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EMEA
European Medicines Agency (EMEA) is a decentralised body
of the European Union with headquarters in London.
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Its main responsibility is the protection and
promotion of public and animal health, through the evaluation and
supervision of medicines for human and veterinary use. The EMEA
coordinates the evaluation and supervision of medicinal products
throughout the European Union. The Agency brings together the
scientific resources of the 25 EU Member States in a network of 42
national competent authorities. It cooperates closely with
international partners, reinforcing the EU contribution to global
harmonisation. |
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The EMEA is headed by the Executive Director and
has a secretariat of about 360 staff members in 2004. The Management
Board is the supervisory body of the EMEA, responsible, in
particular, for budgetary matters. |
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The EMEA began its activities in 1995, when the
European system for authorising medicinal products was introduced,
providing for a centralised and a mutual recognition procedure. The
EMEA has a role in both, but is primarily involved in the
centralised procedure. Where the centralised procedure is used,
companies submit one single marketing authorisation application to
the EMEA. A single evaluation is carried out through the Committee
for Medicinal Products for Human Use (CHMP)
or Committee for Medicinal Products for Veterinary Use (CVMP). If
the relevant Committee concludes that quality, safety and efficacy
of the medicinal product is sufficiently proven, it adopts a
positive opinion. This is sent to the Commission to be transformed
into a single market authorisation valid for the whole of the
European Union. |
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In 2001, the Committee on Orphan Medicinal
Products (COMP) was established, charged with reviewing designation
applications from persons or companies who intend to develop
medicines for rare diseases (so-called ‘orphan drugs’). The
Committee on Herbal Medicinal Products (HMPC) was established in
2004 and provides scientific opinions on traditional herbal
medicines. |
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A network of some 3,500 European experts
underpins the scientific work of the EMEA and its committees. |
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