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Directive 2001/83/EC on the Community code relating to medicinal products for human use

Made: 06-11-2001 | Laid: 06-11-2001 | Forced: 06-11-2001

Overview


The provisions of this Directive apply to industrially produced medicinal products for human use intended to be placed on the market in Member States. Under this Directive, in order better to protect public health and avoid any unnecessary duplication of effort during the examination of application for a marketing authorisation for medicinal products, Member States should systematically prepare assessment reports in respect of each medicinal product which is authorised by them, and exchange the reports upon request. Furthermore, a Member State should be able to suspend the examination of an application for authorization to place a medicinal product on the market which is currently under active consideration in another Member State with a view to recognizing the decision reached by the latter Member State.

Requirements


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Useful Information


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