the borderline between medicinal products and other products i.e. dietary supplements, cosmetics etc. If a product meets the criteria of drug and dietary supplement, it is subject to Pharmaceutical Law as opposed to other regulations. CEBK Central Register of Clinical Trials (Centralna Ewidencja Badan Klinicznych), Poland CEP Certificate of Suitability of Monographs of the European Pharmacopoeia CHMP Committee for Medicinal Products for Human Use Clinical trial A research program conducted with patients to evaluate a new medical treatment, drug, or device the purpose of the clinical trial is to find new and improved methods of treating different diseases and special conditions. CMD(h) Coordination Group for Mutual Recognition and Decentralised Procedure (human) CNAS Health Insurance Fund (Casa Nationala de Asigurari de Sanatate), Romania CNS Central Nervous System CRO Contract Research Organisation, the company which conducts various phases of clinical trials for hiring a company/under a contract Dermocosmetic There is no legal definition of a dermocosmetic in Poland. The notion of a cosmeceutical (synonym for a dermocosmetic ) was introduced in the 1980s by Dr Albert M. Kligman, Professor Emeritus of Dermatology, University of Pennsylvania School of Medicine, US. He defined cosmeceuticals as products from the borderline between cosmetics and medicines which, apart from cosmetic values, exhibit slight medicinal properties or improve treatment . (The law however does not distinguish 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 The Polish definition of dietary supplement was formulated in 2002 in the Act on Health Conditions of Food and Nutrition. Dietary supplements were defined as preparations intended to supply vitamins, minerals, amino acids, fatty acids, fibre, lecithin, etc. in a normal diet. Dietary supplements comprise: herbal products, bee products, oil products, enzymatic preparations, other e.g. products containing coenzyme Q or shark cartilage. Dietary supplements are subject to the provisions of food regulations. Drug development industry Drug development is a complex activity, consisting 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 EDMF European Drug Master File EMEA European Medicines Agency FDA US Food and Drug Administration Finished form of drugs A form in which a drug is produced and dispensed e.g. capsules, tablets FSMP Food for Special Medical Purposes GCP Good Clinical Practice Generic drugs The equivalents of innovative medicines marketed, in the majority of cases, after the latter's patent expiration. They have the same quality, safety and therapeutic efficacy, intended use, dosage, active pharmaceutical substance and pharmaceutical form as the originator product. GIF Main Pharmaceutical Inspectorate (Glowny Inspektorat Farmaceutyczny), Poland GIS Chief Sanitary Inspectorate (Glowny Inspektorat Sanitarny), Poland GLP Good Laboratory Practice GMP rules Rules of Good Manufacturing Practice. It is one of the most important elements of quality assurance in the global pharmaceutical industry. Its main aim is to ensure that products are manufactured and controlled in accordance with the quality standards appropriate for their intended use and the required marketing authorisation in order to minimise risks in any pharmaceutical production. Healthcare market In value terms: 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 Hospital (drug) market The value (and volume) of drugs purchased by hospitals in an analysed period of time ICH International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use Innovative medicines The first version of a drug which is developed and patented by an originator company. The product is covered by exclusive rights to marketing. IZZ National Food and Nutrition Institute (Instytut Zywnosci i Zywienia), Poland MAH Marketing Authorisation Holder Medical devices A group of medical products 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. Medicinal product The Polish Pharmaceutical Law defines medicinal product as 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 functions in human beings or in animals. MRI Magnetic resonance imaging MRP Mutual Recognition Procedure NFZ National Heath Fund (Narodowy Fundusz Zdrowia), Poland NMA National Medicines Agency (Agentia Nationala a Medicamentului), Romania Non-pharmacy outlet Art. 71 of the Polish Pharmaceutical Law lists the following non-pharmacy outlets which may sell OTC medicinal products: herbal-medicine stores, specialist medicine stores, pet shops (with veterinary products), general stores. Non-refundable medicines (non-reimbursed medicines) Medicines not subjected to reimbursement Non-reimbursed medicines See: non-refundable medicines NZOZ Non-public healthcare facility (niepubliczny zaklad opieki zdrowotnej) OSNSS Polish Non-public Autonomy Hospitals Association (Ogolnopolskie Stowarzyszenie Niepublicznych Szpitali Samorzadowych) OTC Over-the-counter products i.e. products sold without a prescription (OTC drugs, dietary supplements and other medicinal products) PET-CT Positron Emission Tomography-Computed Tomography Pharma market (pharmaceutical market) The value (and volume) of drugs and other health-related products (such as parapharmaceuticals) sold in pharmacies, non-pharmacy channels (such as retail shops), through the internet as well as 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. Pharmaceutical contract manufacturing Manufacturing of medicines or their components for another company Pharmacy 1) 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, toothpastes and medical devices; 2) a branch of medical and chemical sciences which deals with medications, their application, composition etc. PIC/S Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme POZ Primary medical care (Podstawowa Opieka Zdrowotna) Private healthcare market The private healthcare market 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. PUZ General heath insurance (Powszechne Ubezpieczenie Zdrowotne) REACH The Regulation on Registration, Evaluation, Authorisation and Restriction of Chemicals, which came into force on 1st June 2007. It streamlines and improves the former legislative framework on chemicals, including those used in the pharmaceutical industry of the European Union. Refundable medicines (reimbursed medicines) Medicines subject to reimbursement (by the state through the National Health Fund in Poland). Such medicines may be reimbursed in full, by 50%, by 30% or have lump-sum prices Reimbursed medicines See: refundable medicines RX drugs prescription medicines RZN RosZdravNadzor (Federal Service for the Supervision of Health and Social Development), Russia SMO Site Management Organisation SPC Summary of Product Characteristics SPZOZ Independent public healthcare centre (samodzielny publiczny zaklad opieki zdrowotnej) SUKL State Institute for Drug Control, Slovakia Supply chain management The supply chain is understood as a network of flows from initial suppliers to final recipients. This network covers flows in 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. SZP Spolocna Zdravotna Poistovna, Slovakia SZPCR Czech Association of Health Insurers of the Czech Republic UDZS Healthcare Supervision Office, Slovakia URPL Office for Registration of Medicinal Products, Medical Devices and Biocides (Urzad Rejestracji Produktow Leczniczych, Wyrobow Medycznych i Produktow Biobojczych), Poland USDMF United States Drug Master File VsZP Vseobecna Zdravotna Poistovna, Slovakia ZOZ healthcare facility (zaklad opieki zdrowotnej) ZUS Social Insurance Institution (Zaklad Ubezpieczen Spolecznych), Poland |
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PMR is a British-American company providing market information, advice and services to international businesses interested in Central and Eastern Europe as well as other emerging markets. PMR key areas of operation include business publications (through PMR Publications), consultancy (through PMR Consulting) and market research (through PMR Research). Being present on the market since 1995, employing highly skilled staff, offering high international standards in projects and publications, providing one of most frequently visited and top-ranked websites, PMR is one of the largest companies of its type in the region.
PMR is a British-American company providing market information, advice and services to international businesses interested in Central and Eastern Europe as well as other emerging markets. PMR key areas of operation include business publications (through PMR Publications), consultancy (through PMR Consulting) and market research (through PMR Research). Being present on the market since 1995, employing highly skilled staff, offering high international standards in projects and publications, providing one of most frequently visited and top-ranked websites, PMR is one of the largest companies of its type in the region.