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The Heads of Medicines Agencies is a network of the Heads of the National Competent Authorities whose organisations are responsible for the regulation of Medicinal Products for human and veterinary use in the European Economic Area.
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The Competent Autorities for Medical Devices -CAMD, is a network of the regulatory
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authorities responsible for the regulation of Medical Devices, Active Implantable Medical
Devices and In Vitro Diagnostic Medical Devices for human use. The meeting involves the
representatives from the national regulatory authorities from the European Economic Area
-EEA, with the participation of the European Commission. -
The European Medicines Agencies Cooperation on Legal and Legislative Issues
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-EMACOLEX, is a working group of Heads of Medicines Agencies (HMA) whose
organizations are responsible for the regulation of medicinal products for human and
veterinary use in the European Economic Area -EEA. -
The Pharmacovigilance Working Party -PhVWP, provides recommendations to the
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Committee for Medicinal Products for Human Use -CHMP, on all matters relating directly or
indirectly to pharmacovigilance, the constant monitoring of medicinal products on the market. -
The Committee on Herbal Medicinal Products -HMPC, was established in September
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2004, replacing the CPMP Working Party on Herbal Medicinal Products. The Committee
was established in accordance with Regulation (EC) No 726/2004 and Directive 2004/24/EC,
which introduced a simplified registration procedure for traditional herbal medicinal products
in EU Member States. -
The CMD(v) was set up in the revised pharmaceutical legislation (Directive 2004/28/EC
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amending Directive 2001/82/EC) for the examination of any question relating to marketing
authorisation of a medicinal product in two or more Member States in accordance with the
mutual recognition procedure or the decentralised procedure. -
The Committee for Medicinal Products for Veterinary Use -CVMP, is responsible
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for preparing the Agency's opinions on all questions concerning veterinary medicines, in
accordance with Regulation (EC) No 726/2004. -
The Homeopathic Medicinal Products Working Group (HMPWG) is a working group of
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Heads of Medicines Agencies (HMA) whose organizations are responsible for the regulation
of medicinal products for human and veterinary use in the European Economic Area (EEA). -
The main responsibility of the Paediatric Committee (PDCO) is to assess the content of
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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. -
The Co-ordination Group for Mutual Recognition and Decentralised Procedures – Human, CMDh, has been set up in the revised Pharmaceutical Legislation (Directive 2004/27/EC amending Directive 2001/83/EC) for the examination of any question relating to marketing authorisation of a medicinal product in two or more Member States in accordance with the mutual recognition procedure or the decentralised procedure.
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The Committee for Medicinal Products for Human Use (CHMP) is responsible for
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preparing the Agency's opinions on all questions concerning medicines for human use, in
accordance with Regulation (EC) No 726/2004.
