
Cmdh 173 Rev 10 July Form


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People also ask
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What is the full form of HMA in pharmaceutical industry?
The Heads of Medicines Agencies ( HMA ) is a network of the heads of the National Competent Authorities ( NCA ) whose organisations are responsible for the regulation of medicinal products for human and veterinary use in the European Economic Area.
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What is coordination group for mutual recognition?
Coordination Group for Mutual Recognition and Decentralised Procedures - Human. The group responsible for the examination and coordination of questions relating to the marketing authorisation of human medicines in two or more Member States in ance with the mutual recognition or decentralised procedure.
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What is coordination group for mutual recognition?
Coordination Group for Mutual Recognition and Decentralised Procedures - Human. The group responsible for the examination and coordination of questions relating to the marketing authorisation of human medicines in two or more Member States in ance with the mutual recognition or decentralised procedure.
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What is an EMA referral?
Referrals are used to address particular issues, such as safety concerns, to resolve disagreements between Member States on issues related to the authorisation of medicines or to give an opinion on an issue of Europe-wide interest.
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What is the DCP procedure?
The procedure for authorising medicines in more than one European Union Member State in parallel. It can be used for medicines that do not need to be authorised via the centralised procedure and have not already been authorised in any Member State.
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What does CMDh stand for?
The Co-ordination group for Mutual recognition and Decentralised procedures – human (CMDh), was set up in Directive 2004/27/ EC for the examination of any question relating to marketing authorisations of a medicinal product in two or more Member States in ance with the mutual recognition procedure or the ...
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