Falsified Medicines Directive
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Falsified Medicines Directive
The Falsified Medicines Directive is a legal framework introduced by the European Commission, to improve the protection of public health within the European Union. The directive applies since 2 January 2013. The European Commission Delegated Regulation, (EU) 2016/161, supplements Directive 2001/83/EC with rules regarding safety features for the packaging of medicinal products for human use. The regulation was adopted in October 2015. Measures to counteract to fake medicines include stricter record-keeping of wholesale distributors, tougher inspections of pharmaceutical producers, an EU-wide quality mark to identify online pharmacies and obligatory safety features on packages. It requires that a unique identifier must be encoded in a two-dimensional Data Matrix code printed on each unit of sale package which is to contain: * Product code * Randomized serial number * Expiration date * Batch or lot number * National Health Reimbursement Number if required There must be a Tamper Eviden ...
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European Commission
The European Commission (EC) is the executive of the European Union (EU). It operates as a cabinet government, with 27 members of the Commission (informally known as "Commissioners") headed by a President. It includes an administrative body of about 32,000 European civil servants. The Commission is divided into departments known as Directorates-General (DGs) that can be likened to departments or ministries each headed by a Director-General who is responsible to a Commissioner. There is one member per member state, but members are bound by their oath of office to represent the general interest of the EU as a whole rather than their home state. The Commission President (currently Ursula von der Leyen) is proposed by the European Council (the 27 heads of state/governments) and elected by the European Parliament. The Council of the European Union then nominates the other members of the Commission in agreement with the nominated President, and the 27 members as a team are t ...
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Public Health
Public health is "the science and art of preventing disease, prolonging life and promoting health through the organized efforts and informed choices of society, organizations, public and private, communities and individuals". Analyzing the determinants of health of a population and the threats it faces is the basis for public health. The ''public'' can be as small as a handful of people or as large as a village or an entire city; in the case of a pandemic it may encompass several continents. The concept of ''health'' takes into account physical, psychological, and social well-being.What is the WHO definition of health?
from the Preamble to the Constitution of WHO as adopted by the International Health Conference, New York, 19 June - 22 July 1946; signed on ...
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European Union
The European Union (EU) is a supranational political and economic union of member states that are located primarily in Europe. The union has a total area of and an estimated total population of about 447million. The EU has often been described as a ''sui generis'' political entity (without precedent or comparison) combining the characteristics of both a federation and a confederation. Containing 5.8per cent of the world population in 2020, the EU generated a nominal gross domestic product (GDP) of around trillion in 2021, constituting approximately 18per cent of global nominal GDP. Additionally, all EU states but Bulgaria have a very high Human Development Index according to the United Nations Development Programme. Its cornerstone, the Customs Union, paved the way to establishing an internal single market based on standardised legal framework and legislation that applies in all member states in those matters, and only those matters, where the states have agreed to ac ...
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Data Matrix
A Data Matrix is a two-dimensional code consisting of black and white "cells" or dots arranged in either a square or rectangular pattern, also known as a matrix. The information to be encoded can be text or numeric data. Usual data size is from a few bytes up to 1556 bytes. The length of the encoded data depends on the number of cells in the matrix. Error correction codes are often used to increase reliability: even if one or more cells are damaged so it is unreadable, the message can still be read. A Data Matrix symbol can store up to 2,335 alphanumeric characters. Data Matrix symbols are rectangular, usually square in shape and composed of square "cells" which represent bits. Depending on the coding used, a "light" cell represents a 0 and a "dark" cell is a 1, or vice versa. Every Data Matrix is composed of two solid adjacent borders in an "L" shape (called the "finder pattern") and two other borders consisting of alternating dark and light "cells" or modules (called the "tim ...
