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Drug Approval Process in the European Union (EU)

Medicinal products are highly regulated in the European Union (EU) and are subject to a complex systems of approvals that dictate how such drugs will be sold in the EU. Two procedures used to bring drugs into market are the "centralized procedure" and the "decentralized procedure". Briefly define and describe these two procedures.

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The Decentralised Procedure

The decentralised procedure should be used for products that have not yet received authorisation in an EU country. The applicant may request one or more concerned Member State(s) to approve a draft assessment report, summary of product characteristics, labelling and package leaflet as proposed by the chosen reference Member State in 210 days. The two groups, CMD(h) and CMD(v), also work for the facilitation of the decentralised procedures. If a member state cannot approve the assessment report, the ...

Solution Summary

This question asks you to define and describe two procedures that are used to bring a medicinal product (a drug) to market in EU.
The solution answers the question in paragraph format by providing a description of the two procedures: the "centralized procedure" and the "decentralized procedure".
In addition, a reference is provided for further reading into this subject.

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