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European Economic Area
The European Economic Area (EEA) was established via the ''Agreement on the European Economic Area'', an international agreement which enables the extension of the European Union's single market to member states of the European Free Trade Association. The EEA links the EU member states and three EFTA states (Iceland, Liechtenstein, and Norway) into an internal market governed by the same basic rules. These rules aim to enable free movement of persons, goods, services, and capital within the European single market, including the freedom to choose residence in any country within this area. The EEA was established on 1 January 1994 upon entry into force of the EEA Agreement. The contracting parties are the EU, its member states, and Iceland, Liechtenstein, and Norway. The EEA Treaty is a commercial treaty and differs from the EU Treaties in certain key respects. According to Article 1 its purpose is to "promote a continuous and balanced strengthening of trade and economic rel ...
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European Medicines Verification Organisation
The European Medicines Verification Organisation was established by the European Commission to administer the Falsified Medicines Directive in 2015. The legal basis is Regulation (EC) No. 726/2004 and Directive 2001/83/EC. The main stakeholders are: *European Federation of Pharmaceutical Industries and Associations *Medicines for Europe * European Association of Euro-Pharmaceutical Companies * European Healthcare Distribution Association * Pharmaceutical Group of the European Union * European Association of Hospital Pharmacists * European Hospital and Healthcare Federation All prescription medicines must have a unique identifier, which is embedded in a two-dimensional Data Matrix code and packaging must have a tamper verification feature. The organisation maintains a database of unique identifiers supplied pharmaceutical suppliers in respect of each unit of sale package they manufacture or repackage. It contains: * Product code * Randomised serial number * Expiration date * Batch o ...
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Bolton
Bolton (, locally ) is a large town in Greater Manchester in North West England, formerly a part of Lancashire. A former mill town, Bolton has been a production centre for textiles since Flemish weavers settled in the area in the 14th century, introducing a wool and cotton-weaving tradition. The urbanisation and development of the town largely coincided with the introduction of textile manufacture during the Industrial Revolution. Bolton was a 19th-century boomtown and, at its zenith in 1929, its 216 cotton mills and 26 bleaching and dyeing works made it one of the largest and most productive centres of cotton spinning in the world. The British cotton industry declined sharply after the First World War and, by the 1980s, cotton manufacture had virtually ceased in Bolton. Close to the West Pennine Moors, Bolton is north-west of Manchester and lies between Manchester, Darwen, Blackburn, Chorley, Bury and Salford. It is surrounded by several neighbouring t ...
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Medicines Verification System
A medication (also called medicament, medicine, pharmaceutical drug, medicinal drug or simply drug) is a drug used to diagnose, cure, treat, or prevent disease. Drug therapy (pharmacotherapy) is an important part of the medical field and relies on the science of pharmacology for continual advancement and on pharmacy for appropriate management. Drugs are classified in multiple ways. One of the key divisions is by level of control, which distinguishes prescription drugs (those that a pharmacist dispenses only on the order of a physician, physician assistant, or qualified nurse) from over-the-counter drugs (those that consumers can order for themselves). Another key distinction is between traditional small molecule drugs, usually derived from chemical synthesis, and biopharmaceuticals, which include recombinant proteins, vaccines, blood products used therapeutically (such as IVIG), gene therapy, monoclonal antibodies and cell therapy (for instance, stem cell therapie ...
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Pharmaceuticals Policy
Pharmaceutical policy is a branch of health policy that deals with the development, provision and use of medications within a health care system. It embraces drugs (both brand name and generic), biologics (products derived from living sources, as opposed to chemical compositions), vaccines and natural health products. Funding of research in the life sciences In many countries, an agency of the national government (in the U.S. the NIH, in the U.K. the MRC, and in India the DST) funds university researchers to study the causes of disease, which in some cases leads to the development of discoveries which can be transferred to pharmaceutical companies and biotechnology companies as a basis for drug development. By setting its budget, its research priorities and making decisions about which researchers to fund, there can be a significant impact on the rate of new drug development and on the disease areas in which new drugs are developed. For example, a major investment by the NIH int ...
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